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Update on Medication Compounding Compliance

08/20/2020

By Robert Campbell, PharmD, BCSCP, director, clinical standards interpretation for Hospital/Ambulatory Programs

The Joint Commission continues to receive questions regarding USP Chapter 797 and its revisions along with expectations for compliance with USP Chapter 800. This updated guidance supersedes previous statements released by The Joint Commission related to medication compounding.  

USP 797 2019 Revision Remanded
On March 12, 2020, USP published that the 2019 revision of USP 797 was remanded as a result of a final appeal hearing. Therefore, the 2019 revision of USP 797 is no longer enforceable. Due to the final appeal decision, the chapter will be reopened, and it is unknown which parts of the chapter will be revised. 

How will The Joint Commission evaluate organizations that already completed remodeling based on the 2019 revision?

Organizations that had begun construction Cto be compliant with the 2019 revision to USP 797 will meet or exceed the 2008 version of USP 797 from a structural perspective, with one exception. 

The one exception is that Category 1 compounding was allowed in a segregated compounding area (SCA) in the 2019 revision, but is not allowed in the 2008 version. This is because the 2008 version addressed compounding from the level of complexity of the compounded product (number and type of products prepared together). The 2019 revision categorized compounding according to the location the product was prepared. Since the two chapters address compounding differently, there is a variation on how items categorized as Medium Risk Compounding in the 2008 version can be performed.

Based on the current USP 797 (2008 version), only low-risk-non-hazardous compounded sterile products may be prepared in the SCA. However, USP has provided interim guidance that allows organizations to perform medium risk compounding in a SCA during the COVID-19 pandemic. Once the declared public health emergency has ended, organizations will once again be expected to be in compliance with the 2008 version of USP 797. 

How will The Joint Commission look at hazardous medication compounding?

The 2019 revision of USP 797 would have made USP 800 enforceable. Because the revision was remanded, USP 800 remains informational at this time. When a new revision of 797 becomes official, USP 800 will become enforceable, and organizations will need to become compliant with USP 800. During the interim, organizations may choose to either utilize the 2008 version of USP 797 as guidance for handling of hazardous medications or they may choose to adopt USP 800. If an organization chooses to adopt USP 800, they should be aware there is conflict between the 797 and 800 on the handling of hazardous medications – organizations adopting USP 800 should follow the guidance listed within that chapter.   

Based on USP structuring, not all of USP 800 would become enforceable. When evaluating compliance with USP 800, The Joint Commission will only survey to compliance with the components that would have been enforceable along with any additional requirements listed within organization policy. Examples of these areas may include, but are not limited to:  : 

  • training of staff
  • garbing of personal protective equipment of compounding staff
  • facility and engineering controls (including microbial sampling)
  • beyond use dating

Are there any provisions to consider during the COVID-19 pandemic related to medication compounding?

To assist with reduction of medication shortages and waste, your organization may want to consider the interim guidance released by USP. The Joint Commission will not prohibit these provisions, therefore, if an organization has chosen to utilize this guidance during the public health emergency, these provisions will not be scored out of compliance with Joint Commission standards.  

Robert Campbell, PharmD, BCSCP, is director, Clinical Standards Interpretation Hospital/Ambulatory Programs and director, Medication Management. Prior to these roles, he served as the pharmacist for Clinical Standards Interpretation in the Division of Healthcare Improvement at The Joint Commission. Campbell also surveys as a field representative for The Joint Commission in the Hospital Accreditation and Critical Access Hospital Accreditation Programs and is a reviewer in the Medication Compounding Certification Program. Prior to joining The Joint Commission, Campbell worked in health care organizations and held leadership positions with oversight responsibilities for performance improvement, accreditation readiness, risk management, infection control, medical staff services, as well as inpatient and outpatient pharmacy services.

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