SYNOPSIS AND DIFFERENCES OF THE PROPOSED RULE OF
THE GEORGIA STATE BOARD OF PHARMACY,
PURPOSE: The purpose of this amendment is to change the requirements for distribution of compounded drugs.
MAIN FEATURES: The main feature of this proposed amendment is the removal of “inordinate amounts of” in paragraph 1(d) and the removal of “except in the course of professional practice for a prescriber to administer to an individual patients” in paragraph 1(f).
RULE 480-11-.02 COMPOUNDED DRUG PREPARATIONS
(1) Compounded drug preparations -Pharmacist.
(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 commercially or not commercially available in the marketplace.
(b) Pharmacists shall receive, store, or use drugs that have been made in a FDA-approved facility. Pharmacists shall also receive, store, or use drugs in compounding prescriptions 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 drugs 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. The compounding of inordinate amounts of drugs, relative to the practice site, in anticipation of receiving prescriptions without any historical basis is considered manufacturing which requires a manufacturer’s license.
(d) The distribution of inordinate amounts of compounded preparations without a prescriber/patient/pharmacist relationship is considered manufacturing.
(e) Based on the existence of a pharmacist/patient/prescriber relationship and the presentation of a valid prescription drug order, pharmacists may compound, in reasonable quantities, drug products that are commercially or not commercially available in the marketplace.
(f) Pharmacists shall not offer compounded drugs to other state-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a prescriber to administer to an individual patient.
(g) Pharmacists engaged in the compounding of drugs shall operate in conformance with applicable state laws and rules regulating the practice of pharmacy.
(2) If low, medium, and/or high risk sterile preparations are being compounded, they must be in accordance with USP 797 and/or Georgia regulations.
(3) Radiopharmaceuticals. If radiopharmaceuticals are being compounded, conditions set forth in the Board’s rules for nuclear pharmacists and pharmacies must be followed.
(4) 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.
(5) 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.
Authority O.C.G.A. Secs. 26-4-4, 26-4-5, 26-4-27, 26-4-28, 26-4-86.