US (United States) Code. Title 21. Chapter 5: Viruses, serums, toxins, antitoxins and analogous products

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

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  • Idioma: inglés
  • País: Estados Unidos Estados Unidos
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-CITE-

21 USC CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS,

AND ANALOGOUS PRODUCTS 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS

PRODUCTS

.

-HEAD-

CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS

PRODUCTS

-MISC1-

Sec.

151. Preparation and sale of worthless or harmful products for

domestic animals prohibited; preparation to be in compliance with

rules at licensed establishments.

152. Importation regulated and prohibited.

153. Inspection of imports; denial of entry and destruction.

154. Regulations for preparation and sale; licenses.

154a. Special licenses for special circumstances; expedited

procedure; conditions; exemptions; criteria.

155. Permits for importation.

156. Licenses conditioned on permitting inspection; suspension of

licenses.

157. Inspection.

158. Offenses; punishment.

159. Enforcement; penalties applicable; Congressional findings.

FEDERAL FOOD, DRUG, AND COSMETIC ACT

By virtue of act June 25, 1938, ch. 675, Sec. 902(c), 52 Stat.

1059 (section 392(b) of this title), nothing contained in section

301 et seq. of this title shall be construed as in any way

affecting, modifying, repealing, or superseding the provisions of

this chapter.

-SECREF-

CHAPTER REFERRED TO IN OTHER SECTIONS

This chapter is referred to in sections 382, 392 of this title;

title 6 section 231; title 7 section 8401; title 15 section 1459;

title 35 sections 156, 271; title 42 section 262a.

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21 USC Sec. 151 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS

PRODUCTS

-HEAD-

Sec. 151. Preparation and sale of worthless or harmful products for

domestic animals prohibited; preparation to be in compliance

with rules at licensed establishments

-STATUTE-

It shall be unlawful for any person, firm, or corporation to

prepare, sell, barter, or exchange in the District of Columbia, or

in the Territories, or in any place under the jurisdiction of the

United States, or to ship or deliver for shipment in or from the

United States, the District of Columbia, any territory of the

United States, or any place under the jurisdiction of the United

States, any worthless, contaminated, dangerous, or harmful virus,

serum, toxin, or analogous product intended for use in the

treatment of domestic animals, and no person, firm, or corporation

shall prepare, sell, barter, exchange, or ship as aforesaid any

virus, serum, toxin, or analogous product manufactured within the

United States and intended for use in the treatment of domestic

animals, unless and until the said virus, serum, toxin, or

analogous product shall have been prepared, under and in compliance

with regulations prescribed by the Secretary of Agriculture, at an

establishment holding an unsuspended and unrevoked license issued

by the Secretary of Agriculture as hereinafter authorized.

-SOURCE-

(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 832; Pub. L.

99-198, title XVII, Sec. 1768(a), Dec. 23, 1985, 99 Stat. 1654.)

-COD-

CODIFICATION

The sections of this chapter are comprised of the sentences of

the eighth paragraph under the heading ''Bureau of Animal

Industry,'' in the Department of Agriculture Appropriation Act,

1914, as amended.

Another section 1768 of Pub. L. 99-198, cited as a credit to this

section, amended section 136y of Title 7, Agriculture.

-MISC3-

AMENDMENTS

1985 - Pub. L. 99-198 substituted ''in or from the United States,

the District of Columbia, any territory of the United States, or

any place under the jurisdiction of the United States'' for ''from

one State or Territory or the District of Columbia to any other

State or Territory or the District of Columbia''.

EFFECTIVE DATE OF 1985 AMENDMENT

Section 1768(f) of Pub. L. 99-198 provided that:

''(1) Except as provided in paragraph (2), the amendments made by

this section (enacting sections 154a and 159 of this title and

amending this section and sections 154 and 157 of this title) shall

become effective on the date of enactment of this Act (Dec. 23,

1985).

