N.M. Admin. Code § 16.19.18.9

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

Section 16.19.18.9 - REQUIREMENTS FOR OPERATION OF A NUCLEAR PHARMACY

A. A nuclear pharmacy shall meet the requirements of 16.19.6 NMAC of the Board, except as provided for in this section.

B. A qualified nuclear pharmacist shall be in personal attendance when the nuclear pharmacy is open for business.

C. A nuclear pharmacy shall meet minimum space requirements established for all pharmacies in the state (see 16.19.6.10 NMAC, with the exception that the space may be interrupted).

D. The nuclear pharmacy shall maintain records of procurement, inventory and disposition of all radioactive drugs and other radioactive materials.

E. A nuclear pharmacy shall have a current copy (paper or electronic) of city, state, and federal regulations governing the safe storage, handling, use, dispensing, transport and disposal of radiopharmaceuticals.

F. The following minimum equipment requirements, as appropriate for the scope of nuclear pharmacy services provided, are in addition to those contained in 16.19.6.11 NMAC;

(1) Radionuclide Dose Calibrator;

(2) Refrigerator;

(3) Single or multiple channel scintillation counter with well-type NaI(T1) or Ge(Li) detector;

(4) Radiochemical fume hood and filter system;

(5) Area rate meter;

(6) At least two (2) GM survey meters;

(7) Microscope and hemacytometer;

(8) Laminar air flow hood and/or biologic safety cabinet;

(9) Syringe and vial radiation shields;

(10) Lead-shielded drawing station;

(11) Decontamination supplies;

(12) Other equipment as needed for radiation safety to workers and the public; or for performance of quality control/quality assurance specified by standards of practice for the individual setting and the products involved.

G. A nuclear pharmacy shall operate in conformance with the United States Pharmacopeia General Chapters: <825> Radiopharmaceuticals - Preparation, Compounding, Dispensing, and Repackaging, and all other applicable chapters numbered 1000 or less.

N.M. Admin. Code § 16.19.18.9

05-20-94; 16.19.18.9 NMAC - Rn, 16 NMAC 19.18.9, 03-30-02, Amended by New Mexico Register, Volume XXX, Issue 23, December 17, 2019, eff. 12/17/2019