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.