CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS > SUBPART B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products (§320.21 to §320.63) > 320.35—Requirements for in vitro testing of each batch.

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.

Code of Federal Regulations

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