§ 35.2063. Records of dosages of unsealed byproduct material for medical use.
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/us/cfr/t10/s§ 35.2063·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.