N.M. Admin. Code § 16.19.18.10

Current through Register Vol. 35, No. 20, October 22, 2024

Section 16.19.18.10 - REQUIREMENTS FOR PROVISION OF RADIOPHARMACEUTICAL SERVICES

A. Medications shall be dispensed from a nuclear pharmacy in accordance with the requirements contained in 16.19.6 NMAC, except as provided for in this section.

B. A radiopharmaceutical shall be dispensed only to a licensed practitioner authorized by the Nuclear Regulatory Commission or an equivalent agreement state agency to possess, use and administer such drug. A radiopharmaceutical shall be dispensed only upon receipt of a prescription from such licensed practitioner. Otherwise, a radiopharmaceutical may be transferred to a person who is authorized to possess and use such drug for non-clinical applications.

C. In addition to other labeling requirements of the Board for nonradioactive drugs, the outer container shield of a radiopharmaceutical to be dispensed or transferred shall also be labeled with the following information:

(1) the standard radiation symbol;

(2) the words "Caution -- Radioactive Materials";

(3) the radionuclide;

(4) the chemical form;

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

(6) the expiration date and time;

(7) if a liquid, the volume;

(8) if a solid, the number of dosage units or weight;

(9) if a gas, the number of ampules or vials;

(10) the name of the patient (required only for radiolabeled blood components and all radiopharmaceuticals intended for therapeutic use).

D. The inner container (e.g., syringe, vial, etc.) used to dispense or transfer a radiopharmaceutical shall be labeled with the following information:

(1) the standard radiation symbol;

(2) the prescription or lot number;

(3) the name of the radiopharmaceutical;

(4) the name of the patient (required only for radiolabeled blood components and all radiopharmaceuticals intended for therapeutic use).

E. A licensed nuclear pharmacy, upon receiving a verbal prescription for a radiopharmaceutical, shall immediately have the prescription reduced to writing or recorded in a data processing system. The writing or record shall contain at least the following information, in addition to other requirements of the Board:

(1) the name of the institution represented;

(2) the date of the prescription;

(3) the name and dose of the radiopharmaceutical;

(4) the name of the procedure;

(5) the requested date/time of calibration (tentative date/time of administration) of the prescribed radiopharmaceutical;

(6) the name of the patient (required for radiolabeled blood components and all radiopharmaceuticals intended for therapeutic use.);

(7) any specific instructions, if required.

F. Whenever a radiopharmaceutical is dispensed under the authority of an Investigational New Drug Application (INDA), the nuclear pharmacy records shall include an investigator's protocol for the preparation of the radiopharmaceutical, a copy of the Institutional Review Board approval form (or letter), and a letter from the manufacturer (sponsor) indicating that the physician requesting the radiopharmaceutical is a qualified investigator.

N.M. Admin. Code § 16.19.18.10

05-20-94; 16.19.18.10 NMAC - Rn, 16 NMAC 19.18.10, 03-30-02, Amended by New Mexico Register, Volume XXX, Issue 23, December 17, 2019, eff. 12/17/2019