''(2)(A) Subject to subparagraphs (B) through (D), in the case of

a person, firm, or corporation preparing, selling, bartering,

exchanging, or shipping a virus, serum, toxin, or analogous product

during the 12-month period ending on the date of enactment of this

Act (Dec. 23, 1985) solely for intrastate commerce or for

exportation, such product shall not after such date of enactment,

as a result of its not having been licensed or produced in a

licensed establishment, be considered in violation of the eighth

paragraph of the matter under the heading 'BUREAU OF ANIMAL

INDUSTRY' of the Act entitled 'An Act making appropriations for the

Department of Agriculture for the fiscal year ending June

thirtieth, nineteen hundred and fourteen', approved March 14, 1913

(as amended by this section) (this chapter), until the first day of

the 49th month following the date of enactment of this Act.

''(B) The exemption granted by subparagraph (A) may be extended

by the Secretary of Agriculture for a period up to 12 months in an

individual case on a showing by a person, firm, or corporation of

good cause and a good faith effort to comply with such eighth

paragraph with due diligence.

''(C) The exemption granted by subparagraph (A) must be claimed

by the person, firm, or corporation preparing such product by the

first day of the 13th month following the date of enactment of this

Act (Dec. 23, 1985), in the form and manner prescribed by the

Secretary, unless the Secretary grants an extension of the time to

claim such exemption in an individual case for good cause shown.

''(D) On the issuance by the Secretary of a license to such

person, firm, or corporation for such product prior to the first

day of the 49th month following the date of enactment of this Act

(Dec. 23, 1985), or the end of an extension of the exemption

granted by the Secretary, the exemption granted by subparagraph (A)

shall terminate with respect to such product.''

SHORT TITLE

Act Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 832, which is

classified to this chapter, is popularly known as the

''Virus-Serum-Toxin Act''.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of the Secretary of Agriculture

relating to agricultural import and entry inspection activities

under this chapter to the Secretary of Homeland Security, and for

treatment of related references, see sections 231, 551(d), 552(d),

and 557 of Title 6, Domestic Security, and the Department of

Homeland Security Reorganization Plan of November 25, 2002, as

modified, set out as a note under section 542 of Title 6.

-MISC5-

APPROPRIATIONS

An appropriation of $25,000 was made by act Mar. 4, 1913, for the

purpose of carrying into effect these provisions. The

appropriation for the fiscal year 1926 was by act Feb. 10, 1925,

ch. 200, 43 Stat. 827.

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21 USC Sec. 152 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS

PRODUCTS

-HEAD-

Sec. 152. Importation regulated and prohibited

-STATUTE-

The importation into the United States of any virus, serum,

toxin, or analogous product for use in the treatment of domestic

animals, and the importation of any worthless, contaminated,

dangerous, or harmful virus, serum, toxin, or analogous product for

use in the treatment of domestic animals, is prohibited without (1)

a permit from the Secretary of Agriculture, or (2) in the case of

an article originating in Canada, such permit or, in lieu of such

permit, such certification by Canada as may be prescribed by the

Secretary of Agriculture.

-SOURCE-

(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 832; Pub. L.

100-449, title III, Sec. 301(d), Sept. 28, 1988, 102 Stat. 1868.)

-COD-

CODIFICATION

See note set out under section 151 of this title.

-MISC3-

AMENDMENTS

1988 - Pub. L. 100-449 amended section generally. Prior to

amendment, section read as follows: ''The importation into the

United States, without a permit from the Secretary of Agriculture,

of any virus, serum, toxin, or analogous product for use in the

treatment of domestic animals, and the importation of any

worthless, contaminated, dangerous, or harmful virus, serum, toxin,

or analogous product for use in the treatment of domestic animals,

are prohibited.''

EFFECTIVE AND TERMINATION DATES OF 1988 AMENDMENT

Amendment by Pub. L. 100-449 effective on the date the United

States-Canada Free-Trade Agreement enters into force (Jan. 1,

1989), and to cease to have effect on the date the Agreement ceases

to be in force, see section 501(a), (c) of Pub. L. 100-449, set out

in a note under section 2112 of Title 19, Customs Duties.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of the Secretary of Agriculture

relating to agricultural import and entry inspection activities

under this chapter to the Secretary of Homeland Security, and for

treatment of related references, see sections 231, 551(d), 552(d),

and 557 of Title 6, Domestic Security, and the Department of

Homeland Security Reorganization Plan of November 25, 2002, as

modified, set out as a note under section 542 of Title 6.

