1. (a)

   1. (1) The practice of nuclear pharmacy is hereby recognized as a specialty of pharmacy practice regulated by the Arkansas State Board of Pharmacy.
   2. (2) As such, the following rules are included to address those areas specific or unique to this specialty practice.
   3. (3) This part is intended to supplement the rules and regulations of other state and federal agencies.

2. (b) Definitions. As used in this part:

   1. (1) “Authentication of product history” means identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical or other drug;

   2. (2) “Nuclear pharmacy” means a pharmacy that:

      1. (A) Provides radiopharmaceutical services; and
      2. (B) Shall be licensed by the Arkansas State Board of Pharmacy;
   3. (3) “Practice of nuclear pharmacy” means a patient-oriented service that embodies the scientific knowledge and professional judgment required to improve and promote health through the assurance of the safe and efficacious use of radiopharmaceuticals and other drugs;

   4. (4) “Qualified nuclear pharmacist” means a pharmacist who holds a current license issued by the Arkansas State Board of Pharmacy and who is certified as a nuclear pharmacist by a certification board recognized by the Arkansas State Board of Pharmacy, or satisfies each of the following requirements:

      1. (A) Meets minimal standards of training for status as an authorized user of radioactive material as specified by the Radiation Control Section of the Department of Health and federal Emergency Management of the Nuclear Regulatory Commission;
      2. (B) Has successfully completed a minimum of two hundred (200) contact hours of instruction in nuclear pharmacy and the safe handling and use of radioactive materials from a college of pharmacy approved by the Arkansas State Board of Pharmacy, or other training program recognized by the Arkansas State Board of Pharmacy, with the minimum two hundred (200) hours apportioned as follows:

3. (i) Radiation physics and instrumentation;

   1. (ii) Radiation protection;

      1. (iii) Mathematics pertaining to the use and measurement of radioactivity;

         1. (iv) Radiation biology; and
         2. (v) Radiopharmaceutical chemistry;

      2. (C) Has attained a minimum of five hundred (500) hours of clinical/practical nuclear pharmacy training under the supervision of a qualified nuclear pharmacist in, but not limited to, the following areas:

         1. (i) Procuring radioactive materials;
         2. (ii) Compounding radiopharmaceuticals;
         3. (iii) Performing routine quality control procedures;
         4. (iv) Dispensing radiopharmaceuticals;
         5. (v) Distributing radiopharmaceuticals;
         6. (vi) Implementing basic radiation protection procedures;
         7. (vii) Consulting and educating:
4. (a) (a) The nuclear medicine community;

5. (b) (b) Pharmacists;

   1. (c) (c) Other health professionals; and

      1. (d) (d) The general public; and
      2. (D) Has submitted an affidavit of experience and training to the Arkansas State Board of Pharmacy;
   2. (5) “Quality assurance procedures” means all activities necessary to ensure the quality of the process used to provide radiopharmaceutical services, including authentication of product history and maintenance of all records as required by pertinent regulatory agencies;

   3. (6) “Quality control testing” means the:

      1. (A) Performance of chemical, biological, and physical tests on compounded radiopharmaceuticals; and
      2. (B) Interpretation of the resulting data to determine their suitability for use in humans and animals;

   4. (7)

      1. (A) “Radiopharmaceutical” means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of any such substance but that does not include drugs such as carbon-containing compounds or potassium-containing salts that contain trace quantities of naturally occurring radionuclides.
      2. (B) The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide; and

   5. (8) “Radiopharmaceutical services” means the procurement, storage, handling, compounding, preparation, labeling, quality control testing, dispensing, distribution, transfer, recordkeeping, and disposal of radiochemicals, radiopharmaceuticals, and ancillary drugs, and also includes quality assurance procedures, radiological health activities, and consulting activities associated with the use of radiopharmaceuticals, health physics, and any other activities required for provision of pharmaceutical care.

      1. (c) General requirements for pharmacies providing radiopharmaceutical services.

   6. (1)

      1. (A) A permit to operate a nuclear pharmacy providing radiopharmaceutical services shall only be issued to a facility employing a qualified nuclear pharmacist.
      2. (B) All personnel performing tasks in the preparation and distribution of radiopharmaceuticals and ancillary drugs shall be under the direct supervision of a qualified nuclear pharmacist who shall be in personal attendance when the nuclear pharmacy is open for business.
      3. (C) The pharmacist-in-charge shall be responsible for all operations of the nuclear pharmacy.
   7. (2) The permit to operate a nuclear pharmacy is effective only so long as the nuclear pharmacy also holds a current Department of Health or Nuclear Regulatory Commission license.

   8. (3)

      1. (A) Nuclear pharmacies shall have adequate space and equipment commensurate with the scope of services required and provided.

      2. (B) All pharmacies handling radiopharmaceuticals shall include, but not be limited to, the following areas:

         1. (i) Radiopharmaceutical preparation/dispensing area;
         2. (ii) Radioactive material shipping/receiving area;
         3. (iii) Radioactive material storage area; and
         4. (iv) Radioactive waste decay area.
      3. (C) The application for a permit to operate a nuclear pharmacy shall include detailed floor plans, and no material change may be made without the permission of the Arkansas State Board of Pharmacy.

   9. (4) The nuclear pharmacy professional service area:

      1. (A) Shall be secured from unauthorized personnel; and
      2. (B) Must be totally enclosed and lockable.
   10. (5) Nuclear pharmacies shall maintain records of acquisition, inventory, and disposition of all radioactive materials in accordance with Arkansas State Board of Pharmacy and Department of Health or Nuclear Regulatory Commission statutes and regulations.

