Facilities

A. 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. 16.19.36 NMAC 6 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.