Nev. Admin. Code § 453A.652

Current through June 11, 2024
Section 453A.652 - Testing methodologies; practices, procedures and programs relating thereto; inspections
1. Each independent testing laboratory must:
(a) Follow the most current version of the Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control monograph published by the American Herbal Pharmacopoeia.
(b) Follow the Recommendations for Regulators -- Cannabis Operations published by the American Herbal Products Association.
(c) Be accredited pursuant to standard ISO/IEC 17025 of the International Organization for Standardization by an impartial organization that operates in conformance with standard ISO/IEC 17011 of the International Organization for Standardization and is a signatory to the Mutual Recognition Arrangement of the International Laboratory Accreditation Cooperation.
(d) Follow the 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.
2. Each independent testing laboratory shall become proficient in testing samples using the analytical methods approved by the Department within 6 months after the date upon which the independent testing laboratory is issued a medical marijuana establishment registration certificate.
3. The Department may require an independent testing laboratory to have its basic proficiency to execute correctly the analytical testing methodologies used by the laboratory validated and monitored on an ongoing basis by an independent third-party.
4. Each independent testing laboratory shall:
(a) Adopt and follow minimum good laboratory practices which must, at a minimum, satisfy the OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring published by the Organisation for Economic Co-operation and Development.
(b) Become certified by the International Organization for Standardization and agree to have the inspections and reports of the International Organization for Standardization made available to the Department.
(c) Maintain internal standard operating procedures.
(d) Maintain a quality control and quality assurance program.
5. The Department or an independent third-party authorized by the Department may conduct an inspection of the practices, procedures and programs adopted, followed and maintained pursuant to subsection 4 and inspect all records of the independent testing laboratory that are related to the inspection.
6. An independent 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 Department of Taxation. If no such testing method is available, an independent testing laboratory may use an alternative testing method or a testing method developed by the independent testing laboratory upon demonstrating the validity of the testing method to and receiving the approval of the Department.
7. The Department hereby adopts by reference:
(a) The Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control monograph published by the American Herbal Pharmacopoeia. A copy of that publication may be obtained from the American Herbal Pharmacopoeia, P.O. Box 66809, Scotts Valley, California 95067, or at the Internet address http://www.herbal-ahp.org/, for the price of $44.95.
(b) The OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring published by the Organisation for Economic Co-operation and Development. A copy of that publication may be obtained free of charge from the Organisation for Economic Cooperation and Development at the Internet address http://www.oecd.org/env/ehs/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpand compliancemonitoring.htm.
(c) Standard ISO/IEC 17025 published by the International Organization for Standardization. A copy of that publication may be obtained from the American National Standards Institute at the Internet address https://webstore.ansi.org/RecordDetail.aspx?sku=ISO%2fIEC+17025%3a2005 for the price of $162.
(d) The 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. A copy of that publication may be obtained from AOAC International at the Internet address http://www.aoac.org/aoac_prod_imis/AOAC/AOAC_Member/PUBSCF/ALACCCF/ALACC M.aspx for the price of $190.

Nev. Admin. Code § 453A.652

Added to NAC by Div. of Pub. & Behavioral Health by R004-14, 3-28-2014, eff. 4-1-2014; A by R148-15A, eff. 9/9/2016; A by R092-17AP, eff. 2/27/2018
NRS 453A.370, as amended by section 47 of Assembly Bill No. 422, chapter 540, Statutes of Nevada 2017, at page 3706 and section 48 of Senate Bill No. 487, chapter 541, Statutes of Nevada 2017, at page 3759