An amendment to the Georgia Pharmacy Practice Act that went into effect July 1, 2016, authorizes the Board of Pharmacy to create rules for the permitting of outsourcing facilities and third-party logistics providers in Georgia. This change allows the state to recognize and create its own rules for outsourcing facilities under Section 503B of the Federal Food, Drug and Cosmetic Act. Those rules, once published, may be more restrictive than the minimum federal standards enforced by the FDA.
The new law makes it explicitly clear that an independent compounding pharmacy may only compound human drug products for “office use” at a licensed outsourcing facility. There is a carve out for hospital-based pharmacies and pharmacies owned or operated by hospitals, as well as for medical doctors who compound drugs for administering or dispensing to their own patients.
Licensed outsourcing facilities must compound drug products in accordance with applicable good manufacturing practices established by the FDA. The Board of Pharmacy can issue rules that include new licensing requirements, limits on the quantities of sterile drugs which may be compounded, rules regarding drug supply chain security, and required reporting to the Georgia Drug and Narcotics Agency.