-CITE-

21 USC Sec. 153 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS

PRODUCTS

-HEAD-

Sec. 153. Inspection of imports; denial of entry and destruction

-STATUTE-

The Secretary of Agriculture is authorized to cause the Bureau of

Animal Industry to examine and inspect all viruses, serums, toxins,

and analogous products, for use in the treatment of domestic

animals, which are being imported or offered for importation into

the United States, to determine whether such viruses, serums,

toxins, and analogous products are worthless, contaminated,

dangerous, or harmful, and if it shall appear that any such virus,

serum, toxin, or analogous product, for use in the treatment of

domestic animals, is worthless, contaminated, dangerous, or

harmful, the same shall be denied entry and shall be destroyed or

returned at the expense of the owner or importer.

-SOURCE-

(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 832.)

-COD-

CODIFICATION

See note set out under section 151 of this title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of the Secretary of Agriculture

relating to agricultural import and entry inspection activities

under this chapter to the Secretary of Homeland Security, and for

treatment of related references, see sections 231, 551(d), 552(d),

and 557 of Title 6, Domestic Security, and the Department of

Homeland Security Reorganization Plan of November 25, 2002, as

modified, set out as a note under section 542 of Title 6.

-CITE-

21 USC Sec. 154 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS

PRODUCTS

-HEAD-

Sec. 154. Regulations for preparation and sale; licenses

-STATUTE-

The Secretary of Agriculture is authorized to make and promulgate

from time to time such rules and regulations as may be necessary to

prevent the preparation, sale, barter, exchange, or shipment as

aforesaid of any worthless, contaminated, dangerous, or harmful

virus, serum, toxin, or analogous product for use in the treatment

of domestic animals, or otherwise to carry out this chapter, and to

issue, suspend, and revoke licenses for the maintenance of

establishments for the preparation of viruses, serums, toxins, and

analogous products, for use in the treatment of domestic animals,

intended for sale, barter, exchange, or shipment as aforesaid.

-SOURCE-

(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 832; Pub. L.

99-198, title XVII, Sec. 1768(b), Dec. 23, 1985, 99 Stat. 1654.)

-COD-

CODIFICATION

See note set out under section 151 of this title.

Another section 1768 of Pub. L. 99-198, cited as a credit to this

section, amended section 136y of Title 7, Agriculture.

-MISC3-

AMENDMENTS

1985 - Pub. L. 99-198 inserted ''or otherwise to carry out this

chapter,'' after ''domestic animals,''.

EFFECTIVE DATE OF 1985 AMENDMENT

Amendment by Pub. L. 99-198 effective Dec. 23, 1985, except as

otherwise provided, see section 1768(f) of Pub. L. 99-198, set out

as a note under section 151 of this title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of the Secretary of Agriculture

relating to agricultural import and entry inspection activities

under this chapter to the Secretary of Homeland Security, and for

treatment of related references, see sections 231, 551(d), 552(d),

and 557 of Title 6, Domestic Security, and the Department of

Homeland Security Reorganization Plan of November 25, 2002, as

modified, set out as a note under section 542 of Title 6.

-CITE-

21 USC Sec. 154a 01/06/03

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TITLE 21 - FOOD AND DRUGS

CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS

PRODUCTS

-HEAD-

Sec. 154a. Special licenses for special circumstances; expedited

procedure; conditions; exemptions; criteria

-STATUTE-

In order to meet an emergency condition, limited market or local

situation, or other special circumstance (including production

solely for intrastate use under a State-operated program), the

Secretary may issue a special license under an expedited procedure

on such conditions as are necessary to assure purity, safety, and a

reasonable expectation of efficacy. The Secretary shall exempt by

regulation from the requirement of preparation pursuant to an

unsuspended and unrevoked license any virus, serum, toxin, or

analogous product prepared by any person, firm, or corporation -

(1) solely for administration to animals of such person, firm,

or corporation;

(2) solely for administration to animals under a

veterinarian-client-patient relationship in the course of the

State licensed professional practice of veterinary medicine by

such person, firm, or corporation; or

(3) solely for distribution within the State of production

pursuant to a license granted by such State under a program

determined by the Secretary to meet criteria under which the

State -

(A) may license virus, serum, toxin, and analogous products

and establishments that produce such products;

(B) may review the purity, safety, potency, and efficacy of

such products prior to licensure;

(C) may review product test results to assure compliance with

applicable standards for purity, safety, and potency, prior to

release to the market;

(D) may deal effectively with violations of State law

regulating virus, serum, toxin, and analogous products; and

(E) exercises the authority referred to in subclauses (A)

through (D) consistent with the intent of this chapter of

prohibiting the preparation, sale, barter, exchange, or

shipment of worthless, contaminated, dangerous, or harmful

virus, serum, toxin, or analogous products.

