[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR320.36]

[Page 191-192]
 
                        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. 320.36  Requirements for maintenance of records of bioequivalence testing.

    (a) All records of in vivo or in vitro tests conducted on any 
marketed batch of a drug product to assure that the product meets a 
bioequivalence requirement shall be maintained by the manufacturer for 
at least 2 years after the expiration date of the batch and submitted to 
the Food and Drug Administration on request.
    (b) Any person who contracts with another party to conduct a 
bioequivalence study from which the data are intended to be submitted to 
FDA as part of an application submitted under part 314 of this chapter 
shall obtain from the person conducting the study sufficient accurate 
financial information to allow the submission of complete and

[[Page 192]]

accurate financial certifications or disclosure statements required 
under part 54 of this chapter and shall maintain that information and 
all records relating to the compensation given for that study and all 
other financial interest information required under part 54 of this 
chapter for 2 years after the date of approval of the application. The 
person maintaining these records shall, upon request for any properly 
authorized officer or employee of the Food and Drug Administration, at 
reasonable time, permit such officer or employee to have access to and 
copy and verify these records.

[42 FR 1635, Jan. 7, 1977. Redesignated at 57 FR 18001, Apr. 28, 1992, 
as amended at 63 FR 5252, Feb. 2, 1998]