   11. (6)

       1. (A) Nuclear pharmacies shall compound and dispense radiopharmaceuticals in accordance with accepted standards of radiopharmaceutical quality assurance.
       2. (B) The Arkansas State Board of Pharmacy recognizes that the preparation of radiopharmaceuticals involves the compounding skills of the nuclear pharmacist to ensure that the final drug product meets accepted professional standards.

   12. (7)

       1. (A) A radiopharmaceutical shall be dispensed only to a licensed practitioner authorized by the Department of Health or Nuclear Regulatory Commission to possess, use, and administer such drug.
       2. (B) A radiopharmaceutical shall be dispensed only upon receipt of a prescription or medication order from such licensed practitioner.
       3. (C) Otherwise, a radiopharmaceutical may be transferred to a person who is authorized to possess and use such drug for nonclinical applications.

   13. (8)

       1. (A) A nuclear pharmacy, upon receipt of an oral prescription order for a radiopharmaceutical, shall immediately have the prescription order reduced to writing or electronically documented.

       2. (B) The written or electronic record shall contain at least the following:

          1. (i) The name of the institution and prescriber or prescriber’s agent;
          2. (ii) The date of dispensing and the calibration time of the radiopharmaceutical;
          3. (iii) The name of the procedure;
          4. (iv) The name of the radiopharmaceutical;
          5. (v) The dose or quantity of the radiopharmaceutical;
          6. (vi) The serial number assigned to the order for the radiopharmaceutical;
          7. (vii) Any specific instructions; and
          8. (viii) The initials of the person who dispensed the order.

       3. (C) Orders for routine diagnostic radiopharmaceuticals that have been previously established by the nuclear pharmacist with the physician may be:

          1. (i) Taken by a pharmacy technician; and
          2. (ii) Entered into the computer.
       4. (D) The nuclear pharmacist shall verify the label with the written order.

       5. (E) However, whenever an order is for a therapeutic or blood-product radiopharmaceutical, the:

          1. (i) Prescription order must be received by a nuclear pharmacist; and
          2. (ii) Patient’s name must be obtained and recorded prior to dispensing.

   14. (9)

       1. (A) The immediate outer container shield of a radiopharmaceutical to be dispensed shall be labeled with:

          1. (i) The name and address of the pharmacy;
          2. (ii) The name of the prescriber;
          3. (iii) The date of dispensing;
          4. (iv) The serial number assigned to the order for the radiopharmaceutical;
          5. (v) The standard radiation symbol;
          6. (vi) The words “Caution Radioactive Material”;
          7. (vii) The name of the procedure;
          8. (viii) The radionuclide and chemical form;
          9. (ix) The amount of radioactivity and the calibration date and time;
          10. (x) If a liquid, the volume;
          11. (xi) If a solid, the number of items or weight;
          12. (xii) If a gas, the number of ampoules or vials;
          13. (xiii) Molybdenum 99 content to USP limits; and
          14. (xiv)
6. (a) (a) The name of the patient or the words “Per Physician’s Order” in the absence of a patient name.

7. (b) (b) The requirements of this subsection shall be met when the name of the patient is readily retrievable from the physician upon demand.

   1. (B) When the prescription is for a therapeutic or blood-product radiopharmaceutical, the patient name shall appear on the label prior to dispensing.

   2. (10) The immediate inner container label of a radiopharmaceutical to be dispensed shall be labeled with:

      1. (A) The standard radiation symbol;
      2. (B) The words “Caution Radioactive Material”;
      3. (C) The identity of the radionuclide;
      4. (D) The chemical form;
      5. (E) The name of the procedure; and
      6. (F) Serial number of the radiopharmaceutical.

   3. (11) When a radiopharmaceutical is dispensed under the authority of an Investigational New Drug Application, the nuclear pharmacy records shall include:

      1. (A) An investigator’s protocol for the preparation of the radiopharmaceutical;
      2. (B) A copy of the Institutional Review Board approval form or letter; and
      3. (C) A letter from the manufacturer (sponsor) indicating that the physician requesting the radiopharmaceutical is a qualified investigator.

   4. (12) Each nuclear pharmacy shall have a current copy of state and applicable federal rules and regulations governing the safe storage, handling, use, dispensing, transport, and disposal of radiopharmaceuticals.

      1. (d) Minimum equipment. The professional area of the pharmacy shall have equipment appropriate for the pharmacy’s specific scope of practice, which may include but is not limited to the following:
   5. (1) Radionuclide dose calibrator;
   6. (2) Refrigerator;
   7. (3) Single-channel or multiple-channel scintillation counter with well-type Nal(TI) or Ge(Li) detector;
   8. (4) Radiochemical fume hood and filter system with suitable air sampling equipment;
   9. (5) At least two (2) GM survey meters, including one (1) high-range meter;
   10. (6) Microscope and hemacytometer;
   11. (7) Supplies to perform quality assurance testing;
   12. (8) Syringe and vial radiation shields;
   13. (9) Lead-shielded drawing station;
   14. (10) Decontamination supplies;
   15. (11) Supplies to perform quality assurance testing;
   16. (12) Lead transport shields for syringes and vials; and
   17. (13) Department of Transportation-approved USA Type A, 7A approved transport containers and other labels and supplies for shipping radioactive materials.

Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “(10/14/98 and 11/1/2007, Amended 5/31/2014)" "USP" means United States Pharmacopeia. "GM" means Geiger-Mueller Meter.