Ala. Admin. Code r. 538-X-10-.03
Current through Register Vol. 43, No. 1, October 31, 2024
Section 538-X-10-.03 - General Licensing And Regulation Of Medical Cannabis As To State Testing Laboratories(1)License Required. State Testing Laboratories are required to be licensed as set forth in Rule 2 of Chapter 3 of these Rules; State Testing Laboratories may not act in the capacity as such without a license provided by the Commission in accordance with the Act and this Chapter.(2)Number of Licenses to be issued by the Commission. The number of licenses to be issued to State Testing Laboratories is within the discretion of the Commission, which will award licenses to State Testing Laboratories based on merit, need, and other factors identified generally and specifically by the Act and this Chapter. (See 20-2A-51, Code of Alabama 1975 (as amended)). (3)Authority. A State Testing Laboratory is authorized, without the use of a Secure Transporter, to do the following:(a) Collect a random sample of cannabis or medical cannabis at the premises of a cultivator, processor, dispensary, or integrated facility for testing. 1. The State Testing Laboratory which performs the test must collect the samples.2. If the licensee facility has segregated the lot or batch of cannabis or medical cannabis into batches smaller than the entire lot or production run, the State Testing Laboratory must sample and test each batch from the lot.3. From the time that a lot or production run has been homogenized for sample testing and eventual packaging and sale to a patient or caregiver, the facility which provided the sample shall segregate and withhold from use the entire lot or production run, except the samples that have been removed by the State Testing Laboratory for testing.4. During segregation, the facility which provided the sample shall maintain the lot or production run in a secure, cool, and dry location so as to prevent the cannabis or medical cannabis from becoming contaminated or losing its efficacy.(b) Take cannabis or medical cannabis from, test cannabis or medical cannabis for, and return cannabis or medical cannabis only to a respective licensed facility. 1. At the time of transport, the State Testing Laboratory selecting a sample shall, using tamper-resistant products, record the name of the licensee and facility providing the sample; the batch, lot, or production run number; and the weight or quantity of the sample.2. The sample shall be sealed into a locked tamper-evident container that shall not be accessible to the State Testing Laboratory transporter during transit.3. Perform testing and analysis and report on the results of such to the licensee from which the sample was obtained.4. A single employee may transport samples of cannabis or medical cannabis from or to a State Testing Laboratory for testing; such employees and transport vehicles carrying cannabis or medical cannabis are otherwise subject to the rules and regulations applicable to Secure Transporters as set forth in Chapter 7 of these Rules.(c) Perform required official testing on behalf of the Commission, the results of which shall fulfill the testing requirements for cannabis and medical cannabis under the Act and these Rules; the results of official testing shall be reported to the Commission and considered dispositive for the purposes of confirming and approving batches of licensee's cannabis and medical cannabis to continue the medical cannabis production process, for ultimate use by patients in this State.(d) Perform private testing on behalf of a Cultivator, Processor, Secure Transporter, Dispensary, or Integrated Facility; private testing may only occur pursuant to an advance request for a private test by a licensee (made at or before the time of collection of the batch or lot for testing). Unlike an official test, the results of such private testing shall not fulfill the requirement of testing under the Act and these Rules, and the State Testing Laboratory shall not report the results to the Commission unless a licensee requests that it do so.(4)Limitations.(a) Under no circumstances shall the licensee which provided the sample sell or transfer the cannabis or medical cannabis to another licensee, patient, or caregiver, unless and until the State Testing Laboratory clears the licensee to do so based on the written results of successfully completed testing.(b) A licensee shall not use more than one State Testing Laboratory to perform official testing on the same batch or sample of cannabis or medical cannabis except as expressly provided in 538-X-10-.08.(c) A State Testing Laboratory may subcontract its testing of cannabis and medical cannabis only to another State Testing Laboratory. A transfer of samples pursuant to such a subcontract must be performed directly by the State Testing Laboratories.(d) A State Testing Laboratory may request additional sample material for the purposes of completing required quality assurance tests but may not use such material for the purposes of resampling or repeating quality assurance tests.(e) A State Testing Laboratory transporting samples may make multiple stops to collect samples if: 1. Each stop is for the sole purpose of retrieving a sample from a licensee's facility; and2. All samples are clearly marked, kept separately, and remain secure at all times during transit. (i) A State Testing Laboratory is not limited in the amount of usable cannabis and medical cannabis it may have on the premises of the laboratory at any given time, but the laboratory must maintain records to prove that all usable cannabis and medical cannabis on the premises are there for testing purposes only.(ii) A license to operate as a State Testing Laboratory does not authorize the State Testing Laboratory to cultivate, process or dispense cannabis, nor may a State Testing Laboratory perform the functions of a Secure Transporter (except as specifically stated herein) or an Integrated Facility as defined in the Act and these Rules.(5)Restrictions.(a) A State Testing Laboratory is not authorized, except at the request of the Commission, to perform testing on behalf of a patient or caregiver.(b) A State Testing Laboratory may not perform testing for individuals and entities other than licensees under the Act and these Rules, including individuals and entities licensed under the laws of another jurisdiction.(c) Except as specifically authorized by the Commission, the ability of a State Testing Laboratory to transport cannabis shall be restricted to furthering its function in testing cannabis and medical cannabis; a State Testing Laboratory is prohibited from transporting any cargo except cannabis, medical cannabis and associated products, materials, packages, or containers.(d) Applicants for a license to operate as a State Testing Laboratory, and any and all investors having any interest in a State Testing Laboratory applicant, are prohibited from having any interest in any applicant for, or a licensee that is, a Cultivator, Secure Transporter, Processor, Dispensary, Integrated Facility, a qualified recommending physician, or another State Testing Laboratory.Ala. Admin. Code r. 538-X-10-.03
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.
The amended version of this section by Alabama Administrative Monthly Volume XLII, Issue No. 12, September 30, 2024, filed September 12, 2024 is not yet available.