Current through Register Vol. 50, No. 9, September 20, 2024
A. A licensee
may use the following radiopharmaceuticals, generators, and reagent kits for
imaging and localization studies:
1.
molybdenum-99/technetium-99mm generators for the elution or extraction of
technetium-99m as pertechnetate;
2.
technetium-99m as pertechnetate;
3.
prepared radiopharmaceuticals and reagent kits for the preparation of the
following technetium-99m labeled radiopharmaceuticals:
a. sulfur colloid;
b. pentetate sodium;
c. human serum albumin
microspheres;
d.
polyphosphate;
e. macroaggregated
human serum albumin;
f. etidronate
sodium;
g. stannous
pyrophosphate;
h. human serum
albumin;
i. medronate
sodium;
j. gluceptate
sodium;
k. oxidronate
sodium;
l. disofenin; and
m. succimer;
4. iodine-131 as sodium iodide, iodinated
human serum albumin, macroaggregated iodinated human serum albumin, colloidal
(macroaggregated) iodinated human serum albumin, rose bengal, or sodium
iodohippurate;
5. iodine-125 as
sodium iodide or fibrinogen;
6.
chromium-51 as human serum albumin;
7. gold-198 in colloidal form;
8. gallium-67 as citrate;
9. indium-111 as chloride or DTPA;
10. thallium-201 as chloride;
11. iodine-123 as sodium iodide or
iodohippurate; and
12. any
radioactive material in a diagnostic radiopharmaceutical, except aerosol or
gaseous form, or any generator or reagent kit for preparation and diagnostic
use of a radiopharmaceutical containing radioactive material for which the Food
and Drug Administration has accepted a "Notice of Claimed Investigational
Exemption for a New Drug" (IND) or approved a "New Drug Application"
(NDA).
B. A licensee
using radiopharmaceuticals for clinical procedures shall comply with the
product label or package insert regarding physical form, route of
administration, and dosage range.
C. A licensee shall elute generators in
compliance with LAC 33:XV.732 and prepare radiopharmaceuticals from kits in
accordance with the manufacturer's instructions.
D. Technetium-99m pentetate as an aerosol for
lung function studies is not subject to the restrictions in Subsection B of
this Section.
E. Provided the
conditions of LAC 33:XV.733 are met, a licensee shall use radioactive aerosols
or gases only if specific application is made to and approved by the
department.
F. The
radiopharmaceuticals specified in Subsection A of this Section shall be either:
1. obtained from a manufacturer or preparer,
or a PET radioactive drug producer, licensed in accordance with LAC
33:XV.328.K, equivalent Nuclear Regulatory Commission requirements, or
agreement state requirements; or
2.
prepared by an authorized nuclear pharmacist, a physician who is an authorized
user and who meets the requirements specified in LAC 33:XV.763.C, or an
individual under the supervision of either as specified in LAC
33:XV.709.
G. Except for
quantities that require a written directive in accordance with LAC 33:XV.777.B,
a licensee may use any unsealed radioactive material prepared for medical use
for imaging and localization studies that is:
1. obtained from a manufacturer or preparer
licensed under LAC 33:XV.328.J or equivalent agreement state
requirements;
2. prepared by an
authorized nuclear pharmacist, a physician who is an authorized user and who
meets the requirements specified in LAC 33:XV.763.D, or an individual under the
supervision of either as specified in LAC 33:XV.709;
3. obtained from and prepared by a Nuclear
Regulatory Commission or agreement state licensee, for use in research in
accordance with a Radioactive Drug Research Committee-approved protocol or an
Investigational New Drug (IND) protocol accepted by FDA; or
4. 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.
H. Use of Unsealed Byproduct Material for
Imaging and Localization Studies for Which a Written Directive Is Not Required
1. Except for quantities that require a
written directive under LAC 33:XV.777.B, a licensee may use any unsealed
byproduct material prepared for medical use for imaging and localization
studies that is:
a. obtained from a
manufacturer or preparer, or a PET radioactive drug preparer, licensed under
LAC 33:XV.328.J, equivalent Nuclear Regulatory Commission requirements, or
equivalent agreement state requirements; or
b. prepared by:
i. an authorized nuclear
pharmacist;
ii. a physician who is
an authorized user and who meets the requirements specified in LAC 33:XV.763.D,
or E.1 and D.3.a.ii.(f); or
iii. an
individual under the supervision, as specified in LAC 33:XV.709, of the
authorized nuclear pharmacist in Clause H.1.b.i of this Section or the
physician who is an authorized user in accordance with Clause H.1.b.ii of this
Section;
c. 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
Investigational New Drug (IND) protocol accepted by the FDA; or
d. prepared by the licensee for use in
research in accordance with a Radioactive Drug Research Committee-approved
application or an IND protocol accepted by the FDA.
I. A licensee may use the
authorization under LAC 33:XV.324.D.1, Nuclear Regulatory Commission, or
agreement state requirements to produce positron emission tomography (PET)
radioactive drugs for noncommercial transfer to medical use licensees in its
consortium. This does not relieve the licensee from complying with applicable
FDA, other federal agencies, and agreement state requirements governing
radioactive drugs.
J. Each
licensee authorized under LAC 33:XV.324.D.1 to produce PET radioactive drugs
for noncommercial transfer to medical use licensees in its consortium shall:
1. satisfy the labeling requirements in this
Chapter for each PET radioactive drug transport radiation shield and each
syringe, vial, or other container used to hold a PET radioactive drug intended
for noncommercial distribution to members of its consortium; and
2. possess and use instrumentation to measure
the radioactivity of the PET radioactive drugs intended for noncommercial
distribution to members of its consortium and meet the procedural,
radioactivity measurement, instrument test, instrument check, and instrument
adjustment requirements in this Chapter.
K. A licensee that is a pharmacy authorized
under LAC 33:XV.324.D.1 to produce PET radioactive drugs for noncommercial
transfer to medical use licensees in its consortium shall require that any
individual who prepares PET radioactive drugs shall be:
1. an authorized nuclear
pharmacist as defined in LAC 33:XV.102 and meets the requirements of
LAC 33:XV.763.K; or
2. an
individual under the supervision of an authorized nuclear
pharmacist as specified in LAC 33:XV.709.A or B.
L. A pharmacy that is authorized under LAC
33:XV.324.D.1 to produce PET radioactive drugs for noncommercial transfer to
medical use licensees in its consortium that allows an individual to work as an
authorized nuclear pharmacist, shall meet the requirements of LAC
33:XV.328.J.2.e.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
30:2001 et seq., and
2104(B)1.
