§ 35.53 - Measurement of dosages of unsealed byproduct material for medical use.

A licensee shall:

(a) Measure the activity of each dosage of a photon-emitting radionuclide prior to medical use.

(b) Measure, by direct measurement or by combination of measurements and calculations, the activity of each dosage of an alpha- or a beta-emitting radionuclide prior to medical use, except for unit dosages obtained from a manufacturer or preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement State requirements;

(c) Retain a record of the measurements required by this section for three years. To satisfy this requirement, the record must contain the:

(1) Generic name, trade name, or abbreviation of the radiopharmaceutical, its lot number, and expiration dates and the radionuclide;

(2) Patient's or human research subject's name, and identification number if one has been assigned;

(3) Prescribed dosage and activity of the dosage at the time of measurement, or a notation that the total activity is less than 1.1 megabecquerels (30 microcuries);

(4) Date and time of the measurement; and

(5) Initials of the individual who made the record.