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Updated Sterile Compounding Standards: Effective Dec. 1, 2019
July 12, 2019

Sterile compounding is a crucial service that Missouri hospitals provide for its patients. However, it is an activity that involves the risk of error and contamination, so it requires strict adherence to quality standards to ensure patient safety and regulatory compliance.

On June 1, the United States Pharmacopeia released significant revisions to General Chapter <797>, which is the list of sterile compounding standards referenced by the Centers for Medicare & Medicaid Services Conditions of Participation and The Joint Commission. These changes are effective Dec. 1, which may result in significant effort and cost for many Missouri hospitals.

Pharmacy and nursing departments will need to review existing policies and procedures to ensure compliance, and in some cases, significant construction and equipment purchases will be necessary. Documentation, record keeping and training will be affected as well. A thorough understanding of the implications of these changes is required to minimize risk and ensure compliance by the upcoming deadline.

Who does this effect?

  • pharmacy
  • nursing
  • finance
  • facilities management
  • infection control
  • regulatory compliance team


Register for the webinar, “USP <797>: Understanding Changes with Sterile Compounding in Hospitals,” taking place on Thursday, Aug. 15, to learn more about these changes. And, watch for additional announcements and educational offerings from MHA.

CMS CoP State Operations Manual (See Appendix A)
USP Sterile Compounding Resources (Free USP 797 Download)

MHA Staff Contact:

Sarah Willson

Vice President of Clinical and Regulatory Affairs
573/893-3700, ext. 1304

Missouri Hospital Association | P.O. Box 60 | Jefferson City, MO 65102
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