The Georgia Board of Pharmacy recently published regulations that allow licensed independent retail pharmacies that meet certain location restrictions and other requirements to obtain a special permit for dispensing low THC products to registered patients who have been prescribed medical marijuana.
Under the regulations, low THC products are products such as oils, tinctures, transdermal patches, lotions, or capsules other than foods that are infused with low THC oil, which is an oil containing not more than 5% by weight of THC, the psychoactive component of the cannabis plant that is responsible for producing a high.
In addition to the requirement for a specialty license from the Board of Pharmacy, key requirements of the regulations include:
- inspection by the Georgia Drugs and Narcotics Agency of any licensed pharmacy, possessing or having possessed any low THC product within a period of two years;
- purchase of all low THC products solely from firms holding a current permit issued by the Georgia Access to Medical Cannabis Commission (the “Commission”);
- storage and securing of all low THC products in the same manner required for dangerous drugs (i.e., legend drugs) within the prescription department of the pharmacy; however, low THC products are not required to be stored separately from such other drugs;
- pharmacy dispensaries must physically view and inspect each patient’s identification and patient registry card, as well as seek and review information on such patient from the prescription drug monitoring program database.
- low THC products that are outdated or expired must be returned to the originating producer licensed by the Commission.
In order to obtain the special license to dispense low THC products, an independent retail pharmacy must either (a) certify that it is not situated within a radius of 1,000 feet of any public or private school; early care and education program; or a church, synagogue, or other place of public religious worship; or (b) provide a certified copy of a zoning order permitting the pharmacy to operate in the proposed location.
The Board of Pharmacy may consider eight factors in determining whether an applicant is eligible for the specialty license, and ultimately reserves the right to deny a license to an applicant if granting the license would not be in the best interest of the public. Some of the factors the Board may consider include:
- any conviction of the applicant under various laws;
- false or fraudulent material in certain drug-related applications;
- suspension or revocation of a healthcare-related license;
- compliance with other applicable licensing requirements; and
- disciplinary history of the applicant with the Board.
Under legislation enacted in 2019, registered patients may possess up to 20 fluid ounces of low THC oil, provided that the oil is in a pharmaceutical container labeled by the manufacturer indicating the percentage of THC therein and the patient has in their possession a registration card issued by the Department of Public Health. Patients are eligible to obtain a registration card if they have one of the conditions or diseases specified in the state’s medical marijuana law, including end stage cancer, seizure disorders, severe or end-stage Alzheimer’s disease, and others.
Although the specialty license is limited to independent pharmacies, which would preclude long-term care pharmacies from licensure, it is nevertheless a step in the right direction. For the time being, marijuana remains a Schedule I controlled substance and is therefore deemed to have no medical value but a high potential for abuse. Recently, the U.S. Department of Health and Human Services recommended that the Drug Enforcement Administration reclassify marijuana as a Schedule III controlled substance. Any such reclassification would need to be effectuated through the formal rulemaking process. If and when such reclassification occurs, however, Georgia will be in a good position to hit the ground running with further legislation and administrative rulemaking to expand its pharmacy licensure program accordingly.