Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-11 - PHARMACEUTICAL COMPOUNDING › Rule 480-11-.02 - Compounded Drug Preparations

Current through Rules and Regulations filed through June 27, 2024
(1)
			 Compounded drug preparations - Pharmacist/Patient/Prescriber Relationship.
(a) Based on the existence of a
			 pharmacist/patient/prescriber relationship and the presentation of a valid
			 prescription drug order or in anticipation of a prescription drug order based
			 on routine, regularly observed prescribing patterns, pharmacists may compound,
			 for an individual patient, drug preparations that are not commercially
			 available in the marketplace or commercially available in the place as outlined
			 by the restrictions under 12(b). Dispensing of pharmaceutical products shall be
			 consistent with the provisions of O.C.G.A. T. 16, Ch. 13 and T. 26, Ch. 4
			 relating to the issuance of prescriptions and the dispensing of
			 drugs.
(b) Pharmacists shall
			 receive, store, or use pharmaceuticals that have been manufactured or
			 repackaged in a FDA-registered facility. Pharmacists shall also receive, store,
			 or use pharmaceuticals in compounding preparations that meet official compendia
			 requirements. If neither of these requirements can be met, pharmacists shall
			 use their professional judgment to procure alternatives.
(c) Pharmacists may compound pharmaceuticals
			 prior to receiving a valid prescription drug order based on a history of
			 receiving valid prescription drug orders within an established
			 pharmacist/patient/prescriber relationship, and provided that they maintain the
			 prescriptions on file for all such preparations compounded at the pharmacy.
			 Preparations compounded in anticipation of a valid prescription drug order
			 shall be properly labeled to include the name of the compounded pharmaceutical,
			 date of compounding, and beyond-use date.
(d) 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.
1. "Emergency Dispensing" shall mean no more
			 than a 10-day supply dispensed for an urgent condition to an animal patient by
			 a licensed veterinarian with a valid veterinarian-client-patient relationship
			 when timely access to a compounding pharmacy is not available.
(e) Pharmacists must maintain a
			 separate compounding log for each compounded preparation that includes the
			 quantity and amount of each pharmaceutical that is compounded. Pharmacists
			 shall label all compounded preparations that are dispensed pursuant to a
			 prescription in accordance with the provisions of O.C.G.A. T. 16, Ch. 13 and
			 O.C.G.A. T. 26, Chs. 3 and 4, and Board rules and regulations, and shall
			 include on the labeling an appropriate beyond-use date as determined by the
			 pharmacist in compliance with USP-NF standards for pharmacy
			 compounding.
(f) All compounded
			 preparations labeled in accordance with Board rules and regulations regarding
			 pharmaceutical compounding shall be deemed to meet the labeling requirements of
			 O.C.G.A. T. 16, Ch. 13, and T. 26, Chs. 3 and 4.