-SOURCE-

(Mar. 4, 1913, ch. 145, Sec. 1 (part), as added Pub. L. 99-198,

title XVII, Sec. 1768(c), Dec. 23, 1985, 99 Stat. 1654.)

-COD-

CODIFICATION

See note set out under section 151 of this title.

Another section 1768 of Pub. L. 99-198, cited as a credit to this

section, amended section 136y of Title 7, Agriculture.

-MISC3-

EFFECTIVE DATE

Section effective Dec. 23, 1985, except as otherwise provided,

see section 1768(f) of Pub. L. 99-198, set out as an Effective Date

of 1985 Amendment note under section 151 of this title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of the Secretary of Agriculture

relating to agricultural import and entry inspection activities

under this chapter to the Secretary of Homeland Security, and for

treatment of related references, see sections 231, 551(d), 552(d),

and 557 of Title 6, Domestic Security, and the Department of

Homeland Security Reorganization Plan of November 25, 2002, as

modified, set out as a note under section 542 of Title 6.

-CITE-

21 USC Sec. 155 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS

PRODUCTS

-HEAD-

Sec. 155. Permits for importation

-STATUTE-

The Secretary of Agriculture is authorized to issue permits for

the importation into the United States of viruses, serums, toxins,

and analogous products, for use in the treatment of domestic

animals, which are not worthless, contaminated, dangerous, or

harmful.

-SOURCE-

(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 833.)

-COD-

CODIFICATION

See note set out under section 151 of this title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of the Secretary of Agriculture

relating to agricultural import and entry inspection activities

under this chapter to the Secretary of Homeland Security, and for

treatment of related references, see sections 231, 551(d), 552(d),

and 557 of Title 6, Domestic Security, and the Department of

Homeland Security Reorganization Plan of November 25, 2002, as

modified, set out as a note under section 542 of Title 6.

-CITE-

21 USC Sec. 156 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS

PRODUCTS

-HEAD-

Sec. 156. Licenses conditioned on permitting inspection; suspension

of licenses

-STATUTE-

All licenses issued under authority of this chapter to

establishments where such viruses, serums, toxins, or analogous

products are prepared for sale, barter, exchange, or shipment as

aforesaid, shall be issued on condition that the licensee shall

permit the inspection of such establishments and of such products

and their preparation; and the Secretary of Agriculture may suspend

or revoke any permit or license issued under authority of said

chapter, after opportunity for hearing has been granted the

licensee or importer, when the Secretary of Agriculture is

satisfied that such license or permit is being used to facilitate

or effect the preparation, sale, barter, exchange, or shipment as

aforesaid, or the importation into the United States of any

worthless, contaminated, dangerous, or harmful virus, serum, toxin,

or analogous product for use in the treatment of domestic animals.

-SOURCE-

(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 833.)

-REFTEXT-

REFERENCES IN TEXT

This chapter, referred to in text, was in the original ''this

Act'', meaning act Mar. 4, 1913, ch. 145, 37 Stat. 828, which

enacted this chapter, sections 155 and 393 of Title 7, Agriculture,

section 316 of Title 15, Commerce and Trade, sections 501, 502,

512, 558, and 560 of Title 16, Conservation, and section 630 of

former Title 31, Money and Finance, and amended section 83 of

former Title 5, Executive Departments and Government Officers and

Employees, and sections 518 and 673 of Title 16.

Section 316 of Title 15 was omitted from the Code as superseded

by section 5701 et seq. of Title 5, Government Organization and

Employees. Section 630 of former Title 31 was repealed by act Sept.

12, 1950, ch. 946, title III, Sec. 301(64), 64 Stat. 842. Section

83 of former Title 5 was repealed and reenacted as section 5946 of

Title 5 by Pub. L. 89-554, Sept. 6, 1966, 80 Stat. 514. For

complete classification of act Mar. 4, 1913, to the Code, see

Tables.

