U.S. Code » Title 21 » Chapter CHAPTER 5— VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS

21 U.S.C. § 154

Regulations for preparation and sale; licenses

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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.

Notes of Decisions
Cited in 17 cases (1 in the last 5 years), 1995–2023 · leading case: Creekstone Farms Premium Beef, L.L.C v. Dep't of Agric., 539 F.3d 492 (D.C. Cir. 2008).
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Creekstone Farms Premium Beef, L.L.C v. Dep't of Agric., 539 F.3d 492 (D.C. Cir. 2008). · cites it 4× “" 21 U.S.C. § 154 . This language authorizes regulations directed at discrete activities— preparation, sale, barter, exchange and shipment—and discrete products—viruses, serums, toxins or analogous products.”
Garrelts v. SmithKline Beecham Corp., 943 F. Supp. 1023 (N.D. Iowa 1996). · cites it 6× “21 U.S.C. § 154 . The Act also broadly confers on the USDA the authority to “make and promulgate from time to time such rules and regulations as may be necessary to prevent the preparation [and] sale .”
Lynnbrook Farms v. SmithKline Beecham Corp., 887 F. Supp. 1100 (C.D. Ill. 1995). · cites it 4× “Under VSTA, all animal vaccines sold in the United States, and all establishments at which animal vaccines are produced, must be licensed by the USDA 21 U.S.C. § 154 (West Supp.1994). Within USDA, licensure of animal vaccines and vaccine-producing establishments is regulated by…”
Murphy v. SmithKline Beecham Animal Health Grp., 898 F. Supp. 811 (D. Kan. 1995). · cites it 2× “Did Congress authorize APHIS to pre-empt state law? 21 U.S.C. § 154 provides as follows: The Secretary of Agriculture is hereby authorized to make and promulgate from time to time such rules and regulations as may be necessary to prevent the preparation, sale, barter, exchange,…”
Cooper v. United Vaccines, Inc., 117 F. Supp. 2d 864 (E.D. Wis. 2000). · cites it 2× “The Court has jurisdiction over the subject matter of this case pursuant to 21 U.S.C. § 154 and 28 U.S.C. § 1331 and venue is proper in this judicial district under 28 U.”
prod.liab.rep. (Cch) P 15,330 Richard Symens Joyce Symens v. Smithkline Beecham Corp., Ivan Sjovall v. Smithkline Beecham Corp., 152 F.3d 1050 (8th Cir. 1998). “We reverse in part and remand. VSTA authorizes the United States Department of Agriculture (USDA) to license and regulate the preparation and sale of “viruses, serums, toxins, and analogous products, for use in the treatment of domestic animals.”
Lynnbrook Farms v. Smithkline Beecham Corp., 79 F.3d 620 (7th Cir. 1996). “21 U.S.C. § 154 . The Act also broadly confers on the USDA the authority to “make and promulgate from time to time such rules and regulations as may be necessary to prevent the preparation [and] sale .”
Brandt v. Marshall Animal Clinic, 540 N.W.2d 870 (Minn. Ct. App. 1995). “21 U.S.C. § 154 (1988). Section 159 of the Act declares the need to “effectively regulate” and to prevent and eliminate “burdens” on interstate and foreign commerce.”
TDM Farms, Inc. of North Carolina v. Wilhoite Fam. Farm, LLC, 969 N.E.2d 97 (Ind. Ct. App. 2012). “21 U.S.C. § 154 . The USDA, in turn, has delegated its authority under the VSTA to the Animal and Plant Health Inspection Service (“APHIS”).”
Creekstone Farms Premium Beef, L.L.C. v. U.S. Dep't of Agric., 517 F. Supp. 2d 8 (D.D.C. 2007). · cites it 2× “The USDA refers to viruses, serums, toxins, and analogous products as “biological products” and has instituted a licensing regime for “[e]very person who prepares biological products” subject to the VSTA. The USDA asserts authority to prescribe “restrictions on the use of a…”
Symens v. Smithkline Beecham Corp., 19 F. Supp. 2d 1062 (D.S.D. 1997). “21 U.S.C. § 154 . The agency within the USDA responsible for administering the VSTA is the Animal and Plant Health Inspection Service (“APHIS”).”
Sjovall v. Smithkline Beecham Corp., 16 F. Supp. 2d 1112 (D.S.D. 1997). “21 U.S.C. § 154 . The agency within the USDA responsible for administering the VSTA is the Animal and Plant Health Inspection Service (“APHIS”).”
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