21 CFR 320.35
§ 320.35 Requirements for in vitro testing of each batch.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 320.35, § 320.35 Requirements for in vitro testing of each batch, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86464
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.