Section 26-4-86. Compounding and distribution of drug products

   (a) The board shall establish rules and regulations governing the compounding and distribution of drug products by pharmacists, practitioners, and pharmacies licensed or registered by this state. Such rules and regulations shall include provisions ensuring compliance with USP-NF standards.

(b) All drug products compounded and labeled in accordance with board rules regarding pharmaceutical compounding shall be deemed to meet the labeling requirements of Chapter 13 of Title 16 and Chapters 3 and 4 of this title.

(c) In regards to pharmacists compounding sterile drugs to be provided to practitioners to use in patient care or altering or repackaging such drugs for practitioners to use in patient care in the practitioner's office, such sterile compounding shall only be conducted as allowed by applicable federal law and board rule for pharmaceutical compounding using USP-NF standards for sterile compounding. Such sterile drugs may be compounded only in quantities determined by board rule following consultation with the Georgia Composite Medical Board. No Schedule II, III, IV, or V controlled substance, as defined in Article 2 of Chapter 13 of Title 16, shall be eligible for such designation. Nothing in this subsection shall be construed to apply to pharmacies owned or operated by institutions or to pharmacists or practitioners within or employed by an institution or affiliated entity; provided, however, that pharmacies owned or operated by institutions and pharmacists and practitioners within or employed by institutions or affiliated entities shall remain subject to other rules and regulations established by the board governing the compounding of medication.

(d) Practitioners who may lawfully compound drugs for administering or dispensing to their own patients pursuant to Code Section 26-4-130 shall comply with all provisions of this Code section and board rules regarding pharmaceutical compounding.

Code 1981, § 26-4-86, enacted by Ga. L. 1998, p. 686, § 1; Ga. L. 2013, p. 127, § 5/HB 209.