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