Current through Register Vol. 50, No. 9, September 20, 2024
A. A licensee may
use the following prepared radiopharmaceuticals for diagnostic studies
involving the measurement of uptake, dilution, or excretion:
1. iodine-131 as sodium iodide, iodinated
human serum albumin (IHSA), labeled rose bengal, or sodium
iodohippurate;
2. iodine-125 as
sodium iodide or iodinated human serum albumin (IHSA);
3. cobalt-57 as labeled
cyanocobalamin;
4. cobalt-58 as
labeled cyanocobalamin;
5.
chromium-51 as sodium chromate or labeled human serum albumin;
6. iron-59 as citrate; and
7. any radioactive material in a
radiopharmaceutical for a diagnostic use involving measurements of uptake,
dilution, or excretion for which the Food and Drug Administration (FDA) has
accepted a "Notice of Claimed Investigational Exemption for a New Drug" (IND)
or approved a "New Drug Application" (NDA).
B. A licensee using a radiopharmaceutical
specified in Subsection A of this Section for a clinical procedure other than
one specified in the product label or package insert instructions shall comply
with the product label or package insert instructions regarding physical form,
route of administration, and dosage range.
C. The radiopharmaceuticals specified in
Subsection A of this Section shall be:
1.
obtained from a manufacturer or preparer, or a PET radioactive drug producer,
licensed in accordance with LAC 33:XV.328.J, equivalent Nuclear Regulatory
Commission requirements, or 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 E.1 and D.3.a.ii.(f), or, before
October 24, 2005, 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.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
30:2001 et seq. and
2104.B.(1).
