64E-5.601. License Required

(1) Radioactive materials shall not be manufactured, produced, acquired, received, possessed, prepared, used, or transferred for medical use except as provided in a specific license.

(2) Any licensee who is licensed for one or more of the medical uses in Rule 64E-5.626, 64E-5.627, 64E-5.630, or 64E-5.632, F.A.C., also is authorized to use radioactive material under a general license in subsection 64E-5.206(8), F.A.C., for specified in vitro uses without filing the certificate required by paragraph 64E-5.206(8)(b), F.A.C., but is subject to the other provisions of subsection 64E-5.206(8), F.A.C.

(3)(a) Unless prohibited by license condition, a physician, in training may receive, possess, acquire, prepare, use, or transfer radioactive materials as provided in these regulations under the supervision of an authorized user as provided in subsections 64E-5.608(1) and 64E-5.608(3), F.A.C.

(b) Current and active certified radiologic technologists as authorized in Part IV, Chapter 468, F.S., may receive, possess, acquire, prepare, use, or transfer radioactive materials as provided in these regulations under the supervision of an authorized user as provided in paragraph 64E-5.607(3)(e) and subsection 64E-5.608(3), F.A.C.

(c) Unless prohibited by license condition, a medical physicist in training may receive, acquire, prepare, use, possess, or transfer radioactive materials as provided in these regulations under the supervision of an authorized medical physicist as provided in subsections 64E-5.608(2) and 64E-5.608(3), F.A.C.

(4) Unless authorized by the department, no individual shall manufacture, produce, acquire, receive, possess, prepare, use, or transfer radioactive materials for medical use unless:

(a) That individual is listed on the licensee’s specific license as an authorized user, authorized medical physicist, or an authorized nuclear pharmacist;

(b) Authorized by Rule 64E-5.609, F.A.C.;

(c) Authorized by subsection 64E-5.601(2), F.A.C., with approval of the radiation safety committee at medical institutions or by management for licensees that are not medical institutions; or

(d) That individual is in training, authorized by subsection 64E-5.601(3), F.A.C., and subpart I of Part VI.

(5) Provisions for the protection of human research subjects are:

(a) A licensee may conduct research involving human research subjects only if it uses the radioactive materials specified on its license for the uses authorized on its license.

(b) If the research is conducted, funded, supported, or regulated by another federal agency that has implemented the “Federal Policy for the Protection of Human Subjects (Federal Policy)”, as described in 45 CFR Part 46, dated 11/9/2009, which is herein incorporated by reference, and may be accessed at http://www.doh.state.fl.us/environment/radiation/, or requested in writing from the Department of Health, Bureau of Radiation Control, Bin #C21, 4052 Bald Cypress Way, Tallahassee, FL 32399-1741, the licensee shall, before conducting research:

1. Obtain review and approval of the research from an “Institutional Review Board (IRB),” as defined and described in the Federal Policy; and

2. Obtain “informed consent,” as defined and described in the Federal Policy, from the human research subject.

(c) If the research will not be conducted, funded, supported, or regulated by another federal agency that has implemented the Federal Policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its radioactive materials medical use license. The amendment request must include a written commitment that the licensee will, before conducting research:

1. Obtain review and approval of the research from an IRB as defined and described in the Federal Policy; and

2. Obtain “informed consent”, as defined and described in the Federal Policy, from the human research subject.

(d) Nothing in this section relieves licensees from complying with the other requirements in this part.

(6) Authorized nuclear pharmacists must be actively licensed as a nuclear pharmacist by the Department of Health, Division of Medical Quality Assurance as specified in Rule 64B16-28.903, F.A.C., and authorized medical physicists must have an active medical physicist license, in the area they are practicing, issued by the Department of Health, Division of Medical Quality Assurance.

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, 483.901 FS. History–New 8-25-91, Amended 5-12-93, Formerly 10D-91.707, Amended 8-6-01, 2-11-10.