Biological products approved under this subpart are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.
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 601.93