[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR2.19]
[Page 51]
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 AOAC INTERNATIONAL
(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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html. 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; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8,
2005]
[[Page 52]]
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