US (United States) Code. Title 21. Chapter 9: Federal Food, Drug and Cosmetic Act

Codificación normativa de EEUU (Estados Unidos) Legislación Federal estadounidense # Food and drugs

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-SOURCE-

(June 25, 1938, ch. 675, Sec. 403, 52 Stat. 1047; Pub. L. 86-537,

Sec. 1, June 29, 1960, 74 Stat. 251; Pub. L. 86-618, title I, Sec.

102(a)(3), July 12, 1960, 74 Stat. 398; Pub. L. 91-601, Sec. 6(c),

formerly Sec. 7(c), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub.

L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981, 95 Stat. 716;

Pub. L. 94-278, title V, Sec. 502(a)(1), Apr. 22, 1976, 90 Stat.

411; Pub. L. 95-203, Sec. 4(a)(1), (b)(1), Nov. 23, 1977, 91 Stat.

1452, 1453; Pub. L. 101-535, Sec. 2(a), 3(a), 7, Nov. 8, 1990, 104

Stat. 2353, 2357, 2364; Pub. L. 102-108, Sec. 2(a), (c), Aug. 17,

1991, 105 Stat. 549; Pub. L. 102-571, title I, Sec. 107(5), (6),

Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 2(b), 3(j),

Aug. 13, 1993, 107 Stat. 773, 776; Pub. L. 103-417, Sec. 6,

7(a)-(c), 10(c), Oct. 25, 1994, 108 Stat. 4329, 4330, 4332; Pub. L.

104-124, Sec. 1, Apr. 1, 1996, 110 Stat. 882; Pub. L. 105-115,

title III, Sec. 301-305, Nov. 21, 1997, 111 Stat. 2350-2353; Pub.

L. 106-554, Sec. 1(a)(1) (title V, Sec. 517), Dec. 21, 2000, 114

Stat. 2763, 2763A-73; Pub. L. 107-171, title X, Sec. 10806(a)(2),

(b)(2), 10808(b), May 13, 2002, 116 Stat. 526, 527, 530; Pub. L.

107-188, title III, Sec. 308(b), June 12, 2002, 116 Stat. 672.)

-MISC1-

AMENDMENTS

2002 - Subsec. (h). Pub. L. 107-171, Sec. 10808(b), added par.

(3) and concluding provisions.

Subsec. (t). Pub. L. 107-171, Sec. 10806(a)(2), added subsec.

(t).

Subsec. (u). Pub. L. 107-171, Sec. 10806(b)(2), added subsec.

(u).

Subsec. (v). Pub. L. 107-188 added subsec. (v).

2000 - Par. (o). Pub. L. 106-554, which directed repeal of

section 403(o) of the Food, Drug, and Cosmetic Act, was executed by

repealing par. (o) of this section, which is section 403 of the

Federal Food, Drug, and Cosmetic Act, to reflect the probable

intent of Congress. Prior to repeal, par. (o) provided that a food

containing saccharin was to be deemed misbranded unless a specified

warning statement was placed in a conspicuous place on its label.

1997 - Par. (r)(2)(B). Pub. L. 105-115, Sec. 305, amended cl. (B)

generally. Prior to amendment, cl. (B) read as follows: ''If a

claim described in subparagraph (1)(A) is made with respect to a

nutrient in a food, the label or labeling of such food shall

contain, prominently and in immediate proximity to such claim, the

following statement: 'See _ _ _ _ _ for nutrition information.'.

In the statement -

''(i) the blank shall identify the panel on which the

information described in the statement may be found, and

''(ii) if the Secretary determines that the food contains a

nutrient at a level which increases to persons in the general

population the risk of a disease or health-related condition

which is diet related, taking into account the significance of

the food in the total daily diet, the statement shall also

identify such nutrient.''

Par. (r)(2)(G), (H). Pub. L. 105-115, Sec. 304, added cls. (G)

and (H).

Par. (r)(3)(C), (D). Pub. L. 105-115, Sec. 303, added cls. (C)

and (D).

Par. (r)(4)(A)(i). Pub. L. 105-115, Sec. 302, inserted after

second sentence ''If the Secretary does not act within such 100

days, the petition shall be deemed to be denied unless an extension

is mutually agreed upon by the Secretary and the petitioner.'',

inserted ''or the petition is deemed to be denied'' after ''If the

Secretary denies the petition'', and inserted at end ''If the

Secretary does not act within such 90 days, the petition shall be

deemed to be denied unless an extension is mutually agreed upon by

the Secretary and the petitioner. If the Secretary issues a

proposed regulation, the rulemaking shall be completed within 540

days of the date the petition is received by the Secretary. If the

Secretary does not issue a regulation within such 540 days, the

Secretary shall provide the Committee on Commerce of the House of

Representatives and the Committee on Labor and Human Resources of

the Senate the reasons action on the regulation did not occur

within such 540 days.''

Par. (r)(7). Pub. L. 105-115, Sec. 301, added subpar. (7).

1996 - Par. (p). Pub. L. 104-124 struck out subsec. (p), which

deemed products containing saccharin and offered for sale, but not

for immediate consumption, by retail establishment, to be

misbranded, unless notice of information required by subsec. (o)

was provided by manufacturer and prominently displayed near

product.

1994 - Par. (q)(5)(F). Pub. L. 103-417, Sec. 7(b), amended cl.

(F) generally. Prior to amendment, cl. (F) read as follows: ''If a

food to which section 350 of this title applies (as defined in

section 350(c) of this title) contains one or more of the nutrients

required by subparagraph (1) or (2) to be in the label or labeling

of the food, the label or labeling of such food shall comply with

the requirements of subparagraphs (1) and (2) in a manner which is

appropriate for such food and which is specified in regulations of

the Secretary.''

Par. (r)(2)(F). Pub. L. 103-417, Sec. 7(c), added cl. (F).

Par. (r)(6). Pub. L. 103-417, Sec. 6, added subpar. (6).

Par. (s). Pub. L. 103-417, Sec. 10(c), inserted at end: ''A

dietary supplement shall not be deemed misbranded solely because

its label or labeling contains directions or conditions of use or

warnings.''

Pub. L. 103-417, Sec. 7(a), added par. (s).

1993 - Par. (e). Pub. L. 103-80, Sec. 3(j)(1), substituted

''count, except that'' for ''count: Provided, That''.

Par. (i). Pub. L. 103-80, Sec. 3(j)(2), substituted ''unless sold

as spices, flavorings, or such colors'' for '', other than those

sold as such'' and ''naming each. To the extent'' for ''naming

each: Provided, That, to the extent''.

Par. (k). Pub. L. 103-80, Sec. 3(j)(3), substituted '', except

that'' for '': Provided, That''.

Par. (l). Pub. L. 103-80, Sec. 3(j)(4), substituted ''chemical,

except that'' for ''chemical: Provided, however, That''.

Par. (q)(5)(E) to (G). Pub. L. 103-80, Sec. 2(b), added cl. (E)

and redesignated former cls. (E) and (F) as (F) and (G),

respectively.

Par. (r)(1)(B). Pub. L. 103-80, Sec. 3(j)(5), substituted

''(5)(D)'' for ''5(D)''.

Par. (r)(4)(B). Pub. L. 103-80, Sec. 3(j)(6), substituted

''paragraph'' for ''subsection''.

1992 - Par. (i). Pub. L. 102-571, Sec. 107(5), substituted

''379e(c)'' for ''376(c)''.

Par. (m). Pub. L. 102-571, Sec. 107(6), substituted ''379e'' for

''376''.

1991 - Par. (i). Pub. L. 102-108, Sec. 2(c), amended directory

language of Pub. L. 101-535, Sec. 7(1), (3). See 1990 Amendment

note below.

Par. (q)(4)(A). Pub. L. 102-108, Sec. 2(a), substituted ''(D)''

for ''(C)''.

1990 - Par. (i). Pub. L. 101-535, Sec. 7, as amended by Pub. L.

102-108, Sec. 2(c), substituted ''Unless'' for ''If it is not

subject to the provisions of paragraph (g) unless'', inserted ''and

if the food purports to be a beverage containing vegetable or fruit

juice, a statement with appropriate prominence on the information

panel of the total percentage of such fruit or vegetable juice

contained in the food'', and substituted ''colors not required to

be certified under section 376(c) of this title'' for ''colorings''

the first time appearing.

Par. (q). Pub. L. 101-535, Sec. 2(a), added par. (q).

Par. (r). Pub. L. 101-535, Sec. 3(a), added par. (r).

1977 - Par. (o). Pub. L. 95-203, Sec. 4(a)(1), added par. (o).

Par. (p). Pub. L. 95-203, Sec. 4(b)(1), added par. (p).

1976 - Par. (a). Pub. L. 94-278 inserted ''(1)'' after ''If'' and

inserted '', or (2) in the case of a food to which section 350 of

this title applies, its advertising is false or misleading in a

material respect or its labeling is in violation of section

350(b)(2) of this title'' after ''any particular''.

1970 - Par. (n). Pub. L. 91-601 added par. (n).

1960 - Par. (k). Pub. L. 86-537, Sec. 1(1), exempted pesticide

chemicals when used in or on a raw agricultural commodity which is

the produce of the soil.

Par. (l). Pub. L. 86-537, Sec. 1(2), added par. (l).

Par. (m). Pub. L. 86-618 added par. (m).

-CHANGE-

CHANGE OF NAME

Committee on Commerce of House of Representatives changed to

Committee on Energy and Commerce of House of Representatives, and

jurisdiction over matters relating to securities and exchanges and

insurance generally transferred to Committee on Financial Services

of House of Representatives by House Resolution No. 5, One Hundred

Seventh Congress, Jan. 3, 2001.

-MISC4-

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,

1997, except as otherwise provided, see section 501 of Pub. L.

105-115, set out as a note under section 321 of this title.

EFFECTIVE DATE OF 1994 AMENDMENT

Section 7(e) of Pub. L. 103-417 provided that: ''Dietary

supplements -

''(1) may be labeled after the date of the enactment of this

Act (Oct. 25, 1994) in accordance with the amendments made by

this section (amending this section and section 350 of this

title), and

''(2) shall be labeled after December 31, 1996, in accordance

with such amendments.''

EFFECTIVE DATE OF 1990 AMENDMENT

Section 10(a) of Pub. L. 101-535, as amended by Pub. L. 102-571,

title II, Sec. 202(a)(3), Oct. 29, 1992, 106 Stat. 4501, provided

that:

''(1) Except as provided in paragraph (2) -

''(A) the amendments made by section 2 (amending this section)

shall take effect 6 months after -

''(i) the date of the promulgation of all final regulations

required to implement section 403(q) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 343(q)), or

''(ii) if such regulations are not promulgated, the date

proposed regulations are to be considered as such final

regulations (Nov. 8, 1992, see 57 F.R. 56347),

except that section 403(q)(4) of such Act shall take effect as

prescribed by such section,

''(B) the amendments made by section 3 (amending this section)

shall take effect 6 months after -

''(i) the date of the promulgation of final regulations to

implement section 403(r) of the Federal Food, Drug, and

Cosmetic Act, or

''(ii) if such regulations are not promulgated, the date

proposed regulations are to be considered as such final

regulations (Nov. 8, 1992, see 57 F.R. 56347), except that any

person marketing a food the brand name of which contains a term

defined by the Secretary under section 403(r)(2)(A)(i) of the

Federal Food, Drug, and Cosmetic Act shall be given an

additional 6 months to comply with section 3,

''(C) the amendments made by section 4 (amending section 337 of

this title) shall take effect 24 months after the date of the

enactment of this Act (Nov. 8, 1990), except that such amendments

shall take effect with respect to such dietary supplements

(probably means dietary supplements of vitamins, minerals, herbs,

or other similar nutritional substances, see section 202(a)(1) of

Pub. L. 102-571, set out below) on December 31, 1993, and

''(D) the amendments made by section 5 (amending sections 321

and 345 of this title) shall take effect on the date the

amendments made by section 3 take effect.

''(2) Section 403(q) of the Federal Food, Drug, and Cosmetic Act

(as added by section 2) shall not apply with respect to food which

was labeled before the effective date of the amendments made by

section 2 and section 403(r) of the Federal Food, Drug, and

Cosmetic Act (as added by section 3) shall not apply with respect

to food which was labeled before the effective date of the

amendments made by section 3.

''(3)(A) If the Secretary finds that a person who is subject to

section 403(q)(4) of such Act is unable to comply with the

requirements of such section upon the effective date of final

regulations to implement section 403(q) of such Act or of proposed

regulations to be considered as such final regulations because the

Secretary has not made available to such person the information

required by such section, the Secretary shall delay the application

of such section to such person for such time as the Secretary may

require to provide such information.

''(B) If the Secretary finds that compliance with section 403(q)

or 403(r)(2) of such Act would cause an undue economic hardship,

the Secretary may delay the application of such sections for no

more than one year.''

Section 10(c) of Pub. L. 101-535, as amended by Pub. L. 102-108,

Sec. 1, Aug. 17, 1991, 105 Stat. 549; Pub. L. 102-571, title I,

Sec. 107(17), Oct. 29, 1992, 106 Stat. 4500, provided that:

''(1) Except as provided in paragraphs (2) and (3), the

amendments made by section 7 (amending this section) shall take

effect one year after the date of the enactment of this Act (Nov.

8, 1990).

''(2)(A) If a food subject to section 403(g) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 343(g)) or a food with one or

more colors required to be certified under section 721(c) (of the

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 379e(c)) bears a

label which was printed before July 1, 1991, and which is attached

to the food before May 8, 1993, such food shall not be subject to

the amendments made by section 7(1) and section 7(3) (amending this

section).

''(B) If a food described in subparagraph (A) -

''(i) bears a label which was printed after July 1, 1991, but

before the date the proposed regulation described in clause (ii)

takes effect as a final regulation and which was attached to the

food before May 8, 1993, and

''(ii) meets the requirements of the proposed regulation of the

Secretary of Health and Human Services published in 56 Fed. Reg.

28592-28636 (June 21, 1991) as it pertains to the amendments made

by this Act (see Short Title of 1990 Amendment note set out under

section 301 of this title),

such food shall not be subject to the amendments made by section

7(1) and section 7(3) (amending this section).

''(3) A food purported to be a beverage containing a vegetable or

fruit juice which bears a label attached to the food before May 8,

1993, shall not be subject to the amendments made by section 7(2)

(amending this section).''

EFFECTIVE DATE OF 1977 AMENDMENT

Section 4(a)(2) of Pub. L. 95-203 provided that: ''The amendment

made by paragraph (1) (amending this section) shall apply only with

respect to food introduced or delivered for introduction in

interstate commerce on and after the 90th day after the date of the

enactment of this Act (Nov. 23, 1977).''

Section 4(b)(2) of Pub. L. 95-203 provided that: ''The amendment

made by paragraph (1) (amending this section) shall apply with

respect to food which is sold in retail establishments on or after

the 90th day after the effective date of the regulations of the

Secretary of Health, Education, and Welfare (now Secretary of

Health and Human Services) under paragraph (p)(4) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 343(p)(4)).''

EFFECTIVE DATE OF 1976 AMENDMENT

Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,

1976, see section 502(c) of Pub. L. 94-278, set out as a note under

section 334 of this title.

EFFECTIVE DATE OF 1970 AMENDMENT

Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and

regulations establishing special packaging standards effective no

sooner than 180 days or later than one year from date regulations

are final, or an earlier date published in Federal Register, see

section 8 of Pub. L. 91-601, set out as an Effective Date note

under section 1471 of Title 15, Commerce and Trade.

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86-618 effective July 12, 1960, subject to

the provisions of section 203 of Pub. L. 86-618, see section 202 of

Pub. L. 86-618, set out as a note under section 379e of this title.

EFFECTIVE DATE; POSTPONEMENT

Subsecs. (e)(1) and (g) to (k) effective Jan. 1, 1940, and such

subsections effective July 1, 1940, as provided by regulations for

certain lithographed labeling and containers bearing certain

labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as

an Effective Date; Postponement in Certain Cases note under section

301 of this title.

CONSTRUCTION OF AMENDMENT BY PUB. L. 107-188

Nothing in amendment by Pub. L. 107-188 to be construed to limit

authority of Secretary of Health and Human Services or Secretary of

the Treasury to require marking of articles of food imported or

offered for import into the United States which are refused

admission, see section 308(c) of Pub. L. 107-188, set out as a note

under section 381 of this title.

CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535

Section 9 of Pub. L. 101-535 provided that: ''The amendments made

by this Act (enacting section 343-1 of this title and amending this

section and sections 321, 337, 345, and 371 of this title) shall

not be construed to alter the authority of the Secretary of Health

and Human Services and the Secretary of Agriculture under the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the

Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry

Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg

Products Inspection Act (21 U.S.C. 1031 et seq.).''

REGULATIONS

Section 2(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,

title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500,

4501, provided that:

''(1) The Secretary of Health and Human Services shall issue

proposed regulations to implement section 403(q) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)) within 12 months

after the date of the enactment of this Act (Nov. 8, 1990), except

that the Secretary shall issue, not later than June 15, 1993,

proposed regulations that are applicable to dietary supplements of

vitamins, minerals, herbs, or other similar nutritional substances

to implement such section. Not later than 24 months after the date

of the enactment of this Act, the Secretary shall issue final

regulations to implement the requirements of such section, except

that the Secretary shall issue, not later than December 31, 1993,

such a final regulation applicable to dietary supplements of

vitamins, minerals, herbs, or other similar nutritional

substances..(sic) Such regulations shall -

''(A) require the required information to be conveyed to the

public in a manner which enables the public to readily observe

and comprehend such information and to understand its relative

significance in the context of a total daily diet,

''(B) include regulations which establish standards, in

accordance with paragraph (1)(A), to define serving size or other

unit of measure for food,

''(C) permit the label or labeling of food to include nutrition

information which is in addition to the information required by

such section 403(q) and which is of the type described in

subparagraph (1) or (2) of such section, and

''(D) permit the nutrition information on the label or labeling

of a food to remain the same or permit the information to be

stated as a range even though (i) there are minor variations in

the nutritional value of the food which occur in the normal

course of the production or processing of the food, or (ii) the

food is comprised of an assortment of similar foods which have

variations in nutritional value.

''(2) If the Secretary of Health and Human Services does not

promulgate final regulations under paragraph (1) upon the

expiration of 24 months after the date of the enactment of this

Act, the proposed regulations issued in accordance with paragraph

(1) shall be considered as the final regulations upon the

expiration of such 24 months, except that the proposed regulations

applicable to dietary supplements of vitamins, minerals, herbs, or

other similar nutritional substances shall not be considered to be

final regulations until December 31, 1993. There shall be promptly

published in the Federal Register notice of new status of the

proposed regulations (see 57 F.R. 56347).

''(3) If the Secretary of Health and Human Services does not

promulgate final regulations under section 403(q)(4) of the Federal

Food, Drug, and Cosmetic Act upon the expiration of 6 months after

the date on which the Secretary makes a finding that there has been

no substantial compliance with section 403(q)(4)(C) of such Act,

the proposed regulations issued in accordance with such section

shall be considered as the final regulations upon the expiration of

such 6 months. There shall be promptly published in the Federal

Register notice of new status of the proposed regulations.''

(Section 202(a)(2)(C) of Pub. L. 102-571 provided that: ''The

amendments made by subparagraph (B) (amending sections 2(b) and

3(b) of Pub. L. 101-535, set out above and below) shall not be

construed to modify the effective date of final regulations under

sections 2(b) and 3(b) of the Nutrition Labeling and Education Act

of 1990 (Pub. L. 101-535) (21 U.S.C. 343 note) with respect to

foods that are not such dietary supplements.'')

Section 3(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,

title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500,

4501, provided that:

''(1)(A) Within 12 months of the date of the enactment of this

Act (Nov. 8, 1990), the Secretary of Health and Human Services

shall issue proposed regulations to implement section 403(r) of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)), except

that the Secretary shall issue, not later than June 15, 1993,

proposed regulations that are applicable to dietary supplements of

vitamins, minerals, herbs, or other similar nutritional substances

to implement such section. Such regulations -

''(i) shall identify claims described in section 403(r)(1)(A)

of such Act which comply with section 403(r)(2) of such Act,

''(ii) shall identify claims described in section 403(r)(1)(B)

of such Act which comply with section 403(r)(3) of such Act,

''(iii) shall, in defining terms used to characterize the level

of any nutrient in food under section 403(r)(2)(A)(i) of such

Act, define -

''(I) free,

''(II) low,

''(III) light or lite,

''(IV) reduced,

''(V) less, and

''(VI) high,

unless the Secretary finds that the use of any such term would be

misleading,

''(iv) shall permit statements describing the amount and

percentage of nutrients in food which are not misleading and are

consistent with the terms defined in section 403(r)(2)(A)(i) of

such Act,

''(v) shall provide that if multiple claims subject to section

403(r)(1)(A) of such Act are made on a single panel of the food

label or page of a labeling brochure, a single statement may be

made to satisfy section 403(r)(2)(B) of such Act,

''(vi) shall determine whether claims respecting the following

nutrients and diseases meet the requirements of section 403(r)(3)

of such Act: Calcium and osteoporosis, dietary fiber and cancer,

lipids and cardiovascular disease, lipids and cancer, sodium and

hypertension, and dietary fiber and cardiovascular disease,

''(vii) shall not require a person who proposes to make a claim

described in section 403(r)(1)(B) of such Act which is in

compliance with such regulations to secure the approval of the

Secretary before making such claim,

''(viii) may permit a claim described in section 403(r)(1)(A)

of such Act to be made for butter,

''(ix) may, in defining terms under section 403(r)(2)(A)(i),

include similar terms which are commonly understood to have the

same meaning, and

''(x) shall establish, as required by section 403(r)(5)(D), the

procedure and standard respecting the validity of claims made

with respect to a dietary supplement of vitamins, minerals,

herbs, or other similar nutritional substances and shall

determine whether claims respecting the following nutrients and

diseases meet the requirements of section 403(r)(5)(D) of such

Act: folic acid and neural tube defects, antioxident (sic)

vitamins and cancer, zinc and immune function in the elderly, and

omega-3 fatty acids and heart disease.

''(B) Not later than 24 months after the date of the enactment of

this Act, the Secretary shall issue final regulations to implement

section 403(r) of the Federal Food, Drug, and Cosmetic Act, except

that the Secretary shall issue, not later than December 31, 1993,

such a final regulation applicable to dietary supplements of

vitamins, minerals, herbs, or other similar nutritional

substances..(sic)

''(2) If the Secretary does not promulgate final regulations

under paragraph (1)(B) upon the expiration of 24 months after the

date of the enactment of this Act, the proposed regulations issued

in accordance with paragraph (1)(A) shall be considered as the

final regulations upon the expiration of such 24 months, except

that the proposed regulations applicable to dietary supplements of

vitamins, minerals, herbs, or other similar nutritional substances

shall not be considered to be final regulations until December 31,

1993. There shall be promptly published in the Federal Register

notice of the new status of the proposed regulations (see 57 F.R.

56347).''

(For construction of amendment made by section 202(a)(2)(B) of

Pub. L. 102-571 to section 3(b) of Pub. L. 101-535 set out above,

see section 202(a)(2)(C) of Pub. L. 102-571 set out above following

section 2(b) of Pub. L. 101-535.)

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-MISC5-

RULEMAKING ON LABELING OF IRRADIATED FOOD; CERTAIN PETITIONS

Pub. L. 107-171, title X, Sec. 10809, May 13, 2002, 116 Stat.

531, provided that: ''The Secretary of Health and Human Services

(referred to in this section as the 'Secretary') shall publish a

proposed rule and, with due consideration to public comment, a

final rule to revise, as appropriate, the current regulation

governing the labeling of foods that have been treated to reduce

pest infestation or pathogens by treatment by irradiation using

radioactive isotope, electronic beam, or x-ray. Pending

promulgation of the final rule required by this subsection

(probably should be ''this section''), any person may petition the

Secretary for approval of labeling, which is not false or

misleading in any material respect, of a food which has been

treated by irradiation using radioactive isotope, electronic beam,

or x-ray. The Secretary shall approve or deny such a petition

within 180 days of receipt of the petition, or the petition shall

be deemed denied, except to the extent additional agency review is

mutually agreed upon by the Secretary and the petitioner. Any

denial of a petition under this subsection shall constitute final

agency action subject to judicial review by the United States Court

of Appeals for the District of Columbia Circuit. Any labeling

approved through the foregoing petition process shall be subject to

the provisions of the final rule referred to in the first sentence

of the subparagraph on the effective date of such final rule.''

COMMISSION ON DIETARY SUPPLEMENT LABELS

Section 12 of Pub. L. 103-417 provided that:

''(a) Establishment. - There shall be established as an

independent agency within the executive branch a commission to be

known as the Commission on Dietary Supplement Labels (hereafter in

this section referred to as the 'Commission').

''(b) Membership. -

''(1) Composition. - The Commission shall be composed of 7

members who shall be appointed by the President.

''(2) Expertise requirement. - The members of the Commission

shall consist of individuals with expertise and experience in

dietary supplements and in the manufacture, regulation,

distribution, and use of such supplements. At least three of the

members of the Commission shall be qualified by scientific

training and experience to evaluate the benefits to health of the

use of dietary supplements and one of such three members shall

have experience in pharmacognosy, medical botany, traditional

herbal medicine, or other related sciences. Members and staff of

the Commission shall be without bias on the issue of dietary

supplements.

''(c) Functions of the Commission. - The Commission shall conduct

a study on, and provide recommendations for, the regulation of

label claims and statements for dietary supplements, including the

use of literature in connection with the sale of dietary

supplements and procedures for the evaluation of such claims. In

making such recommendations, the Commission shall evaluate how best

to provide truthful, scientifically valid, and not misleading

information to consumers so that such consumers may make informed

and appropriate health care choices for themselves and their

families.

''(d) Administrative Powers of the Commission. -

''(1) Hearings. - The Commission may hold hearings, sit and act

at such times and places, take such testimony, and receive such

evidence as the Commission considers advisable to carry out the

purposes of this section.

''(2) Information from federal agencies. - The Commission may

secure directly from any Federal department or agency such

information as the Commission considers necessary to carry out

the provisions of this section.

''(3) Authorization of appropriations. - There are authorized

to be appropriated such sums as may be necessary to carry out

this section.

''(e) Reports and Recommendations. -

''(1) Final report required. - Not later than 24 months after

the date of enactment of this Act (Oct. 25, 1994), the Commission

shall prepare and submit to the President and to the Congress a

final report on the study required by this section.

''(2) Recommendations. - The report described in paragraph (1)

shall contain such recommendations, including recommendations for

legislation, as the Commission deems appropriate.

''(3) Action on recommendations. - Within 90 days of the

issuance of the report under paragraph (1), the Secretary of

Health and Human Services shall publish in the Federal Register a

notice of any recommendation of Commission for changes in

regulations of the Secretary for the regulation of dietary

supplements and shall include in such notice a notice of proposed

rulemaking on such changes together with an opportunity to

present views on such changes. Such rulemaking shall be

completed not later than 2 years after the date of the issuance

of such report. If such rulemaking is not completed on or before

the expiration of such 2 years, regulations of the Secretary

published in 59 FR 395-426 on January 4, 1994, shall not be in

effect.''

EXTENSION OF COMPLIANCE DEADLINE FOR CERTAIN FOOD PRODUCTS PACKAGED

PRIOR TO AUGUST 8, 1994

Pub. L. 103-261, May 26, 1994, 108 Stat. 705, provided: ''That

before August 8, 1994, sections 403(q) and 403(r)(2) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 343(q), (r)(2)) and the

provision of section 403(i) of such Act added by section 7(2) of

the Nutrition Labeling and Education Act of 1990 (Pub. L. 101-535),

shall not apply with respect to a food product which is contained

in a package for which the label was printed before May 8, 1994 (or

before August 8, 1994, in the case of a juice or milk food product

if the person responsible for the labeling of such food product

exercised due diligence in obtaining before such date labels which

are in compliance with such sections 403(q) and 403(r)(2) and such

provision of section 403(i)), if, before June 15, 1994, the person

who introduces or delivers for introduction such food product into

interstate commerce submits to the Secretary of Health and Human

Services a certification that such person will comply with this

section and will comply with such sections 403(q) and 403(r)(2) and

such provision of section 403(i) after August 8, 1994.''

LIMITATIONS ON APPLICATION OF SMALL BUSINESS EXEMPTION

Section 2(a) of Pub. L. 103-80 provided that:

''(1) Before may 8, 1995. - Before May 8, 1995, the exemption

provided by section 403(q)(5)(D) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 343(q)(5)(D)) shall be available in

accordance with the regulations of the Secretary of Health and

Human Services published at 21 C.F.R. 101.9(j)(1)(i)(1993).

''(2) After may 8, 1995. - After May 8, 1995, the exemption

provided by section 403(q)(5)(D) of the Federal Food, Drug, and

Cosmetic Act shall only be available with respect to food when it

is sold to consumers.''

PROHIBITION ON IMPLEMENTATION OF PUB. L. 101-535 WITH RESPECT TO

DIETARY SUPPLEMENTS

Section 202(a)(1) of Pub. L. 102-571 provided that:

''Notwithstanding any other provision of law and except as provided

in subsection (b) (set out as a note below) and in the amendment

made by paragraph (2)(A) (amending provisions set out as notes

above), the Secretary of Health and Human Services may not

implement the Nutrition Labeling and Education Act of 1990 (Public

Law 101-535; 104 Stat. 2353) (see Short Title of 1990 Amendments

note set out under section 301 of this title), or any amendment

made by such Act, earlier than December 15, 1993, with respect to

dietary supplements of vitamins, minerals, herbs, or other similar

nutritional substances.''

HEALTH CLAIMS MADE WITH RESPECT TO DIETARY SUPPLEMENTS

Section 202(b) of Pub. L. 102-571 provided that:

''Notwithstanding section 403(r)(5)(D) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 343(r)(5)(D)) and subsection (a)

(enacting provisions set out as notes above and amending provisions

set out as notes above and under section 343-1 of this title), the

Secretary of Health and Human Services may, earlier than December

15, 1993, approve claims made with respect to dietary supplements

of vitamins, minerals, herbs, or other similar nutritional

substances that are claims described in clauses (vi) and (x) of

section 3(b)(1)(A) of the Nutrition Labeling and Education Act of

1990 (Pub. L. 101-535) (21 U.S.C. 343 note).''

UNITED STATES RECOMMENDED DAILY ALLOWANCES OF VITAMINS OR MINERALS

Section 203 of Pub. L. 102-571 provided that: ''Notwithstanding

any other provision of Federal law, no regulations that require the

use of, or are based upon, recommended daily allowances of vitamins

or minerals may be promulgated before November 8, 1993 (other than

regulations establishing the United States recommended daily

allowances specified at section 101.9(c)(7)(iv) of title 21, Code

of Federal Regulations, as in effect on October 6, 1992, or

regulations under section 403(r)(1)(A) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 343(r)(1)(A)) that are based on such

recommended daily allowances).''

CONSUMER EDUCATION

Section 2(c) of Pub. L. 101-535 provided that: ''The Secretary of

Health and Human Services shall carry out activities which educate

consumers about -

''(1) the availability of nutrition information in the label or

labeling of food, and

''(2) the importance of that information in maintaining healthy

dietary practices.''

STUDIES CONCERNING CARCINOGENIC AND OTHER TOXIC SUBSTANCES IN FOOD

AND IMPURITIES IN AND TOXICITY OF SACCHARIN

Section 2 of Pub. L. 95-203 directed Secretary of Health,

Education, and Welfare to conduct a study concerning carcinogenic

and other toxic substances in food and impurities in and toxicity

of saccharin and make a report respecting the carcinogenic and

other substances to Committee on Human Resources of the Senate

within 12 months of Nov. 23, 1977, and a report respecting

saccharin to such committee within 15 months of Nov. 23, 1977.

REPORT TO CONGRESSIONAL COMMITTEES RESPECTING ACTION TAKEN PURSUANT

TO FORMER PAR. (O)(2)

Section 4(a)(3) of Pub. L. 95-203 provided that the Secretary was

to report to specified congressional committees any action taken

under former par. (o)(2) of this section.

STATE OR TERRITORIAL REQUIREMENTS

Section 2 of Pub. L. 86-537 provided that: ''Nothing in the

amendments made by the first section of this Act (amending this

section) shall affect any requirement of the laws of any State or

Territory.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 333, 334, 337,

343-1, 343-3, 345, 347, 350, 371 of this title.

-CITE-

21 USC Sec. 343-1 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 343-1. National uniform nutrition labeling

-STATUTE-

(a) Except as provided in subsection (b) of this section, no

State or political subdivision of a State may directly or

indirectly establish under any authority or continue in effect as

to any food in interstate commerce -

(1) any requirement for a food which is the subject of a

standard of identity established under section 341 of this title

that is not identical to such standard of identity or that is not

identical to the requirement of section 343(g) of this title,

except that this paragraph does not apply to a standard of

identity of a State or political subdivision of a State for maple

syrup that is of the type required by sections 341 and 343(g) of

this title,

(2) any requirement for the labeling of food of the type

required by section 343(c), 343(e), or 343(i)(2) of this title

that is not identical to the requirement of such section, except

that this paragraph does not apply to a requirement of a State or

political subdivision of a State that is of the type required by

section 343(c) of this title and that is applicable to maple

syrup,

(3) any requirement for the labeling of food of the type

required by section 343(b), 343(d), 343(f), 343(h), 343(i)(1), or

343(k) of this title that is not identical to the requirement of

such section, except that this paragraph does not apply to a

requirement of a State or political subdivision of a State that

is of the type required by section 343(h)(1) of this title and

that is applicable to maple syrup,

(4) any requirement for nutrition labeling of food that is not

identical to the requirement of section 343(q) of this title,

except a requirement for nutrition labeling of food which is

exempt under subclause (i) or (ii) of section 343(q)(5)(A) of

this title, or

(5) any requirement respecting any claim of the type described

in section 343(r)(1) of this title made in the label or labeling

of food that is not identical to the requirement of section

343(r) of this title, except a requirement respecting a claim

made in the label or labeling of food which is exempt under

section 343(r)(5)(B) of this title.

Paragraph (3) shall take effect in accordance with section 6(b) of

the Nutrition Labeling and Education Act of 1990.

(b) Upon petition of a State or a political subdivision of a

State, the Secretary may exempt from subsection (a) of this

section, under such conditions as may be prescribed by regulation,

any State or local requirement that -

(1) would not cause any food to be in violation of any

applicable requirement under Federal law,

(2) would not unduly burden interstate commerce, and

(3) is designed to address a particular need for information

which need is not met by the requirements of the sections

referred to in subsection (a) of this section.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 403A, as added Pub. L. 101-535, Sec.

6(a), Nov. 8, 1990, 104 Stat. 2362; amended Pub. L. 102-108, Sec.

2(b), Aug. 17, 1991, 105 Stat. 549; Pub. L. 103-396, Sec. 3(a),

Oct. 22, 1994, 108 Stat. 4154.)

-REFTEXT-

REFERENCES IN TEXT

Section 6(b) of the Nutrition Labeling and Education Act of 1990

(Pub. L. 101-535), referred to in subsec. (a), is set out below.

-MISC2-

AMENDMENTS

1994 - Subsec. (a)(1). Pub. L. 103-396, Sec. 3(a)(1), inserted at

end ''except that this paragraph does not apply to a standard of

identity of a State or political subdivision of a State for maple

syrup that is of the type required by sections 341 and 343(g) of

this title,''.

Subsec. (a)(2). Pub. L. 103-396, Sec. 3(a)(2), inserted at end

''except that this paragraph does not apply to a requirement of a

State or political subdivision of a State that is of the type

required by section 343(c) of this title and that is applicable to

maple syrup,''.

Subsec. (a)(3). Pub. L. 103-396, Sec. 3(a)(3), inserted at end

''except that this paragraph does not apply to a requirement of a

State or political subdivision of a State that is of the type

required by section 343(h)(1) of this title and that is applicable

to maple syrup,''.

1991 - Subsec. (a)(5). Pub. L. 102-108 substituted ''section

343(r)(5)(B) of this title'' for ''clause (B) of such section''.

EFFECTIVE DATE

Section 10(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,

title I, Sec. 107(16), title II, Sec. 202(a)(4), Oct. 29, 1992, 106

Stat. 4499, 4501, provided that:

''(1) In general. - Except as provided in paragraph (2), the

amendments made by section 6 (enacting this section) shall take

effect -

''(A) with respect to a requirement of a State or political

subdivision described in paragraph (1) of section 403A(a) of the

Federal Food, Drug, and Cosmetic Act (subsec. (a)(1) of this

section), on the date of the enactment of this Act (Nov. 8,

1990),

''(B) with respect to a requirement of a State or political

subdivision described in paragraph (2) of section 403A(a) of the

Federal Food, Drug, and Cosmetic Act, one year after the date of

the enactment of this Act,

''(C) with respect to a requirement of a State or political

subdivision described in paragraph (3) of section 403A(a) of the

Federal Food, Drug, and Cosmetic Act, as prescribed by section

6(b) of the Nutrition Labeling and Education Act of 1990 (Pub. L.

101-535, set out below),

''(D) with respect to a requirement of a State or political

subdivision described in paragraph (4) of section 403A(a) of the

Federal Food, Drug, and Cosmetic Act, on the date regulations to

implement section 403(q) of such Act (21 U.S.C. 343(q)) take

effect, and

''(E) with respect to a requirement of a State or political

subdivision described in paragraph (5) of section 403A(a) of the

Federal Food, Drug, and Cosmetic Act, on the date regulations to

implement section 403(r) of such Act take effect.

''(2) Exception. - If a State or political subdivision submits a

petition under section 403A(b) of the Federal Food, Drug, and

Cosmetic Act for a requirement described in section 403A(a) of such

Act within 18 months of the date of the enactment of this Act,

paragraphs (3) through (5) of such section 403A(a) shall not apply

with respect to such State or political subdivision requirement

until -

''(A) 24 months after the date of the enactment of this Act, or

''(B) action on the petition,

whichever occurs later.

''(3) Requirements pertaining to certain claims. -

Notwithstanding subparagraphs (D) and (E) of paragraph (1) and

except with respect to claims approved in accordance with section

202(b) of the Dietary Supplement Act of 1992 (Pub. L. 102-571, set

out as a note under section 343 of this title), the requirements

described in paragraphs (4) and (5) of section 403A(a) of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-1(a)(4) and

(5)) that pertain to dietary supplements of vitamins, minerals,

herbs, or other similar nutritional substances shall not take

effect until the date final regulations take effect to implement

subsection (q) or (r), as appropriate, of section 403 of such Act

with respect to such dietary supplements.''

Section 6(b) of Pub. L. 101-535 provided that:

''(1) For the purpose of implementing section 403A(a)(3) (21

U.S.C. 343-1(a)(3)), the Secretary of Health and Human Services

shall enter into a contract with a public or nonprofit private

entity to conduct a study of -

''(A) State and local laws which require the labeling of food

that is of the type required by sections 403(b), 403(d), 403(f),

403(h), 403(i)(1), and 403(k) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 343(b), (d), (f), (h), (i)(1), (k)), and

''(B) the sections of the Federal Food, Drug, and Cosmetic Act

referred to in subparagraph (A) and the regulations issued by the

Secretary to enforce such sections to determine whether such

sections and regulations adequately implement the purposes of

such sections.

