§ 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.