C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS › Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products

21 C.F.R. § 320.35

Requirements for in vitro testing of each batch

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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]