N.M. Admin. Code § 16.19.30.8

Current through Register Vol. 35, No. 23, December 10, 2024

Section 16.19.30.8 - PERSONNEL

A. Pharmacist-in-charge. The pharmacist-in-charge shall have the responsibility for, at a minimum, the following concerning non-sterile compounding:

(1) determining that all personnel involved in non-sterile compounding possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken or supervised;

(2) determining that all personnel involved in non-sterile compounding obtain continuing education appropriate for the type of compounding done by the personnel;

(3) assuring that the equipment used in compounding is properly maintained;

(4) maintaining an appropriate environment in the area where non-sterile compounding occurs;

(5) assuring that effective quality control procedures are developed and followed; and

(6) assuring availability of current reference source for the type of compounding conducted.

B. Pharmacists. Special requirements for non-sterile compounding;

(1) all pharmacists engaged in compounding shall:

(a) possess the education, training and proficiency necessary to properly and safely perform compounding duties undertaken or supervised and

(b) obtain continuing education for the type of compounding done by the pharmacist.

(2) A pharmacist shall inspect and approve all components, drug product containers, closures, labeling and any other material involved in the compounding process.

(3) A pharmacist shall review all compounding records for accuracy and conduct in-process and final checks to assure that errors have not occurred in the compounding process.

(4) A pharmacist is responsible for the proper maintenance, cleanliness and use of all equipment used in the compounding process.

C. Pharmacy technicians. All technicians engaged in compounding shall:

(1) possess the education, training and proficiency necessary to properly and safely perform compounding duties undertaken;

(2) obtain continuing education for the type of compounding done by the pharmacy technician; and

(3) perform compounding duties under the direct supervision of and responsible to a pharmacist.

D. Training. All personnel involved in non-sterile compounding shall be trained and must participate in continuing relevant training programs.

N.M. Admin. Code § 16.19.30.8

16.19.30.8 NMAC - N, 09-15-06, Amended by New Mexico Register, Volume XXXII, Issue 17, September 14, 2021, eff. 9/14/2021