Ala. Admin. Code r. 538-X-6-.02

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

Section 538-X-6-.02 - Definitions

As used in this Chapter, the following terms have the following meanings:

(1) "Attractive to or Targets Children"; "Attractive to Minors." Forms, designs, packaging, receptacles, devices, labeling, or branding that contains, features, resembles, or includes:

(a) Cartoons, including artistic, caricature or similar renderings;

(b) Toys;

(c) Products available for consumption as a commercially available candy;

(d) Realistic or fictional characters whose target audience is primarily composed of minors;

(e) Media that has as an audience demographic composed of greater than 15% minors;

(f) Likenesses or images of minors, animals, or fruits;

(g) A non-cannabis consumer product of a type that is commonly marketed to minors;

(h) Symbols or words commonly used to market products to minors, are commonly associated with minors, or refer to products commonly marketed by minors; or

(i) Celebrities whose audience or following is substantially composed of greater than 15% minors.

(2) "Excipients." Inactive (as opposed to active) ingredients in medical cannabis, such as coloring agents, preservatives, and fillers, that serve as the inert vehicle or medium for the medical cannabis product.

(3) "Good Quality Practices." Application of quality control and quality assurance practices in processing medical cannabis, requiring Processors to use a scientific approach and consider factors such as risk assessment, life cycle, and patient protection in all facets of the manufacturing process, using ISO 17025 and/or ISO 9001 Testing and Calibration Laboratories quality standards.

(4) "Pharmaceutical Grade." Manufactured to the same standard or grade as any active or inactive drug, biologic, reagent or other pharmaceutical, in accordance with Good Manufacturing Practices (GMP) and approved, conditionally approved or indexed by the Food and Drug Administration (FDA) or for which a chemical purity standard has been established by recognized compendia.

Ala. Admin. Code r. 538-X-6-.02

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.