A licensee is allowed to use any radioactive material in a
diagnostic radiopharmaceutical, or any generator, or reagent kit, for
preparation and diagnostic use of a radiopharmaceutical containing radioactive
material 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) Obtained from a manufacturer or pharmacy
licensed as specified in subsection
64E-5.210(10),
F.A.C., or in equivalent U.S. Nuclear Regulatory Commission 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 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. 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
Rules
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-5.650 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
(3) For oral
administration of sodium iodide I-131 in quantities less than or equal to 33
millicuries (1.22 gigabecquerels) and 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 a 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.,
(e) The authorized
user must satisfy the applicable training and experience specified in Rules
64E-5.657,
64E-5.660 or
64E-5.661,
F.A.C.
(4) A licensee
shall use radioactive aerosols or gases only if application on DH Form 1322
12/09 is made to and approved by the department and the requirements of Rule
64E-5.629, F.A.C., are
met.
Notes
Fla. Admin.
Code Ann. R. 64E-5.627
Rulemaking Authority 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, Amended
5-12-93, Formerly 10D-91.735, Amended 8-6-01, 2-11-10,
12-26-13.
New 8-25-91, Amended 5-12-93, Formerly 10D-91.735, Amended
8-6-01, 2-11-10, 12-26-13.