Title 10

SECTION 32.18

32.18 Manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license.

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

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]

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