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e-CFR data is current as of July 14, 2020

Title 21Chapter ISubchapter DPart 320Subpart B → §320.35


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.

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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