24.174.841 COMPOUNDED STERILE PREPARATIONS

(1) Any pharmacy facility, including out-of-state mail order pharmacies and outsourcing facilities, engaged in CSP must apply for a sterile compounding endorsement and identify a designated person pursuant to USP 797.  The designated person is responsible and accountable for the performance and operation of the facility and personnel as related to the preparation of CSP.

(2) A pharmacy facility engaged in sterile compounding must meet the minimum standards set forth in USP 797 to ensure the safety, identity, strength, quality, and purity of the finished product.  Policies and procedures must be prepared, developed, and implemented for the compounding, dispensing, delivery, administration, storage, repackaging, and use of sterile pharmaceutical products.  If applicable, other USP chapters relevant to the scope of practice must be met. Pharmacies must comply with section 503A of the Food, Drug, and Cosmetic Act including but not limited to compounding pursuant to a patient-specific prescription.

(3) The designated person must have written or electronic documentation to demonstrate compliance with the requirements in USP available for inspection by the board, including but not limited to:

(a) personnel training, competency assessments, and qualification records including corrective actions for any failures;

(b) certification reports, including corrective actions for any failures;

(c) environmental air and surface monitoring procedures and results;

(d) equipment records (e.g., calibration, verification, and maintenance reports);

(e) receipt of components;

(f) standard operating procedures, master formulation records, and compounding records;

(g) release inspection and testing records if applicable; and

(h) information related to complaints and adverse events including investigations and corrective actions.

(4) A pharmacy compounding sterile hazardous drugs must meet the standards set forth in USP 797 and USP 800 and be performed in an appropriate negative pressure environment.  Policies and procedures must be maintained and address appropriate personal protective equipment, training, proper labeling to identify the drug is hazardous, containment of spills, and proper disposal of waste that complies with applicable local, state, and federal laws.

(5) A pharmacy compounding sterile radiopharmaceuticals must meet the minimum standards set forth in USP 825 for the preparation, compounding, dispensing, and repackaging of radiopharmaceuticals.

 

Authorizing statute(s): 37-7-201, MCA

Implementing statute(s): 37-7-201, 37-7-307, 37-7-308, MCA

History: NEW, 2002 MAR p. 3605, Eff. 12/27/02; AMD and TRANS, from ARM 24.174.1121, 2015 MAR p. 302, Eff. 3/27/15; AMD, 2026 MAR, Notice No. 2026-131, Eff. 9/26/26.