''(2) The contract under paragraph (1) shall provide that the

study required by such paragraph shall be completed within 6 months

of the date of the enactment of this Act (Nov. 8, 1990).

''(3)(A) Within 9 months of the date of the enactment of this

Act, the Secretary shall publish a proposed list of sections which

are adequately being implemented by regulations as determined under

paragraph (1)(B) and sections which are not adequately being

implemented by regulations as so determined. After publication of

the lists, the Secretary shall provide 60 days for comments on such

lists.

''(B) Within 24 months of the date of the enactment of this Act,

the Secretary shall publish a final list of sections which are

adequately being implemented by regulations and a list of sections

which are not adequately being implemented by regulations. With

respect to a section which is found by the Secretary to be

adequately implemented, no State or political subdivision of a

State may establish or continue in effect as to any food in

interstate commerce any requirement which is not identical to the

requirement of such section.

''(C) Within 24 months of the date of the enactment of this Act,

the Secretary shall publish proposed revisions to the regulations

found to be inadequate under subparagraph (B) and within 30 months

of such date shall issue final revisions. Upon the effective date

of such final revisions, no State or political subdivision may

establish or continue in effect any requirement which is not

identical to the requirement of the section which had its

regulations revised in accordance with this subparagraph.

''(D)(i) If the Secretary does not issue a final list in

accordance with subparagraph (B), the proposed list issued under

subparagraph (A) shall be considered the final list and States and

political subdivisions shall be preempted with respect to sections

found to be adequate in such proposed list in accordance with

subparagraph (B).

''(ii) If the Secretary does not issue final revisions of

regulations in accordance with subparagraph (C), the proposed

revisions issued under such subparagraph shall be considered the

final revisions and States and political subdivisions shall be

preempted with respect to sections the regulations of which are

revised by the proposed revisions.

''(E) Subsection (b) of section 403A of the Federal Food, Drug,

and Cosmetic Act shall apply with respect to the prohibition

prescribed by subparagraphs (B) and (C).''

CONSTRUCTION OF PUB. L. 101-535

Section 6(c) of Pub. L. 101-535 provided that:

''(1) The Nutrition Labeling and Education Act of 1990 (Pub. L.

101-535, see Short Title of 1990 Amendment note set out under

section 301 of this title) shall not be construed to preempt any

provision of State law, unless such provision is expressly

preempted under section 403A of the Federal Food, Drug, and

Cosmetic Act (this section).

''(2) The amendment made by subsection (a) (enacting this

section) and the provisions of subsection (b) (set out as a note

above) shall not be construed to apply to any requirement

respecting a statement in the labeling of food that provides for a

warning concerning the safety of the food or component of the food.

''(3) The amendment made by subsection (a), the provisions of

subsection (b) and paragraphs (1) and (2) of this subsection shall

not be construed to affect preemption, express or implied, of any

such requirement of a State or political subdivision, which may

arise under the Constitution, any provision of the Federal Food,

Drug, and Cosmetic Act (this chapter) not amended by subsection

(a), any other Federal law, or any Federal regulation, order, or

other final agency action reviewable under chapter 7 of title 5,

United States Code.''

Amendments by Pub. L. 101-535 not to be construed to alter the

authority of the Secretary of Health and Human Services and the

Secretary of Agriculture under the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21

U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C.

451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031

et seq.), see section 9 of Pub. L. 101-535, set out as a note under

section 343 of this title.

DELAYED APPLICABILITY OF CERTAIN PROVISIONS

Pub. L. 102-408, title III, Sec. 310, Oct. 13, 1992, 106 Stat.

2090, provided that: ''Notwithstanding any other provision of law,

section 403A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 343-1(a)(1)) shall not apply with respect to any requirement

of any State or political subdivision regarding maple syrup until

September 1, 1994.''

-CITE-

21 USC Sec. 343-2 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 343-2. Dietary supplement labeling exemptions

-STATUTE-

(a) In general

A publication, including an article, a chapter in a book, or an

official abstract of a peer-reviewed scientific publication that

appears in an article and was prepared by the author or the editors

of the publication, which is reprinted in its entirety, shall not

be defined as labeling when used in connection with the sale of a

dietary supplement to consumers when it -

(1) is not false or misleading;

(2) does not promote a particular manufacturer or brand of a

dietary supplement;

(3) is displayed or presented, or is displayed or presented

with other such items on the same subject matter, so as to

present a balanced view of the available scientific information

on a dietary supplement;

(4) if displayed in an establishment, is physically separate

from the dietary supplements; and

(5) does not have appended to it any information by sticker or

any other method.

(b) Application

Subsection (a) of this section shall not apply to or restrict a

retailer or wholesaler of dietary supplements in any way whatsoever

in the sale of books or other publications as a part of the

business of such retailer or wholesaler.

(c) Burden of proof

In any proceeding brought under subsection (a) of this section,

the burden of proof shall be on the United States to establish that

an article or other such matter is false or misleading.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 403B, as added Pub. L. 103-417, Sec.

5, Oct. 25, 1994, 108 Stat. 4328.)

-CITE-

21 USC Sec. 343-3 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 343-3. Disclosure

-STATUTE-

(a) No provision of section 321(n), 343(a), or 348 of this title

shall be construed to require on the label or labeling of a food a

separate radiation disclosure statement that is more prominent than

the declaration of ingredients required by section 343(i)(2) of

this title.

(b) In this section, the term ''radiation disclosure statement''

means a written statement that discloses that a food has been

intentionally subject to radiation.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 403C, as added Pub. L. 105-115, title

III, Sec. 306, Nov. 21, 1997, 111 Stat. 2353.)

-MISC1-

EFFECTIVE DATE

Section effective 90 days after Nov. 21, 1997, except as

otherwise provided, see section 501 of Pub. L. 105-115, set out as

an Effective Date of 1997 Amendment note under section 321 of this

title.

-CITE-

21 USC Sec. 343a 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 343a. Repealed. Pub. L. 106-554, Sec. 1(a)(1) (title V, Sec.

517), Dec. 21, 2000, 114 Stat. 2763, 2763A-73

-MISC1-

Section, Pub. L. 95-203, Sec. 4(c), (d), Nov. 23, 1977, 91 Stat.

1453, 1454, related to distribution of information on health risks

of saccharin.

-CITE-

21 USC Sec. 344 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 344. Emergency permit control

-STATUTE-

(a) Conditions on manufacturing, processing, etc., as health

measure

Whenever the Secretary finds after investigation that the

distribution in interstate commerce of any class of food may, by

reason of contamination with micro-organisms during the

manufacture, processing, or packing thereof in any locality, be

injurious to health, and that such injurious nature cannot be

adequately determined after such articles have entered interstate

commerce, he then, and in such case only, shall promulgate

regulations providing for the issuance, to manufacturers,

processors, or packers of such class of food in such locality, of

permits to which shall be attached such conditions governing the

manufacture, processing, or packing of such class of food, for such

temporary period of time, as may be necessary to protect the public

health; and after the effective date of such regulations, and

during such temporary period, no person shall introduce or deliver

for introduction into interstate commerce any such food

manufactured, processed, or packed by any such manufacturer,

processor, or packer unless such manufacturer, processor, or packer

holds a permit issued by the Secretary as provided by such

regulations.

(b) Violation of permit; suspension and reinstatement

The Secretary is authorized to suspend immediately upon notice

any permit issued under authority of this section if it is found

that any of the conditions of the permit have been violated. The

holder of a permit so suspended shall be privileged at any time to

apply for the reinstatement of such permit, and the Secretary

shall, immediately after prompt hearing and an inspection of the

establishment, reinstate such permit if it is found that adequate

measures have been taken to comply with and maintain the conditions

of the permit, as originally issued or as amended.

(c) Inspection of permit-holding establishments

Any officer or employee duly designated by the Secretary shall

have access to any factory or establishment, the operator of which

holds a permit from the Secretary, for the purpose of ascertaining

whether or not the conditions of the permit are being complied

with, and denial of access for such inspection shall be ground for

suspension of the permit until such access is freely given by the

operator.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 404, 52 Stat. 1048.)

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 333, 334, 371 of

this title.

-CITE-

21 USC Sec. 345 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 345. Regulations making exemptions

-STATUTE-

The Secretary shall promulgate regulations exempting from any

labeling requirement of this chapter (1) small open containers of

fresh fruits and fresh vegetables and (2) food which is, in

accordance with the practice of the trade, to be processed,

labeled, or repacked in substantial quantities at establishments

other than those where originally processed or packed, on condition

that such food is not adulterated or misbranded under the

provisions of this chapter upon removal from such processing,

labeling, or repacking establishment. This section does not apply

to the labeling requirements of sections 343(q) and 343(r) of this

title.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 405, 52 Stat. 1049; Pub. L. 101-535,

Sec. 5(a), Nov. 8, 1990, 104 Stat. 2362.)

-MISC1-

AMENDMENTS

1990 - Pub. L. 101-535 inserted at end ''This section does not

apply to the labeling requirements of sections 343(q) and 343(r) of

this title.''

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by Pub. L. 101-535 effective six months after the date

of the promulgation of final regulations to implement section

343(r) of this title, or if such regulations are not promulgated,

the date proposed regulations are to be considered as such final

regulations (Nov. 8, 1992), with exception for persons marketing

food the brand name of which contains a term defined by the

Secretary under section 343(r)(2)(A)(i) of this title, see section

10(a) of Pub. L. 101-535, set out as a note under section 343 of

this title.

CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535

Amendments by Pub. L. 101-535 not to be construed to alter

authority of Secretary of Health and Human Services and Secretary

of Agriculture under the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601

et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et

seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et

seq.), see section 9 of Pub. L. 101-535, set out as a note under

section 343 of this title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 343 of this title.

-CITE-

21 USC Sec. 346 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 346. Tolerances for poisonous or deleterious substances in

food; regulations

-STATUTE-

Any poisonous or deleterious substance added to any food, except

where such substance is required in the production thereof or

cannot be avoided by good manufacturing practice shall be deemed to

be unsafe for purposes of the application of clause (2)(A) of

section 342(a) of this title; but when such substance is so

required or cannot be so avoided, the Secretary shall promulgate

regulations limiting the quantity therein or thereon to such extent

as he finds necessary for the protection of public health, and any

quantity exceeding the limits so fixed shall also be deemed to be

unsafe for purposes of the application of clause (2)(A) of section

342(a) of this title. While such a regulation is in effect

limiting the quantity of any such substance in the case of any

food, such food shall not, by reason of bearing or containing any

added amount of such substance, be considered to be adulterated

within the meaning of clause (1) of section 342(a) of this title.

In determining the quantity of such added substance to be tolerated

in or on different articles of food the Secretary shall take into

account the extent to which the use of such substance is required

or cannot be avoided in the production of each such article, and

the other ways in which the consumer may be affected by the same or

other poisonous or deleterious substances.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 406, 52 Stat. 1049; Pub. L. 85-929,

Sec. 3(c), Sept. 6, 1958, 72 Stat. 1785; Pub. L. 86-618, title I,

Sec. 103(a)(1), July 12, 1960, 74 Stat. 398.)

-MISC1-

AMENDMENTS

1960 - Pub. L. 86-618 repealed subsec. (b) which required

Secretary to promulgate regulations for listing of coal-tar colors.

1958 - Subsec. (a). Pub. L. 85-929 substituted ''clause (2)(A)''

for ''clause (2)'' in first sentence.

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86-618 effective July 12, 1960, subject to

the provisions of section 203 of Pub. L. 86-618, see section 202 of

Pub. L. 86-618, set out as a note under section 379e of this title.

EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, AND

DESICCANT AMENDMENT OF 1959

Effective date of subsec. (a) as in force prior to July 22, 1954,

with respect to particular commercial use of a nematocide, plant

regulator, defoliant, or desiccant in or on a raw agricultural

commodity made before Jan. 1, 1958, see section 3(b) of Pub. L.

86-139, Aug. 7, 1959, 73 Stat. 288.

EFFECTIVE DATE OF 1958 AMENDMENT

For effective date of amendment by Pub. L. 85-929, see section

6(b), (c) of Pub. L. 85-929, set out as a note under section 342 of

this title.

-TRANS-

TRANSFER OF FUNCTIONS

Functions vested in Secretary of Health, Education, and Welfare

(now Health and Human Services) in establishing tolerances for

pesticide chemicals under this section together with authority to

monitor compliance with tolerances and effectiveness of

surveillance and enforcement and to provide technical assistance to

States and conduct research under this chapter and section 201 et

seq. of Title 42, The Public Health and Welfare, transferred to

Administrator of Environmental Protection Agency by Reorg. Plan No.

3 of 1970, Sec. 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84

Stat. 2086, set out in the Appendix to Title 5, Government

Organization and Employees.

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration to Federal Security

Agency, see note set out under section 41 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 342, 346a, 371 of this

title.

-CITE-

21 USC Sec. 346a 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 346a. Tolerances and exemptions for pesticide chemical

residues

-STATUTE-

(a) Requirement for tolerance or exemption

(1) General rule

Except as provided in paragraph (2) or (3), any pesticide

chemical residue in or on a food shall be deemed unsafe for the

purpose of section 342(a)(2)(B) of this title unless -

(A) a tolerance for such pesticide chemical residue in or on

such food is in effect under this section and the quantity of

the residue is within the limits of the tolerance; or

(B) an exemption from the requirement of a tolerance is in

effect under this section for the pesticide chemical residue.

For the purposes of this section, the term ''food'', when used as

a noun without modification, shall mean a raw agricultural

commodity or processed food.

(2) Processed food

Notwithstanding paragraph (1) -

(A) if a tolerance is in effect under this section for a

pesticide chemical residue in or on a raw agricultural

commodity, a pesticide chemical residue that is present in or

on a processed food because the food is made from that raw

agricultural commodity shall not be considered unsafe within

the meaning of section 342(a)(2)(B) of this title despite the

lack of a tolerance for the pesticide chemical residue in or on

the processed food if the pesticide chemical has been used in

or on the raw agricultural commodity in conformity with a

tolerance under this section, such residue in or on the raw

agricultural commodity has been removed to the extent possible

in good manufacturing practice, and the concentration of the

pesticide chemical residue in the processed food is not greater

than the tolerance prescribed for the pesticide chemical

residue in the raw agricultural commodity; or

(B) if an exemption for the requirement for a tolerance is in

effect under this section for a pesticide chemical residue in

or on a raw agricultural commodity, a pesticide chemical

residue that is present in or on a processed food because the

food is made from that raw agricultural commodity shall not be

considered unsafe within the meaning of section 342(a)(2)(B) of

this title.

(3) Residues of degradation products

If a pesticide chemical residue is present in or on a food

because it is a metabolite or other degradation product of a

precursor substance that itself is a pesticide chemical or

pesticide chemical residue, such a residue shall not be

considered to be unsafe within the meaning of section

342(a)(2)(B) of this title despite the lack of a tolerance or

exemption from the need for a tolerance for such residue in or on

such food if -

(A) the Administrator has not determined that the degradation

product is likely to pose any potential health risk from

dietary exposure that is of a different type than, or of a

greater significance than, any risk posed by dietary exposure

to the precursor substance;

(B) either -

(i) a tolerance is in effect under this section for

residues of the precursor substance in or on the food, and

the combined level of residues of the degradation product and

the precursor substance in or on the food is at or below the

stoichiometrically equivalent level that would be permitted

by the tolerance if the residue consisted only of the

precursor substance rather than the degradation product; or

(ii) an exemption from the need for a tolerance is in

effect under this section for residues of the precursor

substance in or on the food; and

(C) the tolerance or exemption for residues of the precursor

substance does not state that it applies only to particular

named substances and does not state that it does not apply to

residues of the degradation product.

(4) Effect of tolerance or exemption

While a tolerance or exemption from the requirement for a

tolerance is in effect under this section for a pesticide

chemical residue with respect to any food, the food shall not by

reason of bearing or containing any amount of such a residue be

considered to be adulterated within the meaning of section

342(a)(1) of this title.

(b) Authority and standard for tolerance

(1) Authority

The Administrator may issue regulations establishing,

modifying, or revoking a tolerance for a pesticide chemical

residue in or on a food -

(A) in response to a petition filed under subsection (d) of

this section; or

(B) on the Administrator's own initiative under subsection

(e) of this section.

As used in this section, the term ''modify'' shall not mean

expanding the tolerance to cover additional foods.

(2) Standard

(A) General rule

(i) Standard

The Administrator may establish or leave in effect a

tolerance for a pesticide chemical residue in or on a food

only if the Administrator determines that the tolerance is

safe. The Administrator shall modify or revoke a tolerance

if the Administrator determines it is not safe.

(ii) Determination of safety

As used in this section, the term ''safe'', with respect to

a tolerance for a pesticide chemical residue, means that the

Administrator has determined that there is a reasonable

certainty that no harm will result from aggregate exposure to

the pesticide chemical residue, including all anticipated

dietary exposures and all other exposures for which there is

reliable information.

(iii) Rule of construction

With respect to a tolerance, a pesticide chemical residue

meeting the standard under clause (i) is not an eligible

pesticide chemical residue for purposes of subparagraph (B).

(B) Tolerances for eligible pesticide chemical residues

(i) Definition

As used in this subparagraph, the term ''eligible pesticide

chemical residue'' means a pesticide chemical residue as to

which -

(I) the Administrator is not able to identify a level of

exposure to the residue at which the residue will not cause

or contribute to a known or anticipated harm to human

health (referred to in this section as a ''nonthreshold

effect'');

(II) the lifetime risk of experiencing the nonthreshold

effect is appropriately assessed by quantitative risk

assessment; and

(III) with regard to any known or anticipated harm to

human health for which the Administrator is able to

identify a level at which the residue will not cause such

harm (referred to in this section as a ''threshold

effect''), the Administrator determines that the level of

aggregate exposure is safe.

(ii) Determination of tolerance

Notwithstanding subparagraph (A)(i), a tolerance for an

eligible pesticide chemical residue may be left in effect or

modified under this subparagraph if -

(I) at least one of the conditions described in clause

(iii) is met; and

(II) both of the conditions described in clause (iv) are

met.

(iii) Conditions regarding use

For purposes of clause (ii), the conditions described in

this clause with respect to a tolerance for an eligible

pesticide chemical residue are the following:

(I) Use of the pesticide chemical that produces the

residue protects consumers from adverse effects on health

that would pose a greater risk than the dietary risk from

the residue.

(II) Use of the pesticide chemical that produces the

residue is necessary to avoid a significant disruption in

domestic production of an adequate, wholesome, and

economical food supply.

(iv) Conditions regarding risk

For purposes of clause (ii), the conditions described in

this clause with respect to a tolerance for an eligible

pesticide chemical residue are the following:

(I) The yearly risk associated with the nonthreshold

effect from aggregate exposure to the residue does not

exceed 10 times the yearly risk that would be allowed under

subparagraph (A) for such effect.

(II) The tolerance is limited so as to ensure that the

risk over a lifetime associated with the nonthreshold

effect from aggregate exposure to the residue is not

greater than twice the lifetime risk that would be allowed

under subparagraph (A) for such effect.

(v) Review

Five years after the date on which the Administrator makes

a determination to leave in effect or modify a tolerance

under this subparagraph, and thereafter as the Administrator

deems appropriate, the Administrator shall determine, after

notice and opportunity for comment, whether it has been

demonstrated to the Administrator that a condition described

in clause (iii)(I) or clause (iii)(II) continues to exist

with respect to the tolerance and that the yearly and

lifetime risks from aggregate exposure to such residue

continue to comply with the limits specified in clause (iv).

If the Administrator determines by such date that such

demonstration has not been made, the Administrator shall, not

later than 180 days after the date of such determination,

issue a regulation under subsection (e)(1) of this section to

modify or revoke the tolerance.

(vi) Infants and children

Any tolerance under this subparagraph shall meet the

requirements of subparagraph (C).

(C) Exposure of infants and children

In establishing, modifying, leaving in effect, or revoking a

tolerance or exemption for a pesticide chemical residue, the

Administrator -

(i) shall assess the risk of the pesticide chemical residue

based on -

(I) available information about consumption patterns

among infants and children that are likely to result in

disproportionately high consumption of foods containing or

bearing such residue among infants and children in

comparison to the general population;

(II) available information concerning the special

susceptibility of infants and children to the pesticide

chemical residues, including neurological differences

between infants and children and adults, and effects of in

utero exposure to pesticide chemicals; and

(III) available information concerning the cumulative

effects on infants and children of such residues and other

substances that have a common mechanism of toxicity; and

(ii) shall -

(I) ensure that there is a reasonable certainty that no

harm will result to infants and children from aggregate

exposure to the pesticide chemical residue; and

(II) publish a specific determination regarding the

safety of the pesticide chemical residue for infants and

children.

The Secretary of Health and Human Services and the Secretary of

Agriculture, in consultation with the Administrator, shall

conduct surveys to document dietary exposure to pesticides

among infants and children. In the case of threshold effects,

for purposes of clause (ii)(I) an additional tenfold margin of

safety for the pesticide chemical residue and other sources of

exposure shall be applied for infants and children to take into

account potential pre- and post-natal toxicity and completeness

of the data with respect to exposure and toxicity to infants

and children. Notwithstanding such requirement for an

additional margin of safety, the Administrator may use a

different margin of safety for the pesticide chemical residue

only if, on the basis of reliable data, such margin will be

safe for infants and children.

(D) Factors

In establishing, modifying, leaving in effect, or revoking a

tolerance or exemption for a pesticide chemical residue, the

Administrator shall consider, among other relevant factors -

(i) the validity, completeness, and reliability of the

available data from studies of the pesticide chemical and

pesticide chemical residue;

(ii) the nature of any toxic effect shown to be caused by

the pesticide chemical or pesticide chemical residue in such

studies;

(iii) available information concerning the relationship of

the results of such studies to human risk;

(iv) available information concerning the dietary

consumption patterns of consumers (and major identifiable

subgroups of consumers);

(v) available information concerning the cumulative effects

of such residues and other substances that have a common

mechanism of toxicity;

(vi) available information concerning the aggregate

exposure levels of consumers (and major identifiable

subgroups of consumers) to the pesticide chemical residue and

to other related substances, including dietary exposure under

the tolerance and all other tolerances in effect for the

pesticide chemical residue, and exposure from other

non-occupational sources;

(vii) available information concerning the variability of

the sensitivities of major identifiable subgroups of

consumers;

(viii) such information as the Administrator may require on

whether the pesticide chemical may have an effect in humans

that is similar to an effect produced by a naturally

occurring estrogen or other endocrine effects; and

(ix) safety factors which in the opinion of experts

qualified by scientific training and experience to evaluate

the safety of food additives are generally recognized as

appropriate for the use of animal experimentation data.

(E) Data and information regarding anticipated and actual

residue levels

(i) Authority

In establishing, modifying, leaving in effect, or revoking

a tolerance for a pesticide chemical residue, the

Administrator may consider available data and information on

the anticipated residue levels of the pesticide chemical in

or on food and the actual residue levels of the pesticide

chemical that have been measured in food, including residue

data collected by the Food and Drug Administration.

(ii) Requirement

If the Administrator relies on anticipated or actual

residue levels in establishing, modifying, or leaving in

effect a tolerance, the Administrator shall pursuant to

subsection (f)(1) of this section require that data be

provided five years after the date on which the tolerance is

established, modified, or left in effect, and thereafter as

the Administrator deems appropriate, demonstrating that such

residue levels are not above the levels so relied on. If

such data are not so provided, or if the data do not

demonstrate that the residue levels are not above the levels

so relied on, the Administrator shall, not later than 180

days after the date on which the data were required to be

provided, issue a regulation under subsection (e)(1) of this

section, or an order under subsection (f)(2) of this section,

as appropriate, to modify or revoke the tolerance.

(F) Percent of food actually treated

In establishing, modifying, leaving in effect, or revoking a

tolerance for a pesticide chemical residue, the Administrator

may, when assessing chronic dietary risk, consider available

data and information on the percent of food actually treated

with the pesticide chemical (including aggregate pesticide use

data collected by the Department of Agriculture) only if the

Administrator -

(i) finds that the data are reliable and provide a valid

basis to show what percentage of the food derived from such

crop is likely to contain such pesticide chemical residue;

(ii) finds that the exposure estimate does not understate

exposure for any significant subpopulation group;

(iii) finds that, if data are available on pesticide use

and consumption of food in a particular area, the population

in such area is not dietarily exposed to residues above those

estimated by the Administrator; and

(iv) provides for the periodic reevaluation of the estimate

of anticipated dietary exposure.

(3) Detection methods

(A) General rule

A tolerance for a pesticide chemical residue in or on a food

shall not be established or modified by the Administrator

unless the Administrator determines, after consultation with

the Secretary, that there is a practical method for detecting

and measuring the levels of the pesticide chemical residue in

or on the food.

(B) Detection limit

A tolerance for a pesticide chemical residue in or on a food

shall not be established at or modified to a level lower than

the limit of detection of the method for detecting and

measuring the pesticide chemical residue specified by the

Administrator under subparagraph (A).

(4) International standards

In establishing a tolerance for a pesticide chemical residue in

or on a food, the Administrator shall determine whether a maximum

residue level for the pesticide chemical has been established by

the Codex Alimentarius Commission. If a Codex maximum residue

level has been established for the pesticide chemical and the

Administrator does not propose to adopt the Codex level, the

Administrator shall publish for public comment a notice

explaining the reasons for departing from the Codex level.

(c) Authority and standard for exemptions

(1) Authority

The Administrator may issue a regulation establishing,

modifying, or revoking an exemption from the requirement for a

tolerance for a pesticide chemical residue in or on food -

(A) in response to a petition filed under subsection (d) of

this section; or

(B) on the Administrator's initiative under subsection (e) of

this section.

(2) Standard

(A) General rule

(i) Standard

The Administrator may establish or leave in effect an

exemption from the requirement for a tolerance for a

pesticide chemical residue in or on food only if the

Administrator determines that the exemption is safe. The

Administrator shall modify or revoke an exemption if the

Administrator determines it is not safe.

(ii) Determination of safety

The term ''safe'', with respect to an exemption for a

pesticide chemical residue, means that the Administrator has

determined that there is a reasonable certainty that no harm

will result from aggregate exposure to the pesticide chemical

residue, including all anticipated dietary exposures and all

other exposures for which there is reliable information.

(B) Factors

In making a determination under this paragraph, the

Administrator shall take into account, among other relevant

considerations, the considerations set forth in subparagraphs

(C) and (D) of subsection (b)(2) of this section.

(3) Limitation

An exemption from the requirement for a tolerance for a

pesticide chemical residue in or on food shall not be established

or modified by the Administrator unless the Administrator

determines, after consultation with the Secretary -

(A) that there is a practical method for detecting and

measuring the levels of such pesticide chemical residue in or

on food; or

(B) that there is no need for such a method, and states the

reasons for such determination in issuing the regulation

establishing or modifying the exemption.

(d) Petition for tolerance or exemption

(1) Petitions and petitioners

Any person may file with the Administrator a petition proposing

the issuance of a regulation -

(A) establishing, modifying, or revoking a tolerance for a

pesticide chemical residue in or on a food; or

(B) establishing, modifying, or revoking an exemption from

the requirement of a tolerance for such a residue.

(2) Petition contents

(A) Establishment

A petition under paragraph (1) to establish a tolerance or

exemption for a pesticide chemical residue shall be supported

by such data and information as are specified in regulations

issued by the Administrator, including -

(i)(I) an informative summary of the petition and of the

data, information, and arguments submitted or cited in

support of the petition; and

(II) a statement that the petitioner agrees that such

summary or any information it contains may be published as a

part of the notice of filing of the petition to be published

under this subsection and as part of a proposed or final

regulation issued under this section;

(ii) the name, chemical identity, and composition of the

pesticide chemical residue and of the pesticide chemical that

produces the residue;

(iii) data showing the recommended amount, frequency,

method, and time of application of that pesticide chemical;

(iv) full reports of tests and investigations made with

respect to the safety of the pesticide chemical, including

full information as to the methods and controls used in

conducting those tests and investigations;

(v) full reports of tests and investigations made with

respect to the nature and amount of the pesticide chemical

residue that is likely to remain in or on the food, including

a description of the analytical methods used;

(vi) a practical method for detecting and measuring the

levels of the pesticide chemical residue in or on the food,

or for exemptions, a statement why such a method is not

needed;

(vii) a proposed tolerance for the pesticide chemical

residue, if a tolerance is proposed;

(viii) if the petition relates to a tolerance for a

processed food, reports of investigations conducted using the

processing method(s) used to produce that food;

(ix) such information as the Administrator may require to

make the determination under subsection (b)(2)(C) of this

section;

(x) such information as the Administrator may require on

whether the pesticide chemical may have an effect in humans

that is similar to an effect produced by a naturally

occurring estrogen or other endocrine effects;

(xi) information regarding exposure to the pesticide

chemical residue due to any tolerance or exemption already

granted for such residue;

(xii) practical methods for removing any amount of the

residue that would exceed any proposed tolerance; and

(xiii) such other data and information as the Administrator

requires by regulation to support the petition.

If information or data required by this subparagraph is

available to the Administrator, the person submitting the

petition may cite the availability of the information or data

in lieu of submitting it. The Administrator may require a

petition to be accompanied by samples of the pesticide chemical

with respect to which the petition is filed.

(B) Modification or revocation

The Administrator may by regulation establish the

requirements for information and data to support a petition to

modify or revoke a tolerance or to modify or revoke an

exemption from the requirement for a tolerance.

(3) Notice

A notice of the filing of a petition that the Administrator

determines has met the requirements of paragraph (2) shall be

published by the Administrator within 30 days after such

determination. The notice shall announce the availability of a

description of the analytical methods available to the

Administrator for the detection and measurement of the pesticide

chemical residue with respect to which the petition is filed or

shall set forth the petitioner's statement of why such a method

is not needed. The notice shall include the summary required by

paragraph (2)(A)(i)(I).

(4) Actions by the Administrator

(A) In general

The Administrator shall, after giving due consideration to a

petition filed under paragraph (1) and any other information

available to the Administrator -

(i) issue a final regulation (which may vary from that

sought by the petition) establishing, modifying, or revoking

a tolerance for the pesticide chemical residue or an

exemption of the pesticide chemical residue from the

requirement of a tolerance (which final regulation shall be

issued without further notice and without further period for

public comment);

(ii) issue a proposed regulation under subsection (e) of

this section, and thereafter issue a final regulation under

such subsection; or

(iii) issue an order denying the petition.

(B) Priorities

The Administrator shall give priority to petitions for the

establishment or modification of a tolerance or exemption for a

pesticide chemical residue that appears to pose a significantly

lower risk to human health from dietary exposure than pesticide

chemical residues that have tolerances in effect for the same

or similar uses.

(C) Expedited review of certain petitions

(i) Date certain for review

If a person files a complete petition with the

Administrator proposing the issuance of a regulation

establishing a tolerance or exemption for a pesticide

chemical residue that presents a lower risk to human health

than a pesticide chemical residue for which a tolerance has

been left in effect or modified under subsection (b)(2)(B) of

this section, the Administrator shall complete action on such

petition under this paragraph within 1 year.

(ii) Required determinations

If the Administrator issues a final regulation establishing

a tolerance or exemption for a safer pesticide chemical

residue under clause (i), the Administrator shall, not later

than 180 days after the date on which the regulation is

issued, determine whether a condition described in subclause

(I) or (II) of subsection (b)(2)(B)(iii) of this section

continues to exist with respect to a tolerance that has been

left in effect or modified under subsection (b)(2)(B) of this

section. If such condition does not continue to exist, the

Administrator shall, not later than 180 days after the date

on which the determination under the preceding sentence is

made, issue a regulation under subsection (e)(1) of this

section to modify or revoke the tolerance.

(e) Action on Administrator's own initiative

(1) General rule

The Administrator may issue a regulation -

(A) establishing, modifying, suspending under subsection

(l)(3) of this section, or revoking a tolerance for a pesticide

chemical or a pesticide chemical residue;

(B) establishing, modifying, suspending under subsection

(l)(3) of this section, or revoking an exemption of a pesticide

chemical residue from the requirement of a tolerance; or

(C) establishing general procedures and requirements to

implement this section.

(2) Notice

Before issuing a final regulation under paragraph (1), the

Administrator shall issue a notice of proposed rulemaking and

provide a period of not less than 60 days for public comment on

the proposed regulation, except that a shorter period for comment

may be provided if the Administrator for good cause finds that it

would be in the public interest to do so and states the reasons

for the finding in the notice of proposed rulemaking.

(f) Special data requirements

(1) Requiring submission of additional data

If the Administrator determines that additional data or

information are reasonably required to support the continuation

of a tolerance or exemption that is in effect under this section

for a pesticide chemical residue on a food, the Administrator

shall -

(A) issue a notice requiring the person holding the pesticide

registrations associated with such tolerance or exemption to

submit the data or information under section 3(c)(2)(B) of the

Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.

136a(c)(2)(B));

(B) issue a rule requiring that testing be conducted on a

substance or mixture under section 4 of the Toxic Substances

Control Act (15 U.S.C. 2603); or

(C) publish in the Federal Register, after first providing

notice and an opportunity for comment of not less than 60 days'

duration, an order -

(i) requiring the submission to the Administrator by one or

more interested persons of a notice identifying the person or

persons who will submit the required data and information;

(ii) describing the type of data and information required

to be submitted to the Administrator and stating why the data

and information could not be obtained under the authority of

section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and

Rodenticide Act (7 U.S.C. 136a(c)(2)(B)) or section 4 of the

Toxic Substances Control Act (15 U.S.C. 2603);

(iii) describing the reports of the Administrator required

to be prepared during and after the collection of the data

and information;

(iv) requiring the submission to the Administrator of the

data, information, and reports referred to in clauses (ii)

and (iii); and

(v) establishing dates by which the submissions described

in clauses (i) and (iv) must be made.

The Administrator may under subparagraph (C) revise any such

order to correct an error. The Administrator may under this

paragraph require data or information pertaining to whether the

pesticide chemical may have an effect in humans that is similar

to an effect produced by a naturally occurring estrogen or

other endocrine effects.

(2) Noncompliance

If a submission required by a notice issued in accordance with

paragraph (1)(A), a rule issued under paragraph (1)(B), or an

order issued under paragraph (1)(C) is not made by the time

specified in such notice, rule, or order, the Administrator may

by order published in the Federal Register modify or revoke the

tolerance or exemption in question. In any review of such an

order under subsection (g)(2) of this section, the only material

issue shall be whether a submission required under paragraph (1)

was not made by the time specified.

(g) Effective date, objections, hearings, and administrative review

(1) Effective date

A regulation or order issued under subsection (d)(4), (e)(1),

or (f)(2) of this section shall take effect upon publication

unless the regulation or order specifies otherwise. The

Administrator may stay the effectiveness of the regulation or

order if, after issuance of such regulation or order, objections

are filed with respect to such regulation or order pursuant to

paragraph (2).

(2) Further proceedings

(A) Objections

Within 60 days after a regulation or order is issued under

subsection (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or

(n)(5)(C) of this section, any person may file objections

thereto with the Administrator, specifying with particularity

the provisions of the regulation or order deemed objectionable

and stating reasonable grounds therefor. If the regulation or

order was issued in response to a petition under subsection

(d)(1) of this section, a copy of each objection filed by a

person other than the petitioner shall be served by the

Administrator on the petitioner.

(B) Hearing

An objection may include a request for a public evidentiary

hearing upon the objection. The Administrator shall, upon the

initiative of the Administrator or upon the request of an

interested person and after due notice, hold a public

evidentiary hearing if and to the extent the Administrator

determines that such a public hearing is necessary to receive

factual evidence relevant to material issues of fact raised by

the objections. The presiding officer in such a hearing may

authorize a party to obtain discovery from other persons and

may upon a showing of good cause made by a party issue a

subpoena to compel testimony or production of documents from

any person. The presiding officer shall be governed by the

Federal Rules of Civil Procedure in making any order for the

protection of the witness or the content of documents produced

and shall order the payment of reasonable fees and expenses as

a condition to requiring testimony of the witness. On contest,

such a subpoena may be enforced by a Federal district court.

(C) Final decision

As soon as practicable after receiving the arguments of the

parties, the Administrator shall issue an order stating the

action taken upon each such objection and setting forth any

revision to the regulation or prior order that the

Administrator has found to be warranted. If a hearing was held

under subparagraph (B), such order and any revision to the

regulation or prior order shall, with respect to questions of

fact at issue in the hearing, be based only on substantial

evidence of record at such hearing, and shall set forth in

detail the findings of facts and the conclusions of law or

policy upon which the order or regulation is based.

(h) Judicial review

(1) Petition

In a case of actual controversy as to the validity of any

regulation issued under subsection (e)(1)(C) of this section, or

any order issued under subsection (f)(1)(C) or (g)(2)(C) of this

section, or any regulation that is the subject of such an order,

any person who will be adversely affected by such order or

regulation may obtain judicial review by filing in the United

States Court of Appeals for the circuit wherein that person

resides or has its principal place of business, or in the United

States Court of Appeals for the District of Columbia Circuit,

within 60 days after publication of such order or regulation, a

petition praying that the order or regulation be set aside in

whole or in part.

(2) Record and jurisdiction

A copy of the petition under paragraph (1) shall be forthwith

transmitted by the clerk of the court to the Administrator, or

any officer designated by the Administrator for that purpose, and

thereupon the Administrator shall file in the court the record of

the proceedings on which the Administrator based the order or

regulation, as provided in section 2112 of title 28. Upon the

filing of such a petition, the court shall have exclusive

jurisdiction to affirm or set aside the order or regulation

complained of in whole or in part. As to orders issued following

a public evidentiary hearing, the findings of the Administrator

with respect to questions of fact shall be sustained only if

supported by substantial evidence when considered on the record

as a whole.

(3) Additional evidence

If a party applies to the court for leave to adduce additional

evidence and shows to the satisfaction of the court that the

additional evidence is material and that there were reasonable

grounds for the failure to adduce the evidence in the proceeding

before the Administrator, the court may order that the additional

evidence (and evidence in rebuttal thereof) shall be taken before

the Administrator in the manner and upon the terms and conditions

the court deems proper. The Administrator may modify prior

findings as to the facts by reason of the additional evidence so

taken and may modify the order or regulation accordingly. The

Administrator shall file with the court any such modified

finding, order, or regulation.

(4) Final judgment; Supreme Court review

The judgment of the court affirming or setting aside, in whole

or in part, any regulation or any order and any regulation which

is the subject of such an order shall be final, subject to review

by the Supreme Court of the United States as provided in section

1254 of title 28. The commencement of proceedings under this

subsection shall not, unless specifically ordered by the court to

the contrary, operate as a stay of a regulation or order.

