# 10 CFR § 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

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-10-32.21

## Section

- **Citation:** 10 CFR § 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
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 10—Energy > CHAPTER I—NUCLEAR REGULATORY COMMISSION > PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL > Subpart A—Exempt Concentrations and Items

## Text

(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 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 of this chapter, provided that the requirements of § 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 § 32.72(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.
[62 FR 63640, Dec. 2, 1997, as amended at 66 FR 64738, Dec. 14, 2001]

## Nearby sections

- [10 CFR § 32.11 § 32.11 Introduction of byproduct material in exempt concentrations into products or materials, and transfer of ownership or possession: Requirements for license.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.11.md)
- [10 CFR § 32.12 § 32.12 Same: Records and material transfer reports.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.12.md)
- [10 CFR § 32.13 § 32.13 Same: Prohibition of introduction.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.13.md)
- [10 CFR § 32.14 § 32.14 Certain items containing byproduct material; requirements for license to apply or initially transfer.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.14.md)
- [10 CFR § 32.15 § 32.15 Same: Quality assurance, prohibition of transfer, and labeling.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.15.md)
- [10 CFR § 32.16 § 32.16 Certain items containing byproduct material: Records and reports of transfer.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.16.md)
- [10 CFR § 32.18 § 32.18 Manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.18.md)
- [10 CFR § 32.19 § 32.19 Same: Conditions of licenses.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.19.md)
- [10 CFR § 32.20 § 32.20 Same: Records and material transfer reports.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.20.md)
- [10 CFR § 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.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.21.md)
- [10 CFR § 32.21a § 32.21a Same: Conditions of license.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.21a.md)
- [10 CFR § 32.22 § 32.22 Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, process, produce, or initially transfer.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.22.md)
- [10 CFR § 32.23 § 32.23 Same: Safety criteria.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.23.md)
- [10 CFR § 32.24 § 32.24 Same: Table of organ doses.](https://www.frixlaw.com/law-library/statutes/ecfr-10-32.24.md)

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-10-32.21. Check the current official text before relying on it. Not legal advice.