Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon14 Urea (62 FR 63634) RATS ID 19977 Effective 1/2/98 Change Title State Compatibility Summary of Change to CFR Difference Significant If Difference, Why or Why to NRC Section Category Yes/No Yes/No Not Was a Comment Section Generated 30.21 Radioactive B New Section: drug: (a) Except as provided in Capsules paragraphs (b) and (c) of this containing section, any person is exempt carbon14 from the requirements for a urea for ``in license set forth in Section 81 vivo'' of the Act and from the diagnostic regulations in this part and part use for 35 of this chapter provided that humans. such person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1 mCi) carbon14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for ``in vivo'' diagnostic use for humans. (b) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to part 35 of this chapter. (c) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license
Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon14 Urea (62 FR 63634) RATS ID 19977 Effective 1/2/98 Change to NRC Section Title State Section Compatibility Category Summary of Change to CFR Difference Yes/No Significant Yes/No If Difference, Why or Why Not Was a Comment Generated 30.21 Radioactive drug: Capsules containing carbon14 urea for ``in vivo'' diagnostic use for humans. B New Section: (a) Except as provided in paragraphs (b) and (c) of this section, any person is exempt from the requirements for a license set forth in Section 81 of the Act and from the regulations in this part and part 35 of this chapter provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1 mCi) carbon14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for ``in vivo'' diagnostic use for humans. (b) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to part 35 of this chapter. (c) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license
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