Ala. Admin. Code r. 538-X-6-.04

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

Section 538-X-6-.04 - Duties Of Processors

Processors must do all of the following:

(1) Using documented good quality practices and meeting current Good Manufacturing Practices, a Processor must process cannabis produced by a Cultivator into an approved medical cannabis product.

(2) A Processor's medical cannabis products must:

(a) Be shown to meet intended levels of purity.

(b) Be shown to be reliably free of toxins and contaminants (see Appendix A to Chapter 10 of these Rules).

(c) Contain no additives other than pharmaceutical grade excipients.

(d) Not be processed into a form that is attractive to or targets children.

(e) As to all gelatinous cube, cuboid, and lozenge medical cannabis products, conform to the universal flavor established by the Commission under § 20-2A-63(f), Code of Ala. 1975, (as amended), which is peach.

(3) Adhere to the rules and regulations for Packaging and Labeling medical cannabis set forth at r. 538-X-6-.05.

(4) Maintain its license status in good standing and properly adhere to rules and regulations regarding Commission inspections, quality control, quality assurance and license renewal.

(5) Maintain at all times the standards and practices set forth in the business plan and operating plan submitted to the Commission at the time of application or as thereafter amended.

Ala. Admin. Code r. 538-X-6-.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.