[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR320.63]

[Page 200]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 320_BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS--
Table of Contents
 
      Subpart B_Procedures for Determining the Bioavailability or 
                     Bioequivalence of Drug Products
 
Sec. 320.63  Retention of bioequivalence samples.

    The applicant of an abbreviated application or a supplemental 
application submitted under section 505 of the Federal Food, Drug, and 
Cosmetic Act, or, if bioequivalence testing was performed under 
contract, the contract research organization shall retain reserve 
samples of any test article and reference standard used in conducting an 
in vivo or in vitro bioequivalence study required for approval of the 
abbreviated application or supplemental application. The applicant or 
contract research organization shall retain the reserve samples in 
accordance with, and for the period specified in, Sec. 320.38 and shall 
release the reserve samples to FDA upon request in accordance with Sec. 
320.38.

[58 FR 25928, Apr. 28, 1993, as amended at 64 FR 402, Jan. 5, 1999]