[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR2.19]

[Page 16]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 2.19  Methods of analysis.

    Where the method of analysis is not prescribed in a regulation, it 
is the policy of the Food and Drug Administration in its enforcement 
programs to utilize the methods of analysis of the Association of 
Official Analytical Chemists (AOAC) as published in the latest edition 
(13th Ed., 1980) of their publication ``Official Methods of Analysis of 
the Association of Official Analytical Chemists,'' and the supplements 
thereto (``Changes in Methods'' as published in the March issues of the 
``Journal of the Association of Official Analytical Chemists''), which 
are incorporated by reference, when available and applicable. Copies are 
available from the Association of Official Analytical Chemists, 2200 
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street NW., suite 700, Washington, DC. In the absence of an AOAC method, 
the Commissioner will furnish a copy of the particular method, or a 
reference to the published method, that the Food and Drug Administration 
will use in its enforcement program. Other methods may be used for 
quality control, specifications, contracts, surveys, and similar 
nonregulatory functions, but it is expected that they will be calibrated 
in terms of the method which the Food and Drug Administration uses in 
its enforcement program. Use of an AOAC method does not relieve the 
practioner of the responsibility to demonstrate that he can perform the 
method properly through the use of positive and negative controls and 
recovery and reproducibility studies.

[42 FR 15559, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 54 
FR 9034, Mar. 3, 1989]