Ala. Admin. Code r. 538-X-10-.05

Current through Register Vol. 43, No. 02, November 27, 2024

Section 538-X-10-.05 - Laboratory Standards

(1) A State Testing Laboratory must be shown to have met and maintained the requirements for a testing laboratory in international standard ISO/IEC 17025 published by the International Organization for Standardization, a copy of which may be obtained from the American National Standards Institute.

(2) Self-Certification that the State Testing Laboratory is operating according to standards sufficient to meet ISO/IEC 17025 requirements must be provided to the Commission prior to commencing testing on behalf of licensees.

(3) A State Testing Laboratory must follow:

(a) The most current version of the Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control monograph published by the American Herbal Pharmacopoeia, and

(b) "Recommendations for Regulators --Cannabis Operations" published by the American Herbal Products Association, and

(c) "Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals -- An Aid to the Interpretation of ISO/IEC 17025:2005" (2015) published by AOAC International.

(4) A State Testing Laboratory must use, when available, testing methods that have undergone validation by the Official Methods of Analysis of AOAC International, the Performance Tested Methods Program of the Research Institute of AOAC International, the Bacteriological Analytical Manual of the Food and Drug Administration, the International Organization for Standardization, the United States Pharmacopeia, the Microbiology Laboratory Guidebook of the Food Safety and Inspection Service of the United States Department of Agriculture, or an equivalent third-party validation study approved by the Commission. If no such testing method is available, a State Testing Laboratory may use an alternative testing method, or a testing method developed by the State Testing Laboratory, upon demonstrating the validity of the testing method to and receiving the approval of the Commission.

Ala. Admin. Code r. 538-X-10-.05

Adopted by Alabama Administrative Monthly Volume XL, Issue No. 11, August 31, 2022, eff. 10/15/2022.

Amended by Alabama Administrative Monthly Volume XLII, Issue No. 12, September 30, 2024, eff. 11/14/2024.

Author: William H. Webster; Justin C. Aday

Statutory Authority:Code of Ala. 1975, §§ 20-2A-22, as amended.