Ala. Admin. Code r. 538-X-10-.04

Current through Register Vol. 43, No. 1, October 31, 2024

Section 538-X-10-.04 - [Effective until 11/14/2024] Requirements For State Testing Laboratories

A State Testing Laboratory must:

(1) 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 Organization for Economic Co-operation and Development.

(2) Become certified by an accreditation body, such as the American Association for Laboratory Accreditation that certifies effective implementation of ISO standards and agree to have the inspections and reports of the accreditation testing made available to the Commission.

(3) Maintain equipment and testing facilities sufficient to perform testing as required by the Act and these Rules.

(4) Perform tests per batch on behalf of licensees (scheduled official testing) at least once during each phase of the cannabis production during which testing is required, prior to the cannabis or medical cannabis leaving the cultivation, processing, or dispensing facility (or in the case of an integrated facility, the cultivation, processing or dispensing phase or department); testing also may occur at any time at the request of the Commission (unscheduled official testing) or informally at the request of a licensee (unscheduled unofficial testing).

(5) Perform tests to ensure that all dispensed medical cannabis is reliably high grade and maintains consistency among batches as required by the Act and this Chapter.

(6) Perform tests pursuant to the protocols and corresponding tolerance limits in accordance with the current minimum standards established by the Commission, which shall be available on the Commission's website, including:

(a) Cannabinoid content and potency, including, but not limited to, all of the following:

(i) Total THC (THC+ THCA).

(ii) Total CBD (CBD + CBDA).

(iii) THC/CBD ratio, if applicable.

(iv) Percent of THC relative to original plant material (w/w).

(b) Terpene profiles.

(c) Heavy metals.

(d) Chemical contamination, such as residual solvents remaining after extraction and concentration.

(e) Microbials, including pathogenic microbials.

(f) Mycotoxins.

(g) Residual pesticides: (insecticides, fungicides, herbicides, and growth inhibitors/regulators) used during cultivation as follows:

1. No pesticides or growth regulators may be used in the cultivation or production of cannabis or medical cannabis if the pesticide appears on any list of prohibited pesticides maintained or published by the Department.

2. When performing pesticide or growth regulator residue analysis, a State Testing Laboratory shall analyze for any non-prohibited pesticides, to determine whether the test product is reasonably free of residue of such pesticides.

3. If a non-prohibited pesticide or growth regulator is detected at a level which exceeds the level specified by the Department or a pesticide prohibited by the Department is detected in any amount which is positively verified, the pesticide residue analysis is failed, and the product must be recalled.

(h) Residual solvents.

(i) Any other testing protocols as may be required by the current minimum standards established by the Commission, which shall be made available on the Commission's website. (See Appendix A to this Chapter).

(7) Use validated test methods to determine delta-9-tetrahydrocannabinol, tetrahydrocannabinolic acid, cannabidiol, and cannabidiolic acid levels, in accordance with the current minimum standards established by the Commission, which shall be available on the Commission's website.

(8) Perform tests that determine whether cannabis and medical cannabis comply with the current minimum standards for microbial and mycotoxin contents established by the Commission, which shall be available on the Commission's website.

(9) Perform other tests necessary to determine licensees' compliance with good manufacturing practices, including but not limited to the following:

(a) Tests demonstrating that medical cannabis is medical grade.

(b) Tests demonstrating that medical cannabis contains no active ingredients other than cannabis provided by a licensee under the Act and this Chapter.

(c) Tests demonstrating that any excipients are pharmaceutical grade· within safe and effective levels, in accordance with the formulae provided by a Processor or Integrated Facility.

(d) Any other tests as may be reasonable, necessary, and appropriate to demonstrate good manufacturing processes.

(10) Have a secured laboratory space that cannot be accessed by the general public, in accordance with the Security Plan provided by the licensee at the time of licensing or pursuant to an approved amendment, waiver or variance thereto.

(11) Retain and employ at least one staff member (a scientific director) with a relevant advanced degree in a medical or laboratory science from an accredited secondary educational institution.

(a) The scientific director shall:

1. Ensure that the State Testing Laboratory achieves and maintains quality standards of practice as required by the Act and this Chapter; and

2. Supervise all staff of the State Testing Laboratory.

(b) If a scientific director is no longer employed by a State Testing Laboratory, the State Testing Laboratory shall not be permitted to conduct any testing.

(c) Upon the appointment of a new scientific director by a State Testing Laboratory, the State Testing Laboratory shall not resume any testing until the Commission conducts an inspection of the State Testing Laboratory.

(12) A sample of cannabis for testing must be at least ten (10) grams and no more than thirty (30) grams; a sample of a production run of medical cannabis must be the lesser of one percent (1%) of the total product weight of the production run or ten (10) units of product. All samples must be homogenized before testing.

(13) A cultivator or integrated facility shall not submit cannabis (as opposed to medical cannabis) to a State Testing Laboratory for testing unless the cannabis is destined for extraction and weighed within two (2) hours after harvest.

(14) At a minimum, monitor, track, and enter the following information into the Statewide Seed-to-Sale Tracking System as to each sample to be tested, including:

(a) The identity of the licensee for whom testing is to be performed.

(b) Where and how the sample was obtained.

(c) The size, count or weight, as available, of the sample obtained.

(d) The date and time the sample was obtained.

(e) The identity of the transporter, including any Secure Transporter, if any, including the identity of the personnel and vehicle involved in the transport.

(f) The date and time of the sample's arrival at the State Testing Laboratory.

(g) The tag, lot, or batch number (and any other information contained on the digital or QR code) applicable to the cannabis or medical cannabis, as available, from which each sample was obtained.

(h) The conditions of storage upon arrival at the State Testing Laboratory.

(i) The date and time testing commenced.

(j) The types of tests undertaken by the State Testing Laboratory and the amount of the sample used for each test.

(k) The date and time testing concluded.

(l) The results of testing.

(m) Any steps to be taken as a result of such testing.

(n) Any steps to be taken to dispose of or return any unused sample material.

(o) If returned, the date and time of the sample material's departure from the laboratory.

Ala. Admin. Code r. 538-X-10-.04

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

Author: William H. Webster

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