Conn. Agencies Regs. § 20-576-62

Current through December 27, 2024

Section 20-576-62 - Records and labeling

(a) Upon receiving an order for a radiopharmaceutical, a nuclear pharmacy shall immediately reduce the prescription to writing or record the order in an automated data processing system. The written or electronic record shall contain at least the following:

(1) the name of the institution and prescribing practitioner or the practitioner's agent;

(2) the requested date of dispensing and the calibration time of the radiopharmaceutical;

(3) the name of the procedure;

(4) the name of the radiopharmaceutical;

(5) the dose or quantity of the radiopharmaceutical;

(6) the prescription number assigned to the order;

(7) any specific instructions;

(8) the identity of the person who dispenses the prescription or medication order; and

(9) the patient's name if the prescription or medication order is for a therapeutic or blood-product radiopharmaceutical.

(b) The outer container (consisting of the radiation shielding) containing a radio-pharmaceutical to be dispensed shall be labeled with:

(1) the name and address of the pharmacy;

(2) the name of the prescribing practitioner;

(3) the date of dispensing;

(4) the prescription number;

(5) if radioactive, the standard radiation symbol and the words "Caution: Radioactive Material";

(6) the name of the procedure;

(7) the radionuclide and chemical form;

(8) the amount of radioactivity and the calibration date and time;

(9) the expiration time;

(10) the appropriate dosage units;

(11) if a solid, the number of items or weight;

(12) if a gas, the number of ampoules or vials; and

(13) the patient name when intended for individual therapeutic use, or the words "For Physician Use" or "For Physician Use Only."

(c) The immediate inner container (containing the dose) of a radiopharmaceutical to be dispensed shall be labeled with:

(1) the name of the radiopharmaceutical;

(2) the serial number assigned to the prescription or medication order of the radiopharmaceutical;

(3) the standard radiation symbol; and

(4) the words "Caution: Radioactive Material."

Conn. Agencies Regs. § 20-576-62

Adopted effective November 30, 2006