RULE 070.00.98-002 - Regulation 38 - Nuclear Pharmacy

RULE 070.00.98-002. Regulation 38 - Nuclear Pharmacy

REGULATION 38

NUCLEAR PHARMACY

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

Definitions:

A. "Authentication of Product History"-Identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical or other drug.

B. "Nuclear Pharmacy"-A pharmacy which provides radiopharmaceutical services, and shall be licensed by the Arkansas State Board of Pharmacy.

C. "Practice of Nuclear Pharmacy"-A patient-oriented service that embodies the scientific knowledge and professional judgement required to improve and promote health through the assurance of the safe and efficacious use of radiopharmaceuticals and other drugs.

D. "Qualified Nuclear Pharmacist"-A pharmacist who holds a current license issued by the 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. Meets minimal standards of training for status as an authorized user of radioactive material, as specified by the Arkansas Department of Health, Division of Radiation Control and Emergency Management of the Nuclear Regulatory Commission.

2. Has successfully completed a minimum of 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 200 hours apportioned as follows:

a. Radiation Physics and Instrumentation

b. Radiation Protection

c. Mathematics pertaining to the use and measurement of radioactivity

d. Radiation Biology

e. Radiopharmaceutical Chemistry

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

a. Procuring radioactive materials

b. Compounding radiopharmaceuticals

c. Performing routine quality control procedures

d. Dispensing radiopharmaceuticals

e. Distributing radiopharmaceuticals

f. Implementing basic radiation protection procedures

g. Consulting and educating the nuclear medicine community, pharmacists, other health professionals, and the general public.

4. Has submitted an affidavit of experience and training to the Board of Pharmacy.

E. "Quality Assurance Procedures"-All activities necessary to assure 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.

F. "Quality Control Testing"-The performance of chemical, biological and physical tests on compounded radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals.

G. "Radiopharmaceutical"-Any drug which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such substance but which does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. The term also includes any biological product, which is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

H. "Radiopharmaceutical Services"-The procurement, storage, handling, compounding, preparation, labeling, quality control testing, dispensing, distribution, transfer, record keeping, 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.

General Requirements for Pharmacies Providing Radiopharmaceutical Services

A. A permit to operate a nuclear pharmacy, providing radiopharmaceutical services, shall only be issued to a facility employing a qualified nuclear pharmacist. 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. The pharmacist-in-charge shall be responsible for all operations of the nuclear pharmacy.

B. The permit to operate a nuclear pharmacy is effective only so long as the nuclear pharmacy also holds a current Arkansas Department of Health or Nuclear Regulatory Commission license.

C. Nuclear pharmacies shall have adequate space and equipment, commensurate with the scope of services required and provided. All pharmacies handling radiopharmaceuticals shall include, but not be limited to, the following areas: radiopharmaceutical preparation/dispensing area; radioactive material shipping/receiving area; radioactive material storage area; and radioactive waste decay area. 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 Board.

D. The nuclear pharmacy professional service area shall be secured from unauthorized personnel and must.be totally enclosed and lockable.

E. Nuclear pharmacies shall maintain records of acquisition, inventory and disposition of all radioactive materials in accordance with Board and Arkansas Department of Health or Nuclear Regulatory Commission statutes and regulations.

F. Nuclear pharmacies shall compound and dispense radiopharmaceuticals in accordance with accepted standards of radiopharmaceutical quality assurance. The Board of Pharmacy recognizes that the preparation of radiopharmaceuticals involves the compounding skills of the nuclear pharmacist to assure that the final drug product meets accepted professional standards.

G. A radiopharmaceutical shall be dispensed only to a licensed practitioner authorized by the Arkansas Department of Health or Nuclear Regulatory Commission to possess, use, and administer such drug. A radiopharmaceutical shall be dispensed only upon receipt of a prescription or medication order from such licensed practitioner. Otherwise, a radiopharmaceutical may be transferred to a person who is authorized to possess and use such drug for non-clinical applications.

H. A nuclear pharmacy, upon receipt of an oral prescription order for a radiopharmaceutical, shall immediately have the prescription order reduced to writing, or recorded in a data processing system, which writing or record shall contain at least the following:

1. the name of the institution and prescriber, or prescriber's agent;

2. the date of dispensing and the calibration time of the radiopharmaceutical;

3. the name of the procedure;

4. the name of the radiopharmaceutical;

5. the dose or quantity of the radiopharmaceutical;

6. the serial number assigned to the order for the radiopharmaceutical;

7. any specific instructions;

8. the initials of the person who dispensed the order.

Orders for routine diagnostic radiopharmaceuticals, which have been previously established by the nuclear pharmacist with the physician, may be taken by a pharmacy technician and entered into the computer. The nuclear pharmacist shall verify the label with the written order. However, whenever an order is for a therapeutic or blood-product radiopharmaceutical, the prescription order must be received by a nuclear pharmacist and the patient's name must be obtained and recorded prior to dispensing.

I. The immediate outer container shield of a radiopharmaceutical to be dispensed shall be labeled with:

1. the name and address of the pharmacy;

2. the name of the prescriber;

3. the date of dispensing;

4. the serial number assigned to the order for the radiopharmaceutical;

5. the standard radiation symbol;

6. the words "Caution Radioactive Material";

7. the name of the procedure;

8. the radionuclide and chemical form;

9. the amount of radioactivity and the calibration date and time;

10. if a liquid, the volume;

11. if a solid, the number of items or weight;

12. if a gas, the number of ampoules or vials;

13. molybdenum 99 content to USP limits; and

14. the name of the patient or the words "Per Physician's Order" in the absence of a patient name. The requirements of this sub-section shall be met when the name of the patient is readily retrievable from the physician upon demand.

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

J. The immediate inner container label of a radiopharmaceutical to be dispensed shall be labeled with:

1. the standard radiation symbol;

2. the words "Caution Radioactive Material";

3. the identity of the radionuclide;

4. the chemical form;

5. the name of the procedure; and

6. serial number of the radiopharmaceutical.

K. When a radiopharmaceutical is dispensed under the authority of an Investigational New Drug Application (IND), the nuclear pharmacy records shall include an investigator's protocol for the preparation of the radiopharmaceutical, a copy of the Institutional Review Board approval form (or letter), and a letter from the manufacturer (sponsor) indicating that the physician requesting the radiopharmaceutical is a qualified investigator.

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

Minimum Equipment:

The professional area of the pharmacy shall have the following equipment:

A. Radionuclide Dose Calibrator;

B. Refrigerator;

C. Single or multiple channel scintillation counter with well-type Nal(TI) or Ge(Li) detector;

D. Radiochemical fume hood and filter system with suitable air sampling equipment;

E. At least two GM survey meters (including one high-range meter);

F. Microscope and hemacytometer;

G. Supplies to perform quality assurance testing;

H. Syringe and vial radiation shields;

I. Lead-shielded drawing station;

J. Decontamination supplies;

K. Supplies to perform quality assurance testing;

L. Lead transport shields for syringes and vials; and

M. D.O.T. approved USA Type A, 7A approved transport containers and other labels and supplies for shipping radioactive materials. (10/14/98)

(3/12/1998)

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