21 U.S.C. § 154 — Regulations for preparation and sale; li-

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. Page 18 TITLE 21—FOOD AND DRUGS § 154a L. 99–198, set out as a note under section 151 of this title. 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. § 154a. Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria In order to meet an emergency condition, lim- ited 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 reason- able 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 relation- ship in the course of the State licensed profes- sional 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 licen- sure; (C) may review product test results to as- sure compliance with applicable standards for purity, safety, and potency, prior to re- lease 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 ship- ment of worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous products. (Mar. 4, 1913, ch. 145, § 1 [part], as added Pub. L. 99–198, title XVII, § 1768(c), 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. Statutory Notes and Related Subsidiaries 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 sec- tion 151 of this title. 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. § 155. Permits for importation 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, con- taminated, dangerous, or harmful. (Mar. 4, 1913, ch. 145, § 1 (part), 37 Stat. 833.) 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. § 156. Licenses conditioned on permitting inspec- tion; suspension of licenses All licenses issued under authority of this chapter to establishments where such viruses, serums, toxins, or analogous products are pre- pared for sale, barter, exchange, or shipment as aforesaid, shall be issued on condition that the licensee shall permit the inspection of such es- tablishments 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 op- portunity for hearing has been granted the li- censee or importer, when the Secretary of Agri- culture is satisfied that such license or permit is being used to facilitate or effect the prepara- tion, sale, barter, exchange, or shipment as aforesaid, or the importation into the United States of any worthless, contaminated, dan- gerous, or harmful virus, serum, toxin, or analo- gous product for use in the treatment of domes- tic animals. (Mar. 4, 1913, ch. 145, § 1 (part), 37 Stat. 833.) Editorial Notes REFERENCES IN TEXT This chapter, referred to in text, was in the original ‘‘this Act’’, meaning act Mar. 4, 1913, ch. 145, 37 Stat.