9 C.F.R. § 102.2

Licenses required

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(a) Every person who prepares biological products subject to the Virus-Serum-Toxin Act shall hold an unexpired, unsuspended, and unrevoked U.S. Veterinary Biologics Establishment License and at least one unexpired, unsuspended, and unrevoked U.S. Veterinary Biological Product License issued by the Administrator to prepare a biological product.

(b) An applicant who applies for an establishment license must also apply for at least one product license. An establishment license will not be issued without a license authorizing the production of a biological product in the establishment.

[52 FR 11026, Apr. 7, 1987, as amended at 56 FR 66783, Dec. 26, 1991; 61 FR 52873, Oct. 9, 1996]

Notes of Decisions

Cited in 1 case, 2002–2002 · leading case: Behrens v. United Vaccines, Inc., 189 F. Supp. 2d 945 (D. Minnesota 2002).

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Behrens v. United Vaccines, Inc., 189 F. Supp. 2d 945 (D. Minnesota 2002). “” 9 C.F.R. § 102.2 (a). In order to obtain a Product License from APHIS, a manufacturer must submit an “Outline of Production,” which details how the product will be developed and tested, including “test reports and research data sufficient to establish purity, safety, potency,…”

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