N.M. Admin. Code § 16.19.36.10

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

Section 16.19.36.10 - EQUIPMENT

Each facility compounding sterile preparations shall have sufficient equipment for the safe and appropriate storage, compounding, packaging, labeling, dispensing and preparation of compounded sterile preparations drugs and parenteral preparations appropriate to the scope of pharmaceutical services provided and as specified in USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations).

A. All equipment shall be cleaned, maintained, monitored, calibrated, tested, and certified as appropriate to insure proper function and operation with documentation retained for three years.

B. Primary and secondary engineering controls used to provide an aseptic environment shall be tested in the course of normal operation by an independent qualified contractor and certified as meeting the requirements presented in USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) at least every six months and when relocated, certification records will be maintained for three years.

C. A library of current references (hard copy or electronic) shall be available including:

(1) All USP/NF chapters applicable to the facility's sterile compounding practice;

(2) New Mexico pharmacy laws, rules and regulations;

(3) specialty references (stability and incompatibility references, sterilization and preservation references, pediatric dosing, and drug monograph references) as appropriate for the scope of services provided.

D. Automated compounding devices shall:

(1) have accuracy verified on a routine basis at least every 30 days per manufacturer's specifications;

(2) be observed every 30 days by the operator during the mixing process to ensure the device is working properly;

(3) have data entry verified by a pharmacist prior to compounding or have accurate final documentation of compounded preparations to allow for verification of ingredients by a pharmacist prior to dispensing; and

(4) have accuracy of delivery of the end product verified according to written policies and procedures.

N.M. Admin. Code § 16.19.36.10

16.19.36.10 NMAC - N, 06-28-14, Amended by New Mexico Register, Volume XXXV, Issue 15, August 13, 2024, eff. 8/13/2024