-COD-

CODIFICATION

See note set out under section 151 of this title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of the Secretary of Agriculture

relating to agricultural import and entry inspection activities

under this chapter to the Secretary of Homeland Security, and for

treatment of related references, see sections 231, 551(d), 552(d),

and 557 of Title 6, Domestic Security, and the Department of

Homeland Security Reorganization Plan of November 25, 2002, as

modified, set out as a note under section 542 of Title 6.

-CITE-

21 USC Sec. 157 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS

PRODUCTS

-HEAD-

Sec. 157. Inspection

-STATUTE-

Any officer, agent, or employee of the Department of Agriculture

duly authorized by the Secretary of Agriculture for the purpose

may, at any hour during the daytime or nighttime, enter and inspect

any establishment where any virus, serum, toxin, or analogous

product for use in the treatment of domestic animals is prepared

for sale, barter, exchange, or shipment as aforesaid.

-SOURCE-

(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 833; Pub. L.

99-198, title XVII, Sec. 1768(d), Dec. 23, 1985, 99 Stat. 1655.)

-COD-

CODIFICATION

See note set out under section 151 of this title.

Another section 1768 of Pub. L. 99-198, cited as a credit to this

section, amended section 136y of Title 7, Agriculture.

-MISC3-

AMENDMENTS

1985 - Pub. L. 99-198 struck out ''licensed under this chapter''

after ''enter and inspect any establishment''.

EFFECTIVE DATE OF 1985 AMENDMENT

Amendment by Pub. L. 99-198 effective Dec. 23, 1985, except as

otherwise provided, see section 1768(f) of Pub. L. 99-198, set out

as a note under section 151 of this title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of the Secretary of Agriculture

relating to agricultural import and entry inspection activities

under this chapter to the Secretary of Homeland Security, and for

treatment of related references, see sections 231, 551(d), 552(d),

and 557 of Title 6, Domestic Security, and the Department of

Homeland Security Reorganization Plan of November 25, 2002, as

modified, set out as a note under section 542 of Title 6.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in title 7 section 394a.

-CITE-

21 USC Sec. 158 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS

PRODUCTS

-HEAD-

Sec. 158. Offenses; punishment

-STATUTE-

Any person, firm, or corporation who shall violate any of the

provisions of this chapter shall be deemed guilty of a misdemeanor,

and shall, upon conviction, be punished by a fine of not exceeding

$1,000 or by imprisonment not exceeding one year, or by both such

fine and imprisonment, in the discretion of the court.

-SOURCE-

(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 833.)

-REFTEXT-

REFERENCES IN TEXT

For explanation of ''this chapter'', referred to in text, see

References in Text note set out under section 156 of this title.

-COD-

CODIFICATION

See note set out under section 151 of this title.

-CITE-

21 USC Sec. 159 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS

PRODUCTS

-HEAD-

Sec. 159. Enforcement; penalties applicable; Congressional findings

-STATUTE-

The procedures of sections 672, 673, and 674 of this title

(relating to detentions, seizures and condemnations, and

injunctions, respectively) shall apply to the enforcement of this

chapter with respect to any product prepared, sold, bartered,

exchanged, or shipped in violation of this chapter or a regulation

promulgated under this chapter. The provisions (including

penalties) of section 675 of this title shall apply to the

performance of official duties under this chapter. Congress finds

that (i) the products and activities that are regulated under this

chapter are either in interstate or foreign commerce or

substantially affect such commerce or the free flow thereof, and

(ii) regulation of the products and activities as provided in this

chapter is necessary to prevent and eliminate burdens on such

commerce and to effectively regulate such commerce.

-SOURCE-

(Mar. 4, 1913, ch. 145, Sec. 1 (part), as added Pub. L. 99-198,

title XVII, Sec. 1768(e), Dec. 23, 1985, 99 Stat. 1655.)

-COD-

CODIFICATION

See note set out under section 151 of this title.

Another section 1768 of Pub. L. 99-198, cited as a credit to this

section, amended section 136y of Title 7, Agriculture.

-MISC3-

EFFECTIVE DATE

Section effective Dec. 23, 1985, except as otherwise provided,

see section 1768(f) of Pub. L. 99-198, set out as an Effective Date

of 1985 Amendment note under section 151 of this title.

-CITE-