---
kind: "section"
citation: "10 C.F.R. § 32.21"
title: "10"
number: "32.21"
heading: "Radioactive drug: Manufacture, preparation, or transfer for commercial distribution of capsules containing carbon-14 urea each for “in vivo” diagnostic use for humans to persons exempt from licensing; Requirements for a license."
url: "https://uscodex.org/cfr/10/32.21"
---

# §32.21. Radioactive drug: Manufacture, preparation, or transfer for commercial distribution of capsules containing carbon-14 urea each for “in vivo” diagnostic use for humans to persons exempt from licensing; Requirements for a license.

- (a) An application for a specific license to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution capsules containing 37 kBq (1 µCi) 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 [§ 30.21](/cfr/10/30.21.md) of this chapter or the equivalent regulations of an Agreement State will be approved if:
  - (1) The applicant satisfies the general requirements specified in [§ 30.33](/cfr/10/30.33.md) of this chapter, provided that the requirements of [§ 30.33(a)](/cfr/10/30.33.md?p=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 [§ 32.72(a)(2)](/cfr/10/32.72.md?p=a-2) of this part;
  - (3) The applicant provides evidence that each capsule contains 37 kBq (1 µCi) 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.

## Notes

### Amendments

[62 FR 63640, Dec. 2, 1997, as amended at 66 FR 64738, Dec. 14, 2001]

### Authority

Authority: Atomic Energy Act of 1954, secs. 81, 161, 170H, 181, 182, 183, 223, 234, 274 (42 U.S.C. 2111, 2201, 2210h, 2231, 2232, 2233, 2273, 2282, 2021); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 44 U.S.C. 3504 note.

### Amendments

[62 FR 63640, Dec. 2, 1997, as amended at 66 FR 64738, Dec. 14, 2001]