Fla. Admin. Code Ann. R. 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.
Notes
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.
New 8-25-91, Amended 5-12-93, Formerly 10D-91.707, Amended 8-6-01, 2-11-10.
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