View all text of Subpart B [§ 320.21 - § 320.63]
§ 320.35 - Requirements for in vitro testing of each batch.
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.