A licensee is allowed to use any unsealed radioactive
material in a radiopharmaceutical for a diagnostic use involving measurements
of uptake, dilution, or excretion for medical use under the following
conditions:
(1) When a written
directive is not required by subsection
64E-5.607(3),
F.A.C., the licensee must satisfy the following:
(a) Radioactive material is obtained from a
manufacturer or pharmacy licensed as specified in subsection
64E-5.210(10),
F.A.C., or in equivalent NRC or agreement state regulations; or
(b) Radioactive material is obtained from and
prepared by a NRC or agreement state licensee for use in research in accordance
with a Radioactive Drug Research Committee-approved protocol, or a Notice of
Claimed Investigational Exemption for a New Drug (IND) protocol accepted by
U.S. Food and Drug Administration (FDA); or
(c) Radioactive material is prepared by the
licensee for use in research in accordance with a Radioactive Drug Research
Committee-approved application, or an IND protocol accepted by FDA;
or
(d) Radioactive material is
prepared by:
1. An authorized nuclear
pharmacist;
2. Except for sodium
iodide I-131 in quantities greater than 30 microcuries (1.11 MBq), a physician
who is an authorized user and meets the training requirements specified in Rule
64E-5.650
or
64E-5.660,
and sub-subparagraph
64E-5.650(3)(a)
2.g., F.A.C.; or
(e) The
authorized user must satisfy the training and experience specified in Rule
64E-5.649
or
64E-5.657,
F.A.C.
(2) When a
written directive is required by subsection
64E-5.607(3),
F.A.C., the licensee must satisfy the following:
(a) Radioactive material is obtained from a
manufacturer or pharmacy licensed as specified in subsection
64E-5.210(10),
F.A.C., or in equivalent NRC or agreement state regulations; or
(b) Radioactive material is obtained from and
prepared by an NRC or agreement state licensee for use in research in
accordance with a Radioactive Drug Research Committee-approved protocol or an
IND protocol accepted by FDA; or
(c) Radioactive material is prepared by the
licensee for use in research in accordance with a Radioactive Drug Research
Committee-approved application, or an IND protocol accepted by FDA;
or
(d) Radioactive material is
prepared by:
1. An authorized nuclear
pharmacist;
2. A physician who is
an authorized user and meets the training requirements specified in Rule
64E-5.650
or
64E-5.660,
F.A.C.; or
Notes
Fla. Admin. Code Ann. R.
64E-5.626
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 8-25-91, Formerly
10D-91.733, Amended 8-6-01, 2-11-10,
12-26-13.
