Revised Hospital Guidance for Pharmaceutical Services and Expanded Guidance Related to Compounding of Medications
Hospital Appendix A Updated: The Centers for Medicare & Medicaid Services (CMS) has updated the State Operations Manual (SOM)
Appendix A with respect to both the hospital survey process and the interpretive guidelines for the pharmaceutical services
Condition of Participation (CoP). The update includes the following features:
• Pharmaceutical Services: Revisions were made to portions of the pharmaceutical services CoP to bring them into alignment
with current accepted standards of practice. To improve clarity, the revised guidance addresses: accepted professional pharmacy
principles, including United States Pharmacopeia (USP) standards; compounding of medications, particularly compounded sterile
preparations (CSPs); determining beyond-use dates (BUDs); safe and appropriate storage and use of medications; and, policies
and procedures related to high-alert medications and minimizing drug errors.
• Additional Tag: We added a new standard-level tag to allow surveyors to cite to the regulatory language found in the condition
stem statement at either the standard- or condition-level, as appropriate, in the Automated Survey Processing Environment
• Preparing CSPs Outside of the Pharmacy: We are updating our guidance for the nursing service regulatory requirements concerning
medication administration to clarify that hospitals must ensure staff adherence to accepted standards of practice in those
limited instances when CSPs may be prepared outside of the pharmacy.