21 CFR § 320.35 Bioavailability and Bioequivalence Requirements

§ 320.35 Requirements for in vitro testing of each batch.

Current through Sep 8, 2026 · Read all of Part 320

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.

[42 FR 1635, Jan. 7, 1977. Redesignated at 57 FR 18001, Apr. 28, 1992]

← § 320.34 Requirements for batch testing and certification by the Food and Drug Administration.§ 320.36 Requirements for maintenance of records of bioequivalence testing. →