In addition to other labeling
requirements of the Board for non-radioactive drugs described in this Chapter,
the container of a radiopharmaceutical shall also be labeled with:
(1) The standard radiation symbol;
(2) The words "CAUTION - RADIOACTIVE
(3) The radionuclide of
the radiopharmaceutical contained therein;
(4) The chemical form of the
radiopharmaceutical contained therein;
(5) The amount of radioactivity of the
radiopharmaceutical contained therein and the date and time of the calibration
of that radioactivity;
(6) The date
and time of the expiration of the radiopharmaceutical contained
(7) If the
radiopharmaceutical is a liquid, the volume;
(8) If the radiopharmaceutical is a solid,
the number of capsules or weight contained therein;
(9) If the radiopharmaceutical is a gas, the
number of ampules, vials, or syringes contained therein;
(10) The name, address and telephone number
of the nuclear pharmacy dispensing the radiopharmaceutical;
(11) The prescription or lot number;
(12) The name of the
radiopharmaceutical may be dispensed unless a tamper-evident seal is applied
and a label is affixed to the delivery container of each dose bearing the
(1) The standard
(2) The words
"Caution - Radioactive Material."
(3) The radionuclide and chemical
(4) The volume if in liquid
(5) The requested activity
and the calibration date and time.
(6) The prescription number.
Labels for radiolabeled blood components
and therapeutic dosages must always contain the patient's name at the time of
Where the patient's name is not available at the time of
dispensing for diagnostic dosing, a 72-hour exemption is allowed to obtain the
name of the patient. No later than 72 hours after dispensing the
radiopharmaceutical, the patient's name must be associated with the
prescription in a readily retrievable manner and must be retained for a period
of three years.
name and address of the nuclear pharmacy.
(9) The name of the end authorized user, must
also be a prescriber.
(10) The lot
number of the preparation.