§ 320.35. Requirements for in vitro testing of each batch.
59 words·~1 min read·
/us/cfr/t21/s§ 320.35·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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]