1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter D - DRUGS FOR HUMAN USE
  5. Part 320 - BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
  6. Subpart B - Procedures for Determining the Bioavailability or Bioequivalence of Drug Products
  7. 21 CFR § 320.35
21 CFR § 320.35
Requirements for in vitro testing of each batch
June 25, 2020
CFR

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]

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§ 320.34 Requirements for batch testing and certification by the Food and Drug Administration
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§ 320.36 Requirements for maintenance of records of bioequivalence testing

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