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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 320 - Bioavailability and Bioequivalence Requirements |
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Subpart B - Procedures for Determining the Bioavailability or Bioequivalence of Drug Products |
§ 320.35 - Requirements for in vitro testing of each batch.
Latest version.
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§ 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]