Ga. Comp. R. & Regs. 351-6-.06

Current through Rules and Regulations filed through October 17, 2024
Rule 351-6-.06 - Labeling and Exit Packaging
(1) Dispensing licensees are prohibited from removing, altering, covering, or otherwise tampering with the originating production licensee's product label affixed to product in final packaged form as set forth in Rule 351-4-.07.
(2) A dispensing licensee shall use weather-resistant and tamper-resistant labels for all product in final packaged form and shall include the following information on such labels:
(a) The date the product in final packaged form is dispensed to the patient;
(b) Patient identification information, including:
1. Name, address, and license number of the dispensing licensee;
2. The unique patient registry serial number of the patient, assigned by the Georgia Department of Public Health;
3. Patient's first and last name;
4. Patient's date of birth; and
5. Where applicable, the caregiver's first and last name and unique patient registry serial number, assigned by the Georgia Department of Public Health.
(c) Directions for use of the product; and
(d) Any cautionary statements or symbols as may be required by the Commission.
(3) A dispensing licensee shall use approved exit packaging for all product in final packaged form prior to dispensing such product in final packaged form to a patient or caregiver. Prior to use, all exit packaging shall meet the following:
(a) Reviewed and approved by the GMCC Executive Director;
(b) Only use trademarks, licensed logos, or imagery previously approved by the Commission or the GMCC Executive Director; and
(c) Be plain-colored, light-resistant, and opaque.

Ga. Comp. R. & Regs. R. 351-6-.06

O.C.G.A. §§ 16-12-203, 16-12-206, 16-12-210.

Original Rule entitled "Labeling and Exit Packaging" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.