[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR2.19]

[Page 17-18]
 
                        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

[[Page 18]]

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]