A licensee shall maintain a record of dosage determinations required by § 35.63 for 3 years.
The record must contain—
The radiopharmaceutical;
The patient's or human research subject's name, or identification number if one has been assigned;
The prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 MBq (30 µCi);
The date and time of the dosage determination; and
The name of the individual who determined the dosage.
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