La. Admin. Code tit. 33 § XV-731

Current through Register Vol. 50, No. 11, November 20, 2024

Section XV-731 - Use of Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies

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.

La. Admin. Code tit. 33, § XV-731

Promulgated by the Department of Environmental Quality, Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), amended LR 24:2104 (November 1998), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:2589 (November 2000), LR 27:1238 (August 2001), LR 30:1178 (June 2004), amended by the Office of the Secretary, Legal Affairs Division, LR 34:982 (June 2008), amended by the Office of the Secretary, Legal Division, LR 40:291 (February 2014), Amended by LR 411280 (7/1/2015).

AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq., and 2104(B)1.