1. A. All facilities compounding sterile preparations must designate a pharmacist in charge of operations who is licensed as a pharmacist in the state of residence of the facility.

2. B. The pharmacist-in-charge (or consultant pharmacist, for in-state clinics) is responsible for:

   1. (1) the development, implementation and continuing review and maintenance of written policies, procedures and SOP’s which comply with USP/NF standards;
   2. (2) providing a pharmacist who is available for 24 hour seven-day-a-week services;
   3. (3) establishing a system to ensure that the CSP’s prepared by compounding personnel are administered by licensed personnel or properly trained and instructed patients;
   4. (4) establishing a system to ensure that CSP’s prepared by compounding personnel are prepared in compliance with USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) standards;
   5. (5) ensuring facility personnel comply with written policies, procedures, and SOP’s; and
   6. (6) developing an appropriate and individualized plan of care in collaboration with patient or caregiver and other healthcare providers for each patient receiving parenteral preparations in a home setting.

[16.19.36.8 NMAC - N, 06-28-14; A, 8/13/2024]