A licensee is allowed to use any unsealed radioactive
material in a radiopharmaceutical that requires a written directive as
described in subsection
64E-5.607(3),
F.A.C., and for a therapeutic medical use provided the following is met:
(1) For any unsealed radiopharmaceutical
including parenteral use listed in subsection 64E-5.630(4), F.A.C., and sodium
iodide I-131 use listed in subsections 64E-5.630(2) and (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
(e) The
authorized user must satisfy the applicable training and experience specified
in Rule
64E-5.660
or
64E-5.657,
F.A.C.
(2) For oral
administration of sodium iodide I-131 in quantities less than or equal to 33
millicuries (1.22 gigabecquerels) 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 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
(e) The
authorized user must satisfy the training and experience specified in Rule
64E-5.661
or
64E-5.657,
F.A.C.
(3) For oral
administration of sodium iodide I-131 in quantities greater than 33 millicuries
(1.22 gigabecquerels) 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
(e) The
authorized user must satisfy the training and experience specified in Rule
64E-5.662
or
64E-5.657,
F.A.C.
(4) For
parenteral use of radioactive materials 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
(e) The
authorized user must satisfy the training and experience specified in Rule
64E-5.663
or
64E-5.657,
F.A.C.
Notes
Fla. Admin. Code Ann. R.
64E-5.630
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, Amended
5-12-93, Formerly 10D-91.739, Amended 8-6-01, 2-11-10,
12-26-13.