21 U.S.C. § 154a — Special licenses for special circumstances;

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.