N.M. Admin. Code § 16.19.36.9
Current through Register Vol. 35, No. 23, December 10, 2024
Section 16.19.36.9 - FACILITIESA. The room or area in which compounded sterile preparations (CSP's) are prepared:(1) must be physically designed and environmentally controlled to meet standards of compliance as required by USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations);(2) must be periodically monitored, evaluated, tested, and certified by environmental sampling testing (includes both viable and nonviable particle sampling) as required by USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) with documentation retained for three years;(3) must have a minimum of 100 square feet dedicated to compounding sterile preparations;(a) the minimum size of a retail pharmacy must be 240 square feet; a retail pharmacy with preparation of sterile products capabilities must have 340 square feet with 100 square feet exclusive to compounding sterile preparations;(b) the stand alone CSP facility must have a minimum of 240 square feet with 100 square feet exclusive to compounding sterile preparations; and(4) must be clean, lighted, and at an average of 80-150 foot candles; and(5) must minimize particle generating activities; and(6) must have a sink of sufficient size for compounding personnel to adequately wash hands and forearms up to the elbows with soap and water.B. Addition of a compounding sterile preparations area in existing pharmacies will require submission of plans for remodeling to the board office for approval and inspection prior to licensure.C. A new CSP facility must comply with 16.19.6.8 NMAC through 16.19.6.11 NMAC of the regulations.N.M. Admin. Code § 16.19.36.9
16.19.36.9 NMAC - N, 06-28-14, Amended by New Mexico Register, Volume XXXV, Issue 15, August 13, 2024, eff. 8/13/2024