21 C.F.R. § 320.35 Requirements for in vitro testing of each batch.
Title 21 - Food and Drugs
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]
Title 21: Food and Drugs
PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products
§ 320.35 Requirements for in vitro testing of each batch.
