§ 20-2A-66 — State Testing Laboratory Licensing

Alabama § 20-2A-66

• Jurisdiction: Alabama
• Title 20: Food, Drugs and Cosmetics
• Ch. 2A: Darren Wesley “Ato” Hall Compassion Act
• Art. 4: Cultivation, Processing, and Dispensing of Medical Cannabis

Text

(a) A state testing laboratory license authorizes the licensee to possess and test cannabis and medical cannabis products cultivated or processed at licensed facilities.
(b) The commission, by rule, shall establish protocols for product testing by a licensed state testing laboratory, which shall be conducted during cultivation, processing, and dispensing to ensure that all dispensed medical cannabis is consistently high grade and maintains a consistency with less than 0.5 percent variability among batches of the same product. The protocols for testing shall include the following, as well as a determination of corresponding tolerance limits:
(1) Cannabinoid content and potency, including, but not limited to, all of the following:
a. Total THC (THC+THCA).
b. Total CBD (CBD+CBDA).
c. THC/CBD ratio, if applicable.
d. Percent of THC relative to original plant material (w/w).
(2) Terpene profiles.
(3) Heavy metals.
(4) Chemical contamination, such as residual solvents remaining after extraction and concentration.
(5) Microbials, including pathogenic microbials.
(6) Mycotoxins.
(7) Residual insecticides, fungicides, herbicides, and growth regulators used during cultivation.
(8) Residual solvents.
(c) A state testing laboratory license authorizes the licensee to do all of the following without using a secure transporter:
(1) Take cannabis or medical cannabis from, test cannabis or medical cannabis for, and return cannabis or medical cannabis to only a respective licensed facility.
(2) Collect a random sample of cannabis or medical cannabis at the premises of a cultivator, processor, or dispensary for testing.
(d) The licensee shall be accredited and shown to meet the requirements for a testing laboratory in international standard ISO/IEC 17025, with the licensee’s scope of accreditation demonstrating testing capabilities in the categories of cannabinoids, pesticides, toxins, metals, and microbiological bacteria.
(e) To be eligible for a state testing laboratory license, the applicant and each investor with any interest in the applicant must not have an interest in any licensed cultivator, secure transporter, processor, or dispensary.
(f) The licensee shall comply with all of the following:
(1) Perform tests to certify that cannabis and medical cannabis is reasonably free of heavy metals, chemical contamination, residual pesticides and growth inhibitors, and residual solvents.
(2) Use validated test methods to determine delta-9-tetrahydrocannabinol, tetrahydrocannabinolic acid, cannabidiol, and cannabidiolic acid levels.
(3) Perform tests that determine whether cannabis and medical cannabis comply with the standards the commission establishes for microbial and mycotoxin contents.
(4) Perform other tests necessary to determine compliance with any other good manufacturing practices as prescribed in rules.
(5) Have a secured laboratory space that cannot be accessed by the general public.
(6) Retain and employ at least one staff member with a relevant advanced degree in a medical or laboratory science.

Legislative History

(Act 2021-450, §1.)