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Code of Federal Regulations Title 21. Food and Drugs § 21.320.35 Requirements for in vitro testing of each batch

Current as of January 02, 2025 | Updated by Findlaw Staff

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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.320.35 Requirements for in vitro testing of each batch - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-320-35/

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