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Chapter 480-25 NUCLEAR PHARMACIES AND PHARMACISTS

Rule 480-25-.01 Definitions

Unless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning hereinafter respectively ascribed to them:

(a) "Authentication of product history" means, but is not limited to, identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical.
(b) "Board" means the State Board of Pharmacy.
(c) "Compounding of radiopharmaceuticals" means the addition of a radioactive substance to nonradioactive substances or the use of a radioactive substance in preparation for single or multidose dispensation upon the prescription order of a physician who is licensed to use radioactive materials. Compounding of radiopharmaceuticals may include: loading and eluting of radionuclide generators; using manufactured reagents; preparing reagent kits; a liquoting reagents; formulation and quality assurance testing of radiochemicals for use as radiopharmaceuticals, and radiolabeling of compounds or products, including biological products, for use as radiopharmaceuticals.
(d) "Department" means the Department of Natural Resources.
(e) "Governing Body" or "Management" means the board of directors, trustees, partnership, corporation, association, person or group of persons who maintain and control the operation of the nuclear pharmacy, and who are legally responsible for its operation.
(f) "Internal Test Assessment" means, but is not limited to conducting those tests of a quality assurance necessary to ensure the integrity of the test.
(g) "Licensed Nuclear Pharmacist" means an authorization granted by the Board to a pharmacist to practice as a nuclear pharmacist.
(h) "Manufacturing of radiopharmaceuticals" means the preparation, derivation, or production of a product to which a radioactive substance is or will be added to provide a radiopharmaceutical for sale, resale, redistribution, or reconstitution.
(i) "Nuclear pharmacist" means a pharmacist who compounds and dispenses radiopharmaceuticals in the course of his/her pharmacy practice.
(j) "Nuclear Pharmacy" means a pharmacy providing radiopharmaceutical services.
(k) "Nuclear Pharmacy Permit" means an authorization granted by the Board to the governing body of a facility to operate a nuclear pharmacy.
(l) "Pharmacist" means an individual who is currently licensed to practice pharmacy under the provisions of O.C.G.A. Title 26, Chapter 4, Article 3.
(m) "Pharmacy Intern" means an individual who is currently licensed to practice as a pharmacy intern under the provisions of O.C.G.A. Title 26, Chapter 4, Article 3.
(n) "Physician" means an individual who is currently licensed to practice medicine under the provisions of O.C.G.A. Title 43, Chapter 34.
(o) "Radiopharmaceutical" means radioactive drugs and chemical products used for diagnostic and therapeutic purposes and includes the terms radioactive pharmaceuticals, radioisotopes, and radioactive tracers.
(p) "Radiopharmaceutical quality assurance" means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on radiopharmaceuticals and their component materials and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.
(q) "Radiopharmaceutical service" means, but is not limited to, the compounding, dispensing, labeling, and delivering of radiopharmaceuticals; the participation in radiopharmaceutical selection and radiopharmaceutical utilization review; the maintenance of radiopharmaceutical quality assurance; and the responsibility for advising, where necessary or where regulated, of therapeutic values, hazards, and use of radiopharmaceuticals; and the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of a nuclear pharmacy.
(r) "Unit dose transport container" (a/k/a "lead pig") means a lead lined container designed to transport doses of radiopharmaceutical agents and prevent the emission of radiation or radioactive materials during the process. The terms "unit dose transport container" and "lead pig" may be used interchangeably.