(5) Application

Any issue as to which review is or was obtainable under this

subsection shall not be the subject of judicial review under any

other provision of law.

(i) Confidentiality and use of data

(1) General rule

Data and information that are or have been submitted to the

Administrator under this section or section 348 of this title in

support of a tolerance or an exemption from a tolerance shall be

entitled to confidential treatment for reasons of business

confidentiality and to exclusive use and data compensation to the

same extent provided by sections 3 and 10 of the Federal

Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a,

136h).

(2) Exceptions

(A) In general

Data and information that are entitled to confidential

treatment under paragraph (1) may be disclosed, under such

security requirements as the Administrator may provide by

regulation, to -

(i) employees of the United States authorized by the

Administrator to examine such data and information in the

carrying out of their official duties under this chapter or

other Federal statutes intended to protect the public health;

or

(ii) contractors with the United States authorized by the

Administrator to examine such data and information in the

carrying out of contracts under this chapter or such

statutes.

(B) Congress

This subsection does not authorize the withholding of data or

information from either House of Congress or from, to the

extent of matter within its jurisdiction, any committee or

subcommittee of such committee or any joint committee of

Congress or any subcommittee of such joint committee.

(3) Summaries

Notwithstanding any provision of this subsection or other law,

the Administrator may publish the informative summary required by

subsection (d)(2)(A)(i) of this section and may, in issuing a

proposed or final regulation or order under this section, publish

an informative summary of the data relating to the regulation or

order.

(j) Status of previously issued regulations

(1) Regulations under section 346

Regulations affecting pesticide chemical residues in or on raw

agricultural commodities promulgated, in accordance with section

371(e) of this title, under the authority of section 346(a)

(FOOTNOTE 1) of this title upon the basis of public hearings

instituted before January 1, 1953, shall be deemed to be

regulations issued under this section and shall be subject to

modification or revocation under subsections (d) and (e) of this

section, and shall be subject to review under subsection (q) of

this section.

(FOOTNOTE 1) See References in Text note below.

(2) Regulations under section 348

Regulations that established tolerances for substances that are

pesticide chemical residues in or on processed food, or that

otherwise stated the conditions under which such pesticide

chemicals could be safely used, and that were issued under

section 348 of this title on or before August 3, 1996, shall be

deemed to be regulations issued under this section and shall be

subject to modification or revocation under subsection (d) or (e)

of this section, and shall be subject to review under subsection

(q) of this section.

(3) Regulations under section 346a

Regulations that established tolerances or exemptions under

this section that were issued on or before August 3, 1996, shall

remain in effect unless modified or revoked under subsection (d)

or (e) of this section, and shall be subject to review under

subsection (q) of this section.

(4) Certain substances

With respect to a substance that is not included in the

definition of the term ''pesticide chemical'' under section

321(q)(1) of this title but was so included on the day before

October 30, 1998, the following applies as of October 30, 1998:

(A) Notwithstanding paragraph (2), any regulation applying to

the use of the substance that was in effect on the day before

October 30, 1998, and was on such day deemed in such paragraph

to have been issued under this section, shall be considered to

have been issued under section 348 of this title.

(B) Notwithstanding paragraph (3), any regulation applying to

the use of the substance that was in effect on such day and was

issued under this section (including any such regulation issued

before August 3, 1996) is deemed to have been issued under

section 348 of this title.

(k) Transitional provision

If, on the day before August 3, 1996, a substance that is a

pesticide chemical was, with respect to a particular pesticidal use

of the substance and any resulting pesticide chemical residue in or

on a particular food -

(1) regarded by the Administrator or the Secretary as generally

recognized as safe for use within the meaning of the provisions

of subsection (a) of this section or section 321(s) of this title

as then in effect; or

(2) regarded by the Secretary as a substance described by

section 321(s)(4) of this title;

such a pesticide chemical residue shall be regarded as exempt from

the requirement for a tolerance, as of August 3, 1996. The

Administrator shall by regulation indicate which substances are

described by this subsection. Any exemption under this subsection

may be modified or revoked as if it had been issued under

subsection (c) of this section.

(l) Harmonization with action under other laws

(1) Coordination with FIFRA

To the extent practicable and consistent with the review

deadlines in subsection (q) of this section, in issuing a final

rule under this subsection that suspends or revokes a tolerance

or exemption for a pesticide chemical residue in or on food, the

Administrator shall coordinate such action with any related

necessary action under the Federal Insecticide, Fungicide, and

Rodenticide Act (7 U.S.C. 136 et seq.).

(2) Revocation of tolerance or exemption following cancellation

of associated registrations

If the Administrator, acting under the Federal Insecticide,

Fungicide, and Rodenticide Act, cancels the registration of each

pesticide that contains a particular pesticide chemical and that

is labeled for use on a particular food, or requires that the

registration of each such pesticide be modified to prohibit its

use in connection with the production, storage, or transportation

of such food, due in whole or in part to dietary risks to humans

posed by residues of that pesticide chemical on that food, the

Administrator shall revoke any tolerance or exemption that allows

the presence of the pesticide chemical, or any pesticide chemical

residue that results from its use, in or on that food.

Subsection (e) of this section shall apply to actions taken under

this paragraph. A revocation under this paragraph shall become

effective not later than 180 days after -

(A) the date by which each such cancellation of a

registration has become effective; or

(B) the date on which the use of the canceled pesticide

becomes unlawful under the terms of the cancellation, whichever

is later.

(3) Suspension of tolerance or exemption following suspension of

associated registrations

(A) Suspension

If the Administrator, acting under the Federal Insecticide,

Fungicide, and Rodenticide Act, suspends the use of each

registered pesticide that contains a particular pesticide

chemical and that is labeled for use on a particular food, due

in whole or in part to dietary risks to humans posed by

residues of that pesticide chemical on that food, the

Administrator shall suspend any tolerance or exemption that

allows the presence of the pesticide chemical, or any pesticide

chemical residue that results from its use, in or on that

food. Subsection (e) of this section shall apply to actions

taken under this paragraph. A suspension under this paragraph

shall become effective not later than 60 days after the date by

which each such suspension of use has become effective.

(B) Effect of suspension

The suspension of a tolerance or exemption under subparagraph

(A) shall be effective as long as the use of each associated

registration of a pesticide is suspended under the Federal

Insecticide, Fungicide, and Rodenticide Act. While a suspension

of a tolerance or exemption is effective the tolerance or

exemption shall not be considered to be in effect. If the

suspension of use of the pesticide under that Act is

terminated, leaving the registration of the pesticide for such

use in effect under that Act, the Administrator shall rescind

any associated suspension of tolerance or exemption.

(4) Tolerances for unavoidable residues

In connection with action taken under paragraph (2) or (3), or

with respect to pesticides whose registrations were suspended or

canceled prior to August 3, 1996, under the Federal Insecticide,

Fungicide, and Rodenticide Act, if the Administrator determines

that a residue of the canceled or suspended pesticide chemical

will unavoidably persist in the environment and thereby be

present in or on a food, the Administrator may establish a

tolerance for the pesticide chemical residue. In establishing

such a tolerance, the Administrator shall take into account both

the factors set forth in subsection (b)(2) of this section and

the unavoidability of the residue. Subsection (e) of this

section shall apply to the establishment of such tolerance. The

Administrator shall review any such tolerance periodically and

modify it as necessary so that it allows no greater level of the

pesticide chemical residue than is unavoidable.

(5) Pesticide residues resulting from lawful application of

pesticide

Notwithstanding any other provision of this chapter, if a

tolerance or exemption for a pesticide chemical residue in or on

a food has been revoked, suspended, or modified under this

section, an article of that food shall not be deemed unsafe

solely because of the presence of such pesticide chemical residue

in or on such food if it is shown to the satisfaction of the

Secretary that -

(A) the residue is present as the result of an application or

use of a pesticide at a time and in a manner that was lawful

under the Federal Insecticide, Fungicide, and Rodenticide Act;

and

(B) the residue does not exceed a level that was authorized

at the time of that application or use to be present on the

food under a tolerance, exemption, food additive regulation, or

other sanction then in effect under this chapter;

unless, in the case of any tolerance or exemption revoked,

suspended, or modified under this subsection or subsection (d) or

(e) of this section, the Administrator has issued a determination

that consumption of the legally treated food during the period of

its likely availability in commerce will pose an unreasonable

dietary risk.

(6) Tolerance for use of pesticides under an emergency exemption

If the Administrator grants an exemption under section 18 of

the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.

136p) for a pesticide chemical, the Administrator shall establish

a tolerance or exemption from the requirement for a tolerance for

the pesticide chemical residue. Such a tolerance or exemption

from a tolerance shall have an expiration date. The

Administrator may establish such a tolerance or exemption without

providing notice or a period for comment on the tolerance or

exemption. The Administrator shall promulgate regulations within

365 days after August 3, 1996, governing the establishment of

tolerances and exemptions under this paragraph. Such regulations

shall be consistent with the safety standard under subsections

(b)(2) and (c)(2) of this section and with section 18 of the

Federal Insecticide, Fungicide, and Rodenticide Act.

(m) Fees

(1) Amount

The Administrator shall by regulation require the payment of

such fees as will in the aggregate, in the judgment of the

Administrator, be sufficient over a reasonable term to provide,

equip, and maintain an adequate service for the performance of

the Administrator's functions under this section. Under the

regulations, the performance of the Administrator's services or

other functions under this section, including -

(A) the acceptance for filing of a petition submitted under

subsection (d) of this section;

(B) establishing, modifying, leaving in effect, or revoking a

tolerance or establishing, modifying, leaving in effect, or

revoking an exemption from the requirement for a tolerance

under this section;

(C) the acceptance for filing of objections under subsection

(g) of this section; or

(D) the certification and filing in court of a transcript of

the proceedings and the record under subsection (h) of this

section;

may be conditioned upon the payment of such fees. The

regulations may further provide for waiver or refund of fees in

whole or in part when in the judgment of the Administrator such a

waiver or refund is equitable and not contrary to the purposes of

this subsection.

(2) Deposit

All fees collected under paragraph (1) shall be deposited in

the Reregistration and Expedited Processing Fund created by

section 4(k) of the Federal Insecticide, Fungicide, and

Rodenticide Act (7 U.S.C. 136a-1(k)). Such fees shall be

available to the Administrator, without fiscal year limitation,

for the performance of the Administrator's services or functions

as specified in paragraph (1).

(n) National uniformity of tolerances

(1) ''Qualifying pesticide chemical residue'' defined

For purposes of this subsection, the term ''qualifying

pesticide chemical residue'' means a pesticide chemical residue

resulting from the use, in production, processing, or storage of

a food, of a pesticide chemical that is an active ingredient and

that -

(A) was first approved for such use in a registration of a

pesticide issued under section 3(c)(5) of the Federal

Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.

136a(c)(5)) on or after April 25, 1985, on the basis of data

determined by the Administrator to meet all applicable

requirements for data prescribed by regulations in effect under

that Act (7 U.S.C. 136 et seq.) on April 25, 1985; or

(B) was approved for such use in a reregistration eligibility

determination issued under section 4(g) of that Act (7 U.S.C.

136a-1(g)) on or after August 3, 1996.

(2) ''Qualifying Federal determination'' defined

For purposes of this subsection, the term ''qualifying Federal

determination'' means a tolerance or exemption from the

requirement for a tolerance for a qualifying pesticide chemical

residue that -

(A) is issued under this section after August 3, 1996, and

determined by the Administrator to meet the standard under

subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in

the case of an exemption) of this section; or

(B)(i) pursuant to subsection (j) of this section is

remaining in effect or is deemed to have been issued under this

section, or is regarded under subsection (k) of this section as

exempt from the requirement for a tolerance; and

(ii) is determined by the Administrator to meet the standard

under subsection (b)(2)(A) (in the case of a tolerance) or

(c)(2) (in the case of an exemption) of this section.

(3) Limitation

The Administrator may make the determination described in

paragraph (2)(B)(ii) only by issuing a rule in accordance with

the procedure set forth in subsection (d) or (e) of this section

and only if the Administrator issues a proposed rule and allows a

period of not less than 30 days for comment on the proposed

rule. Any such rule shall be reviewable in accordance with

subsections (g) and (h) of this section.

(4) State authority

Except as provided in paragraphs (5), (6), and (8) no State or

political subdivision may establish or enforce any regulatory

limit on a qualifying pesticide chemical residue in or on any

food if a qualifying Federal determination applies to the

presence of such pesticide chemical residue in or on such food,

unless such State regulatory limit is identical to such

qualifying Federal determination. A State or political

subdivision shall be deemed to establish or enforce a regulatory

limit on a pesticide chemical residue in or on a food if it

purports to prohibit or penalize the production, processing,

shipping, or other handling of a food because it contains a

pesticide residue (in excess of a prescribed limit).

(5) Petition procedure

(A) In general

Any State may petition the Administrator for authorization to

establish in such State a regulatory limit on a qualifying

pesticide chemical residue in or on any food that is not

identical to the qualifying Federal determination applicable to

such qualifying pesticide chemical residue.

(B) Petition requirements

Any petition under subparagraph (A) shall -

(i) satisfy any requirements prescribed, by rule, by the

Administrator; and

(ii) be supported by scientific data about the pesticide

chemical residue that is the subject of the petition or about

chemically related pesticide chemical residues, data on the

consumption within such State of food bearing the pesticide

chemical residue, and data on exposure of humans within such

State to the pesticide chemical residue.

(C) Authorization

The Administrator may, by order, grant the authorization

described in subparagraph (A) if the Administrator determines

that the proposed State regulatory limit -

(i) is justified by compelling local conditions; and

(ii) would not cause any food to be a violation of Federal

law.

(D) Treatment

In lieu of any action authorized under subparagraph (C), the

Administrator may treat a petition under this paragraph as a

petition under subsection (d) of this section to modify or

revoke a tolerance or an exemption. If the Administrator

determines to treat a petition under this paragraph as a

petition under subsection (d) of this section, the

Administrator shall thereafter act on the petition pursuant to

subsection (d) of this section.

(E) Review

Any order of the Administrator granting or denying the

authorization described in subparagraph (A) shall be subject to

review in the manner described in subsections (g) and (h) of

this section.

(6) Urgent petition procedure

Any State petition to the Administrator pursuant to paragraph

(5) that demonstrates that consumption of a food containing such

pesticide residue level during the period of the food's likely

availability in the State will pose a significant public health

threat from acute exposure shall be considered an urgent

petition. If an order by the Administrator to grant or deny the

requested authorization in an urgent petition is not made within

30 days of receipt of the petition, the petitioning State may

establish and enforce a temporary regulatory limit on a

qualifying pesticide chemical residue in or on the food. The

temporary regulatory limit shall be validated or terminated by

the Administrator's final order on the petition.

(7) Residues from lawful application

No State or political subdivision may enforce any regulatory

limit on the level of a pesticide chemical residue that may

appear in or on any food if, at the time of the application of

the pesticide that resulted in such residue, the sale of such

food with such residue level was lawful under this section and

under the law of such State, unless the State demonstrates that

consumption of the food containing such pesticide residue level

during the period of the food's likely availability in the State

will pose an unreasonable dietary risk to the health of persons

within such State.

(8) Savings

Nothing in this chapter preempts the authority of any State or

political subdivision to require that a food containing a

pesticide chemical residue bear or be the subject of a warning or

other statement relating to the presence of the pesticide

chemical residue in or on such food.

(o) Consumer right to know

Not later than 2 years after August 3, 1996, and annually

thereafter, the Administrator shall, in consultation with the

Secretary of Agriculture and the Secretary of Health and Human

Services, publish in a format understandable to a lay person, and

distribute to large retail grocers for public display (in a manner

determined by the grocer), the following information, at a minimum:

(1) A discussion of the risks and benefits of pesticide

chemical residues in or on food purchased by consumers.

(2) A listing of actions taken under subparagraph (B) of

subsection (b)(2) of this section that may result in pesticide

chemical residues in or on food that present a yearly or lifetime

risk above the risk allowed under subparagraph (A) of such

subsection, and the food on which the pesticide chemicals

producing the residues are used.

(3) Recommendations to consumers for reducing dietary exposure

to pesticide chemical residues in a manner consistent with

maintaining a healthy diet, including a list of food that may

reasonably substitute for food listed under paragraph (2).

Nothing in this subsection shall prevent retail grocers from

providing additional information.

(p) Estrogenic substances screening program

(1) Development

Not later than 2 years after August 3, 1996, the Administrator

shall in consultation with the Secretary of Health and Human

Services develop a screening program, using appropriate validated

test systems and other scientifically relevant information, to

determine whether certain substances may have an effect in humans

that is similar to an effect produced by a naturally occurring

estrogen, or such other endocrine effect as the Administrator may

designate.

(2) Implementation

Not later than 3 years after August 3, 1996, after obtaining

public comment and review of the screening program described in

paragraph (1) by the scientific advisory panel established under

section 25(d) of the Federal Insecticide, Fungicide, and

Rodenticide Act (7 U.S.C. 136w(d)) or the science advisory board

established by section 4365 (FOOTNOTE 2) of title 42, the

Administrator shall implement the program.

(FOOTNOTE 2) See References in Text note below.

(3) Substances

In carrying out the screening program described in paragraph

(1), the Administrator -

(A) shall provide for the testing of all pesticide chemicals;

and

(B) may provide for the testing of any other substance that

may have an effect that is cumulative to an effect of a

pesticide chemical if the Administrator determines that a

substantial population may be exposed to such substance.

(4) Exemption

Notwithstanding paragraph (3), the Administrator may, by order,

exempt from the requirements of this section a biologic substance

or other substance if the Administrator determines that the

substance is anticipated not to produce any effect in humans

similar to an effect produced by a naturally occurring estrogen.

(5) Collection of information

(A) In general

The Administrator shall issue an order to a registrant of a

substance for which testing is required under this subsection,

or to a person who manufactures or imports a substance for

which testing is required under this subsection, to conduct

testing in accordance with the screening program described in

paragraph (1), and submit information obtained from the testing

to the Administrator, within a reasonable time period that the

Administrator determines is sufficient for the generation of

the information.

(B) Procedures

To the extent practicable the Administrator shall minimize

duplicative testing of the same substance for the same

endocrine effect, develop, as appropriate, procedures for fair

and equitable sharing of test costs, and develop, as necessary,

procedures for handling of confidential business information.

(C) Failure of registrants to submit information

(i) Suspension

If a registrant of a substance referred to in paragraph

(3)(A) fails to comply with an order under subparagraph (A)

of this paragraph, the Administrator shall issue a notice of

intent to suspend the sale or distribution of the substance

by the registrant. Any suspension proposed under this

paragraph shall become final at the end of the 30-day period

beginning on the date that the registrant receives the notice

of intent to suspend, unless during that period a person

adversely affected by the notice requests a hearing or the

Administrator determines that the registrant has complied

fully with this paragraph.

(ii) Hearing

If a person requests a hearing under clause (i), the

hearing shall be conducted in accordance with section 554 of

title 5. The only matter for resolution at the hearing shall

be whether the registrant has failed to comply with an order

under subparagraph (A) of this paragraph. A decision by the

Administrator after completion of a hearing shall be

considered to be a final agency action.

(iii) Termination of suspensions

The Administrator shall terminate a suspension under this

subparagraph issued with respect to a registrant if the

Administrator determines that the registrant has complied

fully with this paragraph.

(D) Noncompliance by other persons

Any person (other than a registrant) who fails to comply with

an order under subparagraph (A) shall be liable for the same

penalties and sanctions as are provided under section 16 of the

Toxic Substances Control Act (15 U.S.C. 2615) in the case of a

violation referred to in that section. Such penalties and

sanctions shall be assessed and imposed in the same manner as

provided in such section 16.

(6) Agency action

In the case of any substance that is found, as a result of

testing and evaluation under this section, to have an endocrine

effect on humans, the Administrator shall, as appropriate, take

action under such statutory authority as is available to the

Administrator, including consideration under other sections of

this chapter, as is necessary to ensure the protection of public

health.

(7) Report to Congress

Not later than 4 years after August 3, 1996, the Administrator

shall prepare and submit to Congress a report containing -

(A) the findings of the Administrator resulting from the

screening program described in paragraph (1);

(B) recommendations for further testing needed to evaluate

the impact on human health of the substances tested under the

screening program; and

(C) recommendations for any further actions (including any

action described in paragraph (6)) that the Administrator

determines are appropriate based on the findings.

(q) Schedule for review

(1) In general

The Administrator shall review tolerances and exemptions for

pesticide chemical residues in effect on the day before August 3,

1996, as expeditiously as practicable, assuring that -

(A) 33 percent of such tolerances and exemptions are reviewed

within 3 years of August 3, 1996;

(B) 66 percent of such tolerances and exemptions are reviewed

within 6 years of August 3, 1996; and

(C) 100 percent of such tolerances and exemptions are

reviewed within 10 years of August 3, 1996.

In conducting a review of a tolerance or exemption, the

Administrator shall determine whether the tolerance or exemption

meets the requirements of subsections (FOOTNOTE 3) (b)(2) or

(c)(2) of this section and shall, by the deadline for the review

of the tolerance or exemption, issue a regulation under

subsection (d)(4) or (e)(1) of this section to modify or revoke

the tolerance or exemption if the tolerance or exemption does not

meet such requirements.

(FOOTNOTE 3) So in original. Probably should be ''subsection''.

(2) Priorities

In determining priorities for reviewing tolerances and

exemptions under paragraph (1), the Administrator shall give

priority to the review of the tolerances or exemptions that

appear to pose the greatest risk to public health.

(3) Publication of schedule

Not later than 12 months after August 3, 1996, the

Administrator shall publish a schedule for review of tolerances

and exemptions established prior to August 3, 1996. The

determination of priorities for the review of tolerances and

exemptions pursuant to this subsection is not a rulemaking and

shall not be subject to judicial review, except that failure to

take final action pursuant to the schedule established by this

paragraph shall be subject to judicial review.

(r) Temporary tolerance or exemption

The Administrator may, upon the request of any person who has

obtained an experimental permit for a pesticide chemical under the

Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136

et seq.) or upon the Administrator's own initiative, establish a

temporary tolerance or exemption for the pesticide chemical residue

for the uses covered by the permit. Subsections (b)(2), (c)(2),

(d), and (e) of this section shall apply to actions taken under

this subsection.

(s) Savings clause

Nothing in this section shall be construed to amend or modify the

provisions of the Toxic Substances Control Act (15 U.S.C. 2601 et

seq.) or the Federal Insecticide, Fungicide, and Rodenticide Act (7

U.S.C. 136 et seq.).

-SOURCE-

(June 25, 1938, ch. 675, Sec. 408, as added July 22, 1954, ch. 559,

Sec. 3, 68 Stat. 511; amended Pub. L. 85-791, Sec. 20, Aug. 28,

1958, 72 Stat. 947; Pub. L. 91-515, title VI, Sec. 601(d)(1), Oct.

30, 1970, 84 Stat. 1311; Pub. L. 92-157, title III, Sec. 303(a),

Nov. 18, 1971, 85 Stat. 464; Pub. L. 92-516, Sec. 3(3), Oct. 21,

1972, 86 Stat. 998; Pub. L. 98-620, title IV, Sec. 402(25)(A), Nov.

8, 1984, 98 Stat. 3359; Pub. L. 102-300, Sec. 6(b)(1), June 16,

1992, 106 Stat. 240; Pub. L. 102-571, title I, Sec. 107(7), Oct.

29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 3(k), Aug. 13, 1993,

107 Stat. 776; Pub. L. 104-170, title IV, Sec. 405, Aug. 3, 1996,

110 Stat. 1514; Pub. L. 105-324, Sec. 2(b), Oct. 30, 1998, 112

Stat. 3036.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Rules of Civil Procedure, referred to in subsec.

(g)(2)(B), are set out in the Appendix to Title 28, Judiciary and

Judicial Procedure.

Section 346 of this title, referred to in subsec. (j)(1),

originally consisted of subsecs. (a) and (b). Subsec. (a) was

redesignated as the entire section 346 and subsec. (b) was repealed

by Pub. L. 86-618, title I, Sec. 103(a)(1), 74 Stat. 398.

The Federal Insecticide, Fungicide, and Rodenticide Act, referred

to in subsecs. (l), (n)(1)(A), (r), and (s), is act June 25, 1947,

ch. 125, as amended generally by Pub. L. 92-516, Oct. 21, 1972, 86

Stat. 973, which is classified generally to subchapter II (Sec. 136

et seq.) of chapter 6 of Title 7, Agriculture. For complete

classification of this Act to the Code, see Short Title note set

out under section 136 of Title 7 and Tables.

Section 4365 of title 42, referred to in subsec. (p)(2), was in

the original ''section 8 of the Environmental Research,

Development, and Demonstration Act of 1978'', and was translated as

meaning section 8 of the Environmental Research, Development, and

Demonstration Authorization Act of 1978, to reflect the probable

intent of Congress.

The Toxic Substances Control Act, referred to in subsec. (s), is

Pub. L. 94-469, Oct. 11, 1976, 90 Stat. 2003, as amended, which is

classified generally to chapter 53 (Sec. 2601 et seq.) of Title 15,

Commerce and Trade. For complete classification of this Act to the

Code, see Short Title note set out under section 2601 of Title 15

and Tables.

-COD-

CODIFICATION

August 3, 1996, referred to in subsecs. (k), (n)(1)(B), (2)(A),

and (p)(1), (2), (7), was in the original references to the date of

enactment of this subsection and the date of enactment of this

section, which was translated as meaning the date of enactment of

Pub. L. 104-170, which amended this section generally, to reflect

the probable intent of Congress.

-MISC3-

AMENDMENTS

1998 - Subsec. (j)(4). Pub. L. 105-324 added par. (4).

1996 - Pub. L. 104-170 amended section generally, substituting,

in subsec. (a), provisions relating to requirement for tolerance or

exemption for provisions relating to conditions for safety; in

subsec. (b), provisions relating to authority and standard for

tolerance for provisions relating to establishment of tolerances;

in subsec. (c), provisions relating to authority and standard for

exemptions for provisions relating to exemptions; in subsec. (d),

provisions relating to petition for tolerance or exemption for

provisions relating to regulations pursuant to petition,

publication of notice, time for issuance, referral to advisory

committees, effective date, and hearings; in subsec. (e),

provisions relating to action on Administrator's own initiative for

provisions relating to regulations pursuant to Administrator's

proposals; in subsec. (f), provisions relating to special data

requirements for provisions relating to data submitted as

confidential; in subsec. (g), provisions relating to effective

date, objections, hearings, and administrative review for

provisions relating to advisory committees and their appointment,

composition, compensation, and clerical assistance; in subsec. (h),

provisions relating to judicial review for provisions relating to

right of consultation; in subsec. (i), provisions relating to

confidentiality and use of data for provisions relating to judicial

review; in subsec. (j), provisions relating to status of previously

issued regulations for provisions relating to temporary tolerances;

in subsec. (k), provisions relating to transitions for provisions

relating to regulations based on public hearings before January 1,

1953; in subsec. (l), provisions relating to harmonization with

action under other laws for provisions relating to pesticides under

Federal Insecticide, Fungicide, and Rodenticide Act, functions of

Administrator of Environmental Protection Agency, certifications,

hearings, time limitations, opinions, and regulations; in subsec.

(m), provisions relating to fees for provisions relating to

amendment of regulations; in subsec. (n), provisions relating to

national uniformity of tolerances for provisions relating to

guaranties; in subsec. (o), provisions relating to consumer right

to know for provisions relating to payment of fees, services or

functions conditioned on payment, and waiver or refund of fees; and

adding subsecs. (p) to (s).

1993 - Pub. L. 103-80, Sec. 3(k)(6), substituted

''Administrator'' for ''Secretary'' wherever appearing except when

followed by ''of Agriculture''.

Subsec. (a)(1). Pub. L. 103-80, Sec. 3(k)(1), substituted

''Administrator of the Environmental Protection Agency (hereinafter

in this section referred to as the 'Administrator')'' for

''Secretary of Health and Human Services''.

Subsec. (d)(5). Pub. L. 103-80, Sec. 3(k)(2), substituted

''section 556(c) of title 5'' for ''section 7(c) of the

Administrative Procedure Act (5 U.S.C., sec. 1006(c))''.

Subsec. (l). Pub. L. 103-80, Sec. 3(k)(3), substituted ''In the

event'' for ''It the event'' before ''a hearing is requested''.

Subsec. (n). Pub. L. 103-80, Sec. 3(k)(4), made technical

amendment to reference to section 333(c) of this title to reflect

amendment of corresponding provision of original act.

Subsec. (o). Pub. L. 103-80, Sec. 3(k)(5), which directed the

substitution of ''Administrator'' for ''Secretary of Health and

Human Services'' wherever appearing in the original text, was

executed by making the substitution in the first sentence before

''shall by regulation require'', the only place ''Secretary of

Health and Human Services'' appeared in the original text.

1992 - Subsecs. (a), (d), (h), (i), (l), (m), (o). Pub. L.

102-300 substituted ''Health and Human Services'' for ''Health,

Education, and Welfare'' wherever appearing in the original

statutory text.

Subsec. (g). Pub. L. 102-571 substituted ''379e'' for ''376''.

1984 - Subsec. (i)(5). Pub. L. 98-620 struck out provision that

required the court to advance on the docket and expedite the

disposition of all causes filed therein pursuant to this section.

1972 - Subsecs. (d)(1), (e), (l). Pub. L. 92-516 substituted

references to pesticide for references to economic poison wherever

appearing therein.

1971 - Subsec. (g). Pub. L. 92-157 struck out '', which the

Secretary shall by rules and regulations prescribe,'' after ''as

compensation for their services a reasonable per diem'' prior to

amendment in 1970, by Pub. L. 91-515, which overlooked such

language when amending subsec. (g) as provided in 1970 Amendment

note.

1970 - Subsec. (g). Pub. L. 91-515 substituted provisions

authorizing members of an advisory committee to receive

compensation and travel expenses in accordance with section

376(b)(5)(D) of this title, for provisions authorizing such members

to receive as compensation a reasonable per diem for time actually

spent on committee work, and necessary traveling and subsistence

expenses while serving away from their places of residence.

1958 - Subsec. (i)(2). Pub. L. 85-791, Sec. 20(a), in first

sentence, substituted ''transmitted by the clerk of the court to

the Secretary, or'' for ''served upon the Secretary, or upon'',

substituted ''file in the court the record of the proceedings'' for

''certify and file in the court a transcript of the proceedings and

the record'', and inserted ''as provided in section 2112 of title

28'', and which, in second sentence, substituted ''the filing of

such petition'' for ''such filing''.

Subsec. (i)(3). Pub. L. 85-791, Sec. 20(b), in first sentence,

substituted ''transmitted by the clerk of the court to the

Secretary of Agriculture, or'' for ''served upon the Secretary of

Agriculture, or upon'', substituted ''file in the court the record

of the proceedings'' for ''certify and file in the court a

transcript of the proceedings and the record'', and inserted ''as

provided in section 2112 of title 28'', and, in second sentence,

substituted ''the filing of such petition'' for ''such filing''.

EFFECTIVE DATE OF 1984 AMENDMENT

Amendment by Pub. L. 98-620 not applicable to cases pending on

Nov. 8, 1984, see section 403 of Pub. L. 98-620, set out as an

Effective Date note under section 1657 of Title 28, Judiciary and

Judicial Procedure.

EFFECTIVE DATE OF 1972 AMENDMENT

Amendment by Pub. L. 92-516 effective at close of Oct. 21, 1972,

except if regulations are necessary for implementation of any

provision that becomes effective on Oct. 21, 1972, and continuation

in effect of subchapter I of chapter 6 of Title 7, Agriculture, and

regulations thereunder, relating to control of economic poisons, as

in existence prior to Oct. 21, 1972, until superseded by provisions

of Pub. L. 92-516 and regulations thereunder, see section 4 of Pub.

L. 92-516, set out as an Effective Date note under section 136 of

Title 7.

-TRANS-

TRANSFER OF FUNCTIONS

Functions vested in Secretary of Health, Education, and Welfare

(now Health and Human Services) in establishing tolerances for

pesticide chemicals under this section together with authority to

monitor compliance with tolerances and effectiveness of

surveillance and enforcement and to provide technical assistance to

States and conduct research under this chapter and section 201 et

seq. of Title 42, The Public Health and Welfare, and functions of

Department of Agriculture and Secretary of Agriculture under

subsec. (l) of this section transferred to Administrator of

Environmental Protection Agency by Reorg. Plan No. 3 of 1970, Sec.

2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat. 2086, set out

in the Appendix to Title 5, Government Organization and Employees.

-MISC5-

DATA COLLECTION ACTIVITIES TO ASSURE HEALTH OF INFANTS AND CHILDREN

Section 301 of Pub. L. 104-170 provided that:

''(a) In General. - The Secretary of Agriculture, in consultation

with the Administrator of the Environmental Protection Agency and

the Secretary of Health and Human Services, shall coordinate the

development and implementation of survey procedures to ensure that

adequate data on food consumption patterns of infants and children

are collected.

''(b) Procedures. - To the extent practicable, the procedures

referred to in subsection (a) shall include the collection of data

on food consumption patterns of a statistically valid sample of

infants and children.

''(c) Residue Data Collection. - The Secretary of Agriculture

shall ensure that the residue data collection activities conducted

by the Department of Agriculture in cooperation with the

Environmental Protection Agency and the Department of Health and

Human Services, provide for the improved data collection of

pesticide residues, including guidelines for the use of comparable

analytical and standardized reporting methods, and the increased

sampling of foods most likely consumed by infants and children.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 331, 333, 342, 346b,

453, 601, 1033 of this title; title 7 sections 136, 136a-1, 450i;

title 42 section 300j-17.

-CITE-

21 USC Sec. 346b 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 346b. Authorization of appropriations

-STATUTE-

There are authorized to be appropriated, out of any moneys in the

Treasury not otherwise appropriated, such sums as may be necessary

for the purpose and administration of sections 321(q), (r),

342(a)(2), and 346a of this title.

-SOURCE-

(July 22, 1954, ch. 559, Sec. 4, 68 Stat. 517.)

-COD-

CODIFICATION

Section was not enacted as part of the Federal Food, Drug, and

Cosmetic Act which comprises this chapter.

-CITE-

21 USC Sec. 347 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 347. Intrastate sales of colored oleomargarine

-STATUTE-

(a) Law governing

Colored oleomargarine or colored margarine which is sold in the

same State or Territory in which it is produced shall be subject in

the same manner and to the same extent to the provisions of this

chapter as if it had been introduced in interstate commerce.

(b) Labeling and packaging requirements

No person shall sell, or offer for sale, colored oleomargarine or

colored margarine unless -

(1) such oleomargarine or margarine is packaged,

(2) the net weight of the contents of any package sold in a

retail establishment is one pound or less,

(3) there appears on the label of the package (A) the word

''oleomargarine'' or ''margarine'' in type or lettering at least

as large as any other type or lettering on such label, and (B) a

full and accurate statement of all the ingredients contained in

such oleomargarine or margarine, and

(4) each part of the contents of the package is contained in a

wrapper which bears the word ''oleomargarine'' or ''margarine''

in type or lettering not smaller than 20-point type.

The requirements of this subsection shall be in addition to and not

in lieu of any of the other requirements of this chapter.

(c) Sales in public eating places

No person shall possess in a form ready for serving colored

oleomargarine or colored margarine at a public eating place unless

a notice that oleomargarine or margarine is served is displayed

prominently and conspicuously in such place and in such manner as

to render it likely to be read and understood by the ordinary

individual being served in such eating place or is printed or is

otherwise set forth on the menu in type or lettering not smaller

than that normally used to designate the serving of other food

items. No person shall serve colored oleomargarine or colored

margarine at a public eating place, whether or not any charge is

made therefor, unless (1) each separate serving bears or is

accompanied by labeling identifying it as oleomargarine or

margarine, or (2) each separate serving thereof is triangular in

shape.

(d) Exemption from labeling requirements

Colored oleomargarine or colored margarine when served with meals

at a public eating place shall at the time of such service be

exempt from the labeling requirements of section 343 of this title

(except paragraphs (a) and (f)) if it complies with the

requirements of subsection (b) of this section.

(e) Color content of oleomargarine

For the purpose of this section colored oleomargarine or colored

margarine is oleomargarine or margarine having a tint or shade

containing more than one and six-tenths degrees of yellow, or of

yellow and red collectively, but with an excess of yellow over red,

measured in terms of Lovibond tintometer scale or its equivalent.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 407, as added Mar. 16, 1950, ch. 61,

Sec. 3(c), 64 Stat. 20.)

-MISC1-

EFFECTIVE DATE

Section 7 of act Mar. 16, 1950, provided that: ''This Act

(enacting this section and sections 347a and 347b of this title and

amending sections 331 and 342 of this title and sections 45 and 55

of Title 15, Commerce and Trade) shall become effective on July 1,

1950.''

TRANSFER OF APPROPRIATIONS

Section 5 of act Mar. 16, 1950, provided that: ''So much of the

unexpended balances of appropriations, allocations, or other funds

(including funds available for the fiscal year ending June 30,

1950) for the use of the Bureau of Internal Revenue of the Treasury

Department in the exercise of functions under the Oleomargarine Tax

Act (26 U.S.C., Sec. 2300, subchapter A) (now section 4591 et seq.

of Title 26, Internal Revenue Code), as the Director of the Bureau

of the Budget (now Director of the Office of Management and Budget)

may determine, shall be transferred to the Federal Security Agency

(Food and Drug Administration) (now the Department of Health and

Human Services) for use in the enforcement of this Act (see

Effective Date note above).''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 347b of this title.

-CITE-

21 USC Sec. 347a 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 347a. Congressional declaration of policy regarding

oleomargarine sales

-STATUTE-

The Congress finds and declares that the sale, or the serving in

public eating places, of colored oleomargarine or colored margarine

without clear identification as such or which is otherwise

adulterated or misbranded within the meaning of this chapter

depresses the market in interstate commerce for butter and for

oleomargarine or margarine clearly identified and neither

adulterated nor misbranded, and constitutes a burden on interstate

commerce in such articles. Such burden exists, irrespective of

whether such oleomargarine or margarine originates from an

interstate source or from the State in which it is sold.

-SOURCE-

(Mar. 16, 1950, ch. 61, Sec. 3(a), 64 Stat. 20.)

-COD-

CODIFICATION

Section was not enacted as part of the Federal Food, Drug, and

Cosmetic Act which comprises this chapter.

-MISC3-

EFFECTIVE DATE

Section effective July 1, 1950, see section 7 of act Mar. 16,

1950, set out as a note under section 347 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 347b of this title.

-CITE-

21 USC Sec. 347b 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 347b. Contravention of State laws

-STATUTE-

Nothing in this Act shall be construed as authorizing the

possession, sale, or serving of colored oleomargarine or colored

margarine in any State or Territory in contravention of the laws of

such State or Territory.

-SOURCE-

(Mar. 16, 1950, ch. 61, Sec. 6, 64 Stat. 22.)

