Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35.

CFR · 2024-01-01 · US · Title 10

(a) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing byproduct material for use by persons authorized pursuant to part 35 of this chapter will be approved if: (1) The applicant satisfies the general requirements specified in 10 CFR 30.33; (2) The applicant submits evidence that the applicant is at least one of the following: (i) Registered with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, (ii) Registered or licensed with a state agency as a drug manufacturer; (iii) Licensed as a pharmacy by a State Board of Pharmacy; (iv) Operating as a nuclear pharmacy within a Federal medical institution; or (v) A Positron Emission Tomography (PET) drug production facility registered with a State agency. (3) The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and (4) The applicant commits to the following labeling requirements: (i) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. Th

official document · source cfr-2024 · id 10:§ 32.72