21 C.F.R. § 610.2

Requests for samples and protocols; official release

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(a) Licensed biological products regulated by CBER. Samples of any lot of any licensed product together with the protocols showing results of applicable tests, may at any time be required to be sent to the Director, Center for Biologics Evaluation and Research (see mailing addresses in § 600.2(c) of this chapter). Upon notification by the Director, Center for Biologics Evaluation and Research, a manufacturer shall not distribute a lot of a product until the lot is released by the Director, Center for Biologics Evaluation and Research: Provided, That the Director, Center for Biologics Evaluation and Research, shall not issue such notification except when deemed necessary for the safety, purity, or potency of the product.

(b) Licensed biological products regulated by CDER. Samples of any lot of any licensed product together with the protocols showing results of applicable tests, may at any time be required to be sent to the Director, Center for Drug Evaluation and Research (see mailing addresses in § 600.2(c) of this chapter) for official release. Upon notification by the Director, Center for Drug Evaluation and Research, a manufacturer shall not distribute a lot of a biological product until the lot is released by the Director, Center for Drug Evaluation and Research: Provided, That the Director, Center for Drug Evaluation and Research shall not issue such notification except when deemed necessary for the safety, purity, or potency of the product.

[40 FR 31313, July 25, 1975, as amended at 49 FR 23834, June 8, 1984; 50 FR 10941, Mar. 19, 1985; 55 FR 11013, 11014, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002; 70 FR 14984, Mar. 24, 2005; 80 FR 18093, Apr. 3, 2015]

Notes of Decisions

Cited in 2 cases, 1987–1988 · leading case: Berkovitz v. United States, 486 U.S. 531 (1988).

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Berkovitz v. United States, 486 U.S. 531 (1988). “12 These regulations, however, do not impose a corresponding duty on the Bureau of Biologies, Although the regulations empower the Bureau to examine any vaccine lot and prevent the distribution of a noncomplying lot, see 21 CFR § 610.2 (a) (1978), they do not require the Bureau…”

Berkovitz v. United States, 822 F.2d 1322 (3rd Cir. 1987). · cites it 2× “See 21 C.F.R. § 610.2 (a) (1987) (FDA may demand samples from manufacturer for use in own testing prior to approval); 42 C.”

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