-REFTEXT-

REFERENCES IN TEXT

This Act, referred to in text, is act Mar. 16, 1950, ch. 61, 64

Stat. 20, which is classified to sections 331, 342, 347 to 347b of

this title, and sections 45 and 55 of Title 15, Commerce and Trade.

For complete classification of this Act to the Code, see Tables.

-COD-

CODIFICATION

Section was not enacted as part of the Federal Food, Drug, and

Cosmetic Act which comprises this chapter.

-MISC3-

EFFECTIVE DATE

Section effective July 1, 1950, see section 7 of act Mar. 16,

1950, set out as a note under section 347 of this title.

-CITE-

21 USC Sec. 348 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 348. Food additives

-STATUTE-

(a) Unsafe food additives; exception for conformity with exemption

or regulation

A food additive shall, with respect to any particular use or

intended use of such additives, be deemed to be unsafe for the

purposes of the application of clause (2)(C) of section 342(a) of

this title, unless -

(1) it and its use or intended use conform to the terms of an

exemption which is in effect pursuant to subsection (j) of this

section;

(2) there is in effect, and it and its use or intended use are

in conformity with, a regulation issued under this section

prescribing the conditions under which such additive may be

safely used; or

(3) in the case of a food additive as defined in this chapter

that is a food contact substance, there is -

(A) in effect, and such substance and the use of such

substance are in conformity with, a regulation issued under

this section prescribing the conditions under which such

additive may be safely used; or

(B) a notification submitted under subsection (h) of this

section that is effective.

While such a regulation relating to a food additive, or such a

notification under subsection (h)(1) of this section relating to a

food additive that is a food contact substance, is in effect, and

has not been revoked pursuant to subsection (i) of this section, a

food shall not, by reason of bearing or containing such a food

additive in accordance with the regulation or notification, be

considered adulterated under section 342(a)(1) of this title.

(b) Petition for regulation prescribing conditions of safe use;

contents; description of production methods and controls;

samples; notice of regulation

(1) Any person may, with respect to any intended use of a food

additive, file with the Secretary a petition proposing the issuance

of a regulation prescribing the conditions under which such

additive may be safely used.

(2) Such petition shall, in addition to any explanatory or

supporting data, contain -

(A) the name and all pertinent information concerning such food

additive, including, where available, its chemical identity and

composition;

(B) a statement of the conditions of the proposed use of such

additive, including all directions, recommendations, and

suggestions proposed for the use of such additive, and including

specimens of its proposed labeling;

(C) all relevant data bearing on the physical or other

technical effect such additive is intended to produce, and the

quantity of such additive required to produce such effect;

(D) a description of practicable methods for determining the

quantity of such additive in or on food, and any substance formed

in or on food, because of its use; and

(E) full reports of investigations made with respect to the

safety for use of such additive, including full information as to

the methods and controls used in conducting such investigations.

(3) Upon request of the Secretary, the petitioner shall furnish

(or, if the petitioner is not the manufacturer of such additive,

the petitioner shall have the manufacturer of such additive

furnish, without disclosure to the petitioner) a full description

of the methods used in, and the facilities and controls used for,

the production of such additive.

(4) Upon request of the Secretary, the petitioner shall furnish

samples of the food additive involved, or articles used as

components thereof, and of the food in or on which the additive is

proposed to be used.

(5) Notice of the regulation proposed by the petitioner shall be

published in general terms by the Secretary within thirty days

after filing.

(c) Approval or denial of petition; time for issuance of order;

evaluation of data; factors

(1) The Secretary shall -

(A) by order establish a regulation (whether or not in accord

with that proposed by the petitioner) prescribing, with respect

to one or more proposed uses of the food additive involved, the

conditions under which such additive may be safely used

(including, but not limited to, specifications as to the

particular food or classes of food in or in which such additive

may be used, the maximum quantity which may be used or permitted

to remain in or on such food, the manner in which such additive

may be added to or used in or on such food, and any directions or

other labeling or packaging requirements for such additive deemed

necessary by him to assure the safety of such use), and shall

notify the petitioner of such order and the reasons for such

action; or

(B) by order deny the petition, and shall notify the petitioner

of such order and of the reasons for such action.

(2) The order required by paragraph (1)(A) or (B) of this

subsection shall be issued within ninety days after the date of

filing of the petition, except that the Secretary may (prior to

such ninetieth day), by written notice to the petitioner, extend

such ninety-day period to such time (not more than one hundred and

eighty days after the date of filing of the petition) as the

Secretary deems necessary to enable him to study and investigate

the petition.

(3) No such regulation shall issue if a fair evaluation of the

data before the Secretary -

(A) fails to establish that the proposed use of the food

additive, under the conditions of use to be specified in the

regulation, will be safe: Provided, That no additive shall be

deemed to be safe if it is found to induce cancer when ingested

by man or animal, or if it is found, after tests which are

appropriate for the evaluation of the safety of food additives,

to induce cancer in man or animal, except that this proviso shall

not apply with respect to the use of a substance as an ingredient

of feed for animals which are raised for food production, if the

Secretary finds (i) that, under the conditions of use and feeding

specified in proposed labeling and reasonably certain to be

followed in practice, such additive will not adversely affect the

animals for which such feed is intended, and (ii) that no residue

of the additive will be found (by methods of examination

prescribed or approved by the Secretary by regulations, which

regulations shall not be subject to subsections (f) and (g) of

this section) in any edible portion of such animal after

slaughter or in any food yielded by or derived from the living

animal; or

(B) shows that the proposed use of the additive would promote

deception of the consumer in violation of this chapter or would

otherwise result in adulteration or in misbranding of food within

the meaning of this chapter.

(4) If, in the judgment of the Secretary, based upon a fair

evaluation of the data before him, a tolerance limitation is

required in order to assure that the proposed use of an additive

will be safe, the Secretary -

(A) shall not fix such tolerance limitation at a level higher

than he finds to be reasonably required to accomplish the

physical or other technical effect for which such additive is

intended; and

(B) shall not establish a regulation for such proposed use if

he finds upon a fair evaluation of the data before him that such

data do not establish that such use would accomplish the intended

physical or other technical effect.

(5) In determining, for the purposes of this section, whether a

proposed use of a food additive is safe, the Secretary shall

consider among other relevant factors -

(A) the probable consumption of the additive and of any

substance formed in or on food because of the use of the

additive;

(B) the cumulative effect of such additive in the diet of man

or animals, taking into account any chemically or

pharmacologically related substance or substances in such diet;

and

(C) safety factors which in the opinion of experts qualified by

scientific training and experience to evaluate the safety of food

additives are generally recognized as appropriate for the use of

animal experimentation data.

(d) Regulation issued on Secretary's initiative

The Secretary may at any time, upon his own initiative, propose

the issuance of a regulation prescribing, with respect to any

particular use of a food additive, the conditions under which such

additive may be safely used, and the reasons therefor. After the

thirtieth day following publication of such a proposal, the

Secretary may by order establish a regulation based upon the

proposal.

(e) Publication and effective date of orders

Any order, including any regulation established by such order,

issued under subsection (c) or (d) of this section, shall be

published and shall be effective upon publication, but the

Secretary may stay such effectiveness if, after issuance of such

order, a hearing is sought with respect to such order pursuant to

subsection (f) of this section.

(f) Objections and public hearing; basis and contents of order;

statement

(1) Within thirty days after publication of an order made

pursuant to subsection (c) or (d) of this section, any person

adversely affected by such an order may file objections thereto

with the Secretary, specifying with particularity the provisions of

the order deemed objectionable, stating reasonable grounds

therefor, and requesting a public hearing upon such objections.

The Secretary shall, after due notice, as promptly as possible hold

such public hearing for the purpose of receiving evidence relevant

and material to the issues raised by such objections. As soon as

practicable after completion of the hearing, the Secretary shall by

order act upon such objections and make such order public.

(2) Such order shall be based upon a fair evaluation of the

entire record at such hearing, and shall include a statement

setting forth in detail the findings and conclusions upon which the

order is based.

(3) The Secretary shall specify in the order the date on which it

shall take effect, except that it shall not be made to take effect

prior to the ninetieth day after its publication, unless the

Secretary finds that emergency conditions exist necessitating an

earlier effective date, in which event the Secretary shall specify

in the order his findings as to such conditions.

(g) Judicial review

(1) In a case of actual controversy as to the validity of any

order issued under subsection (f) of this section, including any

order thereunder with respect to amendment or repeal of a

regulation issued under this section, any person who will be

adversely affected by such order may obtain judicial review by

filing in the United States Court of Appeals for the circuit

wherein such person resides or has his principal place of business,

or in the United States Court of Appeals for the District of

Columbia Circuit, within sixty days after the entry of such order,

a petition praying that the order be set aside in whole or in part.

(2) A copy of such petition shall be forthwith transmitted by the

clerk of the court to the Secretary, or any officer designated by

him for that purpose, and thereupon the Secretary shall file in the

court the record of the proceedings on which he based his order, as

provided in section 2112 of title 28. Upon the filing of such

petition the court shall have jurisdiction, which upon the filing

of the record with it shall be exclusive, to affirm or set aside

the order complained of in whole or in part. Until the filing of

the record the Secretary may modify or set aside his order. The

findings of the Secretary with respect to questions of fact shall

be sustained if based upon a fair evaluation of the entire record

at such hearing.

(3) The court, on such judicial review, shall not sustain the

order of the Secretary if he failed to comply with any requirement

imposed on him by subsection (f)(2) of this section.

(4) If application is made to the court for leave to adduce

additional evidence, the court may order such additional evidence

to be taken before the Secretary and to be adduced upon the hearing

in such manner and upon such terms and conditions as to the court

may seem proper, if such evidence is material and there were

reasonable grounds for failure to adduce such evidence in the

proceedings below. The Secretary may modify his findings as to the

facts and order by reason of the additional evidence so taken, and

shall file with the court such modified findings and order.

(5) The judgment of the court affirming or setting aside, in

whole or in part, any order under this section shall be final,

subject to review by the Supreme Court of the United States upon

certiorari or certification as provided in section 1254 of title

28. The commencement of proceedings under this section shall not,

unless specifically ordered by the court to the contrary, operate

as a stay of an order.

(h) Notification relating to food contact substance

(1) Subject to such regulations as may be promulgated under

paragraph (3), a manufacturer or supplier of a food contact

substance may, at least 120 days prior to the introduction or

delivery for introduction into interstate commerce of the food

contact substance, notify the Secretary of the identity and

intended use of the food contact substance, and of the

determination of the manufacturer or supplier that the intended use

of such food contact substance is safe under the standard described

in subsection (c)(3)(A) of this section. The notification shall

contain the information that forms the basis of the determination

and all information required to be submitted by regulations

promulgated by the Secretary.

(2)(A) A notification submitted under paragraph (1) shall become

effective 120 days after the date of receipt by the Secretary and

the food contact substance may be introduced or delivered for

introduction into interstate commerce, unless the Secretary makes a

determination within the 120-day period that, based on the data and

information before the Secretary, such use of the food contact

substance has not been shown to be safe under the standard

described in subsection (c)(3)(A) of this section, and informs the

manufacturer or supplier of such determination.

(B) A decision by the Secretary to object to a notification shall

constitute final agency action subject to judicial review.

(C) In this paragraph, the term ''food contact substance'' means

the substance that is the subject of a notification submitted under

paragraph (1), and does not include a similar or identical

substance manufactured or prepared by a person other than the

manufacturer identified in the notification.

(3)(A) The process in this subsection shall be utilized for

authorizing the marketing of a food contact substance except where

the Secretary determines that submission and review of a petition

under subsection (b) of this section is necessary to provide

adequate assurance of safety, or where the Secretary and any

manufacturer or supplier agree that such manufacturer or supplier

may submit a petition under subsection (b) of this section.

(B) The Secretary is authorized to promulgate regulations to

identify the circumstances in which a petition shall be filed under

subsection (b) of this section, and shall consider criteria such as

the probable consumption of such food contact substance and

potential toxicity of the food contact substance in determining the

circumstances in which a petition shall be filed under subsection

(b) of this section.

(4) The Secretary shall keep confidential any information

provided in a notification under paragraph (1) for 120 days after

receipt by the Secretary of the notification. After the expiration

of such 120 days, the information shall be available to any

interested party except for any matter in the notification that is

a trade secret or confidential commercial information.

(5)(A)(i) Except as provided in clause (ii), the notification

program established under this subsection shall not operate in any

fiscal year unless -

(I) an appropriation equal to or exceeding the applicable

amount under clause (iv) is made for such fiscal year for

carrying out such program in such fiscal year; and

(II) the Secretary certifies that the amount appropriated for

such fiscal year for the Center for Food Safety and Applied

Nutrition of the Food and Drug Administration (exclusive of the

appropriation referred to in subclause (I)) equals or exceeds the

amount appropriated for the Center for fiscal year 1997,

excluding any amount appropriated for new programs.

(ii) The Secretary shall, not later than April 1, 1999, begin

accepting and reviewing notifications submitted under the

notification program established under this subsection if -

(I) an appropriation equal to or exceeding the applicable

amount under clause (iii) is made for the last six months of

fiscal year 1999 for carrying out such program during such

period; and

(II) the Secretary certifies that the amount appropriated for

such period for the Center for Food Safety and Applied Nutrition

of the Food and Drug Administration (exclusive of the

appropriation referred to in subclause (I)) equals or exceeds an

amount equivalent to one-half the amount appropriated for the

Center for fiscal year 1997, excluding any amount appropriated

for new programs.

(iii) For the last six months of fiscal year 1999, the applicable

amount under this clause is $1,500,000, or the amount specified in

the budget request of the President for the six-month period

involved for carrying out the notification program in fiscal year

1999, whichever is less.

(iv) For fiscal year 2000 and subsequent fiscal years, the

applicable amount under this clause is $3,000,000, or the amount

specified in the budget request of the President for the fiscal

year involved for carrying out the notification program under this

subsection, whichever is less.

(B) For purposes of carrying out the notification program under

this subsection, there are authorized to be appropriated such sums

as may be necessary for each of the fiscal years 1999 through

fiscal year 2003, except that such authorization of appropriations

is not effective for a fiscal year for any amount that is less than

the applicable amount under clause (iii) or (iv) of subparagraph

(A), whichever is applicable.

(C) Not later than April 1 of fiscal year 1998 and February 1 of

each subsequent fiscal year, the Secretary shall submit a report to

the Committees on Appropriations of the House of Representatives

and the Senate, the Committee on Commerce of the House of

Representatives, and the Committee on Labor and Human Resources of

the Senate that provides an estimate of the Secretary of the costs

of carrying out the notification program established under this

subsection for the next fiscal year.

(6) In this section, the term ''food contact substance'' means

any substance intended for use as a component of materials used in

manufacturing, packing, packaging, transporting, or holding food if

such use is not intended to have any technical effect in such food.

(i) Amendment or repeal of regulations

The Secretary shall by regulation prescribe the procedure by

which regulations under the foregoing provisions of this section

may be amended or repealed, and such procedure shall conform to the

procedure provided in this section for the promulgation of such

regulations. The Secretary shall by regulation prescribe the

procedure by which the Secretary may deem a notification under

subsection (h) of this section to no longer be effective.

(j) Exemptions for investigational use

Without regard to subsections (b) to (i), inclusive, of this

section, the Secretary shall by regulation provide for exempting

from the requirements of this section any food additive, and any

food bearing or containing such additive, intended solely for

investigational use by qualified experts when in his opinion such

exemption is consistent with the public health.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 409, as added Pub. L. 85-929, Sec. 4,

Sept. 6, 1958, 72 Stat. 1785; amended Pub. L. 86-546, Sec. 2, June

29, 1960, 74 Stat. 255; Pub. L. 87-781, title I, Sec. 104(f)(1),

Oct. 10, 1962, 76 Stat. 785; Pub. L. 98-620, title IV, Sec.

402(25)(B), Nov. 8, 1984, 98 Stat. 3359; Pub. L. 105-115, title

III, Sec. 309, Nov. 21, 1997, 111 Stat. 2354.)

-MISC1-

AMENDMENTS

1997 - Subsec. (a). Pub. L. 105-115, Sec. 309(a)(4), in closing

provisions, substituted ''While such a regulation relating to a

food additive, or such a notification under subsection (h)(1) of

this section relating to a food additive that is a food contact

substance, is in effect, and has not been revoked pursuant to

subsection (i) of this section, a food shall not, by reason of

bearing or containing such a food additive in accordance with the

regulation or notification, be considered adulterated under section

342(a)(1) of this title.'' for ''While such a regulation relating

to a food additive is in effect, a food shall not, by reason of

bearing or containing such an additive in accordance with the

regulation, be considered adulterated within the meaning of clause

(1) of section 342(a) of this title.''

Subsec. (a)(1). Pub. L. 105-115, Sec. 309(a)(1), substituted

''subsection (j)'' for ''subsection (i)''.

Subsec. (a)(3). Pub. L. 105-115, Sec. 309(a)(1)(B), (2), (3),

added par. (3).

Subsec. (h). Pub. L. 105-115, Sec. 309(b)(2), added subsec. (h).

Former subsec. (h) redesignated (i).

Subsec. (i). Pub. L. 105-115, Sec. 309(b)(1), (3), redesignated

subsec. (h) as (i) and inserted at end ''The Secretary shall by

regulation prescribe the procedure by which the Secretary may deem

a notification under subsection (h) of this section to no longer be

effective.''

Subsec. (j). Pub. L. 105-115, Sec. 309(b)(1), (4), redesignated

subsec. (i) as (j) and substituted ''subsections (b) to (i)'' for

''subsections (b) to (h)''.

1984 - Subsec. (g)(2). Pub. L. 98-620 struck out provision that

required the court to advance on the docket and expedite the

disposition of all causes filed therein pursuant to this section.

1962 - Subsec. (c)(3)(A). Pub. L. 87-781 excepted proviso from

applying to use of a substance as an ingredient of feed for animals

raised for food production, if under conditions of use specified in

proposed labeling, and which conditions are reasonably certain to

be followed in practice, such additive will not adversely affect

the animals and no residue will be found in any edible portion of

such animal after slaughter, or in any food from the living animal.

1960 - Subsec. (g)(2). Pub. L. 86-546 substituted ''forthwith

transmitted by the clerk of the court to the Secretary, or any

officer'' for ''served upon the Secretary, or upon any officer'',

''shall file in the court the record of the proceedings on which he

based his order, as provided in section 2112 of title 28'' for

''shall certify and file in the court a transcript of the

proceedings and the record on which he based his order'', and

''Upon the filing of such petition the court shall have

jurisdiction, which upon the filing of the record with it shall be

exclusive,'' for ''Upon such filing, the court shall have exclusive

jurisdiction'', and inserted sentence authorizing the Secretary to

modify or set aside his order until the filing of the record.

-CHANGE-

CHANGE OF NAME

Committee on Commerce of House of Representatives changed to

Committee on Energy and Commerce of House of Representatives, and

jurisdiction over matters relating to securities and exchanges and

insurance generally transferred to Committee on Financial Services

of House of Representatives by House Resolution No. 5, One Hundred

Seventh Congress, Jan. 3, 2001.

-MISC4-

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,

1997, except as otherwise provided, see section 501 of Pub. L.

105-115, set out as a note under section 321 of this title.

EFFECTIVE DATE OF 1984 AMENDMENT

Amendment by Pub. L. 98-620 not applicable to cases pending on

Nov. 8, 1984, see section 403 of Pub. L. 98-620, set out as an

Effective Date note under section 1657 of Title 28, Judiciary and

Judicial Procedure.

EFFECTIVE DATE OF 1962 AMENDMENT; EXCEPTIONS

Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section

107 of Pub. L. 87-781, set out as an Effective Date of 1962

Amendment note under section 321 of this title.

EFFECTIVE DATE

Section effective Sept. 6, 1958, see section 6(a) of Pub. L.

85-929, set out as an Effective Date of 1958 Amendment note under

section 342 of this title.

-TRANS-

TRANSFER OF FUNCTIONS

Functions vested in Secretary of Health, Education, and Welfare

(now Health and Human Services) in establishing tolerances for

pesticide chemicals under this section together with authority to

monitor compliance with tolerances and effectiveness of

surveillance and enforcement and to provide technical assistance to

States and conduct research under this chapter and section 201 et

seq. of Title 42, The Public Health and Welfare, transferred to

Administrator of Environmental Protection Agency by Reorg. Plan No.

3 of 1970, Sec. 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84

Stat. 2086, set out in the Appendix to Title 5, Government

Organization and Employees.

-MISC5-

GLASS AND CERAMIC WARE

Section 308 of Pub. L. 105-115 provided that:

''(a) In General. - The Secretary may not implement any

requirement which would ban, as an unapproved food additive, lead

and cadmium based enamel in the lip and rim area of glass and

ceramic ware before the expiration of one year after the date such

requirement is published.

''(b) Lead and Cadmium Based Enamel. - Unless the Secretary

determines, based on available data, that lead and cadmium based

enamel on glass and ceramic ware -

''(1) which has less than 60 millimeters of decorating area

below the external rim, and

''(2) which is not, by design, representation, or custom of

usage intended for use by children,

is unsafe, the Secretary shall not take any action before January

1, 2003, to ban lead and cadmium based enamel on such glass and

ceramic ware. Any action taken after January 1, 2003, to ban such

enamel on such glass and ceramic ware as an unapproved food

additive shall be taken by regulation and such regulation shall

provide that such products shall not be removed from the market

before 1 year after publication of the final regulation.''

MORATORIUM ON AUTHORITY OF SECRETARY WITH RESPECT TO SACCHARIN

Pub. L. 95-203, Sec. 3, Nov. 23, 1977, 91 Stat. 1452, as amended

by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.

695; Pub. L. 96-273, June 17, 1980, 94 Stat. 536; Pub. L. 97-42,

Sec. 2, Aug. 14, 1981, 95 Stat. 946; Pub. L. 98-22, Sec. 2, Apr.

22, 1983, 97 Stat. 173; Pub. L. 99-46, May 24, 1985, 99 Stat. 81;

Pub. L. 100-71, title I, Sec. 101, July 11, 1987, 101 Stat. 431;

Pub. L. 102-142, title VI, Oct. 28, 1991, 105 Stat. 910; Pub. L.

104-180, title VI, Sec. 602, Aug. 6, 1996, 110 Stat. 1594, provided

that: ''During the period ending May 1, 2002, the Secretary -

''(1) may not amend or revoke the interim food additive

regulation of the Food and Drug Administration of the Department

of Health and Human Services applicable to saccharin and

published on March 15, 1977 (section 180.37 of part 180,

subchapter B, chapter 1, title 21, Code of Federal Regulations

(42 Fed. Reg. 14638)), or

''(2) may, except as provided in section 4 (enacting section

343a of this title, amending sections 321 and 343 of this title,

and enacting provisions set out as notes under section 343 of

this title) and the amendments made by such section, not take any

other action under the Federal Food, Drug, and Cosmetic Act (this

chapter) to prohibit or restrict the sale or distribution of

saccharin, any food permitted by such interim food additive

regulation to contain saccharin, or any drug or cosmetic

containing saccharin,

solely on the basis of the carcinogenic or other toxic effect of

saccharin as determined by any study made available to the

Secretary before the date of the enactment of this Act (Nov. 23,

1977) which involved human studies or animal testing, or both.''

For definition of ''saccharin'' as used in this note, see section

2(d) of Pub. L. 95-203.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 331, 342, 343-3,

346a, 379e, 453, 601, 1033 of this title; title 7 sections 136,

450i; title 15 section 1262; title 35 section 155.

-CITE-

21 USC Sec. 349 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 349. Bottled drinking water standards; publication in Federal

Register

-STATUTE-

(a) Except as provided in subsection (b) of this section,

whenever the Administrator of the Environmental Protection Agency

prescribes interim or revised national primary drinking water

regulations under section 1412 of the Public Health Service Act (42

U.S.C. 300g-1), the Secretary shall consult with the Administrator

and within 180 days after the promulgation of such drinking water

regulations either promulgate amendments to regulations under this

chapter applicable to bottled drinking water or publish in the

Federal Register his reasons for not making such amendments.

(b)(1) Not later than 180 days before the effective date of a

national primary drinking water regulation promulgated by the

Administrator of the Environmental Protection Agency for a

contaminant under section 1412 of the Safe Drinking Water Act (42

U.S.C. 300g-1), the Secretary shall promulgate a standard of

quality regulation under this subsection for that contaminant in

bottled water or make a finding that such a regulation is not

necessary to protect the public health because the contaminant is

contained in water in public water systems (as defined under

section 1401(4) of such Act (42 U.S.C. 300f(4))) but not in water

used for bottled drinking water. The effective date for any such

standard of quality regulation shall be the same as the effective

date for such national primary drinking water regulation, except

for any standard of quality of regulation promulgated by the

Secretary before August 6, 1996, for which (as of August 6, 1996)

an effective date had not been established. In the case of a

standard of quality regulation to which such exception applies, the

Secretary shall promulgate monitoring requirements for the

contaminants covered by the regulation not later than 2 years after

August 6, 1996.

(2) A regulation issued by the Secretary as provided in this

subsection shall include any monitoring requirements that the

Secretary determines appropriate for bottled water.

(3) A regulation issued by the Secretary as provided in this

subsection shall require the following:

(A) In the case of contaminants for which a maximum contaminant

level is established in a national primary drinking water

regulation under section 1412 of the Safe Drinking Water Act (42

U.S.C. 300g-1), the regulation under this subsection shall

establish a maximum contaminant level for the contaminant in

bottled water which is no less stringent than the maximum

contaminant level provided in the national primary drinking water

regulation.

(B) In the case of contaminants for which a treatment technique

is established in a national primary drinking water regulation

under section 1412 of the Safe Drinking Water Act (42 U.S.C.

300g-1), the regulation under this subsection shall require that

bottled water be subject to requirements no less protective of

the public health than those applicable to water provided by

public water systems using the treatment technique required by

the national primary drinking water regulation.

(4)(A) If the Secretary does not promulgate a regulation under

this subsection within the period described in paragraph (1), the

national primary drinking water regulation referred to in paragraph

(1) shall be considered, as of the date on which the Secretary is

required to establish a regulation under paragraph (1), as the

regulation applicable under this subsection to bottled water.

(B) In the case of a national primary drinking water regulation

that pursuant to subparagraph (A) is considered to be a standard of

quality regulation, the Secretary shall, not later than the

applicable date referred to in such subparagraph, publish in the

Federal Register a notice -

(i) specifying the contents of such regulation, including

monitoring requirements; and

(ii) providing that for purposes of this paragraph the

effective date for such regulation is the same as the effective

date for the regulation for purposes of the Safe Drinking Water

Act (42 U.S.C. 300f et seq.) (or, if the exception under

paragraph (1) applies to the regulation, that the effective date

for the regulation is not later than 2 years and 180 days after

August 6, 1996).

-SOURCE-

(June 25, 1938, ch. 675, Sec. 410, as added Pub. L. 93-523, Sec. 4,

Dec. 16, 1974, 88 Stat. 1694; amended Pub. L. 104-182, title III,

Sec. 305, Aug. 6, 1996, 110 Stat. 1684.)

-REFTEXT-

REFERENCES IN TEXT

The Safe Drinking Water Act, referred to in subsec.

(b)(4)(B)(ii), is title XIV of act July 1, 1944, as added Dec. 16,

1974, Pub. L. 93-523, Sec. 2(a), 88 Stat. 1660, as amended, which

is classified generally to subchapter XII (Sec. 300f et seq.) of

chapter 6A of Title 42, The Public Health and Welfare. For complete

classification of this Act to the Code, see Short Title note set

out under section 201 of Title 42 and Tables.

-MISC2-

AMENDMENTS

1996 - Pub. L. 104-182 substituted ''(a) Except as provided in

subsection (b) of this section, whenever'' for ''Whenever'' and

added subsec. (b).

BOTTLED WATER STUDY

Section 114(b) of Pub. L. 104-182 provided that: ''Not later than

18 months after the date of enactment of this Act (Aug. 6, 1996),

the Administrator of the Food and Drug Administration, in

consultation with the Administrator of the Environmental Protection

Agency, shall publish for public notice and comment a draft study

on the feasibility of appropriate methods, if any, of informing

customers of the contents of bottled water. The Administrator of

the Food and Drug Administration shall publish a final study not

later than 30 months after the date of enactment of this Act.''

-CITE-

21 USC Sec. 350 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 350. Vitamins and minerals

-STATUTE-

(a) Authority and limitations of Secretary; applicability

(1) Except as provided in paragraph (2) -

(A) the Secretary may not establish, under section 321(n), 341,

or 343 of this title, maximum limits on the potency of any

synthetic or natural vitamin or mineral within a food to which

this section applies;

(B) the Secretary may not classify any natural or synthetic

vitamin or mineral (or combination thereof) as a drug solely

because it exceeds the level of potency which the Secretary

determines is nutritionally rational or useful;

(C) the Secretary may not limit, under section 321(n), 341, or

343 of this title, the combination or number of any synthetic or

natural -

(i) vitamin,

(ii) mineral, or

(iii) other ingredient of food,

within a food to which this section applies.

(2) Paragraph (1) shall not apply in the case of a vitamin,

mineral, other ingredient of food, or food, which is represented

for use by individuals in the treatment or management of specific

diseases or disorders, by children, or by pregnant or lactating

women. For purposes of this subparagraph, (FOOTNOTE 1) the term

''children'' means individuals who are under the age of twelve

years.

(FOOTNOTE 1) So in original. Probably should be ''paragraph''.

(b) Labeling and advertising requirements for foods

(1) A food to which this section applies shall not be deemed

under section 343 of this title to be misbranded solely because its

label bears, in accordance with section 343(i)(2) of this title,

all the ingredients in the food or its advertising contains

references to ingredients in the food which are not vitamins or

minerals.

(2) The labeling for any food to which this section applies may

not list its ingredients which are not dietary supplement

ingredients described in section 321(ff) of this title (i) except

as a part of a list of all the ingredients of such food, and (ii)

unless such ingredients are listed in accordance with applicable

regulations under section 343 of this title. To the extent that

compliance with clause (i) of this subparagraph is impracticable or

results in deception or unfair competition, exemptions shall be

established by regulations promulgated by the Secretary.

(c) Definitions

(1) For purposes of this section, the term ''food to which this

section applies'' means a food for humans which is a food for

special dietary use -

(A) which is or contains any natural or synthetic vitamin or

mineral, and

(B) which -

(i) is intended for ingestion in tablet, capsule, powder,

softgel, gelcap, or liquid form, or

(ii) if not intended for ingestion in such a form, is not

represented as conventional food and is not represented for use

as a sole item of a meal or of the diet.

(2) For purposes of paragraph (1)(B)(i), a food shall be

considered as intended for ingestion in liquid form only if it is

formulated in a fluid carrier and it is intended for ingestion in

daily quantities measured in drops or similar small units of

measure.

(3) For purposes of paragraph (1) and of section 343(j) of this

title insofar as that section is applicable to food to which this

section applies, the term ''special dietary use'' as applied to

food used by man means a particular use for which a food purports

or is represented to be used, including but not limited to the

following:

(A) Supplying a special dietary need that exists by reason of a

physical, physiological, pathological, or other condition,

including but not limited to the condition of disease,

convalescence, pregnancy, lactation, infancy, allergic

hypersensitivity to food, underweight, overweight, or the need to

control the intake of sodium.

(B) Supplying a vitamin, mineral, or other ingredient for use

by man to supplement his diet by increasing the total dietary

intake.

(C) Supplying a special dietary need by reason of being a food

for use as the sole item of the diet.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 411, as added Pub. L. 94-278, title

V, Sec. 501(a), Apr. 22, 1976, 90 Stat. 410; amended Pub. L.

103-417, Sec. 3(c), 7(d), Oct. 25, 1994, 108 Stat. 4328, 4331.)

-MISC1-

AMENDMENTS

1994 - Subsec. (b)(2). Pub. L. 103-417, Sec. 7(d), redesignated

subpar. (A) as par. (2), substituted ''dietary supplement

ingredients described in section 321(ff) of this title'' for

''vitamins or minerals'', and struck out former subpar. (B), which

read as follows: ''Notwithstanding the provisions of subparagraph

(A), the labeling and advertising for any food to which this

section applies may not give prominence to or emphasize ingredients

which are not -

''(i) vitamins,

''(ii) minerals, or

''(iii) represented as a source of vitamins or minerals.''

Subsec. (c)(1)(B)(i). Pub. L. 103-417, Sec. 3(c)(1), inserted

''powder, softgel, gelcap,'' after ''capsule,''.

Subsec. (c)(1)(B)(ii). Pub. L. 103-417, Sec. 3(c)(2), struck out

''does not simulate and'' after ''in such a form,''.

EFFECTIVE DATE OF 1994 AMENDMENT

For provision that dietary supplements may be labeled after Oct.

25, 1994, in accordance with amendments made by section 7(d) of

Pub. L. 103-417, and shall be so labeled after Dec. 31, 1996, see

section 7(e) of Pub. L. 103-417, set out as a note under section

343 of this title.

AMENDMENT OF INCONSISTENT REGULATIONS BY SECRETARY

Section 501(b) of Pub. L. 94-278, as amended by Pub. L. 96-88,

title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695, provided that:

''The Secretary of Health and Human Services shall amend any

regulation promulgated under the Federal Food, Drug, and Cosmetic

Act (this chapter) which is inconsistent with section 411 of such

Act (section 350 of this title) (as added by subsection (a)) and

such amendments shall be promulgated in accordance with section 553

of title 5, United States Code.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 343 of this title.

-CITE-

21 USC Sec. 350a 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 350a. Infant formulas

-STATUTE-

(a) Adulteration

An infant formula, including an infant formula powder, shall be

deemed to be adulterated if -

(1) such infant formula does not provide nutrients as required

by subsection (i) of this section,

(2) such infant formula does not meet the quality factor

requirements prescribed by the Secretary under subsection (b)(1)

of this section, or

(3) the processing of such infant formula is not in compliance

with the good manufacturing practices and the quality control

procedures prescribed by the Secretary under subsection (b)(2) of

this section.

(b) Requirements for quality factors, good manufacturing practices,

and retention of records

(1) The Secretary shall by regulation establish requirements for

quality factors for infant formulas to the extent possible

consistent with current scientific knowledge, including quality

factor requirements for the nutrients required by subsection (i) of

this section.

(2)(A) The Secretary shall by regulation establish good

manufacturing practices for infant formulas, including quality

control procedures that the Secretary determines are necessary to

assure that an infant formula provides nutrients in accordance with

this subsection and subsection (i) of this section and is

manufactured in a manner designed to prevent adulteration of the

infant formula.

(B) The good manufacturing practices and quality control

procedures prescribed by the Secretary under subparagraph (A) shall

include requirements for -

(i) the testing, in accordance with paragraph (3) and by the

manufacturer of an infant formula or an agent of such

manufacturer, of each batch of infant formula for each nutrient

required by subsection (i) of this section before the

distribution of such batch,

(ii) regularly scheduled testing, by the manufacturer of an

infant formula or an agent of such manufacturer, of samples of

infant formulas during the shelf life of such formulas to ensure

that such formulas are in compliance with this section,

(iii) in-process controls including, where necessary, testing

required by good manufacturing practices designed to prevent

adulteration of each batch of infant formula, and

(iv) the conduct by the manufacturer of an infant formula or an

agent of such manufacturer of regularly scheduled audits to

determine that such manufacturer has complied with the

regulations prescribed under subparagraph (A).

In prescribing requirements for audits under clause (iv), the

Secretary shall provide that such audits be conducted by

appropriately trained individuals who do not have any direct

responsibility for the manufacture or production of infant formula.

(3)(A) At the final product stage, each batch of infant formula

shall be tested for vitamin A, vitamin B1, vitamin C, and vitamin E

to ensure that such infant formula is in compliance with the

requirements of this subsection and subsection (i) of this section

relating to such vitamins.

(B) Each nutrient premix used in the manufacture of an infant

formula shall be tested for each relied upon nutrient required by

subsection (i) of this section which is contained in such premix to

ensure that such premix is in compliance with its specifications or

certifications by a premix supplier.

(C) During the manufacturing process or at the final product

stage and before distribution of an infant formula, an infant

formula shall be tested for all nutrients required to be included

in such formula by subsection (i) of this section for which testing

has not been conducted pursuant to subparagraph (A) or (B). Testing

under this subparagraph shall be conducted to -

(i) ensure that each batch of such infant formula is in

compliance with the requirements of subsection (i) of this

section relating to such nutrients, and

(ii) confirm that nutrients contained in any nutrient premix

used in such infant formula are present in each batch of such

infant formula in the proper concentration.

(D) If the Secretary adds a nutrient to the list of nutrients in

the table in subsection (i) of this section, the Secretary shall by

regulation require that the manufacturer of an infant formula test

each batch of such formula for such new nutrient in accordance with

subparagraph (A), (B), or (C).

(E) For purposes of this paragraph, the term ''final product

stage'' means the point in the manufacturing process, before

distribution of an infant formula, at which an infant formula is

homogenous and is not subject to further degradation.

(4)(A) The Secretary shall by regulation establish requirements

respecting the retention of records. Such requirements shall

provide for -

(i) the retention of all records necessary to demonstrate

compliance with the good manufacturing practices and quality

control procedures prescribed by the Secretary under paragraph

(2), including records containing the results of all testing

required under paragraph (2)(B),

(ii) the retention of all certifications or guarantees of

analysis by premix suppliers,

(iii) the retention by a premix supplier of all records

necessary to confirm the accuracy of all premix certifications

and guarantees of analysis,

(iv) the retention of -

(I) all records pertaining to the microbiological quality and

purity of raw materials used in infant formula powder and in

finished infant formula, and

(II) all records pertaining to food packaging materials which

show that such materials do not cause an infant formula to be

adulterated within the meaning of section 342(a)(2)(C) of this

title,

(v) the retention of all records of the results of regularly

scheduled audits conducted pursuant to the requirements

prescribed by the Secretary under paragraph (2)(B)(iv), and

(vi) the retention of all complaints and the maintenance of

files with respect to, and the review of, complaints concerning

infant formulas which may reveal the possible existence of a

hazard to health.

(B)(i) Records required under subparagraph (A) with respect to an

infant formula shall be retained for at least one year after the

expiration of the shelf life of such infant formula. Except as

provided in clause (ii), such records shall be made available to

the Secretary for review and duplication upon request of the

Secretary.

(ii) A manufacturer need only provide written assurances to the

Secretary that the regularly scheduled audits required by paragraph

(2)(B)(iv) are being conducted by the manufacturer, and need not

make available to the Secretary the actual written reports of such

audits.

(c) Registration of persons distributing new infant formula

(1) No person shall introduce or deliver for introduction into

interstate commerce any new infant formula unless -

(A) such person has, before introducing such new infant

formula, or delivering such new infant formula for introduction,

into interstate commerce, registered with the Secretary the name

of such person, the place of business of such person, and all

establishments at which such person intends to manufacture such

new infant formula, and

(B) such person has at least 90 days before marketing such new

infant formula, made the submission to the Secretary required by

subsection (c)(1) of this section.

