Assyro AI

Title 21 USC reference

Explore the full hierarchy of this title across chapters, subchapters, and parts.

Select a part from the tree to begin

Browse chapters and parts on the left to load sections

United States • Title 21 USC • Part 5

Part 5VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS

This chapter regulates the preparation, sale, and importation of viruses, serums, toxins, antitoxins, and analogous products for use in the treatment of domestic animals. It prohibits worthless, contaminated, dangerous, or harmful products and requires adherence to regulations and licensing for establishments involved in their preparation and distribution.

What this part covers

  • Prohibits the preparation, sale, barter, exchange, or shipment of worthless, contaminated, dangerous, or harmful viruses, serums, toxins, or analogous products intended for domestic animals.
  • Requires that such products manufactured in the U.S. and intended for domestic animals be prepared in licensed establishments under regulations prescribed by the Secretary of Agriculture.
  • Prohibits the importation of such products without a permit from the Secretary of Agriculture, with specific provisions for products originating in Canada.
  • Authorizes the Secretary of Agriculture to inspect imported products to determine if they are worthless, contaminated, dangerous, or harmful, and to deny entry, destroy, or return them.
  • Empowers the Secretary of Agriculture to issue, suspend, and revoke licenses for establishments preparing these products.
  • Allows for special licenses under expedited procedures for emergency conditions, limited markets, or other special circumstances, ensuring purity, safety, and efficacy.
  • Provides exemptions from licensing requirements for certain products prepared for personal use, under a veterinarian-client-patient relationship, or for intrastate use under specific state programs.
  • Specifies that enforcement procedures, including detentions, seizures, condemnations, and injunctions, apply to violations of this chapter or its regulations.

Sections in Part 5

§ 151

Preparation and sale of worthless or harmful products for domestic animals prohibited; preparation to be in compliance with rules at licensed establishments

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS 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 From the U.S. Government Publishing Office, www.gpo.gov §151. Preparation and sale of worthless or harmful 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 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…

§ 152

Importation regulated and prohibited

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS Sec. 152 - Importation regulated and prohibited From the U.S. Government Publishing Office, www.gpo.gov §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 certification 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 Termination Dates of 1988 Amendment note below. Editorial Notes Codification See…

§ 153

Inspection of imports; denial of entry and destruction

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS Sec. 153 - Inspection of imports; denial of entry and destruction From the U.S. Government Publishing Office, www.gpo.gov §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 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. (Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 832.) Editorial Notes Codification See note set out under section 151 of this title. Statutory…

§ 154

Regulations for preparation and sale; licenses

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS Sec. 154 - Regulations for preparation and sale; licenses From the U.S. Government Publishing Office, www.gpo.gov §154. Regulations for preparation and sale; licenses 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. (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…

§ 154a

Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS Sec. 154a - Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria From the U.S. Government Publishing Office, www.gpo.gov §154a. Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria 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…

§ 155

Permits for importation

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS Sec. 155 - Permits for importation From the U.S. Government Publishing Office, www.gpo.gov §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, contaminated, 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 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.

§ 156

Licenses conditioned on permitting inspection; suspension of licenses

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS Sec. 156 - Licenses conditioned on permitting inspection; suspension of licenses From the U.S. Government Publishing Office, www.gpo.gov §156. Licenses conditioned on permitting inspection; suspension of licenses 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…

§ 157

Inspection

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS Sec. 157 - Inspection From the U.S. Government Publishing Office, www.gpo.gov §157. Inspection 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. (Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 833; Pub. L. 99–198, title XVII, §1768(d), Dec. 23, 1985, 99 Stat. 1655.) Editorial Notes 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. Amendments 1985—Pub. L. 99–198 struck out "licensed under this chapter" after "enter and inspect any establishment". Statutory Notes and Related Subsidiaries Effective Date of 1985 Amendment…

§ 158

Offenses; punishment

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS Sec. 158 - Offenses; punishment From the U.S. Government Publishing Office, www.gpo.gov §158. Offenses; punishment 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. (Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 833.) Editorial Notes 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. Codification See note set out under section 151 of this title.

§ 159

Enforcement; penalties applicable; Congressional findings

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS Sec. 159 - Enforcement; penalties applicable; Congressional findings From the U.S. Government Publishing Office, www.gpo.gov §159. Enforcement; penalties applicable; Congressional findings 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…

Regulatory Context

This document sits within United States USC and is most useful when linked to operational submission, quality, and inspection workflows.

United StatesUSC

Related Terms

Operational Use Cases

Related Actions