N.M. Admin. Code § 16.19.36.11

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

Section 16.19.36.11 - DOCUMENTATION REQUIRED

A. Written policies, procedures and SOPs consistent with USP/NF <797> (General Chapter <797> Pharmaceutical Compounding-Sterile Preparations) standards as well as those required below, must be established, implemented, followed by facility personnel, and available for inspection and review by authorized agents of the board of pharmacy. All personnel who perform or oversee sterile compounding must be trained in these policies, procedures and SOPs.

B. Written policies and procedures must be submitted to the state board of pharmacy prior to the issuance of any license. These policies and procedures must include but are not limited to:

(1) cleaning, disinfection, evaluation, validation, testing, certification, and maintenance of the sterile compounding area;

(2) personnel qualifications, training, assessment and performance validation;

(3) operation, maintenance, validation, testing, and certification of facility and equipment;

(4) SOP's for compounding, storing, handling, and dispensing of all components used and all compounded sterile preparations;

(5) SOP's for proper disposal of physical, chemical, and infectious waste;

(6) quality control guidelines and standards;

(7) quality assurance guidelines and standards;

(8) SOP's for determination of stability, incompatibilities, and drug interactions;

(9) error prevention and incident reporting policies and procedure as per 16.19.25 NMAC.

C. All records required by this part shall be kept by the facility for at least three years and shall be readily available for inspection by the board or boards' agent.

N.M. Admin. Code § 16.19.36.11

16.19.36.11 NMAC - N, 06-28-14, Amended by New Mexico Register, Volume XXVI, Issue 05, March 16, 2015, eff. 3/22/2015, Amended by New Mexico Register, Volume XXXV, Issue 15, August 13, 2024, eff. 8/13/2024