Rule 480-25-.02 Applicability of Regulations

(1) All persons who manufacture, possess, transport, or otherwise handle pharmaceuticals or radioactive materials intended for radiopharmaceutical use prior to their arrival at a nuclear pharmacy shall comply with the requirements of the Department's Rules and Regulations for Radioactive Materials, and the requirements of the Rules and Regulations of the Board.
(2) The requirements of these Rules and Regulations are in addition to, and not in substitution of, other applicable Rules and Regulations by the Department for radioactive materials and applicable Rules and Regulations promulgated by the Board for pharmacists and pharmacies.
(3) Nothing in these Rules and Regulations shall be construed as requiring a licensed physician to obtain a separate license as a nuclear pharmacist, when his/her use of radiopharmaceuticals is limited to the diagnosis and treatment of his/her own patients.
(4) Nothing in these Rules and Regulations shall be construed so as to require a licensed clinical laboratory which is also licensed by the Department to handle radioactive materials to obtain the services of a nuclear pharmacist, or to have a nuclear pharmacy license, unless the laboratory is engaged in the commercial sale or resale of radiopharmaceuticals.
(5) Nothing in these Rules and Regulations shall be construed to require a department of nuclear medicine which is located in a hospital of 250 beds or less, which has a board certified radiologist in the practice of nuclear medicine, and which is licensed by the Department to handle radioactive materials to obtain the services of a nuclear pharmacist or to have a nuclear pharmacy license.

Rule 480-25-.03 Licensure of Nuclear Pharmacists

(1) Except as provided for in Rule 480-25-.02, all acts of compounding and dispensing radiopharmaceuticals in the State of Georgia shall be performed by persons licensed as nuclear pharmacists; provided, however, that licensed pharmacists and licensed pharmacy interns/externs under the direct supervision and control of a nuclear pharmacist may compound and dispense radiopharmaceuticals without being separately licensed as nuclear pharmacists.
(2) An applicant for a license as a nuclear pharmacist shall:
(a) Be a currently licensed pharmacist in the State of Georgia, and
(b) Submit to the Board a completed application and the appropriate fee, on forms to be provided by the Board, and an affidavit of training and experience which indicates that the applicant:
1. Meets the minimum requirements to use radioactive materials as required by the Department's Rules and Regulations for Radioactive Materials, and either
(i) Is certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties of the American Pharmaceutical Association; or
(ii) Has completed a minimum of 200 contact hours of didactic instruction in nuclear pharmacy from an accredited college of pharmacy, and, completed a minimum of 500 hours of clinical nuclear pharmacy training:
(I) Under the direct supervision of a licensed nuclear pharmacist in a licensed nuclear pharmacy providing nuclear pharmacy service; or
(II) In a certified nuclear pharmacy residency program approved by the American Society of Hospital Pharmacists or the Board; or
(III) In a structured nuclear pharmacy training program of an accredited college of pharmacy.
(3) Pharmacists engaged in the practice of nuclear pharmacy in the State of Georgia prior to March 18, 1983 shall be exempt from the requirements listed in subsection (2)(b)1. (i) and (2)(b)1. (ii).
(4) A license as a nuclear pharmacist may be issued to any pharmacist who makes application to the Board, together with a required fee, and meets the requirements of these Rules and Regulations. The Board may refuse to issue a license for any of the grounds set forth in O.C.G.A. Section 26-4-60, and may also refuse to issue a license to an applicant who makes any false statement in the application or cheats in any manner upon any examination administered pursuant to these Rules and Regulations.
(5) Licenses shall be renewed biennially on odd numbered years by application to the Board for renewal.
(6) The Board may limit, suspend, or revoke licenses issued under the provisions of these Rules and Regulations, or impose any other reasonable sanctions upon holders of such licenses upon violation of these Rules and Regulations or violation of O.C.G.A. Section 26-4-60.

