(a) Whenever the Commissioner has reasonable grounds to believe that any of the grounds for revocation of a license exist and that by reason thereof there is a danger to health, the Commissioner may notify the licensed manufacturer that the biologics license is suspended and require that the licensed manufacturer do the following:
(1) Notify the selling agents and distributors to whom such product or products have been delivered of such suspension, and
(2) Furnish to the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research, complete records of such deliveries and notice of suspension.
(b) Upon suspension of a license, the Commissioner shall either:
(1) Proceed under the provisions of § 601.5(b) of this chapter to revoke the license, or
(2) If the licensed manufacturer agrees, hold revocation in abeyance pending resolution of the matters involved.
[64 FR 56451, Oct. 20, 1999, as amended at 70 FR 14983, Mar. 24, 2005]
authority: 15 U.S.C. 1451-1561;
21 U.S.C. 321,
351,
352,
353,
355,
356b,
360,
360c-360f,
360h-360j,
371,
374,
379e,
381;
42 U.S.C. 216,
241,
262,
263,
264; sec 122, Pub. L. 105-115, 111 Stat. 2322 (
21 U.S.C. 355 note), sec 7002(e), Pub. L. 111-148, 124 Stat. 817, as amended by sec. 607, Division N, Pub. L. 116-94, 133 Stat. 3127
source: 38 FR 32052, Nov. 20, 1973, unless otherwise noted.
cite as: 21 CFR 601.6