9 C.F.R. § 116.5

Reports

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(a) When required by the Administrator, reports containing accurate and complete information concerning biological products, including but not limited to, product development and preparation, and market suspensions and recalls, shall be prepared and submitted to the Animal and Plant Health Inspection Service by the licensee, permittee, or foreign manufacturer (whose products are being imported or offered for importation). Unless otherwise authorized by the Administrator, records necessary to make such reports shall be maintained in each establishment.

(b) If, at any time, there are indications that raise questions regarding the purity, safety, potency, or efficacy of a product, or if it appears that there may be a problem regarding the preparation, testing, or distribution of a product, the licensee, permittee, or foreign manufacturer must immediately notify the Animal and Plant Health Inspection Service concerning the circumstances and the action taken, if any. Notification may be made by mail to Director, Center for Veterinary Biologics, Inspection and Compliance, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010; by electronic mail to ([email protected]); by fax to (515) 337-6120; or by telephone to (515) 337-6100.

(Approved by the Office of Management and Budget under control number 0579-0013) [61 FR 52874, Oct. 9, 1996, as amended at 64 FR 43045, Aug. 9, 1999; 75 FR 20773, Apr. 21, 2010]

Notes of Decisions

Cited in 2 cases, 1999–2014 · leading case: Boehringer Ingelheim Vetmedica, Inc. v. United Food & Com. Workers, 739 F.3d 1136 (8th Cir. 2014).

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Boehringer Ingelheim Vetmedica, Inc. v. United Food & Com. Workers, 739 F.3d 1136 (8th Cir. 2014). “” 9 C.F.R. § 116.5 (b). As the issue was not raised before the arbitrator, the record does not reflect, for example, how Silkett’s pre-filling violation affected the “purity, safety, potency, or efficacy” of BIVI’s animal pharmaceutical products, whether BIVI reported the…”

Symens v. Smithkline Beecham Corp., 593 F. Supp. 2d 1075 (D.S.D. 1999). · cites it 2× “See 9 C.F.R. § 116.5 (a). The regulations also require the defendant to notify the APHIS if there is any indications which raise questions as to the purity, safety, potency, or efficacy of the vaccine.”

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