Rule 480-11-.02 - Compounded Drug Preparations(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.(2) Compounded drug preparations - Pharmacist for Distribution to Veterinarian.(a) Only a pharmacy licensed or registered by the Board may distribute compounded preparations to veterinarians licensed in this state for administration or emergency dispensing to their patients in the course of their professional practice, either personally or by an authorized person under their direct and immediate supervision.(b) A veterinarian shall make a request to the pharmacy for a compounded preparation in the same manner as ordering products from a wholesale pharmaceutical distributor or manufacturer and not by using a prescription drug order.(c) A pharmacy receiving an order from a veterinarian for a compounded preparation shall maintain such order with its compounding records as required in Rule 480-11-.08 and other rules and regulations of the Board.(d) Pharmacists shall label all compounded preparations distributed to veterinarian for administration or emergency dispensing to their patients with the following: 1. "By purchase order, Not by prescription",2. "For Office Use Administration or Emergency Dispensing by a Veterinarian Only - Not for resale",3. The name of the active ingredients and strengths contained in the compounded preparation,4. The lot number or identification of the compounded preparation,5. The pharmacy's name, address and telephone number,6. The initials of the pharmacist verifying the finished compounded preparation and the date verified,7. The quantity, amount, size, or weight of the compounded preparation in the container,8. An appropriate beyond-use (expiration) date of the compounded preparation as determined by the pharmacist in compliance with Board rule and USP-NF standards for pharmacy compounding, and9. Appropriate ancillary instructions such as storage instructions or cautionary statements, and where appropriate, hazardous drug warning labels.(e) Pharmacists shall enter into a written agreement with a veterinarian for the veterinarian's use and emergency dispensing of the compounded preparation before providing any compounded preparation to the veterinarian. The written agreement shall provide the following information:1. The name and address of the veterinarian, license number and contact information.2. An agreement by the veterinarian that the compounded preparation may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity except for a case in which emergency dispensing is required.3. An agreement by the veterinarian to include on the patient's chart, or medication administration record the lot number and beyond-use date of the compounded preparation administered or dispensed to the patient.4. The procedures for a patient to report an adverse reaction or to submit a complaint about a compounded preparation.5. The procedure to be used when the pharmacy has to recall a batch of compounded preparation.(f) When pharmacists are compounding preparations to be provided to veterinarians for use in patient care or when pharmacists are altering or repackaging such products for veterinarians to use in patient care in the veterinarian's office, the compounding shall be conducted as allowed by applicable federal law and Board rules and shall be in compliance with USP-NF standards for compounding.(g) Pharmacists may not compound Schedule II, III, IV or V controlled substances, as defined in Article 2 of Chapter 13 of Title 16 without a patient specific prescription drug order.(h) Nothing in this paragraph shall be construed to apply to pharmacies owned or operated by institutions or to pharmacists or practitioners employed by an institution or its affiliated entities; provided, however, pharmacies owned or operated by institutions and pharmacists and practitioners within or employed by institutions or affiliated entities shall remain subject to the other rules and regulations of the Board governing the compounding of pharmaceuticals.(3) Pharmacists must maintain documentation of proof that the beyond-use date on compounded pharmaceuticals is valid.(4) Pharmacists shall personally perform or personally supervise the compounding process, which shall include a final verification check for accuracy and conformity to the formula of the product being prepared, correct ingredients and calculations, accurate and precise measurements, appropriate conditions and procedures, and appearance of the final product.(5) Pharmacists shall ensure compliance with USP-NF standards for both sterile and non-sterile compounding.(6) Pharmacists may use prescription bulk substances in compounding when such bulk substances: (a) Comply with the standards of an applicable USP-NF monograph, if such monograph exists, including the testing requirements, and the Board rules on pharmaceutical compounding; or are substances that are components of pharmaceuticals approved by the FDA for use in the United States; or otherwise approved by the FDA;(b) Are manufactured by an establishment that is registered by the FDA; and(c) Are distributed by a wholesale distributor licensed by the Board and registered by the FDA to distribute bulk substances if the pharmacist can establish purity and safety by reasonable means, such as lot analysis, manufacturer reputation, or reliability of the source.