Compliance · State rules
Office-use compounding in Georgia
Georgia expressly prohibits a pharmacy from distributing non-patient-specific compounded preparations for office use by a human prescriber, while carving out two exceptions in the same rule: 503B outsourcing facilities, and veterinarians. So the prohibition is on the pharmacy route rather than on the transaction — the rule says in terms that it does not affect the ability of outsourcing facilities to supply non-patient-specific preparations for office use, which makes Georgia a state that reroutes rather than one that closes the door.
The governing rule
Georgia’s office-use position is set by Ga. Comp. R. & Regs. r. 480-11-.02(1)(d). The text below is quoted verbatim; everything outside a quote block is our summary of it, and the two are kept visually separate on purpose.
The distribution of non-patient specific compounded preparations for office use by a practitioner, excluding veterinarians, is prohibited. This subsection shall not affect 503b outsourcing facilities ability to provide non-patient specific compounded preparations for office use by a practitioner. The distribution of compounded preparations, for office administration or emergency dispensing, to a veterinarian shall not exceed 5% of production of compounded preparation in a calendar year by that pharmacy. Amounts produced greater than 5% shall be considered manufacturing and will require separate licensure as a manufacturer.