Ariz. Admin. Code § R4-23-681 - General Requirements for Limited-service Nuclear Pharmacy

A. To be an authorized nuclear pharmacist, a pharmacist shall:

1. Hold a current pharmacist license issued by the Board; and

2. Be certified as a nuclear pharmacist by:

a. The Board of Pharmaceutical Specialties, or

b. A similar group recognized by the Arizona State Board of Pharmacy; or

3. Satisfy each of the following requirements:

a. Meet minimal standards of training for status as an authorized user of radioactive material, as specified by the Arizona Radiation Regulatory Agency and the United States Nuclear Regulatory Commission;

b. Submit certification of completion of a Board-approved nuclear pharmacy training program or other training program recognized by the Arizona Radiation Regulatory Agency, with 200 hours of didactic training in the following areas:

i. Radiation physics and instrumentation,

ii. Radiation protection,

iii. Mathematics pertaining to the use and measurement of radioactivity,

iv. Radiation biology, and

v. Radiopharmaceutical chemistry;

c. Submit evidence of a minimum of 500 hours of clinical/practical nuclear pharmacy training under the supervision of an authorized nuclear pharmacist in the following areas:

i. Procuring radioactive materials;

ii. Compounding radiopharmaceuticals;

iii. Performing routine quality control procedures;

iv. Dispensing radiopharmaceuticals;

v. Distributing radiopharmaceuticals;

vi. Implementing basic radiation protection procedures; and

vii. Consulting and educating the nuclear medicine community, patients, pharmacists, other health professionals, and the general public; and

d. Submit written certification, signed by a preceptor who is an authorized nuclear pharmacist, that the above training was satisfactorily completed.

B. Radiopharmaceuticals are prescription-only drugs that require specialized techniques in their handling and testing, to obtain optimum results and minimize hazards.

1. A person shall not sell, barter, or otherwise dispose of, or be in possession of any radiopharmaceutical except under the conditions detailed in A.R.S. § 32-1929.

2. A person shall not manufacture, compound, sell, or dispense any radiopharmaceutical unless the person is a pharmacist or a pharmacy intern acting under the direct supervision of a pharmacist in accordance with A.R.S. § 32-1961 and these rules, with the exception of the following, if the following are licensed by the Arizona Radiation Regulatory Agency to use radiopharmaceuticals in compliance with A.R.S. § 30-673;

a. A medical practitioner who administers a radiopharmaceutical to the medical practitioner's patient as provided in A.R.S. § 32-1921(A),

b. A hospital nuclear medicine department, and

c. A medical practitioner's office.

3. The Board shall cooperate with the Arizona Radiation Regulatory Agency and other interested state and federal agencies, in the enforcement of these rules for the protection of the public. This cooperation may include exchange of licensing and other information, joint inspections, and other activities where indicated.

C. In addition to compliance with all the applicable federal and state laws and rules governing drugs, whether radioactive or not, a limited-service nuclear pharmacy permittee shall comply with all laws and rules of the Arizona Radiation Regulatory Agency and the U.S. Nuclear Regulatory Commission, including emergency and safety provisions.

D. A limited-service nuclear pharmacy permittee shall comply with the education, experience, and licensing requirements of the Arizona Radiation Regulatory Agency.

E. A limited-service nuclear pharmacy permittee shall ensure that radiopharmaceuticals are transferred only to a person or firm that holds a current Radioactive Materials License issued by the Arizona Radiation Regulatory Agency.

Notes

Ariz. Admin. Code § R4-23-681

Adopted effective December 3, 1974 (Supp. 75-1). Amended subsections (A), (C) and (D) effective Aug. 12, 1988 (Supp. 88-3). Amended effective July 8, 1997 (Supp. 97-3).