(a) An application for a specific license to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution capsules containing 37 kBq (1 [micro]Ci) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each for ``in vivo'' diagnostic use, to persons exempt from licensing under Sec. 30.21 of this chapter or the equivalent regulations of an Agreement State will be approved if:
(1) The applicant satisfies the general requirements specified in Sec. 30.33 of this chapter, provided that the requirements of Sec. 30.33(a) (2) and (3) of this chapter do not apply to an application for a license to transfer byproduct material manufactured, prepared, processed, produced, packaged, or repackaged pursuant to a license issued by an Agreement State;
(2) The applicant meets the requirements under Sec. 32.72(a)(2) of this part;
(3) The applicant provides evidence that each capsule contains 37 kBq (1 [micro]Ci) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process);
(4) The carbon-14 urea is not contained in any food, beverage, cosmetic, drug (except as described in this section) or other commodity designed for ingestion or inhalation by, or topical application to, a human being;
(5) The carbon-14 urea is in the form of a capsule, identified as radioactive, and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and
(6) The applicant submits copies of prototype labels and brochures and the NRC approves these labels and brochures.
(b) Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing drugs. [62 FR 63640, Dec. 2, 1997, as amended at 66 FR 64738, Dec. 14, 2001] Sec. 32.21a Same: Conditions of license.
Each license issued under Sec. 32.21 of this part is subject to the following conditions:
(a) The immediate container of the capsule(s) must bear a durable, legible label which:
(1) Identifies the radioisotope, the physical and chemical form, the quantity of radioactivity of each capsule at a specific date; and
(2) Bears the words ``Radioactive Material.''
(b) In addition to the labeling information required by paragraph (a) of this section, the label affixed to the immediate container, or an accompanying brochure also must:
(1) State that the contents are exempt from NRC or Agreement State licensing requirements; and
(2) Bears the words ``Radioactive Material. For ``In Vivo'' Diagnostic Use Only. This Material Is Not To Be Used for Research Involving Human Subjects and Must Not Be Introduced into Foods, Beverages, Cosmetics, or Other Drugs or Medicinals, or into Products Manufactured for Commercial Distribution. This Material May Be Disposed of in Ordinary Trash.'' [62 FR 63640, Dec. 2, 1997]