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.