(1) Each institutional pharmacy must be directed by a pharmacist-in-charge who is licensed to engage in the practice of pharmacy in Montana and who is responsible for the storage, compounding, repackaging, dispensing, and distribution of drugs within the facility. Depending upon the needs of the facility, pharmacy services may be provided on a full or part-time basis, with a mechanism for emergency service provided at all times. Contractual providers of pharmacy services shall meet the same requirements as pharmacies located within the institution.
(2) Registered pharmacy technicians or technicians-in-training may be utilized pursuant to the written policies and procedures of the institutional pharmacy. Exemptions to established ratios as defined in ARM 24.174.711 may be granted with board approval.
(3) Personnel shall be provided with appropriate training before beginning to prepare sterile and nonsterile compounded pharmaceuticals, including training in the theoretical principles and practical skills of aseptic manipulations when performing compounded sterile preparation (CSP). The pharmacist-in-charge shall establish pharmacy policies and procedures that contain protocols in accordance with the guidelines in the United States Pharmacopeia (USP) Chapter 797 "Pharmaceutical Compounding - Sterile Preparations" for the initial training and testing of all personnel and for annual retesting in aseptic manipulative skills for those personnel involved in low- and medium-risk compounding.
(4) Personnel involved in high-risk compounding must be retested in aseptic manipulative skills at least semi-annually.
History: 37-7-201, MCA; IMP, 37-7-201, 37-7-307, MCA; NEW, 2002 MAR p. 3605, Eff. 12/27/02; AMD, 2015 MAR p. 302, Eff. 3/27/15.