[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: 21CFR320.34]

[Page 198]
 
                        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. 320.34  Requirements for batch testing and certification 
by the Food and Drug Administration.

    (a) If the Commissioner determines that individual batch testing by 
the Food and Drug Administration is necessary to assure that all batches 
of the same drug product meet an appropriate in vitro test, he shall 
include in the bioequivalence requirement a requirement for 
manufacturers to submit samples of each batch to the Food and Drug 
Administration and to withhold distribution of the batch until notified 
by the Food and Drug Administration that the batch may be introduced 
into interstate commerce.
    (b) The Commissioner will ordinarily terminate a requirement for a 
manufacturer to submit samples for batch testing on a finding that the 
manufacturer has produced four consecutive batches that were tested by 
the Food and Drug Administration and found to meet the bioequivalence 
requirement, unless the public health requires that batch testing be 
extended to additional batches.

[42 FR 1635, Jan. 7, 1977. Redesignated at 57 FR 18001, Apr. 28, 1992]