Compounding and Distribution of Drug Products

  1. Law
  2. Georgia Code
  3. Food, Drugs, and Cosmetics
  4. Pharmacists and Pharmacies
  5. Prescription Drugs
  6. Compounding and Distribution of Drug Products

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  1. 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.
    1. 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.
    2. All drug products compounded by a licensed outsourcing facility shall also be compounded in accordance with applicable current good manufacturing practices established by the federal Food and Drug Administration.
  3. In regards to pharmacists compounding nonpatient-specific 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 nonpatient-specific sterile compounding shall only be conducted by an outsourcing facility and 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 requirements, rules, and regulations established by the board and the federal Food and Drug Administration governing the compounding of medication.
    1. 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.
    2. Nothing in this Code section shall be construed to prohibit or interfere with the ability of a practitioner to compound drugs for administering or dispensing to their own patients pursuant to Code Section 26-4-130.

(Code 1981, §26-4-86, enacted by Ga. L. 1998, p. 686, § 1; Ga. L. 2013, p. 127, § 5/HB 209; Ga. L. 2016, p. 855, § 4/HB 926; Ga. L. 2017, p. 774, § 26/HB 323.)

The 2013 amendment, effective July 1, 2013, substituted the present provisions of this Code section for the former provisions, which read: "The board may establish regulations governing the compounding of medication by pharmacists and pharmacies licensed in this state."

The 2016 amendment, effective July 1, 2016, in subsection (b), designated the previously existing provisions as paragraph (b)(1) and added paragraph (b)(2); in subsection (c), in the first sentence, twice inserted "nonpatient specific" and inserted "by an outsourcing facility and", near the end of the fourth sentence, substituted "requirements, rules, and regulations" for "rules and regulations" and inserted "and the federal Food and Drug Administration"; and, in subsection (d), designated the previously existing provisions as paragraph (d)(1) and added paragraph (d)(2).

The 2017 amendment, effective May 9, 2017, part of an Act to revise, modernize, and correct the Code, added a hyphen to "nonpatient-specific" twice in the first sentence of subsection (c).


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