§ 32.21a - Same: Conditions of license.

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Each license issued under § 32.21 of this part is subject to the following conditions:

The immediate container of the capsule(s) must bear a durable, legible label which:

Identifies the radioisotope, the physical and chemical form, the quantity of radioactivity of each capsule at a specific date; and

Bears the words “Radioactive Material.”

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:

State that the contents are exempt from NRC or Agreement State licensing requirements; and

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.”

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§ 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.

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§ 32.22 - Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, process, produce, or initially transfer.