Minnesota Administrative Rules

4731.4413 AUTHORIZED NUCLEAR PHARMACIST TRAINING.

Subpart 1.

Training and education requirements.

Except as provided in part 4731.4414, a licensee must require an authorized nuclear pharmacist to be a pharmacist who:

A.

is certified by a specialty board whose certification process has been recognized by the NRC or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Use Licensee Toolkit web page; or

B.

(1)

has completed 700 hours in a structured educational program consisting of both:

(a)

200 hours of classroom and laboratory training in the following areas:

i.

radiation physics and instrumentation;

ii.

radiation protection;

iii.

mathematics pertaining to the use and measurement of radioactivity;

iv.

chemistry of radioactive material for medical use; and

v.

radiation biology; and

(b)

supervised practical experience in a nuclear pharmacy involving:

i.

shipping, receiving, and performing related radiation surveys;

ii.

using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;

iii.

calculating, assaying, and safely preparing dosages for patients or human research subjects;

iv.

using administrative controls to avoid medical events in the administration of radioactive material; and

v.

using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and

(2)

has obtained written attestation signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in this item and is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist.

Subp. 2.

Certification requirements.

A specialty board under subpart 1, item A, shall require all candidates for certification to:

A.

have graduated from a pharmacy program accredited by the American Council on Pharmaceutical Education (ACPE) or have passed the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination;

B.

hold a current, active license to practice pharmacy;

C.

provide evidence of having acquired at least 4,000 hours of training or experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2,000 hours of the required training and experience; and

D.

pass an examination in nuclear pharmacy, administered by diplomates of the specialty board, that assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research, and development.

Statutory Authority:

MS s 144.1202; 144.1203

History:

29 SR 755; 32 SR 831; 46 SR 791

Published Electronically:

May 26, 2022