Fla. Admin. Code R. 64E-5.659

Current through Reg. 50, No. 235-239, December 10, 2024

Section 64E-5.659 - Training for an Authorized Nuclear Pharmacist

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized nuclear pharmacist to:

(1) Be certified by a specialty board whose certification process has been recognized by the NRC or an agreement state and who meets the requirements in paragraph 64E-5.659(2)(b), F.A.C., of this section. (The names of board certifications which have been recognized by the NRC or an agreement state will be posted on the NRC's Web page at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.) To have its certification process recognized, a specialty board 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 4000 hours of training/experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience; and

(d) Pass an examination in nuclear pharmacy administered by diplomats of the specialty board, that assess 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; or

(2)

(a) Have completed 700 hours in a structured educational program consisting of both:

1. 200 hours of classroom and laboratory training in the following areas:

a. Radiation physics and instrumentation;

b. Radiation protection;

c. Mathematics pertaining to the use and measurement of radioactivity;

d. Chemistry of radioactive material for medical use; and

e. Radiation biology; and

2. Supervised practical experience in a nuclear pharmacy involving:

a. Shipping, receiving, and performing related radiation surveys;

b. 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;

c. Calculating, assaying, and safely preparing dosages for patients or human research subjects;

d. Using administrative controls to avoid medical events in the administration of radioactive material; and

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

(b) Have obtained written attestation, signed by a preceptor authorized user or a residency program director who represents a consensus of residency program faculties (as long as at least one member of the residency program faculty is an authorized individual in the same category designated by the applicant seeking authorized status) who meets the requirements in paragraphs 64E-5.659(1)(a), 64E-5.659(1)(b) and 64E-5.659(1)(c) or 64E-5.659(2)(a), F.A.C., of this section and have demonstrated the ability to function independently as an authorized nuclear pharmacist to fulfill the radiation safety related duties for a medical use licensee.

Fla. Admin. Code Ann. R. 64E-5.659

Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS.

New 2-11-10.