21 U.S.C. § 151 — Preparation and sale of worthless or harm-

Page 16 TITLE 21—FOOD AND DRUGS § 151 (b) The term ‘‘United States’’ means the fifty States and the District of Columbia. (Feb. 15, 1927, ch. 155, § 9, 44 Stat. 1103; Pub. L. 86–70, § 19, June 25, 1959, 73 Stat. 145; Pub. L. 86–624, § 15, July 12, 1960, 74 Stat. 415.) Editorial Notes AMENDMENTS 1960—Subsec. (b). Pub. L. 86–624 substituted ‘‘means the fifty States and the District of Columbia’’ for ‘‘means continental United States, including Alaska’’. 1959—Subsec. (b). Pub. L. 86–70 inserted ‘‘, including Alaska’’ after ‘‘continental United States’’. CHAPTER 5—VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS 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 de- struction. 154. Regulations for preparation and sale; li- censes. 154a. Special licenses for special circumstances; ex- pedited procedure; conditions; exemptions; criteria. 155. Permits for importation. 156. Licenses conditioned on permitting inspec- tion; suspension of licenses. 157. Inspection. 158. Offenses; punishment. 159. Enforcement; penalties applicable; Congres- sional findings. Statutory Notes and Related Subsidiaries FEDERAL FOOD, DRUG, AND COSMETIC ACT Nothing contained in chapter 9 (§ 301 et seq.) of this title shall be construed as in any way affecting, modi- fying, repealing, or superseding the provisions of this chapter, see section 392(b) of this title. § 151. Preparation and sale of worthless or harm- ful products for domestic animals prohibited; preparation to be in compliance with rules at licensed establishments It shall be unlawful for any person, firm, or corporation to prepare, sell, barter, or exchange in the District of Columbia, or in the Terri- tories, or in any place under the jurisdiction of the United States, or to ship or deliver for ship- ment 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 do- mestic animals, and no person, firm, or corpora- tion shall prepare, sell, barter, exchange, or ship as aforesaid any virus, serum, toxin, or analo- gous 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 un- suspended and unrevoked license issued by the Secretary of Agriculture as hereinafter author- ized. (Mar. 4, 1913, ch. 145, § 1 (part), 37 Stat. 832; Pub. L. 99–198, title XVII, § 1768(a), Dec. 23, 1985, 99 Stat. 1654.) Editorial Notes CODIFICATION The sections of this chapter are comprised of the sen- tences of the eighth paragraph under the heading ‘‘Bu- reau of Animal Industry,’’ in the Department of Agri- culture Appropriation Act, 1914, as amended. Another section 1768 of Pub. L. 99–198, cited as a cred- it to this section, amended section 136y of Title 7, Agri- culture. 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 jurisdic- tion of the United States’’ for ‘‘from one State or Terri- tory or the District of Columbia to any other State or Territory or the District of Columbia’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1985 AMENDMENT Pub. L. 99–198, title XVII, § 1768(f), Dec. 23, 1985, 99 Stat. 1655, provided that: ‘‘(1) Except as provided in paragraph (2), the amend- ments 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 ex- portation, such product shall not after such date of en- actment, 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 De- partment of Agriculture for the fiscal year ending June thirtieth, nineteen hundred and fourteen’, approved March 14, 1913 (as amended by this section) [this chap- ter], 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 pe- riod 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 ter- minate with respect to such product.’’ SHORT TITLE Act Mar. 4, 1913, ch. 145, § 1 [part], 37 Stat. 832, which is classified to this chapter, is popularly known as the ‘‘Virus-Serum-Toxin Act’’. TRANSFER OF FUNCTIONS For transfer of functions of the Secretary of Agri- culture relating to agricultural import and entry in- Page 17 TITLE 21—FOOD AND DRUGS § 154 spection activities under this chapter to the Secretary of Homeland Security, and for treatment of related ref- erences, 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. APPROPRIATIONS An appropriation of $25,000 was made by act Mar. 4, 1913, for the purpose of carrying into effect these provi- sions. The appropriation for the fiscal year 1926 was by act Feb. 10, 1925, ch. 200, 43 Stat. 827. § 152. Importation regulated and prohibited 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 cer- tification by Canada as may be prescribed by the Secretary of Agriculture. (Mar. 4, 1913, ch. 145, § 1 (part), 37 Stat. 832; Pub. L. 100–449, title III, § 301(d), Sept. 28, 1988, 102 Stat. 1868.) AMENDMENT OF SECTION For termination of amendment by section 501(c) of Pub. L. 100–449, see Effective and Ter- mination Dates of 1988 Amendment note below. Editorial Notes CODIFICATION See note set out under section 151 of this title. AMENDMENTS 1988—Pub. L. 100–449 temporarily 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 treat- ment of domestic animals, and the importation of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treat- ment of domestic animals, are prohibited.’’ See Effec- tive and Termination Dates of 1988 Amendment note below. Statutory Notes and Related Subsidiaries EFFECTIVE AND TERMINATION DATES OF 1988 AMENDMENT Amendment by Pub. L. 100–449 effective on the date the United States-Canada Free-Trade Agreement en- ters 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. TRANSFER OF FUNCTIONS For transfer of functions of the Secretary of Agri- culture relating to agricultural import and entry in- spection activities under this chapter to the Secretary of Homeland Security, and for treatment of related ref- erences, 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. § 153. Inspection of imports; denial of entry and destruction The Secretary of Agriculture is authorized to cause the Bureau of Animal Industry to examine and inspect all viruses, serums, toxins, and anal- ogous products, for use in the treatment of do- mestic animals, which are being imported or of- fered for importation into the United States, to determine whether such viruses, serums, toxins, and analogous products are worthless, contami- nated, dangerous, or harmful, and if it shall ap- pear that any such virus, serum, toxin, or analo- gous product, for use in the treatment of domes- tic animals, is worthless, contaminated, dan- gerous, or harmful, the same shall be denied entry and shall be destroyed or returned at the expense of the owner or importer. (Mar. 4, 1913, ch. 145, § 1 (part), 37 Stat. 832.) Editorial Notes CODIFICATION See note set out under section 151 of this title. Statutory Notes and Related Subsidiaries TRANSFER OF FUNCTIONS For transfer of functions of the Secretary of Agri- culture relating to agricultural import and entry in- spection activities under this chapter to the Secretary of Homeland Security, and for treatment of related ref- erences, 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. § 154. Regulations for preparation and sale; li- censes 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, con- taminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treat- ment of domestic animals, or otherwise to carry out this chapter, and to issue, suspend, and re- voke licenses for the maintenance of establish- ments 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. (Mar. 4, 1913, ch. 145, § 1 (part), 37 Stat. 832; Pub. L. 99–198, title XVII, § 1768(b), Dec. 23, 1985, 99 Stat. 1654.) Editorial Notes CODIFICATION See note set out under section 151 of this title. Another section 1768 of Pub. L. 99–198, cited as a cred- it to this section, amended section 136y of Title 7, Agri- culture. AMENDMENTS 1985—Pub. L. 99–198 inserted ‘‘or otherwise to carry out this chapter,’’ after ‘‘domestic animals,’’. Statutory Notes and Related Subsidiaries 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.