(2) For purposes of paragraph (1), the term ''new infant

formula'' includes -

(A) an infant formula manufactured by a person which has not

previously manufactured an infant formula, and

(B) an infant formula manufactured by a person which has

previously manufactured infant formula and in which there is a

major change, in processing or formulation, from a current or any

previous formulation produced by such manufacturer.

For purposes of this paragraph, the term ''major change'' has the

meaning given to such term in section 106.30(c)(2) of title 21,

Code of Federal Regulations (as in effect on August 1, 1986), and

guidelines issued thereunder.

(d) Submission of information about new infant formula required

(1) A person shall, with respect to any infant formula subject to

subsection (c) of this section, make a submission to the Secretary

which shall include -

(A) the quantitative formulation of the infant formula,

(B) a description of any reformulation of the formula or change

in processing of the infant formula,

(C) assurances that the infant formula will not be marketed

unless it meets the requirements of subsections (b)(1) and (i) of

this section, as demonstrated by the testing required under

subsection (b)(3) of this section, and

(D) assurances that the processing of the infant formula

complies with subsection (b)(2) of this section.

(2) After the first production of an infant formula subject to

subsection (c) of this section, and before the introduction into

interstate commerce of such formula, the manufacturer of such

formula shall submit to the Secretary, in such form as may be

prescribed by the Secretary, a written verification which

summarizes test results and records demonstrating that such formula

complies with the requirements of subsections (b)(1), (b)(2)(A),

(b)(2)(B)(i), (b)(2)(B)(iii), (b)(3)(A), (b)(3)(C), and (i) of this

section.

(3) If the manufacturer of an infant formula for commercial or

charitable distribution for human consumption determines that a

change in the formulation of the formula or a change in the

processing of the formula may affect whether the formula is

adulterated under subsection (a) of this section, the manufacturer

shall, before the first processing of such formula, make the

submission to the Secretary required by paragraph (1).

(e) Additional notice requirements for manufacturer

(1) If the manufacturer of an infant formula has knowledge which

reasonably supports the conclusion that an infant formula which has

been processed by the manufacturer and which has left an

establishment subject to the control of the manufacturer -

(A) may not provide the nutrients required by subsection (i) of

this section, or

(B) may be otherwise adulterated or misbranded,

the manufacturer shall promptly notify the Secretary of such

knowledge. If the Secretary determines that the infant formula

presents a risk to human health, the manufacturer shall immediately

take all actions necessary to recall shipments of such infant

formula from all wholesale and retail establishments, consistent

with recall regulations and guidelines issued by the Secretary.

(2) For purposes of paragraph (1), the term ''knowledge'' as

applied to a manufacturer means (A) the actual knowledge that the

manufacturer had, or (B) the knowledge which a reasonable person

would have had under like circumstances or which would have been

obtained upon the exercise of due care.

(f) Procedures applicable to recalls by manufacturer; regulatory

oversight

(1) If a recall of infant formula is begun by a manufacturer, the

recall shall be carried out in accordance with such requirements as

the Secretary shall prescribe under paragraph (2) and -

(A) the Secretary shall, not later than the 15th day after the

beginning of such recall and at least once every 15 days

thereafter until the recall is terminated, review the actions

taken under the recall to determine whether the recall meets the

requirements prescribed under paragraph (2), and

(B) the manufacturer shall, not later than the 14th day after

the beginning of such recall and at least once every 14 days

thereafter until the recall is terminated, report to the

Secretary the actions taken to implement the recall.

(2) The Secretary shall by regulation prescribe the scope and

extent of recalls of infant formulas necessary and appropriate for

the degree of risks to human health presented by the formula

subject to the recall.

(3) The Secretary shall by regulation require each manufacturer

of an infant formula who begins a recall of such formula because of

a risk to human health to request each retail establishment at

which such formula is sold or available for sale to post at the

point of purchase of such formula a notice of such recall at such

establishment for such time that the Secretary determines necessary

to inform the public of such recall.

(g) Recordkeeping requirements for manufacturer; regulatory

oversight and enforcement

(1) Each manufacturer of an infant formula shall make and retain

such records respecting the distribution of the infant formula

through any establishment owned or operated by such manufacturer as

may be necessary to effect and monitor recalls of the formula.

Such records shall be retained for at least one year after the

expiration of the shelf life of the infant formula.

(2) To the extent that the Secretary determines that records are

not being made or maintained in accordance with paragraph (1), the

Secretary may by regulation prescribe the records required to be

made under paragraph (1) and requirements respecting the retention

of such records under such paragraph. Such regulations shall take

effect on such date as the Secretary prescribes but not sooner than

the 180th day after the date such regulations are promulgated.

Such regulations shall apply only with respect to distributions of

infant formulas made after such effective date.

(h) Exemptions; regulatory oversight

(1) Any infant formula which is represented and labeled for use

by an infant -

(A) who has an inborn error of metabolism or a low birth

weight, or

(B) who otherwise has an unusual medical or dietary problem,

is exempt from the requirements of subsections (a), (b), and (c) of

this section. The manufacturer of an infant formula exempt under

this paragraph shall, in the case of the exempt formula, be

required to provide the notice required by subsection (e)(1) of

this section only with respect to adulteration or misbranding

described in subsection (e)(1)(B) of this section and to comply

with the regulations prescribed by the Secretary under paragraph

(2).

(2) The Secretary may by regulation establish terms and

conditions for the exemption of an infant formula from the

requirements of subsections (a), (b), and (c) of this section. An

exemption of an infant formula under paragraph (1) may be withdrawn

by the Secretary if such formula is not in compliance with

applicable terms and conditions prescribed under this paragraph.

(i) Nutrient requirements

(1) An infant formula shall contain nutrients in accordance with

the table set out in this subsection or, if revised by the

Secretary under paragraph (2), as so revised.

(2) The Secretary may by regulation -

(A) revise the list of nutrients in the table in this

subsection, and

(B) revise the required level for any nutrient required by the

table.

NUTRIENTS

---------------------------------------------------------------------

Nutrient : :Minimum a :Maximum a

---------------------------------------------------------------------

Protein (gm) :1.8 b : : 4.5.

Fat: : : :

gm :3.3 : : 6.0.

percent cal :30.0 : : 54.0.

Essential fatty: : :

acids : : :

(linoeate): : : :

percent cal :2.7 : :

mg :300.0 : :

Vitamins: : : :

A (IU) :250.0 :(75 mg)c :750.0 (225

: : : mg).c

D (IU) :40.0 : :100.0.

K (mg) :4.0 : :

E (IU) :0.7 :(with 0.7 IU/gm:

: : linoleic acid):

C (ascorbic :8.0 : :

acid) (mg) : : :

B1 (thiamine) :40.0 : :

(mg) : : :

B2 (riboflavin):60.0 : :

(mg) : : :

B6 (pyridoxine):35.0 :(with 15 mg/gm :

(mg) : : of protein in :

: : formula) :

B12 (mg) :0.15 : :

Niacin (mg) :250.0 : :

Folic acid (mg):4.0 : :

Pantothenic :300.0 : :

acid (mg) : : :

Biotin (mg) :1.5 d : :

Choline (mg) :7.0 d : :

Inositol (mg) :4.0 d : :

Minerals: : : :

Calcium (mg) :50.0 e : :

Phosphorus (mg):25.0 e : :

Magnesium (mg) :6.0 : :

Iron (mg) :0.15 : :

Iodine (mg) :5.0 : :

Zinc (mg) :0.5 : :

Copper (mg) :60.0 : :

Manganese (mg) :5.0 : :

Sodium (mg) :20.0 : : 60.0.

Potassium (mg) :80.0 : :200.0.

Chloride (mg) :55.0 : :150.0.

-------------------------------

a Stated per 100 kilocalories.

b The source of protein shall be at least nutritionally equivalent

to casein.

c Retinol equivalents.

d Required to be included in this amount only in formulas which are

not milk-based.

e Calcium to phosphorus ratio must be no less than 1.1 nor more than

2.0.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 412, as added Pub. L. 96-359, Sec. 2,

Sept. 26, 1980, 94 Stat. 1190; amended Pub. L. 99-570, title IV,

Sec. 4014(a), (b)(1), Oct. 27, 1986, 100 Stat. 3207-116, 3207-120;

Pub. L. 103-80, Sec. 3(l), Aug. 13, 1993, 107 Stat. 777.)

-MISC1-

AMENDMENTS

1993 - Subsec. (h)(1). Pub. L. 103-80 substituted ''(e)(1)(B) of

this section'' for ''(c)(1)(B) of this section,'' in concluding

provisions.

1986 - Subsecs. (a) to (d). Pub. L. 99-570, Sec. 4014(a)(7),

added subsecs. (a) to (d) and struck out former subsecs. (a)

relating to adulteration and regulatory oversight, (b) relating to

notice to the Secretary by a manufacturer and requirements and

scope of that notice, (c) relating to additional notice

requirements for the manufacturer, and (d) relating to procedures

applicable to recalls by a manufacturer.

Subsecs. (e), (f). Pub. L. 99-570, Sec. 4014(a)(1), (7), added

subsecs. (e) and (f) and redesignated former subsecs. (e) and (f)

as (g) and (h), respectively.

Subsec. (g). Pub. L. 99-570, Sec. 4014(a)(1), (2), redesignated

subsec. (e) as (g) and substituted ''Such records shall be retained

for at least one year after the expiration of the shelf life of the

infant formula'' for ''No manufacturer shall be required under this

subsection to retain any record respecting the distribution of an

infant formula for a period of longer than 2 years from the date

the record was made''. Former subsec. (g) redesignated (i).

Subsec. (h). Pub. L. 99-570, Sec. 4014(a)(1), redesignated

subsec. (f) as (h).

Subsec. (h)(1). Pub. L. 99-570, Sec. 4014(a)(3), (4), substituted

''(a), (b), and (c)'' for ''(a) and (b)'' and ''(e)(1)'' for

''(c)(1)''.

Pub. L. 99-570, Sec. 4014(a)(5), which directed that

''(d)(1)(B)'' be substituted for ''(e)(1)(B)'' in second sentence

could not be executed because ''(e)(1)(B)'' did not appear. See

1993 Amendment note above.

Subsec. (h)(2). Pub. L. 99-570, Sec. 4014(a)(6), substituted

''(a), (b), and (c)'' for ''(a) and (b)''.

Subsec. (i). Pub. L. 99-570, Sec. 4014(a)(1), (b)(1),

redesignated subsec. (g) as (i), designated existing provisions as

par. (1), substituted ''paragraph (2)'' for ''subsection (a)(2) of

this section'', substituted a period for the colon after ''as so

revised'', and added par. (2).

EFFECTIVE DATE OF 1980 AMENDMENT

Section 6 of Pub. L. 96-359 provided that: ''Section 412 of the

Federal Food, Drug, and Cosmetic Act (added by section 2) (this

section) shall apply with respect to infant formulas manufactured

on or after the 90th day after the date of the enactment of this

Act (Sept. 26, 1980).''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 343, 374 of this

title.

-CITE-

21 USC Sec. 350b 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 350b. New dietary ingredients

-STATUTE-

(a) In general

A dietary supplement which contains a new dietary ingredient

shall be deemed adulterated under section 342(f) of this title

unless it meets one of the following requirements:

(1) The dietary supplement contains only dietary ingredients

which have been present in the food supply as an article used for

food in a form in which the food has not been chemically altered.

(2) There is a history of use or other evidence of safety

establishing that the dietary ingredient when used under the

conditions recommended or suggested in the labeling of the

dietary supplement will reasonably be expected to be safe and, at

least 75 days before being introduced or delivered for

introduction into interstate commerce, the manufacturer or

distributor of the dietary ingredient or dietary supplement

provides the Secretary with information, including any citation

to published articles, which is the basis on which the

manufacturer or distributor has concluded that a dietary

supplement containing such dietary ingredient will reasonably be

expected to be safe.

The Secretary shall keep confidential any information provided

under paragraph (2) for 90 days following its receipt. After the

expiration of such 90 days, the Secretary shall place such

information on public display, except matters in the information

which are trade secrets or otherwise confidential, commercial

information.

(b) Petition

Any person may file with the Secretary a petition proposing the

issuance of an order prescribing the conditions under which a new

dietary ingredient under its intended conditions of use will

reasonably be expected to be safe. The Secretary shall make a

decision on such petition within 180 days of the date the petition

is filed with the Secretary. For purposes of chapter 7 of title 5,

the decision of the Secretary shall be considered final agency

action.

(c) ''New dietary ingredient'' defined

For purposes of this section, the term ''new dietary ingredient''

means a dietary ingredient that was not marketed in the United

States before October 15, 1994 and does not include any dietary

ingredient which was marketed in the United States before October

15, 1994.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 413, as added Pub. L. 103-417, Sec.

8, Oct. 25, 1994, 108 Stat. 4331.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 331 of this title.

-CITE-

21 USC 350c 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

350c. Maintenance and inspection of records

-STATUTE-

(a) Records inspection

If the Secretary has a reasonable belief that an article of food

is adulterated and presents a threat of serious adverse health

consequences or death to humans or animals, each person (excluding

farms and restaurants) who manufactures, processes, packs,

distributes, receives, holds, or imports such article shall, at the

request of an officer or employee duly designated by the Secretary,

permit such officer or employee, upon presentation of appropriate

credentials and a written notice to such person, at reasonable

times and within reasonable limits and in a reasonable manner, to

have access to and copy all records relating to such article that

are needed to assist the Secretary in determining whether the food

is adulterated and presents a threat of serious adverse health

consequences or death to humans or animals. The requirement under

the preceding sentence applies to all records relating to the

manufacture, processing, packing, distribution, receipt, holding,

or importation of such article maintained by or on behalf of such

person in any format (including paper and electronic formats) and

at any location.

(b) Regulations concerning recordkeeping

The Secretary, in consultation and coordination, as appropriate,

with other Federal departments and agencies with responsibilities

for regulating food safety, may by regulation establish

requirements regarding the establishment and maintenance, for not

longer than two years, of records by persons (excluding farms and

restaurants) who manufacture, process, pack, transport, distribute,

receive, hold, or import food, which records are needed by the

Secretary for inspection to allow the Secretary to identify the

immediate previous sources and the immediate subsequent recipients

of food, including its packaging, in order to address credible

threats of serious adverse health consequences or death to humans

or animals. The Secretary shall take into account the size of a

business in promulgating regulations under this section.

(c) Protection of sensitive information

The Secretary shall take appropriate measures to ensure that

there are in effect effective procedures to prevent the

unauthorized disclosure of any trade secret or confidential

information that is obtained by the Secretary pursuant to this

section.

(d) Limitations

This section shall not be construed -

(1) to limit the authority of the Secretary to inspect records

or to require establishment and maintenance of records under any

other provision of this chapter;

(2) to authorize the Secretary to impose any requirements with

respect to a food to the extent that it is within the exclusive

jurisdiction of the Secretary of Agriculture pursuant to the

Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry

Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg

Products Inspection Act (21 U.S.C. 1031 et seq.);

(3) to have any legal effect on section 552 of title 5 or

section 1905 of title 18; or

(4) to extend to recipes for food, financial data, pricing

data, personnel data, research data, or sales data (other than

shipment data regarding sales).

-SOURCE-

(June 25, 1938, ch. 675, Sec. 414, as added Pub. L. 107-188, title

III, Sec. 306(a), June 12, 2002, 116 Stat. 669.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Meat Inspection Act, referred to in subsec. (d)(2),

is titles I to IV of act Mar. 4, 1907, ch. 2907, as added Pub. L.

90-201, Dec. 15, 1967, 81 Stat. 584, and amended, which are

classified generally to subchapters I to IV (Sec. 601 et seq.) of

chapter 12 of this title. For complete classification of this Act

to the Code, see Short Title note set out under section 601 of this

title and Tables.

The Poultry Products Inspection Act, referred to in subsec.

(d)(2), is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended,

which is classified generally to chapter 10 (Sec. 451 et seq.) of

this title. For complete classification of this Act to the Code,

see Short Title note set out under section 451 of this title and

Tables.

The Egg Products Inspection Act, referred to in subsec. (d)(2),

is Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, as amended, which

is classified generally to chapter 15 (Sec. 1031 et seq.) of this

title. For complete classification of this Act to the Code, see

Short Title note set out under section 1031 of this title and

Tables.

-MISC2-

EXPEDITED RULEMAKING

Pub. L. 107-188, title III, Sec. 306(d), June 12, 2002, 116 Stat.

670, provided that: ''Not later than 18 months after the date of

the enactment of this Act (June 12, 2002), the Secretary shall

promulgate proposed and final regulations establishing

recordkeeping requirements under subsection 414(b) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 350c(b)) (as added by

subsection (a)).''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 374 of this title.

-CITE-

21 USC Sec. 350d 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 350d. Registration of food facilities

-STATUTE-

(a) Registration

(1) In general

The Secretary shall by regulation require that any facility

engaged in manufacturing, processing, packing, or holding food

for consumption in the United States be registered with the

Secretary. To be registered -

(A) for a domestic facility, the owner, operator, or agent in

charge of the facility shall submit a registration to the

Secretary; and

(B) for a foreign facility, the owner, operator, or agent in

charge of the facility shall submit a registration to the

Secretary and shall include with the registration the name of

the United States agent for the facility.

(2) Registration

An entity (referred to in this section as the ''registrant'')

shall submit a registration under paragraph (1) to the Secretary

containing information necessary to notify the Secretary of the

name and address of each facility at which, and all trade names

under which, the registrant conducts business and, when

determined necessary by the Secretary through guidance, the

general food category (as identified under section 170.3 of title

21, Code of Federal Regulations) of any food manufactured,

processed, packed, or held at such facility. The registrant

shall notify the Secretary in a timely manner of changes to such

information.

(3) Procedure

Upon receipt of a completed registration described in paragraph

(1), the Secretary shall notify the registrant of the receipt of

such registration and assign a registration number to each

registered facility.

(4) List

The Secretary shall compile and maintain an up-to-date list of

facilities that are registered under this section. Such list and

any registration documents submitted pursuant to this subsection

shall not be subject to disclosure under section 552 of title 5.

Information derived from such list or registration documents

shall not be subject to disclosure under section 552 of title 5

to the extent that it discloses the identity or location of a

specific registered person.

(b) Facility

For purposes of this section:

(1) The term ''facility'' includes any factory, warehouse, or

establishment (including a factory, warehouse, or establishment

of an importer) that manufactures, processes, packs, or holds

food. Such term does not include farms; restaurants; other

retail food establishments; nonprofit food establishments in

which food is prepared for or served directly to the consumer; or

fishing vessels (except such vessels engaged in processing as

defined in section 123.3(k) of title 21, Code of Federal

Regulations).

(2) The term ''domestic facility'' means a facility located in

any of the States or Territories.

(3)(A) The term ''foreign facility'' means a facility that

manufacturers, processes, packs, or holds food, but only if food

from such facility is exported to the United States without

further processing or packaging outside the United States.

(B) A food may not be considered to have undergone further

processing or packaging for purposes of subparagraph (A) solely

on the basis that labeling was added or that any similar activity

of a de minimis nature was carried out with respect to the food.

(c) Rule of construction

Nothing in this section shall be construed to authorize the

Secretary to require an application, review, or licensing process.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 415, as added Pub. L. 107-188, title

III, Sec. 305(a), June 12, 2002, 116 Stat. 667.)

-MISC1-

REGULATIONS

Pub. L. 107-188, title III, Sec. 305(e), June 12, 2002, 116 Stat.

669, provided that: ''Not later than 18 months after the date of

the enactment of this Act (June 12, 2002), the Secretary of Health

and Human Services shall promulgate proposed and final regulations

for the requirement of registration under section 415 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) (as added by

subsection (a) of this section). Such requirement of registration

takes effect -

''(1) upon the effective date of such final regulations; or

''(2) upon the expiration of such 18-month period if the final

regulations have not been made effective as of the expiration of

such period, subject to compliance with the final regulations

when the final regulations are made effective.''

ELECTRONIC FILING

Pub. L. 107-188, title III, Sec. 305(d), June 12, 2002, 116 Stat.

668, provided that: ''For the purpose of reducing paperwork and

reporting burdens, the Secretary of Health and Human Services may

provide for, and encourage the use of, electronic methods of

submitting to the Secretary registrations required pursuant to this

section (enacting this section, amending sections 331 and 381 of

this title, and enacting provisions set out as a note under this

section). In providing for the electronic submission of such

registrations, the Secretary shall ensure adequate authentication

protocols are used to enable identification of the registrant and

validation of the data as appropriate.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 381 of this title.

-CITE-

21 USC SUBCHAPTER V - DRUGS AND DEVICES 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

.

-HEAD-

SUBCHAPTER V - DRUGS AND DEVICES

-CITE-

21 USC Part A - Drugs and Devices 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part A - Drugs and Devices

.

-HEAD-

Part A - Drugs and Devices

-CITE-

21 USC Sec. 351 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part A - Drugs and Devices

-HEAD-

Sec. 351. Adulterated drugs and devices

-STATUTE-

A drug or device shall be deemed to be adulterated -

(a) Poisonous, insanitary, etc., ingredients; adequate controls in

manufacture

(1) If it consists in whole or in part of any filthy, putrid, or

decomposed substance; or (2)(A) if it has been prepared, packed, or

held under insanitary conditions whereby it may have been

contaminated with filth, or whereby it may have been rendered

injurious to health; or (B) if it is a drug and the methods used

in, or the facilities or controls used for, its manufacture,

processing, packing, or holding do not conform to or are not

operated or administered in conformity with current good

manufacturing practice to assure that such drug meets the

requirements of this chapter as to safety and has the identity and

strength, and meets the quality and purity characteristics, which

it purports or is represented to possess; or (C) if it is a

compounded positron emission tomography drug and the methods used

in, or the facilities and controls used for, its compounding,

processing, packing, or holding do not conform to or are not

operated or administered in conformity with the positron emission

tomography compounding standards and the official monographs of the

United States Pharmacopoeia to assure that such drug meets the

requirements of this chapter as to safety and has the identity and

strength, and meets the quality and purity characteristics, that it

purports or is represented to possess; or (3) if its container is

composed, in whole or in part, of any poisonous or deleterious

substance which may render the contents injurious to health; or (4)

if (A) it bears or contains, for purposes of coloring only, a color

additive which is unsafe within the meaning of section 379e(a) of

this title, or (B) it is a color additive the intended use of which

in or on drugs or devices is for purposes of coloring only and is

unsafe within the meaning of section 379e(a) of this title; or (5)

if it is a new animal drug which is unsafe within the meaning of

section 360b of this title; or (6) if it is an animal feed bearing

or containing a new animal drug, and such animal feed is unsafe

within the meaning of section 360b of this title.

(b) Strength, quality, or purity differing from official compendium

If it purports to be or is represented as a drug the name of

which is recognized in an official compendium, and its strength

differs from, or its quality or purity falls below, the standard

set forth in such compendium. Such determination as to strength,

quality, or purity shall be made in accordance with the tests or

methods of assay set forth in such compendium, except that whenever

tests or methods of assay have not been prescribed in such

compendium, or such tests or methods of assay as are prescribed

are, in the judgment of the Secretary, insufficient for the making

of such determination, the Secretary shall bring such fact to the

attention of the appropriate body charged with the revision of such

compendium, and if such body fails within a reasonable time to

prescribe tests or methods of assay which, in the judgment of the

Secretary, are sufficient for purposes of this paragraph, then the

Secretary shall promulgate regulations prescribing appropriate

tests or methods of assay in accordance with which such

determination as to strength, quality, or purity shall be made. No

drug defined in an official compendium shall be deemed to be

adulterated under this paragraph because it differs from the

standard of strength, quality, or purity therefor set forth in such

compendium, if its difference in strength, quality, or purity from

such standard is plainly stated on its label. Whenever a drug is

recognized in both the United States Pharmacopoeia and the

Homoeopathic Pharmacopoeia of the United States it shall be subject

to the requirements of the United States Pharmacopoeia unless it is

labeled and offered for sale as a homoeopathic drug, in which case

it shall be subject to the provisions of the Homoeopathic

Pharmacopoeia of the United States and not to those of the United

States Pharmacopoeia.

(c) Misrepresentation of strength, etc., where drug is unrecognized

in compendium

If it is not subject to the provisions of paragraph (b) of this

section and its strength differs from, or its purity or quality

falls below, that which it purports or is represented to possess.

(d) Mixture with or substitution of another substance

If it is a drug and any substance has been (1) mixed or packed

therewith so as to reduce its quality or strength or (2)

substituted wholly or in part therefor.

(e) Devices not in conformity with performance standards

(1) If it is, or purports to be or is represented as, a device

which is subject to a performance standard established under

section 360d of this title unless such device is in all respects in

conformity with such standard.

(2) If it is declared to be, purports to be, or is represented

as, a device that is in conformity with any standard recognized

under section 360d(c) of this title unless such device is in all

respects in conformity with such standard.

(f) Certain class III devices

(1) If it is a class III device -

(A)(i) which is required by a regulation promulgated under

subsection (b) of section 360e of this title to have an approval

under such section of an application for premarket approval and

which is not exempt from section 360e of this title under section

360j(g) of this title, and

(ii)(I) for which an application for premarket approval or a

notice of completion of a product development protocol was not

filed with the Secretary within the ninety-day period beginning

on the date of the promulgation of such regulation, or

(II) for which such an application was filed and approval of

the application has been denied, suspended, or withdrawn, or such

a notice was filed and has been declared not completed or the

approval of the device under the protocol has been withdrawn;

(B)(i) which was classified under section 360c(f) of this title

into class III, which under section 360e(a) of this title is

required to have in effect an approved application for premarket

approval, and which is not exempt from section 360e of this title

under section 360j(g) of this title, and

(ii) which has an application which has been suspended or is

otherwise not in effect; or

(C) which was classified under section 360j(l) of this title

into class III, which under such section is required to have in

effect an approved application under section 360e of this title,

and which has an application which has been suspended or is

otherwise not in effect.

(2)(A) In the case of a device classified under section 360c(f)

of this title into class III and intended solely for

investigational use, paragraph (FOOTNOTE 1) (1)(B) shall not apply

with respect to such device during the period ending on the

ninetieth day after the date of the promulgation of the regulations

prescribing the procedures and conditions required by section

360j(g)(2) of this title.

(FOOTNOTE 1) So in original. Probably should be

''subparagraph''.

(B) In the case of a device subject to a regulation promulgated

under subsection (b) of section 360e of this title, paragraph

(FOOTNOTE 1) (1) shall not apply with respect to such device during

the period ending -

(i) on the last day of the thirtieth calendar month beginning

after the month in which the classification of the device in

class III became effective under section 360c of this title, or

(ii) on the ninetieth day after the date of the promulgation of

such regulation,

whichever occurs later.

(g) Banned devices

If it is a banned device.

(h) Manufacture, packing, storage, or installation of device not in

conformity with applicable requirements or conditions

If it is a device and the methods used in, or the facilities or

controls used for, its manufacture, packing, storage, or

installation are not in conformity with applicable requirements

under section 360j(f)(1) of this title or an applicable condition

prescribed by an order under section 360j(f)(2) of this title.

(i) Failure to comply with requirements under which device was

exempted for investigational use

If it is a device for which an exemption has been granted under

section 360j(g) of this title for investigational use and the

person who was granted such exemption or any investigator who uses

such device under such exemption fails to comply with a requirement

prescribed by or under such section.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 501, 52 Stat. 1049; Pub. L. 86-618,

title I, Sec. 102(b)(1), July 12, 1960, 74 Stat. 398; Pub. L.

87-781, title I, Sec. 101, Oct. 10, 1962, 76 Stat. 780; Pub. L.

90-399, Sec. 101(a), July 13, 1968, 82 Stat. 343; Pub. L. 94-295,

Sec. 3(d), 9(b)(1), May 28, 1976, 90 Stat. 576, 583; Pub. L.

101-629, Sec. 9(b), Nov. 28, 1990, 104 Stat. 4521; Pub. L. 102-571,

title I, Sec. 107(8), Oct. 29, 1992, 106 Stat. 4499; Pub. L.

105-115, title I, Sec. 121(b)(1), title II, Sec. 204(c), Nov. 21,

1997, 111 Stat. 2320, 2336.)

-MISC1-

AMENDMENTS

1997 - Par. (a)(2)(C). Pub. L. 105-115, Sec. 121(b)(1), inserted

''; or (C) if it is a compounded positron emission tomography drug

and the methods used in, or the facilities and controls used for,

its compounding, processing, packing, or holding do not conform to

or are not operated or administered in conformity with the positron

emission tomography compounding standards and the official

monographs of the United States Pharmacopoeia to assure that such

drug meets the requirements of this chapter as to safety and has

the identity and strength, and meets the quality and purity

characteristics, that it purports or is represented to possess;''

before ''or (3)''.

Par. (e). Pub. L. 105-115, Sec. 204(c), designated existing

provisions as subpar. (1) and added subpar. (2).

1992 - Par. (a)(4). Pub. L. 102-571 substituted ''379e(a)'' for

''376(a)'' in cls. (A) and (B).

1990 - Par. (f)(1). Pub. L. 101-629, Sec. 9(b), which directed

the amendment of subpars. (A) to (C) of par. (f), was executed by

making the amendments in cls. (A) to (C) of subpar. (1) of par. (f)

as follows to reflect the probable intent of Congress: in cl.

(A)(ii)(II), substituted '', suspended, or withdrawn'' for ''or

withdrawn''; in cl. (B)(ii), substituted ''which has an application

which has been suspended or is otherwise not in effect'' for

''which does not have such an application in effect''; and in cl.

(C), substituted ''which has an application which has been

suspended or is otherwise not in effect'' for ''which does not have

such an application in effect''.

1976 - Par. (a). Pub. L. 94-295, Sec. 9(b)(1), substituted ''(3)

if its'' for ''(3) if it is a drug and its'' in cl. (3),

substituted ''(4) if (A) it bears or contains'' for ''(4) if (A) it

is a drug which bears or contains'' in cl. (4)(A), and substituted

''drugs or devices'' for ''drugs'' in cl. (4)(B).

Pars. (e) to (i). Pub. L. 94-295, Sec. 3(d), added pars. (e) to

(i).

1968 - Par. (a). Pub. L. 90-399 added cls. (5) and (6).

1962 - Par. (a). Pub. L. 87-781 designated existing provisions of

cl. (2) as (A) and added (B).

1960 - Par. (a). Pub. L. 86-618 substituted provisions in cl. (4)

relating to unsafe color additives for provisions which related to

a coal-tar color other than one from a batch that has been

certified in accordance with regulations as provided by section 354

of this title.

EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT

Section 121(b)(2) of Pub. L. 105-115 provided that: ''Section

501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

351(a)(2)(C)) shall not apply 4 years after the date of enactment

of this Act (Nov. 21, 1997) or 2 years after the date on which the

Secretary of Health and Human Services establishes the requirements

described in subsection (c)(1)(B) (section 121(c)(1)(B) of Pub. L.

105-115, set out as a note under section 355 of this title),

whichever is later.''

Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,

1997, except as otherwise provided, see section 501 of Pub. L.

105-115, set out as an Effective Date of 1997 Amendment note under

section 321 of this title.

EFFECTIVE DATE OF 1968 AMENDMENT

Amendment by Pub. L. 90-399 effective on first day of thirteenth

calendar month after July 13, 1968, see section 108(a) of Pub. L.

90-399, set out as an Effective Date and Transitional Provisions

note under section 360b of this title.

EFFECTIVE DATE OF 1962 AMENDMENT; EXCEPTIONS

Amendment by Pub. L. 87-781 effective on first day of seventh

calendar month following October 1962, see section 107 of Pub. L.

87-781, set out as a note under section 321 of this title.

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86-618 effective July 12, 1960, subject to

the provisions of section 203 of Pub. L. 86-618, see section 202 of

Pub. L. 86-618, set out as a note under section 379e of this title.

EFFECTIVE DATE; POSTPONEMENT

Par. (a)(4) effective Jan. 1, 1940, see act June 23, 1939, ch.

242, 53 Stat. 853, set out as an Effective Date; Postponement in

Certain Cases note under section 301 of this title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 333, 334, 353a, 360,

360b, 360c, 360j, 371, 374, 379e, 382, 384 of this title.

-CITE-

21 USC Sec. 352 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part A - Drugs and Devices

-HEAD-

Sec. 352. Misbranded drugs and devices

-STATUTE-

A drug or device shall be deemed to be misbranded -

(a) False or misleading label

If its labeling is false or misleading in any particular. Health

care economic information provided to a formulary committee, or

other similar entity, in the course of the committee or the entity

carrying out its responsibilities for the selection of drugs for

managed care or other similar organizations, shall not be

considered to be false or misleading under this paragraph if the

health care economic information directly relates to an indication

approved under section 355 of this title or under section 262(a) of

title 42 for such drug and is based on competent and reliable

scientific evidence. The requirements set forth in section 355(a)

of this title or in section 262(a) of title 42 shall not apply to

health care economic information provided to such a committee or

entity in accordance with this paragraph. Information that is

relevant to the substantiation of the health care economic

information presented pursuant to this paragraph shall be made

available to the Secretary upon request. In this paragraph, the

term ''health care economic information'' means any analysis that

identifies, measures, or compares the economic consequences,

including the costs of the represented health outcomes, of the use

of a drug to the use of another drug, to another health care

intervention, or to no intervention.

(b) Package form; contents of label

If in package form unless it bears a label containing (1) the

name and place of business of the manufacturer, packer, or

distributor; and (2) an accurate statement of the quantity of the

contents in terms of weight, measure, or numerical count: Provided,

That under clause (2) of this paragraph reasonable variations shall

be permitted, and exemptions as to small packages shall be

established, by regulations prescribed by the Secretary.

(c) Prominence of information on label

If any word, statement, or other information required by or under

authority of this chapter to appear on the label or labeling is not

prominently placed thereon with such conspicuousness (as compared

with other words, statements, designs, or devices, in the labeling)

and in such terms as to render it likely to be read and understood

by the ordinary individual under customary conditions of purchase

and use.

(d) Repealed. Pub. L. 105-115, title I, Sec. 126(b), Nov. 21, 1997,

111 Stat. 2327

(e) Designation of drugs or devices by established names

(1)(A) If it is a drug, unless its label bears, to the exclusion

of any other nonproprietary name (except the applicable systematic

chemical name or the chemical formula) -

(i) the established name (as defined in subparagraph (3)) of

the drug, if there is such a name;

(ii) the established name and quantity or, if determined to be

appropriate by the Secretary, the proportion of each active

ingredient, including the quantity, kind, and proportion of any

alcohol, and also including whether active or not the established

name and quantity or if determined to be appropriate by the

Secretary, the proportion of any bromides, ether, chloroform,

acetanilide, acetophenetidin, amidopyrine, antipyrine, atropine,

hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides,

mercury, ouabain, strophanthin, strychnine, thyroid, or any

derivative or preparation of any such substances, contained

therein, except that the requirement for stating the quantity of

the active ingredients, other than the quantity of those

specifically named in this subclause, shall not apply to

nonprescription drugs not intended for human use; and

(iii) the established name of each inactive ingredient listed

in alphabetical order on the outside container of the retail

package and, if determined to be appropriate by the Secretary, on

the immediate container, as prescribed in regulation promulgated

by the Secretary, except that nothing in this subclause shall be

deemed to require that any trade secret be divulged, and except

that the requirements of this subclause with respect to

alphabetical order shall apply only to nonprescription drugs that

are not also cosmetics and that this subclause shall not apply to

nonprescription drugs not intended for human use.

(B) For any prescription drug the established name of such drug

or ingredient, as the case may be, on such label (and on any

labeling on which a name for such drug or ingredient is used) shall

be printed prominently and in type at least half as large as that

used thereon for any proprietary name or designation for such drug

or ingredient, except that to the extent that compliance with the

requirements of subclause (ii) or (iii) of clause (A) or this

clause is impracticable, exemptions shall be established by

regulations promulgated by the Secretary.

(2) If it is a device and it has an established name, unless its

label bears, to the exclusion of any other nonproprietary name, its

established name (as defined in subparagraph (4)) prominently

printed in type at least half as large as that used thereon for any

proprietary name or designation for such device, except that to the

extent compliance with the requirements of this subparagraph is

impracticable, exemptions shall be established by regulations

promulgated by the Secretary.

(3) As used in subparagraph (1), the term ''established name'',

with respect to a drug or ingredient thereof, means (A) the

applicable official name designated pursuant to section 358 of this

title, or (B), if there is no such name and such drug, or such

ingredient, is an article recognized in an official compendium,

then the official title thereof in such compendium, or (C) if

neither clause (A) nor clause (B) of this subparagraph applies,

then the common or usual name, if any, of such drug or of such

ingredient, except that where clause (B) of this subparagraph

applies to an article recognized in the United States Pharmacopeia

and in the Homoeopathic Pharmacopoeia under different official

titles, the official title used in the United States Pharmacopeia

shall apply unless it is labeled and offered for sale as a

homoeopathic drug, in which case the official title used in the

Homoeopathic Pharmacopoeia shall apply.

(4) As used in subparagraph (2), the term ''established name''

with respect to a device means (A) the applicable official name of

the device designated pursuant to section 358 of this title, (B) if

there is no such name and such device is an article recognized in

an official compendium, then the official title thereof in such

compendium, or (C) if neither clause (A) nor clause (B) of this

subparagraph applies, then any common or usual name of such device.

(f) Directions for use and warnings on label

Unless its labeling bears (1) adequate directions for use; and

(2) such adequate warnings against use in those pathological

conditions or by children where its use may be dangerous to health,

or against unsafe dosage or methods or duration of administration

or application, in such manner and form, as are necessary for the

protection of users, except that where any requirement of clause

(1) of this paragraph, as applied to any drug or device, is not

necessary for the protection of the public health, the Secretary

shall promulgate regulations exempting such drug or device from

such requirement. Required labeling for prescription devices

intended for use in health care facilities may be made available

solely by electronic means provided that the labeling complies with

all applicable requirements of law and, that the manufacturer

affords health care facilities the opportunity to request the

labeling in paper form, and after such request, promptly provides

the health care facility the requested information without

additional cost.

(g) Representations as recognized drug; packing and labeling;

inconsistent requirements for designation of drug

If it purports to be a drug the name of which is recognized in an

official compendium, unless it is packaged and labeled as

prescribed therein. The method of packing may be modified with the

consent of the Secretary. Whenever a drug is recognized in both the

United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of

the United States, it shall be subject to the requirements of the

United States Pharmacopoeia with respect to packaging and labeling

unless it is labeled and offered for sale as a homoeopathic drug,

in which case it shall be subject to the provisions of the

Homoeopathic Pharmacopoeia of the United States, and not those of

the United States Pharmacopoeia, except that in the event of

inconsistency between the requirements of this paragraph and those

of paragraph (e) as to the name by which the drug or its

ingredients shall be designated, the requirements of paragraph (e)

shall prevail.

