1. (a) An application for a specific license to manufacture and distribute generators or reagent kits containing byproduct material or reagent kits not containing byproduct material used for preparation of radiopharmaceuticals by persons licensed pursuant to He-P 4035 shall be approved if:

   1. (1) The applicant satisfies the general requirements specified in He‑P 4030.09;

   2. (2) The applicant submits evidence that:

      1. 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 (NDA) approved by the Food and Drug Administration (FDA), a biological product license issued by FDA, or a “Notice of Claimed Investigational Exemption for a New Drug” (IND) that has been accepted by the FDA; or
      2. b. The manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act;

   3. (3) The applicant submits the following information:

      1. a. The radionuclide;
      2. b. The chemical and physical form;
      3. c. The packaging including maximum activity per package; and
      4. d. The shielding provided by the packaging of the byproduct material contained in the generator or reagent kit;
   4. (4) The label affixed to the generator or reagent kit contains information on the radionuclide, quantity, and date of assay; and

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

      1. a. Radiation safety information on the procedures to be followed and the equipment and shielding to be used in eluding the generator or processing byproduct material with the reagent kit; and
      2. b. A statement that this generator or reagent kit is approved for use by persons licensed by the DHHS/RHS pursuant to He‑P 4035 or under equivalent licenses of the Nuclear Regulatory Commission, an agreement state or licensing state.
2. (b) The labels, leaflets, or brochures required by He‑P 4032.06(a)(4) and (a)(5) are in addition to the labeling required by FDA and they may be separate from, or if approved by the FDA may be combined with, the labeling required by FDA.

Source. (See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07 New. #8959, eff 8-7-07; ss by #10983, eff 11-24-15