9 C.F.R. § 102.5

U.S. Veterinary Biological Product License

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(a) Authorization to produce each biological product shall be specified on a U.S. Veterinary Biological Product License, issued by the Administrator, and supplementary to the U.S. Veterinary Biologics Establishment License named therein.

(b) The following shall appear on the U.S. Veterinary Biological Product License:

(1) The U.S. Veterinary Biologics Establishment License Number for the establishment from which the product is released for marketing.

(2) The true name of the product.

(3) The product code number for the product.

(4) The date of issuance.

(5) Any restrictions designated by the Administrator under paragraph (e) of this section.

(6) When necessary to comply with § 102.6 of this part, a termination date and a brief description of requirements to be met for reissuance.

(1) Licensed biological products shall be prepared as required by the regulations and in accordance with a filed Outline of Production as prescribed in §§ 114.8 and 114.9 of this subchapter. No change shall be made in the preparation of a biological product without prior approval of the Administrator.

(2) In addition to restrictions imposed by the Administrator pursuant to paragraph (e) of this section, biological products may be subject to restrictions which are imposed by any State or other jurisdiction pertaining to the distribution and use of such products, based on local disease conditions.

(3) When requested by the Administrator, a licensee shall submit a list of licensed biological products prepared in the licensed establishment.

(d) Where the Administrator determines that the protection of domestic animals or the public health, interest, or safety, or both, necessitates restrictions on the use of a product, the product shall be subject to such additional restrictions as are prescribed on the license. Such restrictions may include, but are not limited to, limits on distribution of the product or provisions that the biological product is restricted to use by veterinarians, or under the supervision of veterinarians, or both.

(e) Any person may request that the distribution and use of a veterinary biological product be restricted if the restriction pertains to the protection of domestic animals or the public health, interest, or safety, or both. All requests must be sent, in writing, to the Director, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010. Requests must specify the restriction(s) being requested and must explain why the restrictions are needed. Copies of any supporting documents, such as scientific literature, published or unpublished articles, or data from tests, should be attached to the request. When a decision is reached regarding the request, the person submitting the request will be sent written notification of such decision.

(Approved by the Office of Management and Budget under control number 0579-0013) [39 FR 37763, Oct. 24, 1974, as amended at 48 FR 57472, Dec. 30, 1983; 50 FR 50764, Dec. 12, 1985; 52 FR 11026, Apr. 7, 1987; 56 FR 66783, Dec. 26, 1991; 57 FR 38760, Aug. 27, 1992; 59 FR 67616, Dec. 30, 1994; 62 FR 13294, Mar. 20, 1997; 64 FR 43044, Aug. 9, 1999; 75 FR 20772, Apr. 21, 2010]

Notes of Decisions

Cited in 7 cases, 1996–2008 · 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 12× “" 9 C.F.R. § 102.5 (d). [2] The second regulation under review provides that "[n]o biological product shall be brought into the United States unless a permit has been issued for such product" by the APHIS Administrator.”

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). · cites it 2× “42,392 (1990), proposing to amend 9 C.F.R. § 102.5 (d)(2). In promulgating the final rule, APHIS responded to comments that States should have broader authority: Seven commentators indicated that States should have the authority to add to Féderal restrictions, as appropriate.”

Lynnbrook Farms v. Smithkline Beecham Corp., 79 F.3d 620 (7th Cir. 1996). “9 C.F.R. § 102.5 (d)(1). In addition, the regulations provide an elaborate testing protocol that must be administered by the manufacturer or by 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 first challenge is to 9 C.F.R. § 102.5 (d), which asserts USDA’s authority to prescribe “restrictions on the use of a product.”

Garrelts v. SmithKline Beecham Corp., 943 F. Supp. 1023 (N.D. Iowa 1996). “9 C.F.R. § 102.5 (e). Thus, SBC contends that APHIS intended to bar states from imposing “different” or “additional” restrictions regardless of whether a state’s restriction pertains to animal or human health.”

Behrens v. United Vaccines, Inc., 189 F. Supp. 2d 945 (D. Minnesota 2002). “9 C.F.R. § 102.5 . Since the Regulations mandate that “[n]o biological product shall be released prior to the completion of tests prescribed in a filed Outline of Production,” a manufacturer must test each batch of the biotic prior to its sale.”

Richard Symens v. Smithkline Beecham (8th Cir. 1998). · cites it 2× “42,392 (1990), proposing to amend 9 C.F.R. § 102.5 (d)(2). In promulgating the final rule, APHIS responded to comments that States should have broader authority: -4- Seven commentators indicated that States should have the authority to add to Federal restrictions, as appropriate…”

— 9 C.F.R. § 102.5(d) — 1 case

Creekstone Farms Premium Beef, L.L.C. v. U.S. Dep't of Agric., 517 F. Supp. 2d 8 (D.D.C. 2007). “The first challenge is to 9 C.F.R. § 102.5 (d), which asserts USDA’s authority to prescribe “restrictions on the use of a product.”

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