(h) Deteriorative drugs; packing and labeling

If it has been found by the Secretary to be a drug liable to

deterioration, unless it is packaged in such form and manner, and

its label bears a statement of such precautions, as the Secretary

shall by regulations require as necessary for the protection of the

public health. No such regulation shall be established for any

drug recognized in an official compendium until the Secretary shall

have informed the appropriate body charged with the revision of

such compendium of the need for such packaging or labeling

requirements and such body shall have failed within a reasonable

time to prescribe such requirements.

(i) Drug; misleading container; imitation; offer for sale under

another name

(1) If it is a drug and its container is so made, formed, or

filled as to be misleading; or (2) if it is an imitation of another

drug; or (3) if it is offered for sale under the name of another

drug.

(j) Health-endangering when used as prescribed

If it is dangerous to health when used in the dosage or manner,

or with the frequency or duration prescribed, recommended, or

suggested in the labeling thereof.

(k), (l) Repealed. Pub. L. 105-115, title I, Sec. 125(a)(2)(B),

(b)(2)(D), Nov. 21, 1997, 111 Stat. 2325

(m) Color additives; packing and labeling

If it is a color additive the intended use of which is for the

purpose of coloring only, unless its packaging and labeling are in

conformity with such packaging and labeling requirements applicable

to such color additive, as may be contained in regulations issued

under section 379e of this title.

(n) Prescription drug advertisements: established name;

quantitative formula; side effects, contraindications, and

effectiveness; prior approval; false advertising; labeling;

construction of the Convention on Psychotropic Substances

In the case of any prescription drug distributed or offered for

sale in any State, unless the manufacturer, packer, or distributor

thereof includes in all advertisements and other descriptive

printed matter issued or caused to be issued by the manufacturer,

packer, or distributor with respect to that drug a true statement

of (1) the established name as defined in paragraph (e) of this

section, printed prominently and in type at least half as large as

that used for any trade or brand name thereof, (2) the formula

showing quantitatively each ingredient of such drug to the extent

required for labels under paragraph (e) of this section, and (3)

such other information in brief summary relating to side effects,

contraindications, and effectiveness as shall be required in

regulations which shall be issued by the Secretary in accordance

with the procedure specified in section 371(e) of this title,

except that (A) except in extraordinary circumstances, no

regulation issued under this paragraph shall require prior approval

by the Secretary of the content of any advertisement, and (B) no

advertisement of a prescription drug, published after the effective

date of regulations issued under this paragraph applicable to

advertisements of prescription drugs, shall with respect to the

matters specified in this paragraph or covered by such regulations,

be subject to the provisions of sections 52 to 57 of title 15. This

paragraph (n) shall not be applicable to any printed matter which

the Secretary determines to be labeling as defined in section

321(m) of this title. Nothing in the Convention on Psychotropic

Substances, signed at Vienna, Austria, on February 21, 1971, shall

be construed to prevent drug price communications to consumers.

(o) Drugs or devices from nonregistered establishments

If it was manufactured, prepared, propagated, compounded, or

processed in an establishment in any State not duly registered

under section 360 of this title, if it was not included in a list

required by section 360(j) of this title, if a notice or other

information respecting it was not provided as required by such

section or section 360(k) of this title, or if it does not bear

such symbols from the uniform system for identification of devices

prescribed under section 360(e) of this title as the Secretary by

regulation requires.

(p) Packaging or labeling of drugs in violation of regulations

If it is a drug and its packaging or labeling is in violation of

an applicable regulation issued pursuant to section 1472 or 1473 of

title 15.

(q) Restricted devices using false or misleading advertising or

used in violation of regulations

In the case of any restricted device distributed or offered for

sale in any State, if (1) its advertising is false or misleading in

any particular, or (2) it is sold, distributed, or used in

violation of regulations prescribed under section 360j(e) of this

title.

(r) Restricted devices not carrying requisite accompanying

statements in advertisements and other descriptive printed

matter

In the case of any restricted device distributed or offered for

sale in any State, unless the manufacturer, packer, or distributor

thereof includes in all advertisements and other descriptive

printed matter issued or caused to be issued by the manufacturer,

packer, or distributor with respect to that device (1) a true

statement of the device's established name as defined in subsection

(e) of this section, printed prominently and in type at least half

as large as that used for any trade or brand name thereof, and (2)

a brief statement of the intended uses of the device and relevant

warnings, precautions, side effects, and contraindications and, in

the case of specific devices made subject to a finding by the

Secretary after notice and opportunity for comment that such action

is necessary to protect the public health, a full description of

the components of such device or the formula showing quantitatively

each ingredient of such device to the extent required in

regulations which shall be issued by the Secretary after an

opportunity for a hearing. Except in extraordinary circumstances,

no regulation issued under this paragraph shall require prior

approval by the Secretary of the content of any advertisement and

no advertisement of a restricted device, published after the

effective date of this paragraph shall, with respect to the matters

specified in this paragraph or covered by regulations issued

hereunder, be subject to the provisions of sections 52 through 55

of title 15. This paragraph shall not be applicable to any printed

matter which the Secretary determines to be labeling as defined in

section 321(m) of this title.

(s) Devices subject to performance standards not bearing requisite

labeling

If it is a device subject to a performance standard established

under section 360d of this title, unless it bears such labeling as

may be prescribed in such performance standard.

(t) Devices for which there has been a failure or refusal to give

required notification or to furnish required material or

information

If it is a device and there was a failure or refusal (1) to

comply with any requirement prescribed under section 360h of this

title respecting the device, (2) to furnish any material or

information required by or under section 360i of this title

respecting the device, or (3) to comply with a requirement under

section 360l of this title.

(u) Identification of manufacturer

If it is a device, unless it, or an attachment thereto,

prominently and conspicuously bears the name of the manufacturer of

the device, a generally recognized abbreviation of such name, or a

unique and generally recognized symbol identifying such

manufacturer, except that the Secretary may waive any requirement

under this paragraph for the device if the Secretary determines

that compliance with the requirement is not feasible for the device

or would compromise the provision of reasonable assurance of the

safety or effectiveness of the device.

(v) Reprocessed single-use devices

If it is a reprocessed single-use device, unless all labeling of

the device prominently and conspicuously bears the statement

''Reprocessed device for single use. Reprocessed by _ _.'' The

name of the manufacturer of the reprocessed device shall be placed

in the space identifying the person responsible for reprocessing.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 502, 52 Stat. 1050; June 23, 1939,

ch. 242, Sec. 3, 53 Stat. 854; Dec. 22, 1941, ch. 613, Sec. 2, 55

Stat. 851; July 6, 1945, ch. 281, Sec. 2, 59 Stat. 463; Mar. 10,

1947, ch. 16, Sec. 2, 61 Stat. 11; July 13, 1949, ch. 305, Sec. 1,

63 Stat. 409; Aug. 5, 1953, ch. 334, Sec. 1, 67 Stat. 389; Pub. L.

86-618, title I, Sec. 102(b)(2), July 12, 1960, 74 Stat. 398; Pub.

L. 87-781, title I, Sec. 105(c), 112(a), (b), 131(a), title III,

Sec. 305, Oct. 10, 1962, 76 Stat. 785, 790, 791, 795; Pub. L.

90-399, Sec. 105(a), July 13, 1968, 82 Stat. 352; Pub. L. 91-601,

Sec. 6(d), formerly Sec. 7(d), Dec. 30, 1970, 84 Stat. 1673,

renumbered Pub. L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981,

95 Stat. 716; Pub. L. 94-295, Sec. 3(e), 4(b)(2), 5(a), 9(b)(2),

May 28, 1976, 90 Stat. 577, 580, 583; Pub. L. 95-633, title I, Sec.

111, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 102-300, Sec. 3(a)(2),

June 16, 1992, 106 Stat. 239; Pub. L. 102-571, title I, Sec.

107(9), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 3(m),

Aug. 13, 1993, 107 Stat. 777; Pub. L. 105-115, title I, Sec.

114(a), 125(a)(2)(B), (b)(2)(D), 126(b), title IV, Sec. 412(c),

Nov. 21, 1997, 111 Stat. 2312, 2325, 2327, 2375; Pub. L. 107-250,

title II, Sec. 206, title III, Sec. 301(a), 302(a)(1), Oct. 26,

2002, 116 Stat. 1613, 1616.)

-MISC1-

AMENDMENTS

2002 - Par. (f). Pub. L. 107-250, Sec. 206, inserted at end

''Required labeling for prescription devices intended for use in

health care facilities may be made available solely by electronic

means provided that the labeling complies with all applicable

requirements of law and, that the manufacturer affords health care

facilities the opportunity to request the labeling in paper form,

and after such request, promptly provides the health care facility

the requested information without additional cost.''

Par. (u). Pub. L. 107-250, Sec. 301(a), which directed amendment

of section by adding par. (u) at end, was executed by adding par.

(u) before par. (v) to reflect the probable intent of Congress.

Par. (v). Pub. L. 107-250, Sec. 302(a)(1), added par. (v).

1997 - Par. (a). Pub. L. 105-115, Sec. 114(a), inserted at end

''Health care economic information provided to a formulary

committee, or other similar entity, in the course of the committee

or the entity carrying out its responsibilities for the selection

of drugs for managed care or other similar organizations, shall not

be considered to be false or misleading under this paragraph if the

health care economic information directly relates to an indication

approved under section 355 of this title or under section 262(a) of

title 42 for such drug and is based on competent and reliable

scientific evidence. The requirements set forth in section 355(a)

of this title or in section 262(a) of title 42 shall not apply to

health care economic information provided to such a committee or

entity in accordance with this paragraph. Information that is

relevant to the substantiation of the health care economic

information presented pursuant to this paragraph shall be made

available to the Secretary upon request. In this paragraph, the

term 'health care economic information' means any analysis that

identifies, measures, or compares the economic consequences,

including the costs of the represented health outcomes, of the use

of a drug to the use of another drug, to another health care

intervention, or to no intervention.''

Par. (d). Pub. L. 105-115, Sec. 126(b), struck out par. (d) which

read as follows: ''If it is for use by man and contains any

quantity of the narcotic or hypnotic substance alpha eucaine,

barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral,

coca, cocaine, codeine, heroin, marihuana, morphine, opium,

paraldehyde, peyote, or sulphonmethane; or any chemical derivative

of such substance, which derivative has been by the Secretary,

after investigation, found to be, and by regulations designated as,

habit forming; unless its label bears the name and quantity or

proportion of such substance or derivative and in juxtaposition

therewith the statement 'Warning - May be habit forming.' ''

Par. (e)(1). Pub. L. 105-115, Sec. 412(c), amended subpar. (1)

generally. Prior to amendment, subpar. (1) read as follows: ''If

it is a drug, unless (A) its label bears, to the exclusion of any

other nonproprietary name (except the applicable systematic

chemical name or the chemical formula), (i) the established name

(as defined in subparagraph (3)) of the drug, if such there be, and

(ii), in case it is fabricated from two or more ingredients, the

established name and quantity of each active ingredient, including

the quantity, kind, and proportion of any alcohol, and also

including, whether active or not, the established name and quantity

or proportion of any bromides, ether, chloroform, acetanilid,

acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine,

hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury

ouabain strophanthin, strychnine, thyroid, or any derivative or

preparation of any such substances, contained therein; Provided,

That the requirement for stating the quantity of the active

ingredients, other than the quantity of those specifically named in

this paragraph, shall apply only to prescription drugs; and (B) for

any prescription drug the established name of such drug or

ingredient, as the case may be, on such label (and on any labeling

on which a name for such drug or ingredient is used) is printed

prominently and in type at least half as large as that used thereon

for any proprietary name or designation for such drug or

ingredient: Provided, That to the extent that compliance with the

requirements of clause (A)(ii) or clause (B) of this subparagraph

is impracticable, exemptions shall be established by regulations

promulgated by the Secretary.''

Par. (k). Pub. L. 105-115, Sec. 125(a)(2)(B), struck out par. (k)

which read as follows: ''If it is, or purports to be, or is

represented as a drug composed wholly or partly of insulin, unless

(1) it is from a batch with respect to which a certificate or

release has been issued pursuant to section 356 of this title, and

(2) such certificate or release is in effect with respect to such

drug.''

Par. (l). Pub. L. 105-115, Sec. 125(b)(2)(D), struck out par. (l)

which read as follows: ''If it is, or purports to be, or is

represented as a drug (except a drug for use in animals other than

man) composed wholly or partly of any kind of penicillin,

streptomycin, chlortetracycline, chloramphenicol, bacitracin, or

any other antibiotic drug, or any derivative thereof, unless (1) it

is from a batch with respect to which a certificate or release has

been issued pursuant to section 357 of this title, and (2) such

certificate or release is in effect with respect to such drug:

Provided, That this paragraph shall not apply to any drug or class

of drugs exempted by regulations promulgated under section 357(c)

or (d) of this title.''

1993 - Par. (e)(3). Pub. L. 103-80, Sec. 3(m)(1), substituted

''of such ingredient, except that'' for ''of such ingredient:

Provided, That''.

Par. (f). Pub. L. 103-80, Sec. 3(m)(2), substituted ''users,

except that where'' for ''users: Provided, That where''.

Par. (g). Pub. L. 103-80, Sec. 3(m)(3), substituted ''prescribed

therein. The method'' for ''prescribed therein: Provided, That the

method'' and ''Pharmacopoeia, except that'' for ''Pharmacopoeia:

Provided further, That,''.

Par. (n). Pub. L. 103-80, Sec. 3(m)(4), substituted '', except

that (A)'' for '': Provided, That (A)''.

1992 - Par. (m). Pub. L. 102-571 substituted ''379e'' for

''376''.

Par. (t)(3). Pub. L. 102-300 added cl. (3).

1978 - Par. (n). Pub. L. 95-633 inserted provision relating to

the construction of the Convention on Psychotropic Substances.

1976 - Par. (e). Pub. L. 94-295, Sec. 5(a), substituted

''subparagraph (3)'' for ''subparagraph (2)'' in subpar. (1), added

subpar. (2), redesignated former subpar. (2) as (3) and in subpar.

(3) as so redesignated substituted ''subparagraph (1)'' for ''this

paragraph (e)'', and added subpar. (4).

Par. (j). Pub. L. 94-295, Sec. 3(e)(2), substituted ''dosage or

manner,'' for ''dosage,''.

Par. (m). Pub. L. 94-295, Sec. 9(b)(2), substituted ''the

intended use of which is for'' for ''the intended use of which in

or on drugs is for''.

Par. (o). Pub. L. 94-295, Sec. 4(b)(2), substituted ''If it was

manufactured'' for ''If it is a drug and was manufactured'' and

inserted '', if it was not included in a list required by section

360(j) of this title, if a notice or other information respecting

it was not provided as required by such section or section 360(k)

of this title, or if it does not bear such symbols from the uniform

system for identification of devices prescribed under section

360(e) of this title as the Secretary by regulation requires''.

Pars. (q) to (t). Pub. L. 94-295, Sec. 3(e)(1), added pars. (q)

to (t).

1970 - Par. (p). Pub. L. 91-601 added par. (p).

1968 - Par. (l). Pub. L. 90-399 inserted ''(except a drug for use

in animals other than man)'' after ''represented as a drug''.

1962 - Par. (e). Pub. L. 87-781, Sec. 112(a), designated existing

provisions as subpar. (1), substituted '', unless (A) its label

bears, to the exclusion of any other nonproprietary name (except

the applicable systematic chemical name or the chemical formula),

(i) the established name (as defined in subparagraph (2) of this

subsection) of the drug, if such there be, and (ii), in case it is

fabricated from two or more ingredients, the established name and

quantity'' for ''and is not designated solely by a name recognized

in an official compendium unless its label bears (1) the common or

usual name of the drug, if such there be; and (2), in case it is

fabricated from two or more ingredients, the common or usual

name'', and ''the established name'' for ''the name'', provided

that the requirement for stating the quantity of active

ingredients, other than those specified in this par., applies only

to prescription drugs, and that the established name of a drug on a

label is to be printed prominently and in type at least half as

large as used for any proprietary designation, and added subpar.

(2) defining ''established name''.

Par. (g). Pub. L. 87-781, Sec. 112(b), provided that if there is

an inconsistency between the provisions of this par. and those of

par. (e), as to the name of a drug, the requirements of par. (e)

should prevail.

Par. (l). Pub. L. 87-781, Sec. 105(c), substituted ''bacitracin,

or any other antibiotic drug'' for ''or bacitracin.''

Par. (n). Pub. L. 87-781, Sec. 131(a), added par. (n).

Par. (o). Pub. L. 87-781, Sec. 305, added par. (o).

1960 - Par. (m). Pub. L. 86-618 added par. (m).

1953 - Par. (l). Act Aug. 5, 1953, substituted

''chlortetracycline'' for ''aureomycin''.

1949 - Par. (l). Act July 13, 1949, inserted '', aureomycin,

chloramphenicol, or bacitracin'' after ''streptomycin''.

1947 - Par. (l). Act Mar. 10, 1947, inserted ''or streptomycin''

after ''penicillin''.

1945 - Par. (l). Act July 6, 1945, added par. (l).

1941 - Par. (k). Act Dec. 22, 1941, added par. (k).

1939 - Par. (d). Act June 29, 1939, substituted ''name, and

quality or proportion'' for ''name, quantity, and percentage''.

EFFECTIVE DATE OF 2002 AMENDMENT

Pub. L. 107-250, title III, Sec. 301(b), Oct. 26, 2002, 116 Stat.

1616, provided that: ''The amendment made by subsection (a)

(amending this section) takes effect 18 months after the date of

the enactment of this Act (Oct. 26, 2002), and only applies to

devices introduced or delivered for introduction into interstate

commerce after such effective date.''

Pub. L. 107-250, title III, Sec. 302(a)(2), Oct. 26, 2002, 116

Stat. 1616, provided that: ''The amendment made by paragraph (1)

(amending this section) takes effect 15 months after the date of

the enactment of this Act (Oct. 26, 2002), and only applies to

devices introduced or delivered for introduction into interstate

commerce after such effective date.''

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by sections 114(a), 126(b), and 412(c) of Pub. L.

105-115 effective 90 days after Nov. 21, 1997, except as otherwise

provided, see section 501 of Pub. L. 105-115, set out as a note

under section 321 of this title.

EFFECTIVE DATE OF 1978 AMENDMENT

Amendment by Pub. L. 95-633 effective on date the Convention on

Psychotropic Substances enters into force in the United States

(July 15, 1980), see section 112 of Pub. L. 95-633, set out as an

Effective Date note under section 801a of this title.

EFFECTIVE DATE OF 1970 AMENDMENT

Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and

regulations establishing special packaging standards effective no

sooner than 180 days or later than one year from date regulations

are final, or an earlier date published in Federal Register, see

section 8 of Pub. L. 91-601, set out as an Effective Date note

under section 1471 of Title 15, Commerce and Trade.

EFFECTIVE DATE OF 1968 AMENDMENT

Amendment by Pub. L. 90-399 effective on first day of thirteenth

calendar month after July 13, 1968, see section 108(a) of Pub. L.

90-399, set out as an Effective Date and Transitional Provisions

note under section 360b of this title.

EFFECTIVE DATE OF 1962 AMENDMENT

Section 112(c) of Pub. L. 87-781 provided that: ''This section

(amending this section) shall take effect on the first day of the

seventh calendar month following the month in which this Act is

enacted (October 1962).''

Section 131(b) of Pub. L. 87-781 provided that: ''No drug which

was being commercially distributed prior to the date of enactment

of this Act (Oct. 10, 1962) shall be deemed to be misbranded under

paragraph (n) of section 502 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 352(n)), as added by this section, until

the earlier of the following dates: (1) the first day of the

seventh month following the month in which this Act is enacted; or

(2) the effective date of regulations first issued under clause (3)

of such paragraph (n) in accordance with the procedure specified in

section 701(e) of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 371(e)).''

Amendment by Pub. L. 87-781 effective on first day of seventh

calendar month following October 1962, see section 107 of Pub. L.

87-781, set out as a note under section 321 of this title.

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86-618 effective July 12, 1960, subject to

the provisions of section 203 of Pub. L. 86-618, see section 202 of

Pub. L. 86-618, set out as a note under section 379e of this title.

EFFECTIVE DATE; POSTPONEMENT

Pars. (b) and (d) to (h) effective Jan. 1, 1940, and such

paragraphs effective July 1, 1940, as provided by regulations for

certain lithographed labeling and containers bearing certain

labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as

an Effective Date: Postponement in Certain Cases note under section

301 of this title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-MISC5-

STUDY AND REPORT

Section 114(b) of Pub. L. 105-115 provided that: ''The

Comptroller General of the United States shall conduct a study of

the implementation of the provisions added by the amendment made by

subsection (a) (amending this section). Not later than 4 years and

6 months after the date of enactment of this Act (Nov. 21, 1997),

the Comptroller General of the United States shall prepare and

submit to Congress a report containing the findings of the study.''

COUNTERFEITING OF DRUGS; CONGRESSIONAL FINDINGS AND DECLARATION OF

POLICY

Section 9(a) of Pub. L. 89-74, July 15, 1965, 79 Stat. 234,

provided that: ''The Congress finds and declares that there is a

substantial traffic in counterfeit drugs simulating the brand or

other identifying mark or device of the manufacturer of the genuine

article; that such traffic poses a serious hazard to the health of

innocent consumers of such drugs because of the lack of proper

qualifications, facilities, and manufacturing controls on the part

of the counterfeiter, whose operations are clandestine; that, while

such drugs are deemed misbranded within the meaning of section

502(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

352(i)), the controls for the suppression of the traffic in such

drugs are inadequate because of the difficulty of determining the

place of interstate origin of such drugs and, if that place is

discovered, the fact that the implements for counterfeiting are not

subject to seizure, and that these factors require enactment of

additional controls with respect to such drugs without regard to

their interstate or intrastate origins.''

Provisions as effective Feb. 1, 1966, see section 11 of Pub. L.

89-74, set out as an Effective Date of 1965 Amendment note under

section 321 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 333, 334, 353, 353a,

354, 355a, 360, 360b, 360c, 360j, 360aaa, 360aaa-6, 371, 374, 384

of this title; title 42 section 1396r-8.

-CITE-

21 USC Sec. 353 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part A - Drugs and Devices

-HEAD-

Sec. 353. Exemptions and consideration for certain drugs, devices,

and biological products

-STATUTE-

(a) Regulations for goods to be processed, labeled, or repacked

elsewhere

The Secretary is directed to promulgate regulations exempting

from any labeling or packaging requirement of this chapter drugs

and devices which are, in accordance with the practice of the

trade, to be processed, labeled, or repacked in substantial

quantities at establishments other than those where originally

processed or packed, on condition that such drugs and devices are

not adulterated or misbranded under the provisions of this chapter

upon removal from such processing, labeling, or repacking

establishment.

(b) Prescription by physician; exemption from labeling and

prescription requirements; misbranded drugs; compliance with

narcotic and marihuana laws

(1) A drug intended for use by man which -

(A) because of its toxicity or other potentiality for harmful

effect, or the method of its use, or the collateral measures

necessary to its use, is not safe for use except under the

supervision of a practitioner licensed by law to administer such

drug; or

(B) is limited by an approved application under section 355 of

this title to use under the professional supervision of a

practitioner licensed by law to administer such drug;

shall be dispensed only (i) upon a written prescription of a

practitioner licensed by law to administer such drug, or (ii) upon

an oral prescription of such practitioner which is reduced promptly

to writing and filed by the pharmacist, or (iii) by refilling any

such written or oral prescription if such refilling is authorized

by the prescriber either in the original prescription or by oral

order which is reduced promptly to writing and filed by the

pharmacist. The act of dispensing a drug contrary to the

provisions of this paragraph shall be deemed to be an act which

results in the drug being misbranded while held for sale.

(2) Any drug dispensed by filling or refilling a written or oral

prescription of a practitioner licensed by law to administer such

drug shall be exempt from the requirements of section 352 of this

title, except paragraphs (a), (i)(2) and (3), (k), and (l), and the

packaging requirements of paragraphs (g), (h), and (p), if the drug

bears a label containing the name and address of the dispenser, the

serial number and date of the prescription or of its filling, the

name of the prescriber, and, if stated in the prescription, the

name of the patient, and the directions for use and cautionary

statements, if any, contained in such prescription. This exemption

shall not apply to any drug dispensed in the course of the conduct

of a business of dispensing drugs pursuant to diagnosis by mail, or

to a drug dispensed in violation of paragraph (1) of this

subsection.

(3) The Secretary may by regulation remove drugs subject to

section 355 of this title from the requirements of paragraph (1) of

this subsection when such requirements are not necessary for the

protection of the public health.

(4)(A) A drug that is subject to paragraph (1) shall be deemed to

be misbranded if at any time prior to dispensing the label of the

drug fails to bear, at a minimum, the symbol ''Rx only''.

(B) A drug to which paragraph (1) does not apply shall be deemed

to be misbranded if at any time prior to dispensing the label of

the drug bears the symbol described in subparagraph (A).

(5) Nothing in this subsection shall be construed to relieve any

person from any requirement prescribed by or under authority of law

with respect to drugs now included or which may hereafter be

included within the classifications stated in sections 4721, 6001,

and 6151 of title 26, or to marihuana as defined in section 4761 of

title 26.

(c) Sales restrictions

(1) No person may sell, purchase, or trade or offer to sell,

purchase, or trade any drug sample. For purposes of this paragraph

and subsection (d) of this section, the term ''drug sample'' means

a unit of a drug, subject to subsection (b) of this section, which

is not intended to be sold and is intended to promote the sale of

the drug. Nothing in this paragraph shall subject an officer or

executive of a drug manufacturer or distributor to criminal

liability solely because of a sale, purchase, trade, or offer to

sell, purchase, or trade in violation of this paragraph by other

employees of the manufacturer or distributor.

(2) No person may sell, purchase, or trade, offer to sell,

purchase, or trade, or counterfeit any coupon. For purposes of

this paragraph, the term ''coupon'' means a form which may be

redeemed, at no cost or at a reduced cost, for a drug which is

prescribed in accordance with subsection (b) of this section.

(3)(A) No person may sell, purchase, or trade, or offer to sell,

purchase, or trade, any drug -

(i) which is subject to subsection (b) of this section, and

(ii)(I) which was purchased by a public or private hospital or

other health care entity, or

(II) which was donated or supplied at a reduced price to a

charitable organization described in section 501(c)(3) of title

26.

(B) Subparagraph (A) does not apply to -

(i) the purchase or other acquisition by a hospital or other

health care entity which is a member of a group purchasing

organization of a drug for its own use from the group purchasing

organization or from other hospitals or health care entities

which are members of such organization,

(ii) the sale, purchase, or trade of a drug or an offer to

sell, purchase, or trade a drug by an organization described in

subparagraph (A)(ii)(II) to a nonprofit affiliate of the

organization to the extent otherwise permitted by law,

(iii) a sale, purchase, or trade of a drug or an offer to sell,

purchase, or trade a drug among hospitals or other health care

entities which are under common control,

(iv) a sale, purchase, or trade of a drug or an offer to sell,

purchase, or trade a drug for emergency medical reasons, or

(v) a sale, purchase, or trade of a drug, an offer to sell,

purchase, or trade a drug, or the dispensing of a drug pursuant

to a prescription executed in accordance with subsection (b) of

this section.

For purposes of this paragraph, the term ''entity'' does not

include a wholesale distributor of drugs or a retail pharmacy

licensed under State law and the term ''emergency medical reasons''

includes transfers of a drug between health care entities or from a

health care entity to a retail pharmacy undertaken to alleviate

temporary shortages of the drug arising from delays in or

interruptions of regular distribution schedules.

(d) Distribution of drug samples

(1) Except as provided in paragraphs (2) and (3), no person may

distribute any drug sample. For purposes of this subsection, the

term ''distribute'' does not include the providing of a drug sample

to a patient by a -

(A) practitioner licensed to prescribe such drug,

(B) health care professional acting at the direction and under

the supervision of such a practitioner, or

(C) pharmacy of a hospital or of another health care entity

that is acting at the direction of such a practitioner and that

received such sample pursuant to paragraph (2) or (3).

(2)(A) The manufacturer or authorized distributor of record of a

drug subject to subsection (b) of this section may, in accordance

with this paragraph, distribute drug samples by mail or common

carrier to practitioners licensed to prescribe such drugs or, at

the request of a licensed practitioner, to pharmacies of hospitals

or other health care entities. Such a distribution of drug samples

may only be made -

(i) in response to a written request for drug samples made on a

form which meets the requirements of subparagraph (B), and

(ii) under a system which requires the recipient of the drug

sample to execute a written receipt for the drug sample upon its

delivery and the return of the receipt to the manufacturer or

authorized distributor of record.

(B) A written request for a drug sample required by subparagraph

(A)(i) shall contain -

(i) the name, address, professional designation, and signature

of the practitioner making the request,

(ii) the identity of the drug sample requested and the quantity

requested,

(iii) the name of the manufacturer of the drug sample

requested, and

(iv) the date of the request.

(C) Each drug manufacturer or authorized distributor of record

which makes distributions by mail or common carrier under this

paragraph shall maintain, for a period of 3 years, the request

forms submitted for such distributions and the receipts submitted

for such distributions and shall maintain a record of distributions

of drug samples which identifies the drugs distributed and the

recipients of the distributions. Forms, receipts, and records

required to be maintained under this subparagraph shall be made

available by the drug manufacturer or authorized distributor of

record to Federal and State officials engaged in the regulation of

drugs and in the enforcement of laws applicable to drugs.

(3) The manufacturer or authorized distributor of record of a

drug subject to subsection (b) of this section may, by means other

than mail or common carrier, distribute drug samples only if the

manufacturer or authorized distributor of record makes the

distributions in accordance with subparagraph (A) and carries out

the activities described in subparagraphs (B) through (F) as

follows:

(A) Drug samples may only be distributed -

(i) to practitioners licensed to prescribe such drugs if they

make a written request for the drug samples, or

(ii) at the written request of such a licensed practitioner,

to pharmacies of hospitals or other health care entities.

A written request for drug samples shall be made on a form which

contains the practitioner's name, address, and professional

designation, the identity of the drug sample requested, the

quantity of drug samples requested, the name of the manufacturer

or authorized distributor of record of the drug sample, the date

of the request and signature of the practitioner making the

request.

(B) Drug manufacturers or authorized distributors of record

shall store drug samples under conditions that will maintain

their stability, integrity, and effectiveness and will assure

that the drug samples will be free of contamination,

deterioration, and adulteration.

(C) Drug manufacturers or authorized distributors of record

shall conduct, at least annually, a complete and accurate

inventory of all drug samples in the possession of

representatives of the manufacturer or authorized distributor of

record. Drug manufacturers or authorized distributors of record

shall maintain lists of the names and address of each of their

representatives who distribute drug samples and of the sites

where drug samples are stored. Drug manufacturers or authorized

distributors of record shall maintain records for at least 3

years of all drug samples distributed, destroyed, or returned to

the manufacturer or authorized distributor of record, of all

inventories maintained under this subparagraph, of all thefts or

significant losses of drug samples, and of all requests made

under subparagraph (A) for drug samples. Records and lists

maintained under this subparagraph shall be made available by the

drug manufacturer or authorized distributor of record to the

Secretary upon request.

(D) Drug manufacturers or authorized distributors of record

shall notify the Secretary of any significant loss of drug

samples and any known theft of drug samples.

(E) Drug manufacturers or authorized distributors of record

shall report to the Secretary any conviction of their

representatives for violations of subsection (c)(1) of this

section or a State law because of the sale, purchase, or trade of

a drug sample or the offer to sell, purchase, or trade a drug

sample.

(F) Drug manufacturers or authorized distributors of record

shall provide to the Secretary the name and telephone number of

the individual responsible for responding to a request for

information respecting drug samples.

(e) Wholesale distributors; guidelines for licensing; definitions

(1)(A) Each person who is engaged in the wholesale distribution

of a drug subject to subsection (b) of this section and who is not

the manufacturer or an authorized distributor of record of such

drug shall, before each wholesale distribution of such drug

(including each distribution to an authorized distributor of record

or to a retail pharmacy), provide to the person who receives the

drug a statement (in such form and containing such information as

the Secretary may require) identifying each prior sale, purchase,

or trade of such drug (including the date of the transaction and

the names and addresses of all parties to the transaction).

(B) Each manufacturer of a drug subject to subsection (b) of this

section shall maintain at its corporate offices a current list of

the authorized distributors of record of such drug.

(2)(A) No person may engage in the wholesale distribution in

interstate commerce of drugs subject to subsection (b) of this

section in a State unless such person is licensed by the State in

accordance with the guidelines issued under subparagraph (B).

(B) The Secretary shall by regulation issue guidelines

establishing minimum standards, terms, and conditions for the

licensing of persons to make wholesale distributions in interstate

commerce of drugs subject to subsection (b) of this section. Such

guidelines shall prescribe requirements for the storage and

handling of such drugs and for the establishment and maintenance of

records of the distributions of such drugs.

(3) For the purposes of this subsection and subsection (d) of

this section -

(A) the term ''authorized distributors of record'' means those

distributors with whom a manufacturer has established an ongoing

relationship to distribute such manufacturer's products, and

(B) the term ''wholesale distribution'' means distribution of

drugs subject to subsection (b) of this section to other than the

consumer or patient but does not include intracompany sales and

does not include distributions of drugs described in subsection

(c)(3)(B) of this section.

(f) Veterinary prescription drugs

(1)(A) A drug intended for use by animals other than man, other

than a veterinary feed directive drug intended for use in animal

feed or an animal feed bearing or containing a veterinary feed

directive drug, which -

(i) because of its toxicity or other potentiality for harmful

effect, or the method of its use, or the collateral measures

necessary for its use, is not safe for animal use except under

the professional supervision of a licensed veterinarian, or

(ii) is limited by an approved application under subsection (b)

of section 360b of this title to use under the professional

supervision of a licensed veterinarian,

shall be dispensed only by or upon the lawful written or oral order

of a licensed veterinarian in the course of the veterinarian's

professional practice.

(B) For purposes of subparagraph (A), an order is lawful if the

order -

(i) is a prescription or other order authorized by law,

(ii) is, if an oral order, promptly reduced to writing by the

person lawfully filling the order, and filed by that person, and

(iii) is refilled only if authorized in the original order or

in a subsequent oral order promptly reduced to writing by the

person lawfully filling the order, and filed by that person.

(C) The act of dispensing a drug contrary to the provisions of

this paragraph shall be deemed to be an act which results in the

drug being misbranded while held for sale.

(2) Any drug when dispensed in accordance with paragraph (1) of

this subsection -

(A) shall be exempt from the requirements of section 352 of

this title, except subsections (a), (g), (h), (i)(2), (i)(3), and

(p) of such section, and

(B) shall be exempt from the packaging requirements of

subsections (g), (h), and (p) of such section, if -

(i) when dispensed by a licensed veterinarian, the drug bears

a label containing the name and address of the practitioner and

any directions for use and cautionary statements specified by

the practitioner, or

(ii) when dispensed by filling the lawful order of a licensed

veterinarian, the drug bears a label containing the name and

address of the dispenser, the serial number and date of the

order or of its filling, the name of the licensed veterinarian,

and the directions for use and cautionary statements, if any,

contained in such order.

The preceding sentence shall not apply to any drug dispensed in the

course of the conduct of a business of dispensing drugs pursuant to

diagnosis by mail.

(3) The Secretary may by regulation exempt drugs for animals

other than man subject to section 360b of this title from the

requirements of paragraph (1) when such requirements are not

necessary for the protection of the public health.

(4) A drug which is subject to paragraph (1) shall be deemed to

be misbranded if at any time prior to dispensing its label fails to

bear the statement ''Caution: Federal law restricts this drug to

use by or on the order of a licensed veterinarian.''. A drug to

which paragraph (1) does not apply shall be deemed to be misbranded

if at any time prior to dispensing its label bears the statement

specified in the preceding sentence.

(g) Regulation of combination products

(1) The Secretary shall in accordance with this subsection assign

an agency center to regulate products that constitute a combination

of a drug, device, or biological product. The Secretary shall

determine the primary mode of action of the combination product.

If the Secretary determines that the primary mode of action is that

of -

(A) a drug (other than a biological product), the agency center

charged with premarket review of drugs shall have primary

jurisdiction,

(B) a device, the agency center charged with premarket review

of devices shall have primary jurisdiction, or

(C) a biological product, the agency center charged with

premarket review of biological products shall have primary

jurisdiction.

(2) Nothing in this subsection shall prevent the Secretary from

using any agency resources of the Food and Drug Administration

necessary to ensure adequate review of the safety, effectiveness,

or substantial equivalence of an article.

(3) The Secretary shall promulgate regulations to implement

market clearance procedures in accordance with paragraphs (1) and

(2) not later than 1 year after November 28, 1990.

(4)(A) Not later than 60 days after October 26, 2002, the

Secretary shall establish within the Office of the Commissioner of

Food and Drugs an office to ensure the prompt assignment of

combination products to agency centers, the timely and effective

premarket review of such products, and consistent and appropriate

postmarket regulation of like products subject to the same

statutory requirements to the extent permitted by law.

Additionally, the office shall, in determining whether a product is

to be designated a combination product, consult with the component

within the Office of the Commissioner of Food and Drugs that is

responsible for such determinations. Such office (referred to in

this paragraph as the ''Office'') shall have appropriate scientific

and medical expertise, and shall be headed by a director.

(B) In carrying out this subsection, the Office shall, for each

combination product, promptly assign an agency center with primary

jurisdiction in accordance with paragraph (1) for the premarket

review of such product.

(C)(i) In carrying out this subsection, the Office shall ensure

timely and effective premarket reviews by overseeing the timeliness

of and coordinating reviews involving more than one agency center.

(ii) In order to ensure the timeliness of the premarket review of

a combination product, the agency center with primary jurisdiction

for the product, and the consulting agency center, shall be

responsible to the Office with respect to the timeliness of the

premarket review.

(D) In carrying out this subsection, the Office shall ensure the

consistency and appropriateness of postmarket regulation of like

products subject to the same statutory requirements to the extent

permitted by law.

(E)(i) Any dispute regarding the timeliness of the premarket

review of a combination product may be presented to the Office for

resolution, unless the dispute is clearly premature.

(ii) During the review process, any dispute regarding the

substance of the premarket review may be presented to the

Commissioner of Food and Drugs after first being considered by the

agency center with primary jurisdiction of the premarket review,

under the scientific dispute resolution procedures for such

center. The Commissioner of Food and Drugs shall consult with the

Director of the Office in resolving the substantive dispute.

(F) The Secretary, acting through the Office, shall review each

agreement, guidance, or practice of the Secretary that is specific

to the assignment of combination products to agency centers and

shall determine whether the agreement, guidance, or practice is

consistent with the requirements of this subsection. In carrying

out such review, the Secretary shall consult with stakeholders and

the directors of the agency centers. After such consultation, the

Secretary shall determine whether to continue in effect, modify,

revise, or eliminate such agreement, guidance, or practice, and

shall publish in the Federal Register a notice of the availability

of such modified or revised agreement, guidance or practice.