Rule 480-25-.04 Licensure of Nuclear Pharmacies

(1) No nuclear pharmacy shall be operated in the State of Georgia without a valid permit.
(2) The governing body of the facility shall submit a completed application with the required fee to the Board for a permit using forms provided by the Board.
(3) Separate applications and permits are required for nuclear pharmacies maintained on separate premises, even though they are owned or operated by the same person(s), business or corporation; and may be doing business under the same trade name.
(4) Permits are not transferable or assignable.
(5) The applicant shall comply with additional application requirements as may be required by the Board.
(6) Following inspection and evidence of compliance with these Rules and Regulations, the Board may issue a nuclear pharmacy permit to the applicant(s). The Board may refuse to issue a permit to any applicant for any of the grounds set forth in O.C.G.A. Section 26-4-113, and may also refuse to issue or revoke a permit if an applicant makes any false statements in the application.
(7) Permits shall be renewed biennially on even numbered years by application to the Board for renewal.
(8) The Board may limit, suspend, or revoke permits issued under the provisions of these Rules and Regulations, or impose any other reasonable sanctions upon holders of such permits upon violation of these Rules and Regulations or violation of O.C.G.A. Section 26-4-113.

Rule 480-25-.05 Inspections

(1) Any nuclear pharmacy shall be open during all business hours for observation and examination by properly identified representatives of the Board and the Department.
(2) All nuclear pharmacies shall be inspected by the Board prior to licensure and may be inspected at the discretion of the Board or the Department to determine whether it continues to meet these requirements.

Rule 480-25-.06 Nuclear Pharmacy General Requirements

(1) In addition to complying with these Rules and Regulations, nuclear pharmacies shall comply with the Rules and Regulations of the Board and with all applicable Federal and State laws and regulations pertaining to nonradioactive drugs and pharmaceuticals.
(2) The pharmacist in charge at a nuclear pharmacy shall be a licensed nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radiopharmaceuticals shall be under the direct supervision of a licensed nuclear pharmacist. All acts of compounding and dispensing of radiopharmaceuticals shall be performed by the nuclear pharmacist or by a pharmacist or pharmacy intern, under the direct supervision and control of a nuclear pharmacist. A nuclear pharmacist shall be responsible for all operations of the nuclear pharmacy and shall be in personal attendance at all times when the acts of compounding and dispensing are performed and the pharmacy is open for business.
(3) Nuclear pharmacies shall only dispense radiopharmaceuticals which comply with acceptable professional standards of radiopharmaceutical quality assurance.
(4) Radiopharmaceuticals are to be dispensed only upon prescription drug order by a practitioner who is authorized by the Department to possess, use, and administer radioactive materials.
(5) A nuclear pharmacist may transfer to authorized persons radioactive materials not intended for drug use, in accordance with the Department Rules and Regulations for Radioactive Materials. A nuclear pharmacy may also furnish radioactive materials for use to practitioners, for individual patient use in accordance with subsection (4) of this regulation.
(6) The amount of radioactivity dispensed in each individual preparation shall be determined by the nuclear pharmacist through radiometric methods immediately prior to dispensing.
(7) Nuclear pharmacies may redistribute Federal Food and Drug Administration approved radiopharmaceuticals if the pharmacy does not possess the radiopharmaceuticals in any manner or violate the product packaging. Such redistribution may only be made to another nuclear pharmacy or other authorized person or institution.

Rule 480-25-.07 Space Requirements

(1) Nuclear pharmacies shall have adequate space, commensurate with the scope of service required and provided and meet the minimal space requirements of all pharmacies in the State.
(2) Nuclear pharmacies shall have a minimum area, secured from unauthorized personnel, which comprise at least 600 square feet designed for the compounding and dispensing and quality assurance of radiopharmaceuticals.
(3) The foregoing nuclear pharmacy areas shall be exclusive from other pharmacy areas such as those for nonradioactive drugs and office space.
(4) Detailed floor plans shall be submitted to the Board before the permit is granted.

