Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 5 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER D - DRUGS FOR HUMAN USE
/ 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.
§ 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.