Nothing in this paragraph shall be construed as preventing the

Secretary from following each agreement, guidance, or practice

until continued, modified, revised, or eliminated.

(G) Not later than one year after October 26, 2002, and annually

thereafter, the Secretary shall report to the appropriate

committees of Congress on the activities and impact of the Office.

The report shall include provisions -

(i) describing the numbers and types of combination products

under review and the timeliness in days of such assignments,

reviews, and dispute resolutions;

(ii) identifying the number of premarket reviews of such

products that involved a consulting agency center; and

(iii) describing improvements in the consistency of postmarket

regulation of combination products.

(H) Nothing in this paragraph shall be construed to limit the

regulatory authority of any agency center.

(5) As used in this subsection:

(A) The term ''agency center'' means a center or alternative

organizational component of the Food and Drug Administration.

(B) The term ''biological product'' has the meaning given the

term in section 262(i) of title 42.

(C) The term ''market clearance'' includes -

(i) approval of an application under section 355, 357,

(FOOTNOTE 1) 360e, or 360j(g) of this title,

(FOOTNOTE 1) See References in Text note below.

(ii) a finding of substantial equivalence under this part,

and

(iii) approval of a biologics license application under

subsection (a) of section 262 of title 42.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 503, 52 Stat. 1051; Oct. 26, 1951,

ch. 578, Sec. 1, 65 Stat. 648; Pub. L. 87-781, title I, Sec.

104(e)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 91-601, Sec. 6(e),

formerly Sec. 7(e), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub.

L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981, 95 Stat. 716;

Pub. L. 100-293, Sec. 4-6, Apr. 22, 1988, 102 Stat. 96-98; Pub. L.

100-670, title I, Sec. 105, Nov. 16, 1988, 102 Stat. 3983; Pub. L.

101-629, Sec. 16(a), Nov. 28, 1990, 104 Stat. 4526; Pub. L.

102-108, Sec. 2(d), Aug. 17, 1991, 105 Stat. 550; Pub. L. 102-300,

Sec. 6(d), June 16, 1992, 106 Stat. 240; Pub. L. 102-353, Sec.

2(a)-(c), 4, Aug. 26, 1992, 106 Stat. 941, 942; Pub. L. 104-250,

Sec. 5(a), Oct. 9, 1996, 110 Stat. 3155; Pub. L. 105-115, title I,

Sec. 123(e), 126(a), (c)(1), (2), Nov. 21, 1997, 111 Stat. 2324,

2327, 2328; Pub. L. 107-250, title II, Sec. 204, Oct. 26, 2002, 116

Stat. 1611.)

-REFTEXT-

REFERENCES IN TEXT

Section 357 of this title, referred to in subsec. (g)(5)(C)(i),

was repealed by Pub. L. 105-115, title I, Sec. 125(b)(1), Nov. 21,

1997, 111 Stat. 2325.

-COD-

CODIFICATION

In subsec. (b)(5), ''sections 4721, 6001, and 6151 of title 26''

and ''section 4761 of title 26'' substituted for ''section 3220 of

the Internal Revenue Code (26 U.S.C. 3220)'' and ''section 3238(b)

of the Internal Revenue Code (26 U.S.C. 3238(b))'', respectively,

on authority of section 7852(b) of Title 26, Internal Revenue Code.

-MISC3-

AMENDMENTS

2002 - Subsec. (g)(1). Pub. L. 107-250, Sec. 204(1)(A),

substituted ''shall in accordance with this subsection assign an

agency center'' for ''shall designate a component of the Food and

Drug Administration'' in first sentence of introductory provisions.

Subsec. (g)(1)(A) to (C). Pub. L. 107-250, Sec. 204(1)(B),

substituted ''the agency center charged'' for ''the persons

charged''.

Subsec. (g)(4). Pub. L. 107-250, Sec. 204(3), added par. (4).

Former par. (4) redesignated (5).

Subsec. (g)(5). Pub. L. 107-250, Sec. 204(2), (4), redesignated

par. (4) as (5), added subpar. (A), and redesignated former

subpars. (A) and (B) as (B) and (C), respectively.

1997 - Subsec. (b)(1)(A) to (C). Pub. L. 105-115, Sec. 126(c)(1),

redesignated subpars. (B) and (C) as (A) and (B), respectively, and

struck out former subpar. (A), which read as follows: ''is a

habit-forming drug to which section 352(d) of this title applies;

or''.

Subsec. (b)(3). Pub. L. 105-115, Sec. 126(c)(2), struck out

reference to section 352(d) of this title before ''355''.

Subsec. (b)(4). Pub. L. 105-115, Sec. 126(a), amended par. (4)

generally. Prior to amendment, par. (4) read as follows: ''A drug

which is subject to paragraph (1) of this subsection shall be

deemed to be misbranded if at any time prior to dispensing its

label fails to bear the statement 'Caution: Federal law prohibits

dispensing without prescription'. A drug to which paragraph (1) of

this subsection does not apply shall be deemed to be misbranded if

at any time prior to dispensing its label bears the caution

statement quoted in the preceding sentence.''

Subsec. (g)(4)(A). Pub. L. 105-115, Sec. 123(e)(1), substituted

''section 262(i) of title 42'' for ''section 262(a) of title 42''.

Subsec. (g)(4)(B)(iii). Pub. L. 105-115, Sec. 123(e)(2),

substituted ''biologics license application under subsection (a)''

for ''product or establishment license under subsection (a) or

(d)''.

1996 - Subsec. (f)(1)(A). Pub. L. 104-250 inserted '', other than

a veterinary feed directive drug intended for use in animal feed or

an animal feed bearing or containing a veterinary feed directive

drug,'' after ''other than man'' in introductory provisions.

1992 - Subsec. (d)(1). Pub. L. 102-353, Sec. 4(1), amended par.

(1) generally. Prior to amendment, par. (1) read as follows:

''Except as provided in paragraphs (2) and (3), no representative

of a drug manufacturer or distributor may distribute any drug

sample.''

Subsec. (d)(2). Pub. L. 102-353, Sec. 4(2), substituted

''authorized distributor of record'' for ''distributor'' wherever

appearing.

Subsec. (d)(3). Pub. L. 102-353, Sec. 4(2), substituted

''authorized distributor of record'' for ''distributor'' and

''authorized distributors of record'' for ''distributors'' wherever

appearing.

Subsec. (e)(1). Pub. L. 102-353, Sec. 4(3), amended par. (1)

generally. Prior to amendment, par. (1) read as follows: ''Each

person who is engaged in the wholesale distribution of drugs

subject to subsection (b) of this section and who is not an

authorized distributor of record of such drugs shall provide to

each wholesale distributor of such drugs a statement identifying

each sale of the drug (including the date of the sale) before the

sale to such wholesale distributor. Each manufacturer shall

maintain at its corporate offices a current list of such authorized

distributors.''

Subsec. (e)(2)(A). Pub. L. 102-353, Sec. 2(a), (d), temporarily

inserted ''or has registered with the Secretary in accordance with

paragraph (3)''. See Termination Date of 1992 Amendment note below.

Subsec. (e)(3). Pub. L. 102-353, Sec. 2(b), (d), temporarily

added par. (3). Former par. (3) redesignated (4). See Termination

Date of 1992 Amendment note below.

Subsec. (e)(4). Pub. L. 102-353, Sec. 4(4), inserted ''and

subsection (d) of this section'' after ''For the purposes of this

subsection''.

Pub. L. 102-353, Sec. 2(b), (d), temporarily redesignated par.

(3) as (4). See Termination Date of 1992 Amendment note below.

Subsec. (f)(1)(B). Pub. L. 102-353, Sec. 2(c), which directed the

substitution of ''an order'' for ''and order'', could not be

executed because ''and order'' did not appear in subpar. (B).

Subsec. (g)(3). Pub. L. 102-300 substituted ''clearance'' for

''approval''.

1991 - Subsec. (c). Pub. L. 102-108, Sec. 2(d)(3), redesignated

subsec. (c), relating to veterinary prescription drugs, as (f).

Former subsec. (f) redesignated (g).

Subsec. (c)(2), (3)(B)(v). Pub. L. 102-108, Sec. 2(d)(1), made

technical amendment to reference to subsection (b) of this section

involving corresponding provision of original act.

Subsec. (d)(3)(E). Pub. L. 102-108, Sec. 2(d)(2), made technical

amendment to reference to subsection (c)(1) of this section

involving corresponding provision of original act.

Subsec. (f). Pub. L. 102-108, Sec. 2(d)(4), redesignated subsec.

(f), relating to regulation of combination products, as (g).

Pub. L. 102-108, Sec. 2(d)(3), redesignated subsec. (c), relating

to veterinary prescription drugs, as (f).

Subsec. (g). Pub. L. 102-108, Sec. 2(d)(4), redesignated subsec.

(f), relating to regulation of combination products, as (g).

1990 - Pub. L. 101-629, Sec. 16(a)(1), substituted ''Exemptions

and consideration for certain drugs, devices, and biological

products'' for ''Exemptions in case of drugs and devices'' in

section catchline.

Subsec. (f). Pub. L. 101-629, Sec. 16(a)(2), added subsec. (f).

1988 - Subsec. (c). Pub. L. 100-670 added subsec. (c) relating to

veterinary prescription drugs.

Pub. L. 100-293, Sec. 4, added subsec. (c) relating to sales

restrictions.

Subsec. (d). Pub. L. 100-293, Sec. 5, added subsec. (d).

Subsec. (e). Pub. L. 100-293, Sec. 6, added subsec. (e).

1970 - Subsec. (b)(2). Pub. L. 91-601 included exemption from

packaging requirements of subsec. (p) of section 352 of this title.

1962 - Subsec. (b)(1)(C). Pub. L. 87-781 substituted ''approved''

for ''effective''.

1951 - Subsec. (b). Act Oct. 26, 1951, amended subsec. (b)

generally to protect the public from abuses in the sale of potent

prescription drugs, and to relieve retail pharmacists and the

public from unnecessary restrictions on the dispensation of drugs

that are safe to use without supervision of a doctor.

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,

1997, except as otherwise provided, see section 501 of Pub. L.

105-115, set out as a note under section 321 of this title.

TERMINATION DATE OF 1992 AMENDMENT

Section 2(d) of Pub. L. 102-353 provided that: ''Effective

September 14, 1994, the amendments made by subsections (a) and (b)

(amending this section) shall no longer be in effect.''

EFFECTIVE DATE OF 1988 AMENDMENT

Section 8 of Pub. L. 100-293 provided that:

''(a) General Rule. - Except as provided in subsection (b), this

Act and the amendments made by this Act (amending this section and

sections 331, 333, and 381 of this title and enacting provisions

set out as notes under this section and section 301 of this title)

shall take effect upon the expiration of 90 days after the date of

the enactment of this Act (Apr. 22, 1988).

''(b) Exception. -

''(1) Section 503(d) of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 353(d)) (as added by section 5 of this Act) shall

take effect upon the expiration of 180 days after the date of the

enactment of this Act (Apr. 22, 1988).

''(2) The Secretary of Health and Human Services shall by

regulation issue the guidelines required by section 503(e)(2)(B)

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

353(e)(2)(B)) (as added by section 6 of this Act) not later than

180 days after the date of the enactment of this Act. Section

503(e)(2)(A) of such Act shall take effect upon the expiration of

2 years after the date such regulations are promulgated and take

effect.''

EFFECTIVE DATE OF 1970 AMENDMENT

Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and

regulations establishing special packaging standards effective no

sooner than 180 days or later than one year from date regulations

are final, or an earlier date published in Federal Register, see

section 8 of Pub. L. 91-601, set out as an Effective Date note

under section 1471 of Title 15, Commerce and Trade.

EFFECTIVE DATE OF 1962 AMENDMENT

Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section

107 of Pub. L. 87-781, set out as a note under section 321 of this

title.

EFFECTIVE DATE OF 1951 AMENDMENT

Amendment by act Oct. 26, 1951, effective six months after Oct.

26, 1951, see section 3 of act Oct. 26, 1951, set out as a note

under section 333 of this title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-MISC5-

EFFECTIVE MEDICATION GUIDES

Pub. L. 104-180, title VI, Sec. 601, Aug. 6, 1996, 110 Stat.

1593, provided that:

''(a) In General. - Not later than 30 days after the date of

enactment of this Act (Aug. 6, 1996), the Secretary of the

Department of Health and Human Services shall request that national

organizations representing health care professionals, consumer

organizations, voluntary health agencies, the pharmaceutical

industry, drug wholesalers, patient drug information database

companies, and other relevant parties collaborate to develop a

long-range comprehensive action plan to achieve goals consistent

with the goals of the proposed rule of the Food and Drug

Administration on 'Prescription Drug Product Labeling: Medication

Guide Requirements' (60 Fed. Reg. 44182; relating to the provision

of oral and written prescription information to consumers).

''(b) Goals. - Goals consistent with the proposed rule described

in subsection (a) are the distribution of useful written

information to 75 percent of individuals receiving new precriptions

(sic) by the year 2000 and to 95 percent by the year 2006.

''(c) Plan. - The plan described in subsection (a) shall -

''(1) identify the plan goals;

''(2) assess the effectiveness of the current private-sector

approaches used to provide oral and written prescription

information to consumers;

''(3) develop guidelines for providing effective oral and

written prescription information consistent with the findings of

any such assessment;

''(4) contain elements necessary to ensure the transmittal of

useful information to the consuming public, including being

scientifically accurate, non-promotional in tone and content,

sufficiently specific and comprehensive as to adequately inform

consumers about the use of the product, and in an understandable,

legible format that is readily comprehensible and not confusing

to consumers expected to use the product.(;)

''(5) develop a mechanism to assess periodically the quality of

the oral and written prescription information and the frequency

with which the information is provided to consumers; and

''(6) provide for compliance with relevant State board

regulations.

''(d) Limitation on the Authority of the Secretary. - The

Secretary of the Department of Health and Human Services shall have

no authority to implement the proposed rule described in subsection

(a), or to develop any similar regulation, policy statement, or

other guideline specifying a uniform content or format for written

information voluntarily provided to consumers about prescription

drugs if, (1) not later than 120 days after the date of enactment

of this Act (Aug. 6, 1996), the national organizations described in

subsection (a) develop and submit to the Secretary for Health and

Human Services a comprehensive, long-range action plan (as

described in subsection (a)) which shall be acceptable to the

Secretary of Health and Human Services; (2) the aforementioned plan

is submitted to the Secretary of Health and Human Services for

review and acceptance: Provided, That the Secretary shall give due

consideration to the submitted plan and that any such acceptance

shall not be arbitrarily withheld; and (3) the implementation of

(a) a plan accepted by the Secretary commences within 30 days of

the Secretary's acceptance of such plan, or (b) the plan submitted

to the Secretary commences within 60 days of the submission of such

plan if the Secretary fails to take any action on the plan within

30 days of the submission of the plan. The Secretary shall accept,

reject or suggest modifications to the plan submitted within 30

days of its submission. The Secretary may confer with and assist

private parties in the development of the plan described in

subsections (a) and (b).

''(e) Secretary Review. - Not later than January 1, 2001, the

Secretary of the Department of Health and Human Services shall

review the status of private-sector initiatives designed to achieve

the goals of the plan described in subsection (a), and if such

goals are not achieved, the limitation in subsection (d) shall not

apply, and the Secretary shall seek public comment on other

initiatives that may be carried out to meet such goals.''

CONGRESSIONAL FINDINGS

Section 2 of Pub. L. 100-293 provided that: ''The Congress finds

the following:

''(1) American consumers cannot purchase prescription drugs

with the certainty that the products are safe and effective.

''(2) The integrity of the distribution system for prescription

drugs is insufficient to prevent the introduction and eventual

retail sale of substandard, ineffective, or even counterfeit

drugs.

''(3) The existence and operation of a wholesale submarket,

commonly known as the 'diversion market', prevents effective

control over or even routine knowledge of the true sources of

prescription drugs in a significant number of cases.

''(4) Large amounts of drugs are being reimported to the United

States as American goods returned. These imports are a health

and safety risk to American consumers because they may have

become subpotent or adulterated during foreign handling and

shipping.

''(5) The ready market for prescription drug reimports has been

the catalyst for a continuing series of frauds against American

manufacturers and has provided the cover for the importation of

foreign counterfeit drugs.

''(6) The existing system of providing drug samples to

physicians through manufacturer's representatives has been abused

for decades and has resulted in the sale to consumers of

misbranded, expired, and adulterated pharmaceuticals.

''(7) The bulk resale of below wholesale priced prescription

drugs by health care entities, for ultimate sale at retail, helps

fuel the diversion market and is an unfair form of competition to

wholesalers and retailers that must pay otherwise prevailing

market prices.

''(8) The effect of these several practices and conditions is

to create an unacceptable risk that counterfeit, adulterated,

misbranded, subpotent, or expired drugs will be sold to American

consumers.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 333, 360, 360bbb-2,

379g, 379r, 381, 384, 825, 829, 885, 1602 of this title; title 15

section 1459; title 35 section 156.

-CITE-

21 USC Sec. 353a 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part A - Drugs and Devices

-HEAD-

Sec. 353a. Pharmacy compounding

-STATUTE-

(a) In general

Sections 351(a)(2)(B), 352(f)(1), and 355 of this title shall not

apply to a drug product if the drug product is compounded for an

identified individual patient based on the unsolicited receipt of a

valid prescription order or a notation, approved by the prescribing

practitioner, on the prescription order that a compounded product

is necessary for the identified patient, if the drug product meets

the requirements of this section, and if the compounding -

(1) is by -

(A) a licensed pharmacist in a State licensed pharmacy or a

Federal facility, or

(B) a licensed physician,

on the prescription order for such individual patient made by a

licensed physician or other licensed practitioner authorized by

State law to prescribe drugs; or

(2)(A) is by a licensed pharmacist or licensed physician in

limited quantities before the receipt of a valid prescription

order for such individual patient; and

(B) is based on a history of the licensed pharmacist or

licensed physician receiving valid prescription orders for the

compounding of the drug product, which orders have been generated

solely within an established relationship between -

(i) the licensed pharmacist or licensed physician; and

(ii)(I) such individual patient for whom the prescription

order will be provided; or

(II) the physician or other licensed practitioner who will

write such prescription order.

(b) Compounded drug

(1) Licensed pharmacist and licensed physician

A drug product may be compounded under subsection (a) of this

section if the licensed pharmacist or licensed physician -

(A) compounds the drug product using bulk drug substances, as

defined in regulations of the Secretary published at section

207.3(a)(4) of title 21 of the Code of Federal Regulations -

(i) that -

(I) comply with the standards of an applicable United

States Pharmacopoeia or National Formulary monograph, if a

monograph exists, and the United States Pharmacopoeia

chapter on pharmacy compounding;

(II) if such a monograph does not exist, are drug

substances that are components of drugs approved by the

Secretary; or

(III) if such a monograph does not exist and the drug

substance is not a component of a drug approved by the

Secretary, that appear on a list developed by the Secretary

through regulations issued by the Secretary under

subsection (d) of this section;

(ii) that are manufactured by an establishment that is

registered under section 360 of this title (including a

foreign establishment that is registered under section 360(i)

of this title); and

(iii) that are accompanied by valid certificates of

analysis for each bulk drug substance;

(B) compounds the drug product using ingredients (other than

bulk drug substances) that comply with the standards of an

applicable United States Pharmacopoeia or National Formulary

monograph, if a monograph exists, and the United States

Pharmacopoeia chapter on pharmacy compounding;

(C) does not compound a drug product that appears on a list

published by the Secretary in the Federal Register of drug

products that have been withdrawn or removed from the market

because such drug products or components of such drug products

have been found to be unsafe or not effective; and

(D) does not compound regularly or in inordinate amounts (as

defined by the Secretary) any drug products that are

essentially copies of a commercially available drug product.

(2) Definition

For purposes of paragraph (1)(D), the term ''essentially a copy

of a commercially available drug product'' does not include a

drug product in which there is a change, made for an identified

individual patient, which produces for that patient a significant

difference, as determined by the prescribing practitioner,

between the compounded drug and the comparable commercially

available drug product.

(3) Drug product

A drug product may be compounded under subsection (a) only if -

(A) such drug product is not a drug product identified by the

Secretary by regulation as a drug product that presents

demonstrable difficulties for compounding that reasonably

demonstrate an adverse effect on the safety or effectiveness of

that drug product; and

(B) such drug product is compounded in a State -

(i) that has entered into a memorandum of understanding

with the Secretary which addresses the distribution of

inordinate amounts of compounded drug products interstate and

provides for appropriate investigation by a State agency of

complaints relating to compounded drug products distributed

outside such State; or

(ii) that has not entered into the memorandum of

understanding described in clause (i) and the licensed

pharmacist, licensed pharmacy, or licensed physician

distributes (or causes to be distributed) compounded drug

products out of the State in which they are compounded in

quantities that do not exceed 5 percent of the total

prescription orders dispensed or distributed by such pharmacy

or physician.

The Secretary shall, in consultation with the National

Association of Boards of Pharmacy, develop a standard memorandum

of understanding for use by the States in complying with

subparagraph (B)(i).

(c) Advertising and promotion

A drug may be compounded under subsection (a) of this section

only if the pharmacy, licensed pharmacist, or licensed physician

does not advertise or promote the compounding of any particular

drug, class of drug, or type of drug. The pharmacy, licensed

pharmacist, or licensed physician may advertise and promote the

compounding service provided by the licensed pharmacist or licensed

physician.

(d) Regulations

(1) In general

The Secretary shall issue regulations to implement this

section. Before issuing regulations to implement subsections

(b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A) of this section, the

Secretary shall convene and consult an advisory committee on

compounding unless the Secretary determines that the issuance of

such regulations before consultation is necessary to protect the

public health. The advisory committee shall include

representatives from the National Association of Boards of

Pharmacy, the United States Pharmacopoeia, pharmacy, physician,

and consumer organizations, and other experts selected by the

Secretary.

(2) Limiting compounding

The Secretary, in consultation with the United States

Pharmacopoeia Convention, Incorporated, shall promulgate

regulations identifying drug substances that may be used in

compounding under subsection (b)(1)(A)(i)(III) of this section

for which a monograph does not exist or which are not components

of drug products approved by the Secretary. The Secretary shall

include in the regulation the criteria for such substances, which

shall include historical use, reports in peer reviewed medical

literature, or other criteria the Secretary may identify.

(e) Application

This section shall not apply to -

(1) compounded positron emission tomography drugs as defined in

section 321(ii) of this title; or

(2) radiopharmaceuticals.

(f) ''Compounding'' defined

As used in this section, the term ''compounding'' does not

include mixing, reconstituting, or other such acts that are

performed in accordance with directions contained in approved

labeling provided by the product's manufacturer and other

manufacturer directions consistent with that labeling.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 503A, as added Pub. L. 105-115, title

I, Sec. 127(a), Nov. 21, 1997, 111 Stat. 2328.)

-MISC1-

EFFECTIVE DATE

Section 127(b) of Pub. L. 105-115 provided that: ''Section 503A

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a), added

by subsection (a), shall take effect upon the expiration of the

1-year period beginning on the date of the enactment of this Act

(Nov. 21, 1997).''

-CITE-

21 USC Sec. 354 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part A - Drugs and Devices

-HEAD-

Sec. 354. Veterinary feed directive drugs

-STATUTE-

(a) Lawful veterinary feed directive requirement

(1) A drug intended for use in or on animal feed which is limited

by an approved application filed pursuant to section 360b(b) of

this title to use under the professional supervision of a licensed

veterinarian is a veterinary feed directive drug. Any animal feed

bearing or containing a veterinary feed directive drug shall be fed

to animals only by or upon a lawful veterinary feed directive

issued by a licensed veterinarian in the course of the

veterinarian's professional practice. When labeled, distributed,

held, and used in accordance with this section, a veterinary feed

directive drug and any animal feed bearing or containing a

veterinary feed directive drug shall be exempt from section 352(f)

of this title.

(2) A veterinary feed directive is lawful if it -

(A) contains such information as the Secretary may by general

regulation or by order require; and

(B) is in compliance with the conditions and indications for

use of the drug set forth in the notice published pursuant to

section 360b(i) of this title.

(3)(A) Any persons involved in the distribution or use of animal

feed bearing or containing a veterinary feed directive drug and the

licensed veterinarian issuing the veterinary feed directive shall

maintain a copy of the veterinary feed directive applicable to each

such feed, except in the case of a person distributing such feed to

another person for further distribution. Such person distributing

the feed shall maintain a written acknowledgment from the person to

whom the feed is shipped stating that that person shall not ship or

move such feed to an animal production facility without a

veterinary feed directive or ship such feed to another person for

further distribution unless that person has provided the same

written acknowledgment to its immediate supplier.

(B) Every person required under subparagraph (A) to maintain

records, and every person in charge or custody thereof, shall, upon

request of an officer or employee designated by the Secretary,

permit such officer or employee at all reasonable times to have

access to and copy and verify such records.

(C) Any person who distributes animal feed bearing or containing

a veterinary feed directive drug shall upon first engaging in such

distribution notify the Secretary of that person's name and place

of business. The failure to provide such notification shall be

deemed to be an act which results in the drug being misbranded.

(b) Labeling and advertising

A veterinary feed directive drug and any feed bearing or

containing a veterinary feed directive drug shall be deemed to be

misbranded if their labeling fails to bear such cautionary

statement and such other information as the Secretary may by

general regulation or by order prescribe, or their advertising

fails to conform to the conditions and indications for use

published pursuant to section 360b(i) of this title or fails to

contain the general cautionary statement prescribed by the

Secretary.

(c) Nonprescription status

Neither a drug subject to this section, nor animal feed bearing

or containing such a drug, shall be deemed to be a prescription

article under any Federal or State law.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 504, as added Pub. L. 104-250, Sec.

5(b), Oct. 9, 1996, 110 Stat. 3155.)

-MISC1-

PRIOR PROVISIONS

A prior section 354, act June 25, 1938, ch. 675, Sec. 504, 52

Stat. 1052, which directed Secretary to promulgate regulations for

listing of coal-tar colors, was repealed effective July 12, 1960,

subject to provisions of section 203 of Pub. L. 86-618, by Pub. L.

86-618, title I, Sec. 103(a)(2), title II, Sec. 202, July 12, 1960,

74 Stat. 398, 404.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 360b of this title.

-CITE-

21 USC Sec. 355 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

Part A - Drugs and Devices

-HEAD-

Sec. 355. New drugs

-STATUTE-

(a) Necessity of effective approval of application

No person shall introduce or deliver for introduction into

interstate commerce any new drug, unless an approval of an

application filed pursuant to subsection (b) or (j) of this section

is effective with respect to such drug.

(b) Filing application; contents

(1) Any person may file with the Secretary an application with

respect to any drug subject to the provisions of subsection (a) of

this section. Such person shall submit to the Secretary as a part

of the application (A) full reports of investigations which have

been made to show whether or not such drug is safe for use and

whether such drug is effective in use; (B) a full list of the

articles used as components of such drug; (C) a full statement of

the composition of such drug; (D) a full description of the methods

used in, and the facilities and controls used for, the manufacture,

processing, and packing of such drug; (E) such samples of such drug

and of the articles used as components thereof as the Secretary may

require; and (F) specimens of the labeling proposed to be used for

such drug. The applicant shall file with the application the

patent number and the expiration date of any patent which claims

the drug for which the applicant submitted the application or which

claims a method of using such drug and with respect to which a

claim of patent infringement could reasonably be asserted if a

person not licensed by the owner engaged in the manufacture, use,

or sale of the drug. If an application is filed under this

subsection for a drug and a patent which claims such drug or a

method of using such drug is issued after the filing date but

before approval of the application, the applicant shall amend the

application to include the information required by the preceding

sentence. Upon approval of the application, the Secretary shall

publish information submitted under the two preceding sentences.

The Secretary shall, in consultation with the Director of the

National Institutes of Health and with representatives of the drug

manufacturing industry, review and develop guidance, as

appropriate, on the inclusion of women and minorities in clinical

trials required by clause (A).

(2) An application submitted under paragraph (1) for a drug for

which the investigations described in clause (A) of such paragraph

and relied upon by the applicant for approval of the application

were not conducted by or for the applicant and for which the

applicant has not obtained a right of reference or use from the

person by or for whom the investigations were conducted shall also

include -

(A) a certification, in the opinion of the applicant and to the

best of his knowledge, with respect to each patent which claims

the drug for which such investigations were conducted or which

claims a use for such drug for which the applicant is seeking

approval under this subsection and for which information is

required to be filed under paragraph (1) or subsection (c) of

this section -

(i) that such patent information has not been filed,

(ii) that such patent has expired,

(iii) of the date on which such patent will expire, or

(iv) that such patent is invalid or will not be infringed by

the manufacture, use, or sale of the new drug for which the

application is submitted; and

(B) if with respect to the drug for which investigations

described in paragraph (1)(A) were conducted information was

filed under paragraph (1) or subsection (c) of this section for a

method of use patent which does not claim a use for which the

applicant is seeking approval under this subsection, a statement

that the method of use patent does not claim such a use.

(3)(A) An applicant who makes a certification described in

paragraph (2)(A)(iv) shall include in the application a statement

that the applicant will give the notice required by subparagraph

(B) to -

(i) each owner of the patent which is the subject of the

certification or the representative of such owner designated to

receive such notice, and

(ii) the holder of the approved application under subsection

(b) of this section for the drug which is claimed by the patent

or a use of which is claimed by the patent or the representative

of such holder designated to receive such notice.

(B) The notice referred to in subparagraph (A) shall state that

an application has been submitted under this subsection for the

drug with respect to which the certification is made to obtain

approval to engage in the commercial manufacture, use, or sale of

the drug before the expiration of the patent referred to in the

certification. Such notice shall include a detailed statement of

the factual and legal basis of the applicant's opinion that the

patent is not valid or will not be infringed.

(C) If an application is amended to include a certification

described in paragraph (2)(A)(iv), the notice required by

subparagraph (B) shall be given when the amended application is

submitted.

(4)(A) The Secretary shall issue guidance for the individuals who

review applications submitted under paragraph (1) or under section

262 of title 42, which shall relate to promptness in conducting the

review, technical excellence, lack of bias and conflict of

interest, and knowledge of regulatory and scientific standards, and

which shall apply equally to all individuals who review such

applications.

(B) The Secretary shall meet with a sponsor of an investigation

or an applicant for approval for a drug under this subsection or

section 262 of title 42 if the sponsor or applicant makes a

reasonable written request for a meeting for the purpose of

reaching agreement on the design and size of clinical trials

intended to form the primary basis of an effectiveness claim. The

sponsor or applicant shall provide information necessary for

discussion and agreement on the design and size of the clinical

trials. Minutes of any such meeting shall be prepared by the

Secretary and made available to the sponsor or applicant upon

request.

(C) Any agreement regarding the parameters of the design and size

of clinical trials of a new drug under this paragraph that is

reached between the Secretary and a sponsor or applicant shall be

reduced to writing and made part of the administrative record by

the Secretary. Such agreement shall not be changed after the

testing begins, except -

(i) with the written agreement of the sponsor or applicant; or

(ii) pursuant to a decision, made in accordance with

subparagraph (D) by the director of the reviewing division, that

a substantial scientific issue essential to determining the

safety or effectiveness of the drug has been identified after the

testing has begun.

(D) A decision under subparagraph (C)(ii) by the director shall

be in writing and the Secretary shall provide to the sponsor or

applicant an opportunity for a meeting at which the director and

the sponsor or applicant will be present and at which the director

will document the scientific issue involved.

(E) The written decisions of the reviewing division shall be

binding upon, and may not directly or indirectly be changed by, the

field or compliance division personnel unless such field or

compliance division personnel demonstrate to the reviewing division

why such decision should be modified.

(F) No action by the reviewing division may be delayed because of

the unavailability of information from or action by field personnel

unless the reviewing division determines that a delay is necessary

to assure the marketing of a safe and effective drug.

(G) For purposes of this paragraph, the reviewing division is the

division responsible for the review of an application for approval

of a drug under this subsection or section 262 of title 42

(including all scientific and medical matters, chemistry,

manufacturing, and controls).

(c) Period for approval of application; period for, notice, and

expedition of hearing; period for issuance of order

(1) Within one hundred and eighty days after the filing of an

application under subsection (b) of this section, or such

additional period as may be agreed upon by the Secretary and the

applicant, the Secretary shall either -

(A) approve the application if he then finds that none of the

grounds for denying approval specified in subsection (d) of this

section applies, or

(B) give the applicant notice of an opportunity for a hearing

before the Secretary under subsection (d) of this section on the

question whether such application is approvable. If the

applicant elects to accept the opportunity for hearing by written

request within thirty days after such notice, such hearing shall

commence not more than ninety days after the expiration of such

thirty days unless the Secretary and the applicant otherwise

agree. Any such hearing shall thereafter be conducted on an

expedited basis and the Secretary's order thereon shall be issued

within ninety days after the date fixed by the Secretary for

filing final briefs.

(2) If the patent information described in subsection (b) of this

section could not be filed with the submission of an application

under subsection (b) of this section because the application was

filed before the patent information was required under subsection

(b) of this section or a patent was issued after the application

was approved under such subsection, the holder of an approved

application shall file with the Secretary the patent number and the

expiration date of any patent which claims the drug for which the

application was submitted or which claims a method of using such

drug and with respect to which a claim of patent infringement could

reasonably be asserted if a person not licensed by the owner

engaged in the manufacture, use, or sale of the drug. If the

holder of an approved application could not file patent information

under subsection (b) of this section because it was not required at

the time the application was approved, the holder shall file such

information under this subsection not later than thirty days after

September 24, 1984, and if the holder of an approved application

could not file patent information under subsection (b) of this

section because no patent had been issued when an application was

filed or approved, the holder shall file such information under

this subsection not later than thirty days after the date the

patent involved is issued. Upon the submission of patent

information under this subsection, the Secretary shall publish it.

(3) The approval of an application filed under subsection (b) of

this section which contains a certification required by paragraph

(2) of such subsection shall be made effective on the last

applicable date determined under the following:

(A) If the applicant only made a certification described in

clause (i) or (ii) of subsection (b)(2)(A) of this section or in

both such clauses, the approval may be made effective

immediately.

(B) If the applicant made a certification described in clause

(iii) of subsection (b)(2)(A) of this section, the approval may

be made effective on the date certified under clause (iii).

(C) If the applicant made a certification described in clause

(iv) of subsection (b)(2)(A) of this section, the approval shall

be made effective immediately unless an action is brought for

infringement of a patent which is the subject of the

certification before the expiration of forty-five days from the

date the notice provided under paragraph (3)(B) is received. If

such an action is brought before the expiration of such days, the

approval may be made effective upon the expiration of the

thirty-month period beginning on the date of the receipt of the

notice provided under paragraph (3)(B) or such shorter or longer

period as the court may order because either party to the action

failed to reasonably cooperate in expediting the action, except

that -

(i) if before the expiration of such period the court decides

that such patent is invalid or not infringed, the approval may

be made effective on the date of the court decision,

(ii) if before the expiration of such period the court

decides that such patent has been infringed, the approval may

be made effective on such date as the court orders under

section 271(e)(4)(A) of title 35, or

(iii) if before the expiration of such period the court

grants a preliminary injunction prohibiting the applicant from

engaging in the commercial manufacture or sale of the drug

until the court decides the issues of patent validity and

infringement and if the court decides that such patent is

invalid or not infringed, the approval shall be made effective

on the date of such court decision.

In such an action, each of the parties shall reasonably cooperate

in expediting the action. Until the expiration of forty-five

days from the date the notice made under paragraph (3)(B) is

received, no action may be brought under section 2201 of title 28

for a declaratory judgment with respect to the patent. Any

action brought under such section 2201 shall be brought in the

judicial district where the defendant has its principal place of

business or a regular and established place of business.

(D)(i) If an application (other than an abbreviated new drug

application) submitted under subsection (b) of this section for a

drug, no active ingredient (including any ester or salt of the

active ingredient) of which has been approved in any other

application under subsection (b) of this section, was approved

during the period beginning January 1, 1982, and ending on

September 24, 1984, the Secretary may not make the approval of

another application for a drug for which the investigations

described in clause (A) of subsection (b)(1) of this section and

relied upon by the applicant for approval of the application were

not conducted by or for the applicant and for which the applicant

has not obtained a right of reference or use from the person by

or for whom the investigations were conducted effective before

the expiration of ten years from the date of the approval of the

application previously approved under subsection (b) of this

section.

(ii) If an application submitted under subsection (b) of this

section for a drug, no active ingredient (including any ester or

salt of the active ingredient) of which has been approved in any

other application under subsection (b) of this section, is

approved after September 24, 1984, no application which refers to

the drug for which the subsection (b) application was submitted

and for which the investigations described in clause (A) of

subsection (b)(1) of this section and relied upon by the

applicant for approval of the application were not conducted by

or for the applicant and for which the applicant has not obtained

a right of reference or use from the person by or for whom the

investigations were conducted may be submitted under subsection

(b) of this section before the expiration of five years from the

date of the approval of the application under subsection (b) of

this section, except that such an application may be submitted

under subsection (b) of this section after the expiration of four

years from the date of the approval of the subsection (b)

application if it contains a certification of patent invalidity

or noninfringement described in clause (iv) of subsection

(b)(2)(A) of this section. The approval of such an application

shall be made effective in accordance with this paragraph except

that, if an action for patent infringement is commenced during

the one-year period beginning forty-eight months after the date

of the approval of the subsection (b) application, the

thirty-month period referred to in subparagraph (C) shall be

extended by such amount of time (if any) which is required for

seven and one-half years to have elapsed from the date of

approval of the subsection (b) application.

(iii) If an application submitted under subsection (b) of this

section for a drug, which includes an active ingredient

(including any ester or salt of the active ingredient) that has

been approved in another application approved under subsection

(b) of this section, is approved after September 24, 1984, and if

such application contains reports of new clinical investigations

(other than bioavailability studies) essential to the approval of

the application and conducted or sponsored by the applicant, the

Secretary may not make the approval of an application submitted

under subsection (b) of this section for the conditions of

approval of such drug in the approved subsection (b) application

effective before the expiration of three years from the date of

the approval of the application under subsection (b) of this

section if the investigations described in clause (A) of

subsection (b)(1) of this section and relied upon by the

applicant for approval of the application were not conducted by

or for the applicant and if the applicant has not obtained a

right of reference or use from the person by or for whom the

investigations were conducted.

(iv) If a supplement to an application approved under

subsection (b) of this section is approved after September 24,

1984, and the supplement contains reports of new clinical

investigations (other than bioavailabilty (FOOTNOTE 1) studies)

essential to the approval of the supplement and conducted or

sponsored by the person submitting the supplement, the Secretary

may not make the approval of an application submitted under

subsection (b) of this section for a change approved in the

supplement effective before the expiration of three years from

the date of the approval of the supplement under subsection (b)

of this section if the investigations described in clause (A) of

subsection (b)(1) of this section and relied upon by the

applicant for approval of the application were not conducted by

or for the applicant and if the applicant has not obtained a

right of reference or use from the person by or for whom the

investigations were conducted.

