What 10 CFR Part 35 - NRC Medical Use of Byproduct Material requires
10 CFR Part 35 governs the medical use of byproduct material (radioactive material) administered by the U.S. Nuclear Regulatory Commission and Agreement States. A person must hold a specific license before receiving, possessing, using or administering byproduct material for medical use, and must apply for and maintain that license and any amendments. The licensee must establish a radiation protection program with assigned authority and responsibilities, including a Radiation Safety Officer, and must ensure the required training of the Radiation Safety Officer, authorized users and authorized medical physicists. A written directive must be prepared before administering byproduct material in the cases that require one, and the prescribed procedures for such administrations must be followed. The licensee must supervise individuals working under an authorized user, maintain the required records, make the required notifications and reports including medical events, and comply with the provisions protecting human research subjects and with applicable FDA, other Federal and State requirements.
Pillar: Medical & Healthcare · Authority: US Nuclear Regulatory Commission (NRC) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-10/chapter-I/part-35
SHA-256 integrity: 23fc8f8e9ac07889202d0af80ba19dff46b7e9722a759aaa5878371a43dcba62
Primary Citations — 8 traced to source
- Atomic Energy Act of 1954, 42 U.S.C. 2011 et seq., and Energy Reorganization Act of 1974 - statutory authority
- 10 CFR Part 35, § 35.11 and § 35.12 - license required and application for license, amendment or renewal
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