Ala. Admin. Code r. 538-X-6-.05

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

Section 538-X-6-.05 - Labeling And Packaging By Processors

(1) A Processor must properly package its approved medical cannabis products as follows:

(a) Packaging and containers must be child-resistant.

(b) Packaging and containers must be tamper-evident.

(c) Packaging and containers (or labels, see below) must identify the Processor and type of product.

(d) Packaging and containers must not be attractive to minors.

(e) Packaging and containers must be designed to minimize appeal to children.

(f) Packaging and containers must not contain any false statement or statement that advertises health benefits or therapeutic benefits of medical cannabis.

(2) A Processor must properly label its packages of medical cannabis as follows:

(a) Labels must be securely attached to or imprinted on the accompanying packaging.

(b) Labels must be clear and contain print of a size and quality so as to be legible to the average patient or caregiver with a sixth-grade education.

(c) Labels must identify the type of product (pills, tinctures, transdermal patches, etc.).

(d) Labels must contain lot and batch numbers.

(e) Labels must contain the name of and a license identification number for the Cultivator.

(f) Labels must contain the name of and a license identification number for the Processor.

(g) Labels must identify the cannabinoid content and potency of the product.

(h) Labels must identify the amount, number or count of the product in the package on which they are attached.

(i) Labels must contain the universal state symbol approved by the Commission, printed in color at least one-half inch by one-half inch in size.

(j) Labels must contain the words "Keep out of reach of children."

(k) Labels must contain a digital image or QR Code for purposes of tracking medical cannabis products and must interface with the Statewide Seed-to-Sale Tracking System.

(l) Labels, or if space is not available, a package insert, must contain the following: "WARNING:

This product may make you drowsy or dizzy. Do not drink alcohol with this product. Use care when operating a vehicle or other machinery. Taking this product with medication may lead to harmful side effects or complications. Consult your physician before taking this product with any medication. Women who are breastfeeding, pregnant, or plan to become pregnant should discuss medical cannabis use with their physicians."

(m) Labels must not be attractive to minors.

(n) Labels must not contain any false statement or statement that advertises health benefits or therapeutic benefits of medical cannabis.

(o) At the time of labeling, Processors must provide QR Coding or other approved digital coding to identify, at a minimum, the following:

1. The Cultivator or Integrated Facility, by facility, from which the medical cannabis was sourced,

2. The name of the Processor and the Processor's facility of origin,

3. The type of product,

4. The date of processing and packaging,

5. The date of the Processor's State Testing Laboratory approval,

6. The expiration date (or, if no expiration date, a notation that the expiration date does not apply), and

7. The Alabama Poison Control contact information as provided on the AMCC website.

Ala. Admin. Code r. 538-X-6-.05

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.