NAC459.302. Specific licenses: Manufacture and distribution of generators or reagent kits for preparing radioactive drugs.

An application for a specific license to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radioactive drugs by persons authorized under a license issued by the Nuclear Regulatory Commission or any other agreement state will be approved if:

     1. The applicant satisfies the general requirements specified in NAC 459.238;

     2. The applicant submits evidence that:

     (a) The generator or reagent kit is to be manufactured, labeled and packaged in accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application approved by the Food and Drug Administration, a biologic product license issued by the Administration, or a Notice of Claimed Investigational Exemption for a New Drug that has been accepted by the Administration; or

     (b) The manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug and Cosmetic Act and Public Health Service Act;

     3. The applicant submits information on the radionuclide, chemical and physical form, packaging, including maximum activity per package, and shielding provided by the packaging of the radioactive material contained in the generator or reagent kit;

     4. The label affixed to the generator or reagent kit contains information on the radionuclide, quantity and date of assay; and

     5. The label affixed to the generator or reagent kit, or the leaflet or brochure which accompanies the generator or reagent kit, contains:

     (a) Adequate information from a radiation safety standpoint on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit; and

     (b) A statement that this generator or reagent kit is approved for use by persons licensed by the Nuclear Regulatory Commission or an agreement state. The labels, leaflets or brochures required by this paragraph are in addition to the labeling required by the Administration, and they may be separate from or, with the approval of the Administration, may be combined with the labeling required by the Administration.

     [Bd. of Health, Radiation Control Reg. §§ 3.5.5.11-3.5.5.11.1.5.2, eff. 2-28-80]—(NAC A 9-6-88; 11-1-95; R085-06, 11-13-2006; R149-07, 1-30-2008)