[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR320.32]

[Page 196]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 320_BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS--Table of Contents
 
      Subpart B_Procedures for Determining the Bioavailability or 
                     Bioequivalence of Drug Products
 
Sec. 320.32  Procedures for establishing or amending a bioequivalence 
requirement.

    (a) The Food and Drug Administration, on its own initiative or in 
response to a petition by an interested person, may propose and 
promulgate a regulation to establish a bioequivalence requirement for a 
product not subject to section 505(j) of the act if it finds there is 
well-documented evidence that specific pharmaceutical equivalents or 
pharmaceutical alternatives intended to be used interchangeably for the 
same therapeutic effect:
    (1) Are not bioequivalent drug products; or
    (2) May not be bioequivalent drug products based on the criteria set 
forth in Sec. 320.33; or
    (3) May not be bioequivalent drug products because they are members 
of a class of drug products that have close structural similarity and 
similar physicochemical or pharmacokinetic properties to other drug 
products in the same class that FDA finds are not bioequivalent drug 
products.
    (b) FDA shall include in a proposed rule to establish a 
bioequivalence requirement the evidence and criteria set forth in Sec. 
320.33 that are to be considered in determining whether to issue the 
proposal. If the rulemaking is proposed in response to a petition, FDA 
shall include in the proposal a summary and analysis of the relevant 
information that was submitted in the petition as well as other 
available information to support the establishment of a bioequivalence 
requirement.
    (c) FDA, on its own initiative or in response to a petition by an 
interested person, may propose and promulgate an amendment to a 
bioequivalence requirement established under this subpart.

[57 FR 18000, Apr. 28, 1992]