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Title 21

Displaying title 21, up to date as of 9/23/2021. Title 21 was last amended 9/21/2021.
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Title 21 Food and Drugs Part / Section
Chapter I Food and Drug Administration, Department of Health and Human Services 1 – 1299
Subchapter D Drugs for Human Use 300 – 499
Part 320 Bioavailability and Bioequivalence Requirements 320.1 – 320.63
Subpart A General Provisions 320.1
§ 320.1 Definitions.
Subpart B Procedures for Determining the Bioavailability or Bioequivalence of Drug Products 320.21 – 320.63
§ 320.21 Requirements for submission of bioavailability and bioequivalence data.
§ 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
§ 320.23 Basis for measuring in vivo bioavailability or demonstrating bioequivalence.
§ 320.24 Types of evidence to measure bioavailability or establish bioequivalence.
§ 320.25 Guidelines for the conduct of an in vivo bioavailability study.
§ 320.26 Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.
§ 320.27 Guidelines on the design of a multiple-dose in vivo bioavailability study.
§ 320.28 Correlation of bioavailability with an acute pharmacological effect or clinical evidence.
§ 320.29 Analytical methods for an in vivo bioavailability or bioequivalence study.
§ 320.30 Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration.
§ 320.31 Applicability of requirements regarding an “Investigational New Drug Application.”
§ 320.32 Procedures for establishing or amending a bioequivalence requirement.
§ 320.33 Criteria and evidence to assess actual or potential bioequivalence problems.
§ 320.34 Requirements for batch testing and certification by the Food and Drug Administration.
§ 320.35 Requirements for in vitro testing of each batch.
§ 320.36 Requirements for maintenance of records of bioequivalence testing.
§ 320.38 Retention of bioavailability samples.
§ 320.63 Retention of bioequivalence samples.