New Mexico Administrative Code
Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING
Chapter 19 - PHARMACISTS
Part 36 - COMPOUNDED STERILE PREPARATIONS
Section 16.19.36.9 - FACILITIES

Universal Citation: 16 NM Admin Code 16.19.36.9

Current through Register Vol. 35, No. 24, December 23, 2024

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.

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.

Disclaimer: These regulations may not be the most recent version. New Mexico may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.