(7) Pharmacists shall maintain records of all compounded pharmaceutical products. Pharmacist shall maintain a complete compounding formula listing all procedures, necessary equipment, necessary environmental considerations, and other factors in detail when such instructions are necessary to replicate a compounded product or where the compounding is difficult or complex and must be done by a certain process in order to ensure the integrity of the finished product. (a) This record-keeping requirement does not apply when FDA-approved and labeled sterile injectable drug products, produced by registered pharmaceutical manufacturers, are reconstituted under conditions as allowed by USP 797, and each such sterile drug product must be administered within 24 hours of being reconstituted.(8) Pharmacists engaged in the compounding of pharmaceuticals shall operate in conformance with Georgia laws and regulations. Non-sterile compounded preparations shall be subject to USP 795. All sterile compounded preparations shall be subject to USP 797.(9) Radiopharmaceuticals. If radiopharmaceuticals are being compounded, conditions set forth in the Board's rules for nuclear pharmacists and pharmacies must be followed.(10) Special precaution preparations. If drug preparations with special precautions for contamination are involved in a compounding operation, appropriate measures, including either the dedication of equipment for such operations or the meticulous cleaning of contaminated equipment prior to its return to inventory, must be utilized in order to prevent cross-contamination.(11) Cytotoxic drugs. In addition to the minimum requirements for a pharmacy established by rules of the Board, the following requirements are necessary for those pharmacies that prepare cytotoxic drugs to insure the protection of the personnel involved.(a) All cytotoxic drugs should be compounded in a vertical flow, Class II, biological safety cabinet or an appropriate barrier isolator. Other preparations should not be compounded in this cabinet.(b) Personnel compounding cytotoxic drugs shall wear protective apparel as outlined in the National Institute of Occupation Hazards (NIOSH) in addition to appropriate compounding attire as described in USP 797.(c) Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile preparations.(d) Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements.(e) Written procedures for handling both major and minor spills of cytotoxic agents must be developed and must be included in the policy and procedure manual.(f) Prepared doses of cytotoxic drugs must be dispensed, labeled with proper precautions inside and outside, and delivered in a manner to minimize the risk of accidental rupture of the primary container.(g) Disposal of cytotoxic and/or hazardous wastes. The pharmacist-in-charge is responsible for assuring that there is a system for the disposal of cytotoxic and/or infectious waste in a manner so as not to endanger the public health.(12) Pharmacists shall not engage in the following:(a) The compounding for human use of a pharmaceutical product that has been withdrawn or removed from the market by the FDA because such drug product or a component of such drug product has been found to be unsafe.(b) The compounding of any pharmaceutical products that are essentially copies of commercially available pharmaceutical products. However, this prohibition shall not include:1. The compounding of any commercially available product when there is a change in the product ordered by the prescriber for an individual patient,2. The compounding of a commercially available manufactured pharmaceutical during times when the product is not available from the manufacturer or wholesale distributor,3. The compounding of a commercially manufactured pharmaceutical that appears on the drug shortages list, or4. The mixing of two or more commercially available products of which the end product is a commercially available product.(13) Practitioners who may lawfully compound pharmaceuticals for administering or dispensing to their own patients pursuant to O.C.G.A. Section 26-4-130 shall comply with all the provisions of this rule and other applicable Board laws, rules and regulations.Ga. Comp. R. & Regs. R. 480-11-.02
O.C.G.A. §§ 26-4-4, 26-4-5, 26-4-27, 26-4-28, 26-4-86.
Original Rule entitled "Compounded Drug Products" adopted. F. Apr. 19, 2004; eff. May 9, 2004.Repealed: New Rule entitled "Compounded Drug Preparations" adopted. F. Nov. 22, 2006; eff. Dec. 12, 2006.Amended: F. Dec. 14, 2012; eff. Jan. 3, 2013.Amended: F. Dec. 19, 2013; eff. Jan. 8, 2014.Amended: F. Jun. 20, 2014; eff. July 10, 2014.Amended: F. Nov. 26, 2014; eff. Dec. 16, 2014.Amended: F. Nov. 06, 2019; eff. Nov. 26, 2019.Amended: F. May 4, 2023; eff. May 24, 2023.