Rule 480-25-.08 Equipment

(1) In addition to other articles and equipment required by the Board for all pharmacies in the State, the nuclear pharmacy shall have:
(a) dose calibrator;
(b) vertical laminar flow hood;
(c) single or multiple channel scintillation analyzer;
(d) microscope and hemocytometer;
(e) adequate glassware, utensils, and gloves;
(f) calculator;
(g) laboratory incubator;
(h) water or oil bath;
(i) aluminum ion test kit; and
(j) adequate apparatus and supplies for performing chromatography.
(2) Nuclear pharmacies shall also have equipment required for the safe handling and storage of radioactive materials, as required by the Department's Rules and Regulations for radioactive materials.
(3) Each nuclear pharmacy shall utilize unit dose transport containers, a/k/a lead pigs,
(a) Unit dose transport containers, a/k/a lead pigs, for radioactive doses shall include:
1. an effective tamper-evident seal;
2. an effective mechanism to avoid radioactive contamination; and
3. an effective system to prevent contamination of the transport container with blood, bodily fluids, or other biohazardous substances.
(b) No nuclear pharmacist or nuclear pharmacy shall re-use a unit dose transport container or lead pig that has been contaminated with blood, bodily fluids, or other hazardous substances.
(c) Any unit dose transport container or lead pig returned to a nuclear pharmacy with the tamper-evident seal broken and containing an exposed unit dose syringe shall be considered contaminated.
(d) Section 3 of this Rule shall not apply to:
1. an individual prescriber preparing radiopharmaceuticals for administration to his or her own patients;
2. transfer of radioactive material, not intended for use as a drug, to other legally authorized persons; and
3. the occasional transfer of bulk radiopharmaceuticals to other authorized entities or persons to meet shortages.
(e) Biohazardous prevention systems containing a barrier that if used properly eliminates or substantially reduces the potential for contamination of the unit dose transport container, or lead pig, would meet the requirements of these regulations. Improper use of such system resulting in ineffective sanitation of the unit dose transport container, or lead pig, would require that such containers be effectively sanitized prior to subsequent use or discarding of that container.

Rule 480-25-.09 Labeling

All radiopharmaceuticals dispensed from a nuclear pharmacy shall be dispensed in appropriate containers and labeled in accordance with the following:

(a) The immediate inner container shall be labeled with:
1. the identifying prescription number; and
2. the name of the radioactive drug.
(b) In addition to any labeling standards established by law the immediate outer container shall be labeled with:
1. the name of the radionuclide;
2. the chemical form;
3. the amount of radioactive material contained, in millicuries (mCi) or microcuries (uCi);
4. if a liquid, the volume expressed in cubiccentimeters (cc) or milliliters (ml);
5. the requested calibration time and date;
6. the words "For Physician Use Only" in the absence of the name of the patient;
7. the name and address of the institution where the radiopharmaceutical will be administered;
8. the expiration date and time of the radioactive drug;
9. auxillary instructions for use, if applicable;
10. name of the procedure for which drug is intended;
11. name of prescribing practitioner;
12. The standard radiation symbol; and
13. The words "Caution - Radioactive Material".

Rule 480-25-.10 Library

In addition to any reference material required by the Board of all pharmacies in the State, a nuclear pharmacy shall maintain a reference library which shall include the following:

(a) Current U.S. Pharmacopoeia/National Formulary with supplements or computer or electronic access to same;
(b) Computer or electronic access to Federal and State Laws and Regulations relating to pharmacy practice in Georgia;
(c) A minimum of three texts dealing with nuclear medicine;
(d) Current Department of Human Resources Rules and Regulations for Radioactive Materials.

Rule 480-25-.11 Records

The nuclear pharmacy shall maintain acquisition and disposition records as required by the Board of all pharmacies in the State.

Rule 480-25-.12 Enforcement

The enforcement and administration of these Rules and Regulations shall be as prescribed in the Georgia Administrative Procedure Act, O.C.G.A., Title 50, Chapter 13, Title 26, Chapter 4, and Title 43, Chapter 1.

Rule 480-25-.13 Severability

In the event that any rule, sentence, clause or phrase or any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof and such remaining rules or portions thereof shall remain of full force and effect, as if such rule or portions thereof so determined, declared or adjudged invalid or unconstitutional were not originally a part hereof. It is the intent of the Board of Pharmacy to establish rules and regulations that are constitutional and enforceable so as to safeguard the health and well-being of the people of the State.