§320.35. Requirements for in vitro testing of each batch.
21 C.F.R. § 320.35
If a bioequivalence requirement specifies a currently available in vitro test or an in vitro bioequivalence standard comparing the drug product to a reference standard, the manufacturer shall conduct the test on a sample of each batch of the drug product to assure batch-to-batch uniformity.
Notes, amendments, and revision history
Amendments
[42 FR 1635, Jan. 7, 1977. Redesignated at 57 FR 18001, Apr. 28, 1992]
Source
Source: 42 FR 1648, Jan. 7, 1977, unless otherwise noted.
Authority
Authority: 21 U.S.C. 321, 351, 352, 355, 371.
Amendments
[42 FR 1635, Jan. 7, 1977. Redesignated at 57 FR 18001, Apr. 28, 1992]