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10 CFR 35.2063

§ 35.2063 Records of dosages of unsealed byproduct material for medical use.

United States · 10 CFR — Energy · Status: effective

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10 CFR 35.2063, § 35.2063 Records of dosages of unsealed byproduct material for medical use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/37024
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(a) A licensee shall maintain a record of dosage determinations required by § 35.63 for 3 years. (b) The record must contain— (1) The radiopharmaceutical; (2) The patient's or human research subject's name, or identification number if one has been assigned; (3) The prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 MBq (30 µCi); (4) The date and time of the dosage determination; and (5) The name of the individual who determined the dosage.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.