# 10 CFR § 32.18: Manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-10-32.18

## Section

- **Citation:** 10 CFR § 32.18
- **Heading:** Manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for 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

An application for a specific license to manufacture, process, produce, package, repackage, or transfer quantities of byproduct material for commercial distribution to persons exempt pursuant to § 30.18 of this chapter or the equivalent regulations of an Agreement State will be approved if:
(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter: Provided, however, 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, processed, produced, packaged, or repackaged pursuant to a license issued by an Agreement State;
(b) The byproduct material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;
(c) The byproduct material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, 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
(d) The applicant submits copies of prototype labels and brochures and the Commission approves such labels and brochures.
[35 FR 6428, Apr. 22, 1970, as amended at 43 FR 6922, Feb. 17, 1978]

## 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)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-10-32.18. Check the current official text before relying on it. Not legal advice.