(FOOTNOTE 1) So in original. Probably should be

''bioavailability''.

(v) If an application (or supplement to an application)

submitted under subsection (b) of this section for a drug, which

includes an active ingredient (including any ester or salt of the

active ingredient) that has been approved in another application

under subsection (b) of this section, was approved during the

period beginning January 1, 1982, and ending on September 24,

1984, the Secretary may not make the approval of an application

submitted under this subsection and for which the investigations

described in clause (A) of subsection (b)(1) of this section and

relied upon by the applicant for approval of the application were

not conducted by or for the applicant and for which the applicant

has not obtained a right of reference or use from the person by

or for whom the investigations were conducted and which refers to

the drug for which the subsection (b) application was submitted

effective before the expiration of two years from September 24,

1984.

(4) A drug manufactured in a pilot or other small facility may be

used to demonstrate the safety and effectiveness of the drug and to

obtain approval for the drug prior to manufacture of the drug in a

larger facility, unless the Secretary makes a determination that a

full scale production facility is necessary to ensure the safety or

effectiveness of the drug.

(d) Grounds for refusing application; approval of application;

''substantial evidence'' defined

If the Secretary finds, after due notice to the applicant in

accordance with subsection (c) of this section and giving him an

opportunity for a hearing, in accordance with said subsection, that

(1) the investigations, reports of which are required to be

submitted to the Secretary pursuant to subsection (b) of this

section, do not include adequate tests by all methods reasonably

applicable to show whether or not such drug is safe for use under

the conditions prescribed, recommended, or suggested in the

proposed labeling thereof; (2) the results of such tests show that

such drug is unsafe for use under such conditions or do not show

that such drug is safe for use under such conditions; (3) the

methods used in, and the facilities and controls used for, the

manufacture, processing, and packing of such drug are inadequate to

preserve its identity, strength, quality, and purity; (4) upon the

basis of the information submitted to him as part of the

application, or upon the basis of any other information before him

with respect to such drug, he has insufficient information to

determine whether such drug is safe for use under such conditions;

or (5) evaluated on the basis of the information submitted to him

as part of the application and any other information before him

with respect to such drug, there is a lack of substantial evidence

that the drug will have the effect it purports or is represented to

have under the conditions of use prescribed, recommended, or

suggested in the proposed labeling thereof; or (6) the application

failed to contain the patent information prescribed by subsection

(b) of this section; or (7) based on a fair evaluation of all

material facts, such labeling is false or misleading in any

particular; he shall issue an order refusing to approve the

application. If, after such notice and opportunity for hearing,

the Secretary finds that clauses (1) through (6) do not apply, he

shall issue an order approving the application. As used in this

subsection and subsection (e) of this section, the term

''substantial evidence'' means evidence consisting of adequate and

well-controlled investigations, including clinical investigations,

by experts qualified by scientific training and experience to

evaluate the effectiveness of the drug involved, on the basis of

which it could fairly and responsibly be concluded by such experts

that the drug will have the effect it purports or is represented to

have under the conditions of use prescribed, recommended, or

suggested in the labeling or proposed labeling thereof. If the

Secretary determines, based on relevant science, that data from one

adequate and well-controlled clinical investigation and

confirmatory evidence (obtained prior to or after such

investigation) are sufficient to establish effectiveness, the

Secretary may consider such data and evidence to constitute

substantial evidence for purposes of the preceding sentence.

(e) Withdrawal of approval; grounds; immediate suspension upon

finding imminent hazard to public health

The Secretary shall, after due notice and opportunity for hearing

to the applicant, withdraw approval of an application with respect

to any drug under this section if the Secretary finds (1) that

clinical or other experience, tests, or other scientific data show

that such drug is unsafe for use under the conditions of use upon

the basis of which the application was approved; (2) that new

evidence of clinical experience, not contained in such application

or not available to the Secretary until after such application was

approved, or tests by new methods, or tests by methods not deemed

reasonably applicable when such application was approved, evaluated

together with the evidence available to the Secretary when the

application was approved, shows that such drug is not shown to be

safe for use under the conditions of use upon the basis of which

the application was approved; or (3) on the basis of new

information before him with respect to such drug, evaluated

together with the evidence available to him when the application

was approved, that there is a lack of substantial evidence that the

drug will have the effect it purports or is represented to have

under the conditions of use prescribed, recommended, or suggested

in the labeling thereof; or (4) the patent information prescribed

by subsection (c) of this section was not filed within thirty days

after the receipt of written notice from the Secretary specifying

the failure to file such information; or (5) that the application

contains any untrue statement of a material fact: Provided, That if

the Secretary (or in his absence the officer acting as Secretary)

finds that there is an imminent hazard to the public health, he may

suspend the approval of such application immediately, and give the

applicant prompt notice of his action and afford the applicant the

opportunity for an expedited hearing under this subsection; but the

authority conferred by this proviso to suspend the approval of an

application shall not be delegated. The Secretary may also, after

due notice and opportunity for hearing to the applicant, withdraw

the approval of an application submitted under subsection (b) or

(j) of this section with respect to any drug under this section if

the Secretary finds (1) that the applicant has failed to establish

a system for maintaining required records, or has repeatedly or

deliberately failed to maintain such records or to make required

reports, in accordance with a regulation or order under subsection

(k) of this section or to comply with the notice requirements of

section 360(k)(2) of this title, or the applicant has refused to

permit access to, or copying or verification of, such records as

required by paragraph (2) of such subsection; or (2) that on the

basis of new information before him, evaluated together with the

evidence before him when the application was approved, the methods

used in, or the facilities and controls used for, the manufacture,

processing, and packing of such drug are inadequate to assure and

preserve its identity, strength, quality, and purity and were not

made adequate within a reasonable time after receipt of written

notice from the Secretary specifying the matter complained of; or

(3) that on the basis of new information before him, evaluated

together with the evidence before him when the application was

approved, the labeling of such drug, based on a fair evaluation of

all material facts, is false or misleading in any particular and

was not corrected within a reasonable time after receipt of written

notice from the Secretary specifying the matter complained of. Any

order under this subsection shall state the findings upon which it

is based.

(f) Revocation of order refusing, withdrawing or suspending

approval of application

Whenever the Secretary finds that the facts so require, he shall

revoke any previous order under subsection (d) or (e) of this

section refusing, withdrawing, or suspending approval of an

application and shall approve such application or reinstate such

approval, as may be appropriate.

(g) Service of orders

Orders of the Secretary issued under this section shall be served

(1) in person by any officer or employee of the department

designated by the Secretary or (2) by mailing the order by

registered mail or by certified mail addressed to the applicant or

respondent at his last-known address in the records of the

Secretary.

(h) Appeal from order

An appeal may be taken by the applicant from an order of the

Secretary refusing or withdrawing approval of an application under

this section. Such appeal shall be taken by filing in the United

States court of appeals for the circuit wherein such applicant

resides or has his principal place of business, or in the United

States Court of Appeals for the District of Columbia Circuit,

within sixty days after the entry of such order, a written petition

praying that the order of the Secretary be set aside. A copy of

such petition shall be forthwith transmitted by the clerk of the

court to the Secretary, or any officer designated by him for that

purpose, and thereupon the Secretary shall certify and file in the

court the record upon which the order complained of was entered, as

provided in section 2112 of title 28. Upon the filing of such

petition such court shall have exclusive jurisdiction to affirm or

set aside such order, except that until the filing of the record

the Secretary may modify or set aside his order. No objection to

the order of the Secretary shall be considered by the court unless

such objection shall have been urged before the Secretary or unless

there were reasonable grounds for failure so to do. The finding of

the Secretary as to the facts, if supported by substantial

evidence, shall be conclusive. If any person shall apply to the

court for leave to adduce additional evidence, and shall show to

the satisfaction of the court that such additional evidence is

material and that there were reasonable grounds for failure to

adduce such evidence in the proceeding before the Secretary, the

court may order such additional evidence to be taken before the

Secretary and to be adduced upon the hearing in such manner and

upon such terms and conditions as to the court may seem proper.

The Secretary may modify his findings as to the facts by reason of

the additional evidence so taken, and he shall file with the court

such modified findings which, if supported by substantial evidence,

shall be conclusive, and his recommendation, if any, for the

setting aside of the original order. The judgment of the court

affirming or setting aside any such order of the Secretary shall be

final, subject to review by the Supreme Court of the United States

upon certiorari or certification as provided in section 1254 of

title 28. The commencement of proceedings under this subsection

shall not, unless specifically ordered by the court to the

contrary, operate as a stay of the Secretary's order.

(i) Exemptions of drugs for research; discretionary and mandatory

conditions; direct reports to Secretary

(1) The Secretary shall promulgate regulations for exempting from

the operation of the foregoing subsections of this section drugs

intended solely for investigational use by experts qualified by

scientific training and experience to investigate the safety and

effectiveness of drugs. Such regulations may, within the

discretion of the Secretary, among other conditions relating to the

protection of the public health, provide for conditioning such

exemption upon -

(A) the submission to the Secretary, before any clinical

testing of a new drug is undertaken, of reports, by the

manufacturer or the sponsor of the investigation of such drug, of

preclinical tests (including tests on animals) of such drug

adequate to justify the proposed clinical testing;

(B) the manufacturer or the sponsor of the investigation of a

new drug proposed to be distributed to investigators for clinical

testing obtaining a signed agreement from each of such

investigators that patients to whom the drug is administered will

be under his personal supervision, or under the supervision of

investigators responsible to him, and that he will not supply

such drug to any other investigator, or to clinics, for

administration to human beings;

(C) the establishment and maintenance of such records, and the

making of such reports to the Secretary, by the manufacturer or

the sponsor of the investigation of such drug, of data (including

but not limited to analytical reports by investigators) obtained

as the result of such investigational use of such drug, as the

Secretary finds will enable him to evaluate the safety and

effectiveness of such drug in the event of the filing of an

application pursuant to subsection (b) of this section; and

(D) the submission to the Secretary by the manufacturer or the

sponsor of the investigation of a new drug of a statement of

intent regarding whether the manufacturer or sponsor has plans

for assessing pediatric safety and efficacy.

(2) Subject to paragraph (3), a clinical investigation of a new

drug may begin 30 days after the Secretary has received from the

manufacturer or sponsor of the investigation a submission

containing such information about the drug and the clinical

investigation, including -

(A) information on design of the investigation and adequate

reports of basic information, certified by the applicant to be

accurate reports, necessary to assess the safety of the drug for

use in clinical investigation; and

(B) adequate information on the chemistry and manufacturing of

the drug, controls available for the drug, and primary data

tabulations from animal or human studies.

(3)(A) At any time, the Secretary may prohibit the sponsor of an

investigation from conducting the investigation (referred to in

this paragraph as a ''clinical hold'') if the Secretary makes a

determination described in subparagraph (B). The Secretary shall

specify the basis for the clinical hold, including the specific

information available to the Secretary which served as the basis

for such clinical hold, and confirm such determination in writing.

(B) For purposes of subparagraph (A), a determination described

in this subparagraph with respect to a clinical hold is that -

(i) the drug involved represents an unreasonable risk to the

safety of the persons who are the subjects of the clinical

investigation, taking into account the qualifications of the

clinical investigators, information about the drug, the design of

the clinical investigation, the condition for which the drug is

to be investigated, and the health status of the subjects

involved; or

(ii) the clinical hold should be issued for such other reasons

as the Secretary may by regulation establish (including reasons

established by regulation before November 21, 1997).

(C) Any written request to the Secretary from the sponsor of an

investigation that a clinical hold be removed shall receive a

decision, in writing and specifying the reasons therefor, within 30

days after receipt of such request. Any such request shall include

sufficient information to support the removal of such clinical

hold.

(4) Regulations under paragraph (1) shall provide that such

exemption shall be conditioned upon the manufacturer, or the

sponsor of the investigation, requiring that experts using such

drugs for investigational purposes certify to such manufacturer or

sponsor that they will inform any human beings to whom such drugs,

or any controls used in connection therewith, are being

administered, or their representatives, that such drugs are being

used for investigational purposes and will obtain the consent of

such human beings or their representatives, except where it is not

feasible or it is contrary to the best interests of such human

beings. Nothing in this subsection shall be construed to require

any clinical investigator to submit directly to the Secretary

reports on the investigational use of drugs.

(j) Abbreviated new drug applications

(1) Any person may file with the Secretary an abbreviated

application for the approval of a new drug.

(2)(A) An abbreviated application for a new drug shall contain -

(i) information to show that the conditions of use prescribed,

recommended, or suggested in the labeling proposed for the new

drug have been previously approved for a drug listed under

paragraph (7) (hereinafter in this subsection referred to as a

''listed drug'');

(ii)(I) if the listed drug referred to in clause (i) has only

one active ingredient, information to show that the active

ingredient of the new drug is the same as that of the listed

drug;

(II) if the listed drug referred to in clause (i) has more than

one active ingredient, information to show that the active

ingredients of the new drug are the same as those of the listed

drug, or

(III) if the listed drug referred to in clause (i) has more

than one active ingredient and if one of the active ingredients

of the new drug is different and the application is filed

pursuant to the approval of a petition filed under subparagraph

(C), information to show that the other active ingredients of the

new drug are the same as the active ingredients of the listed

drug, information to show that the different active ingredient is

an active ingredient of a listed drug or of a drug which does not

meet the requirements of section 321(p) of this title, and such

other information respecting the different active ingredient with

respect to which the petition was filed as the Secretary may

require;

(iii) information to show that the route of administration, the

dosage form, and the strength of the new drug are the same as

those of the listed drug referred to in clause (i) or, if the

route of administration, the dosage form, or the strength of the

new drug is different and the application is filed pursuant to

the approval of a petition filed under subparagraph (C), such

information respecting the route of administration, dosage form,

or strength with respect to which the petition was filed as the

Secretary may require;

(iv) information to show that the new drug is bioequivalent to

the listed drug referred to in clause (i), except that if the

application is filed pursuant to the approval of a petition filed

under subparagraph (C), information to show that the active

ingredients of the new drug are of the same pharmacological or

therapeutic class as those of the listed drug referred to in

clause (i) and the new drug can be expected to have the same

therapeutic effect as the listed drug when administered to

patients for a condition of use referred to in clause (i);

(v) information to show that the labeling proposed for the new

drug is the same as the labeling approved for the listed drug

referred to in clause (i) except for changes required because of

differences approved under a petition filed under subparagraph

(C) or because the new drug and the listed drug are produced or

distributed by different manufacturers;

(vi) the items specified in clauses (B) through (F) of

subsection (b)(1) of this section;

(vii) a certification, in the opinion of the applicant and to

the best of his knowledge, with respect to each patent which

claims the listed drug referred to in clause (i) or which claims

a use for such listed drug for which the applicant is seeking

approval under this subsection and for which information is

required to be filed under subsection (b) or (c) of this section

-

(I) that such patent information has not been filed,

(II) that such patent has expired,

(III) of the date on which such patent will expire, or

(IV) that such patent is invalid or will not be infringed by

the manufacture, use, or sale of the new drug for which the

application is submitted; and

(viii) if with respect to the listed drug referred to in clause

(i) information was filed under subsection (b) or (c) of this

section for a method of use patent which does not claim a use for

which the applicant is seeking approval under this subsection, a

statement that the method of use patent does not claim such a

use.

The Secretary may not require that an abbreviated application

contain information in addition to that required by clauses (i)

through (viii).

(B)(i) An applicant who makes a certification described in

subparagraph (A)(vii)(IV) shall include in the application a

statement that the applicant will give the notice required by

clause (ii) to -

(I) each owner of the patent which is the subject of the

certification or the representative of such owner designated to

receive such notice, and

(II) the holder of the approved application under subsection

(b) of this section for the drug which is claimed by the patent

or a use of which is claimed by the patent or the representative

of such holder designated to receive such notice.

(ii) The notice referred to in clause (i) shall state that an

application, which contains data from bioavailability or

bioequivalence studies, has been submitted under this subsection

for the drug with respect to which the certification is made to

obtain approval to engage in the commercial manufacture, use, or

sale of such drug before the expiration of the patent referred to

in the certification. Such notice shall include a detailed

statement of the factual and legal basis of the applicant's opinion

that the patent is not valid or will not be infringed.

(iii) If an application is amended to include a certification

described in subparagraph (A)(vii)(IV), the notice required by

clause (ii) shall be given when the amended application is

submitted.

(C) If a person wants to submit an abbreviated application for a

new drug which has a different active ingredient or whose route of

administration, dosage form, or strength differ from that of a

listed drug, such person shall submit a petition to the Secretary

seeking permission to file such an application. The Secretary

shall approve or disapprove a petition submitted under this

subparagraph within ninety days of the date the petition is

submitted. The Secretary shall approve such a petition unless the

Secretary finds -

(i) that investigations must be conducted to show the safety

and effectiveness of the drug or of any of its active

ingredients, the route of administration, the dosage form, or

strength which differ from the listed drug; or

(ii) that any drug with a different active ingredient may not

be adequately evaluated for approval as safe and effective on the

basis of the information required to be submitted in an

abbreviated application.

(3)(A) The Secretary shall issue guidance for the individuals who

review applications submitted under paragraph (1), which shall

relate to promptness in conducting the review, technical

excellence, lack of bias and conflict of interest, and knowledge of

regulatory and scientific standards, and which shall apply equally

to all individuals who review such applications.

(B) The Secretary shall meet with a sponsor of an investigation

or an applicant for approval for a drug under this subsection if

the sponsor or applicant makes a reasonable written request for a

meeting for the purpose of reaching agreement on the design and

size of bioavailability and bioequivalence studies needed for

approval of such application. The sponsor or applicant shall

provide information necessary for discussion and agreement on the

design and size of such studies. Minutes of any such meeting shall

be prepared by the Secretary and made available to the sponsor or

applicant.

(C) Any agreement regarding the parameters of design and size of

bioavailability and bioequivalence studies of a drug under this

paragraph that is reached between the Secretary and a sponsor or

applicant shall be reduced to writing and made part of the

administrative record by the Secretary. Such agreement shall not be

changed after the testing begins, except -

(i) with the written agreement of the sponsor or applicant; or

(ii) pursuant to a decision, made in accordance with

subparagraph (D) by the director of the reviewing division, that

a substantial scientific issue essential to determining the

safety or effectiveness of the drug has been identified after the

testing has begun.

(D) A decision under subparagraph (C)(ii) by the director shall

be in writing and the Secretary shall provide to the sponsor or

applicant an opportunity for a meeting at which the director and

the sponsor or applicant will be present and at which the director

will document the scientific issue involved.

(E) The written decisions of the reviewing division shall be

binding upon, and may not directly or indirectly be changed by, the

field or compliance office personnel unless such field or

compliance office personnel demonstrate to the reviewing division

why such decision should be modified.

(F) No action by the reviewing division may be delayed because of

the unavailability of information from or action by field personnel

unless the reviewing division determines that a delay is necessary

to assure the marketing of a safe and effective drug.

(G) For purposes of this paragraph, the reviewing division is the

division responsible for the review of an application for approval

of a drug under this subsection (including scientific matters,

chemistry, manufacturing, and controls).

(4) Subject to paragraph (5), the Secretary shall approve an

application for a drug unless the Secretary finds -

(A) the methods used in, or the facilities and controls used

for, the manufacture, processing, and packing of the drug are

inadequate to assure and preserve its identity, strength,

quality, and purity;

(B) information submitted with the application is insufficient

to show that each of the proposed conditions of use have been

previously approved for the listed drug referred to in the

application;

(C)(i) if the listed drug has only one active ingredient,

information submitted with the application is insufficient to

show that the active ingredient is the same as that of the listed

drug;

(ii) if the listed drug has more than one active ingredient,

information submitted with the application is insufficient to

show that the active ingredients are the same as the active

ingredients of the listed drug, or

(iii) if the listed drug has more than one active ingredient

and if the application is for a drug which has an active

ingredient different from the listed drug, information submitted

with the application is insufficient to show -

(I) that the other active ingredients are the same as the

active ingredients of the listed drug, or

(II) that the different active ingredient is an active

ingredient of a listed drug or a drug which does not meet the

requirements of section 321(p) of this title,

or no petition to file an application for the drug with the

different ingredient was approved under paragraph (2)(C);

(D)(i) if the application is for a drug whose route of

administration, dosage form, or strength of the drug is the same

as the route of administration, dosage form, or strength of the

listed drug referred to in the application, information submitted

in the application is insufficient to show that the route of

administration, dosage form, or strength is the same as that of

the listed drug, or

(ii) if the application is for a drug whose route of

administration, dosage form, or strength of the drug is different

from that of the listed drug referred to in the application, no

petition to file an application for the drug with the different

route of administration, dosage form, or strength was approved

under paragraph (2)(C);

(E) if the application was filed pursuant to the approval of a

petition under paragraph (2)(C), the application did not contain

the information required by the Secretary respecting the active

ingredient, route of administration, dosage form, or strength

which is not the same;

(F) information submitted in the application is insufficient to

show that the drug is bioequivalent to the listed drug referred

to in the application or, if the application was filed pursuant

to a petition approved under paragraph (2)(C), information

submitted in the application is insufficient to show that the

active ingredients of the new drug are of the same

pharmacological or therapeutic class as those of the listed drug

referred to in paragraph (2)(A)(i) and that the new drug can be

expected to have the same therapeutic effect as the listed drug

when administered to patients for a condition of use referred to

in such paragraph;

(G) information submitted in the application is insufficient to

show that the labeling proposed for the drug is the same as the

labeling approved for the listed drug referred to in the

application except for changes required because of differences

approved under a petition filed under paragraph (2)(C) or because

the drug and the listed drug are produced or distributed by

different manufacturers;

(H) information submitted in the application or any other

information available to the Secretary shows that (i) the

inactive ingredients of the drug are unsafe for use under the

conditions prescribed, recommended, or suggested in the labeling

proposed for the drug, or (ii) the composition of the drug is

unsafe under such conditions because of the type or quantity of

inactive ingredients included or the manner in which the inactive

ingredients are included;

(I) the approval under subsection (c) of this section of the

listed drug referred to in the application under this subsection

has been withdrawn or suspended for grounds described in the

first sentence of subsection (e) of this section, the Secretary

has published a notice of opportunity for hearing to withdraw

approval of the listed drug under subsection (c) of this section

for grounds described in the first sentence of subsection (e) of

this section, the approval under this subsection of the listed

drug referred to in the application under this subsection has

been withdrawn or suspended under paragraph (6), or the Secretary

has determined that the listed drug has been withdrawn from sale

for safety or effectiveness reasons;

(J) the application does not meet any other requirement of

paragraph (2)(A); or

(K) the application contains an untrue statement of material

fact.

(5)(A) Within one hundred and eighty days of the initial receipt

of an application under paragraph (2) or within such additional

period as may be agreed upon by the Secretary and the applicant,

the Secretary shall approve or disapprove the application.

(B) The approval of an application submitted under paragraph (2)

shall be made effective on the last applicable date determined

under the following:

(i) If the applicant only made a certification described in

subclause (I) or (II) of paragraph (2)(A)(vii) or in both such

subclauses, the approval may be made effective immediately.

(ii) If the applicant made a certification described in

subclause (III) of paragraph (2)(A)(vii), the approval may be

made effective on the date certified under subclause (III).

(iii) If the applicant made a certification described in

subclause (IV) of paragraph (2)(A)(vii), the approval shall be

made effective immediately unless an action is brought for

infringement of a patent which is the subject of the

certification before the expiration of forty-five days from the

date the notice provided under paragraph (2)(B)(i) is received.

If such an action is brought before the expiration of such days,

the approval shall be made effective upon the expiration of the

thirty-month period beginning on the date of the receipt of the

notice provided under paragraph (2)(B)(i) or such shorter or

longer period as the court may order because either party to the

action failed to reasonably cooperate in expediting the action,

except that -

(I) if before the expiration of such period the court decides

that such patent is invalid or not infringed, the approval

shall be made effective on the date of the court decision,

(II) if before the expiration of such period the court

decides that such patent has been infringed, the approval shall

be made effective on such date as the court orders under

section 271(e)(4)(A) of title 35, or

(III) if before the expiration of such period the court

grants a preliminary injunction prohibiting the applicant from

engaging in the commercial manufacture or sale of the drug

until the court decides the issues of patent validity and

infringement and if the court decides that such patent is

invalid or not infringed, the approval shall be made effective

on the date of such court decision.

In such an action, each of the parties shall reasonably cooperate

in expediting the action. Until the expiration of forty-five

days from the date the notice made under paragraph (2)(B)(i) is

received, no action may be brought under section 2201 of title

28, for a declaratory judgment with respect to the patent. Any

action brought under section 2201 shall be brought in the

judicial district where the defendant has its principal place of

business or a regular and established place of business.

(iv) If the application contains a certification described in

subclause (IV) of paragraph (2)(A)(vii) and is for a drug for

which a previous application has been submitted under this

subsection continuing such a certification, the application shall

be made effective not earlier than one hundred and eighty days

after -

(I) the date the Secretary receives notice from the applicant

under the previous application of the first commercial

marketing of the drug under the previous application, or

(II) the date of a decision of a court in an action described

in clause (iii) holding the patent which is the subject of the

certification to be invalid or not infringed,

whichever is earlier.

(C) If the Secretary decides to disapprove an application, the

Secretary shall give the applicant notice of an opportunity for a

hearing before the Secretary on the question of whether such

application is approvable. If the applicant elects to accept the

opportunity for hearing by written request within thirty days after

such notice, such hearing shall commence not more than ninety days

after the expiration of such thirty days unless the Secretary and

the applicant otherwise agree. Any such hearing shall thereafter

be conducted on an expedited basis and the Secretary's order

thereon shall be issued within ninety days after the date fixed by

the Secretary for filing final briefs.

(D)(i) If an application (other than an abbreviated new drug

application) submitted under subsection (b) of this section for a

drug, no active ingredient (including any ester or salt of the

active ingredient) of which has been approved in any other

application under subsection (b) of this section, was approved

during the period beginning January 1, 1982, and ending on

September 24, 1984, the Secretary may not make the approval of an

application submitted under this subsection which refers to the

drug for which the subsection (b) application was submitted

effective before the expiration of ten years from the date of the

approval of the application under subsection (b) of this section.

(ii) If an application submitted under subsection (b) of this

section for a drug, no active ingredient (including any ester or

salt of the active ingredient) of which has been approved in any

other application under subsection (b) of this section, is approved

after September 24, 1984, no application may be submitted under

this subsection which refers to the drug for which the subsection

(b) application was submitted before the expiration of five years

from the date of the approval of the application under subsection

(b) of this section, except that such an application may be

submitted under this subsection after the expiration of four years

from the date of the approval of the subsection (b) application if

it contains a certification of patent invalidity or noninfringement

described in subclause (IV) of paragraph (2)(A)(vii). The approval

of such an application shall be made effective in accordance with

subparagraph (B) except that, if an action for patent infringement

is commenced during the one-year period beginning forty-eight

months after the date of the approval of the subsection (b)

application, the thirty-month period referred to in subparagraph

(B)(iii) shall be extended by such amount of time (if any) which is

required for seven and one-half years to have elapsed from the date

of approval of the subsection (b) application.

(iii) If an application submitted under subsection (b) of this

section for a drug, which includes an active ingredient (including

any ester or salt of the active ingredient) that has been approved

in another application approved under subsection (b) of this

section, is approved after September 24, 1984, and if such

application contains reports of new clinical investigations (other

than bioavailability studies) essential to the approval of the

application and conducted or sponsored by the applicant, the

Secretary may not make the approval of an application submitted

under this subsection for the conditions of approval of such drug

in the subsection (b) application effective before the expiration

of three years from the date of the approval of the application

under subsection (b) of this section for such drug.

(iv) If a supplement to an application approved under subsection

(b) of this section is approved after September 24, 1984, and the

supplement contains reports of new clinical investigations (other

than bioavailability studies) essential to the approval of the

supplement and conducted or sponsored by the person submitting the

supplement, the Secretary may not make the approval of an

application submitted under this subsection for a change approved

in the supplement effective before the expiration of three years

from the date of the approval of the supplement under subsection

(b) of this section.

(v) If an application (or supplement to an application) submitted

under subsection (b) of this section for a drug, which includes an

active ingredient (including any ester or salt of the active

ingredient) that has been approved in another application under

subsection (b) of this section, was approved during the period

beginning January 1, 1982, and ending on September 24, 1984, the

Secretary may not make the approval of an application submitted

under this subsection which refers to the drug for which the

subsection (b) application was submitted or which refers to a

change approved in a supplement to the subsection (b) application

effective before the expiration of two years from September 24,

1984.

(6) If a drug approved under this subsection refers in its

approved application to a drug the approval of which was withdrawn

or suspended for grounds described in the first sentence of

subsection (e) of this section or was withdrawn or suspended under

this paragraph or which, as determined by the Secretary, has been

withdrawn from sale for safety or effectiveness reasons, the

approval of the drug under this subsection shall be withdrawn or

suspended -

(A) for the same period as the withdrawal or suspension under

subsection (e) of this section or this paragraph, or

(B) if the listed drug has been withdrawn from sale, for the

period of withdrawal from sale or, if earlier, the period ending

on the date the Secretary determines that the withdrawal from

sale is not for safety or effectiveness reasons.

(7)(A)(i) Within sixty days of September 24, 1984, the Secretary

shall publish and make available to the public -

(I) a list in alphabetical order of the official and

proprietary name of each drug which has been approved for safety

and effectiveness under subsection (c) of this section before

September 24, 1984;

(II) the date of approval if the drug is approved after 1981

and the number of the application which was approved; and

(III) whether in vitro or in vivo bioequivalence studies, or

both such studies, are required for applications filed under this

subsection which will refer to the drug published.

(ii) Every thirty days after the publication of the first list

under clause (i) the Secretary shall revise the list to include

each drug which has been approved for safety and effectiveness

under subsection (c) of this section or approved under this

subsection during the thirty-day period.

(iii) When patent information submitted under subsection (b) or

(c) of this section respecting a drug included on the list is to be

published by the Secretary, the Secretary shall, in revisions made

under clause (ii), include such information for such drug.

(B) A drug approved for safety and effectiveness under subsection

(c) of this section or approved under this subsection shall, for

purposes of this subsection, be considered to have been published

under subparagraph (A) on the date of its approval or September 24,

1984, whichever is later.

(C) If the approval of a drug was withdrawn or suspended for

grounds described in the first sentence of subsection (e) of this

section or was withdrawn or suspended under paragraph (6) or if the

Secretary determines that a drug has been withdrawn from sale for

safety or effectiveness reasons, it may not be published in the

list under subparagraph (A) or, if the withdrawal or suspension

occurred after its publication in such list, it shall be

immediately removed from such list -

(i) for the same period as the withdrawal or suspension under

subsection (e) of this section or paragraph (6), or

(ii) if the listed drug has been withdrawn from sale, for the

period of withdrawal from sale or, if earlier, the period ending

on the date the Secretary determines that the withdrawal from

sale is not for safety or effectiveness reasons.

A notice of the removal shall be published in the Federal Register.

(8) For purposes of this subsection:

(A) The term ''bioavailability'' means the rate and extent to

which the active ingredient or therapeutic ingredient is absorbed

from a drug and becomes available at the site of drug action.

(B) A drug shall be considered to be bioequivalent to a listed

drug if -

(i) the rate and extent of absorption of the drug do not show

a significant difference from the rate and extent of absorption

of the listed drug when administered at the same molar dose of

the therapeutic ingredient under similar experimental

conditions in either a single dose or multiple doses; or

(ii) the extent of absorption of the drug does not show a

significant difference from the extent of absorption of the

listed drug when administered at the same molar dose of the

therapeutic ingredient under similar experimental conditions in

either a single dose or multiple doses and the difference from

the listed drug in the rate of absorption of the drug is

intentional, is reflected in its proposed labeling, is not

essential to the attainment of effective body drug

concentrations on chronic use, and is considered medically

insignificant for the drug.

(9) The Secretary shall, with respect to each application

submitted under this subsection, maintain a record of -

(A) the name of the applicant,

(B) the name of the drug covered by the application,

(C) the name of each person to whom the review of the chemistry

of the application was assigned and the date of such assignment,

and

(D) the name of each person to whom the bioequivalence review

for such application was assigned and the date of such

assignment.

The information the Secretary is required to maintain under this

paragraph with respect to an application submitted under this

subsection shall be made available to the public after the approval

of such application.

(k) Records and reports; required information; regulations and

orders; access to records

(1) In the case of any drug for which an approval of an

application filed under subsection (b) or (j) of this section is in

effect, the applicant shall establish and maintain such records,

and make such reports to the Secretary, of data relating to

clinical experience and other data or information, received or

otherwise obtained by such applicant with respect to such drug, as

the Secretary may by general regulation, or by order with respect

to such application, prescribe on the basis of a finding that such

records and reports are necessary in order to enable the Secretary

to determine, or facilitate a determination, whether there is or

may be ground for invoking subsection (e) of this section.

Regulations and orders issued under this subsection and under

subsection (i) of this section shall have due regard for the

professional ethics of the medical profession and the interests of

patients and shall provide, where the Secretary deems it to be

appropriate, for the examination, upon request, by the persons to

whom such regulations or orders are applicable, of similar

information received or otherwise obtained by the Secretary.

(2) Every person required under this section to maintain records,

and every person in charge or custody thereof, shall, upon request

of an officer or employee designated by the Secretary, permit such

officer or employee at all reasonable times to have access to and

copy and verify such records.

(l) Public disclosure of safety and effectiveness data

Safety and effectiveness data and information which has been

submitted in an application under subsection (b) of this section

for a drug and which has not previously been disclosed to the

public shall be made available to the public, upon request, unless

extraordinary circumstances are shown -

(1) if no work is being or will be undertaken to have the

application approved,

(2) if the Secretary has determined that the application is not

approvable and all legal appeals have been exhausted,

(3) if approval of the application under subsection (c) of this

section is withdrawn and all legal appeals have been exhausted,

(4) if the Secretary has determined that such drug is not a new

drug, or

(5) upon the effective date of the approval of the first

application under subsection (j) of this section which refers to

such drug or upon the date upon which the approval of an

application under subsection (j) of this section which refers to

such drug could be made effective if such an application had been

submitted.

(m) ''Patent'' defined

For purposes of this section, the term ''patent'' means a patent

issued by the United States Patent and Trademark Office.

(n) Scientific advisory panels

(1) For the purpose of providing expert scientific advice and

recommendations to the Secretary regarding a clinical investigation

of a drug or the approval for marketing of a drug under this

section or section 262 of title 42, the Secretary shall establish

panels of experts or use panels of experts established before

November 21, 1997, or both.

(2) The Secretary may delegate the appointment and oversight

authority granted under section 394 of this title to a director of

a center or successor entity within the Food and Drug

Administration.

(3) The Secretary shall make appointments to each panel

established under paragraph (1) so that each panel shall consist of

-

(A) members who are qualified by training and experience to

evaluate the safety and effectiveness of the drugs to be referred

to the panel and who, to the extent feasible, possess skill and

experience in the development, manufacture, or utilization of

such drugs;

(B) members with diverse expertise in such fields as clinical

and administrative medicine, pharmacy, pharmacology,

pharmacoeconomics, biological and physical sciences, and other

related professions;

(C) a representative of consumer interests, and a

representative of interests of the drug manufacturing industry

not directly affected by the matter to be brought before the

panel; and

(D) two or more members who are specialists or have other

expertise in the particular disease or condition for which the

drug under review is proposed to be indicated.

Scientific, trade, and consumer organizations shall be afforded an

opportunity to nominate individuals for appointment to the panels.

No individual who is in the regular full-time employ of the United

States and engaged in the administration of this chapter may be a

voting member of any panel. The Secretary shall designate one of

the members of each panel to serve as chairman thereof.

(4) Each member of a panel shall publicly disclose all conflicts

of interest that member may have with the work to be undertaken by

the panel. No member of a panel may vote on any matter where the

member or the immediate family of such member could gain

financially from the advice given to the Secretary. The Secretary

may grant a waiver of any conflict of interest requirement upon

public disclosure of such conflict of interest if such waiver is

necessary to afford the panel essential expertise, except that the

Secretary may not grant a waiver for a member of a panel when the

member's own scientific work is involved.

(5) The Secretary shall, as appropriate, provide education and

training to each new panel member before such member participates

in a panel's activities, including education regarding requirements

under this chapter and related regulations of the Secretary, and

the administrative processes and procedures related to panel

meetings.

(6) Panel members (other than officers or employees of the United

States), while attending meetings or conferences of a panel or

otherwise engaged in its business, shall be entitled to receive

compensation for each day so engaged, including traveltime, at

rates to be fixed by the Secretary, but not to exceed the daily

equivalent of the rate in effect for positions classified above

grade GS-15 of the General Schedule. While serving away from their

homes or regular places of business, panel members may be allowed

travel expenses (including per diem in lieu of subsistence) as

authorized by section 5703 of title 5, for persons in the

Government service employed intermittently.

(7) The Secretary shall ensure that scientific advisory panels

meet regularly and at appropriate intervals so that any matter to

be reviewed by such a panel can be presented to the panel not more

than 60 days after the matter is ready for such review. Meetings

of the panel may be held using electronic communication to convene

the meetings.

(8) Within 90 days after a scientific advisory panel makes

recommendations on any matter under its review, the Food and Drug

Administration official responsible for the matter shall review the

conclusions and recommendations of the panel, and notify the

affected persons of the final decision on the matter, or of the

reasons that no such decision has been reached. Each such final

decision shall be documented including the rationale for the

decision.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 505, 52 Stat. 1052; Pub. L. 86-507,

Sec. 1(18), June 11, 1960, 74 Stat. 201; Pub. L. 87-781, title I,

Sec. 102(b)-(d), 103(a), (b), 104(a)-(d)(2), Oct. 10, 1962, 76

Stat. 781-783, 784, 785; Pub. L. 92-387, Sec. 4(d), Aug. 16, 1972,

86 Stat. 562; Pub. L. 98-417, title I, Sec. 101, 102(a)-(b)(5),

103, 104, Sept. 24, 1984, 98 Stat. 1585, 1592, 1593, 1597; Pub. L.

102-282, Sec. 5, May 13, 1992, 106 Stat. 161; Pub. L. 103-80, Sec.

3(n), Aug. 13, 1993, 107 Stat. 777; Pub. L. 105-115, title I, Sec.

115, 117, 119, 120, 124(a), Nov. 21, 1997, 111 Stat. 2313, 2315,

2316, 2318, 2324; Pub. L. 106-113, div. B, Sec. 1000(a)(9) (title

IV, Sec. 4732(b)(11)), Nov. 29, 1999, 113 Stat. 1536, 1501A-584;

Pub. L. 107-109, Sec. 15(c)(1), Jan. 4, 2002, 115 Stat. 1420.)

-REFTEXT-

REFERENCES IN TEXT

The General Schedule, referred to in subsec. (n)(6), is set out

under section 5332 of Title 5, Government Organization and

Employees.

-MISC2-