Section 21a-408-59 - Laboratory requirements(a) No laboratory shall handle, test or analyze marijuana unless such laboratory: (1) Is registered with the department as a controlled substance laboratory;(2) Is independent from all other persons involved in the marijuana industry in Connecticut, which shall mean that no person with a direct or indirect interest in the laboratory shall have a direct or indirect financial interest in a dispensary, dispensary facility, producer, production facility, certifying physician, certifying APRN, or any other entity that may benefit from the production, manufacture, dispensing, sale, purchase or use of marijuana; and(3) Has employed at least one person to oversee and be responsible for the laboratory testing who has earned, from a college or university accredited by a national or regional certifying authority, at least a master's level degree in chemical or biological sciences and has a minimum of two years of post-degree laboratory experience, or earned a bachelor's degree in biological sciences and has a minimum of four years of post-degree laboratory experience.(4) Has provided proof to the department of accreditation in testing and calibration in accordance with the most current version of the International Standard for Organization and the International Electrotechnical Commission ("ISO/IEC") 17025 or proof that the laboratory has applied for accreditation in testing and calibration in the most current version of ISO/IEC 17025. Any testing and calibration method utilized to perform a medical marijuana analysis shall be in accordance with the laboratory's ISO/IEC 17025 accreditation. The accrediting body shall be recognized by International Laboratory Accreditation Cooperation. (A) A laboratory applying for authorization to provide medical marijuana analytical tests shall receive ISO/IEC 17025 accreditation within eighteen months from the date the laboratory applied for ISO/IEC 17025 accreditation. A laboratory may request, and the commissioner may grant for good cause shown, additional time for the laboratory to receive ISO/IEC 17025 accreditation.(B) A laboratory shall send proof of ISO/IEC 17025 accreditation to the department for all medical marijuana related analytical test methods for which it has received ISO/IEC 17025 accreditation no later than five business days after the date in which the accreditation as received.(C) A laboratory may use non-accredited analytical test methods so long as the laboratory has commenced an application for ISO/IEC 17025 accreditation for analytical test methods for medical marijuana analysis. No laboratory shall use non-accredited analytical test methods for medical marijuana analysis if it has applied for and has not received ISO/IEC 17025 accreditation within eighteen months. The laboratory may request and the commissioner may grant for good cause shown additional time for the laboratory to utilize non-accredited analytical test methods for medical marijuana analysis.(D) At such time that a laboratory loses its ISO/IEC 17025 accreditation for any medical marijuana related analytical test methods, it shall inform the department within twenty-four hours. The laboratory shall immediately stop handling, testing or analyzing marijuana.(b) A laboratory that transports medical marijuana to or from itself a producer, dispensary facility or research program location shall have a transportation protocol approved by the commissioner.Conn. Agencies Regs. § 21a-408-59
Effective September 6, 2013; amended 8/28/2018