USP 797 Law – MONTANA

SUMMARY INFORMATION

The Board expects pharmacies/pharmacists engaged in compounding to have policies and procedures to adhere to those guidelines that apply to their practice setting and in all situations to comply with the spirit of United States Pharmacopeia (USP) Chapter 795 “Compounding Nonsterile Preparations” and USP Chapter 797 “Pharmaceutical Compounding-Sterile Preparations.” It references the 2015 version only.

COVID-19 Note: Board has issued a statement based on USP’s letter regarding discretionary enforcement of USP 797’s PPE requirements during the COVID-19 pandemic. A BOP has also provided a document with strategies how to preserve PPE.

Citations

Montana Pharmacy Laws

Montana 24.174.841 Sterile Products

ADOPTED BY REFERENCE ONLY? No