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Updated CMS Interpretive Guidelines for Pharmaceutical Services

MCN Question of the Week

Updated CMS Interpretive Guidelines for Pharmaceutical Services


Did CMS release updated guidance for hospital Pharmaceutical Services?  If so, where I can I find it?


On October 30, 2015, CMS published a Memorandum, Revised Hospital Guidance for Pharmaceutical Services and Expanded Guidance Related to Compounding of Medications.

CMS 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.
    • CMS 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 (ASPEN).
    • Preparing CSPs Outside of the Pharmacy:
      • CMS is updating 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

Related Products from MCN:

Pharmacy and Medication Management Manual

Compounded Sterile Preparation – USP 797 Compliance Manual


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