21 U.S.C. § 151

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

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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.

Notes of Decisions
Cited in 27 cases (4 in the last 5 years), 1946–2025 · leading case: Creekstone Farms Premium Beef, L.L.C v. Dep't of Agric., 539 F.3d 492 (D.C. Cir. 2008).
Creekstone Farms Premium Beef, L.L.C v. Dep't of Agric., 539 F.3d 492 (D.C. Cir. 2008). · cites it 10× “" 21 U.S.C. § 151 (emphasis added). To this end, VSTA requires that "any virus, serum, toxin, or analogous product manufactured within the United States and intended for use in the treatment of domestic animals .”
Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990). · cites it 2× “§ 360b (new animal drugs), and the Act of March 4, 1913, see 21 U. S. C. §§ 151 , 154 (veterinary biological products) — each "a Federal law which regulates the manufacture, use, or sale of drugs" — neither product was included in the patent-term extension provision of § 201.”
Garrelts v. SmithKline Beecham Corp., 943 F. Supp. 1023 (N.D. Iowa 1996). · cites it 8× “The codified provision stating Congress’s purpose in passing the legislation in 1913 is as follows: 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…”
Animal Health Inst. v. United States Dep't of Agric., 487 F. Supp. 376 (D. Colo. 1980). · cites it 4× “Plaintiffs seek a declaratory judgment construing the provisions of 21 U.S.C. § 151 , et seq., as prohibiting the preparation of veterinary biological drugs manufactured within the United States at any establishment that has not been licensed by the Secretary of Agriculture.”
Patrick Fur Farm, Inc. v. United Vaccines, Inc., 2005 WI App 190 (Wis. Ct. App. 2005). “" See 21 U.S.C. § 151 (1999). The Act also delegates authority to regulate animal vaccines such as BIOCOM-DE Regulatory authority of this vaccine ultimately rests with a federal agency, the Animal and Plant Health Inspection Service.”
McGuire v. Ameritech Servs., Inc., 253 F. Supp. 2d 988 (S.D. Ohio 2003). “Plaintiffs erroneously cite 21 U.S.C. § 151 , et seq., in their jurisdictional pleadings as the “Telecommunications Act.”
Impro Prods., Inc. v. John R. Block, Sec'y of Agric. of the United States, 722 F.2d 845 (D.C. Cir. 1983). “Background Almost twenty years ago, in 1965, Impro applied to USDA under the Virus, Serum and Toxin Act of 1913, 21 U.S.C. §§ 151— 158 (1976) (“VST Act”), for a license to produce, ship and sell a veterinary product later named “Whey Antibody Blend.”
Robb v. Connecticut Bd. of Veterinary Med., 204 Conn. App. 595 (Conn. App. Ct. 2021). “§§ 151 through 159 (2018), ‘‘authorizes the United States Department of Agriculture (USDA) to license and regu- late the preparation and sale of viruses, serums, toxins, and analogous products, for use in the treatment of domestic animals.”
Impro Prods., Inc. v. Herrick, 715 F.2d 1267 (8th Cir. 1983). · cites it 2× “Animal biologies are products prepared from animal tissues or fluids, or from microorganisms, and are used to prevent or treat disease in animals.”
Lynnbrook Farms v. Smithkline Beecham Corp., 79 F.3d 620 (7th Cir. 1996). “The amendments reflect the Congressional finding that federal regulation was “necessary to prevent and eliminate burdens on commerce and to effectively regulate such commerce.”
Grand Labs., Inc. v. Patricia Harris, Sec'y of Health, Educ., & Welfare, 660 F.2d 1288 (8th Cir. 1981). “21 U.S.C. § 151 . It is agreed, on the other hand, that the VSTA does not authorize the Agriculture Department to regulate animal biologies manufactured and distributed wholly within one state, as Grand’s products are, even if a component used in the biologic has passed through…”
Am. Coop. Serum Ass'n v. Anchor Serum Co., 153 F.2d 907 (7th Cir. 1946). “The production and distribution of this serum is regulated by the Federal Serum and Virus Act of 1913, 21 U.S.C.A. §§ 151— 158; the Anti-Hog-Cholera Serum and Iiog-Cholera Virus Act of 1935, 7 U.”
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