e-CFR banner

Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government produced by the Office of the Federal Register (OFR) and the Government Publishing Office.

Download the Code of Federal Regulations in XML.

Download the Electronic Code of Federal Regulations in XML.

Monthly Title and Part user viewing data for the e-CFR is available for download in CSV format.

Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
Text | PDF

Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.

Purchase individual CFR titles from the U.S. Government Online Bookstore.

Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.

[A1]

 

Electronic Code of Federal Regulations

e-CFR data is current as of June 1, 2020

Title 21 → Chapter I → Subchapter D → Part 320

TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER D—DRUGS FOR HUMAN USE

PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

rule

Subpart A—GENERAL PROVISIONS

§320.1
Definitions.
rule

Subpart B—PROCEDURES FOR DETERMINING THE BIOAVAILABILITY OR BIOEQUIVALENCE OF DRUG PRODUCTS

§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.

Need assistance?