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USP Chapter 797 and 800 revisions will go live Nov. 1 – are you ready?
The United States Pharmacopeia (USP) has updated its standards for pharmaceutical compounding and hazardous drug handling. The long-awaited USP Chapter 797 revision becomes official on Nov. 1, 2023. This also makes the latest revision of USP Chapter 800 compendial. Because hospitals have had plenty of time to prepare for the changes, it’s likely that many state pharmacy boards and accrediting agencies will expect immediate compliance.
That’s why health systems need to be aware of what’s changing in order to avoid potential sanctions or fines. Here are five key considerations that should be top-of-mind as you prepare for the USP changes starting in November.
1. Medication waste
The changes to beyond use dates highlighted in USP <797> are more conservative now, and do not allow for extending as they previously did. This may cause more waste for your operation. If you’re not willing to meet all the requirements for Category 3 compounded sterile preparations (CSPs) your organization may need to devise alternative ways to provide just-in-time or on-demand medications. Meeting Category 3 CSP requirements could also increase costs for gowning, environmental monitoring, and testing.
2. Facility operations
USP <800> changes could have a major impact on your facility operations. The engineering control requirements alone may necessitate building an entirely new cleanroom, costing between $200,000 to more than $1 million. Personal protective equipment requirements will also increase costs, as your organization will need to obtain special gowns and gloves that are resistant to hazardous drugs (HDs).
3. Enforcement of USP standards
Health systems need to be prepared for how these changes could be enforced. Because the USP is not an enforcement agency, this responsibility is left to individual states and the federal government (i.e., the FDA). USP Chapters are typically regarded as the nationwide standard and can certainly be enforced on the federal level.
States, however, have the option to opt out of adopting the changes. So it’s important to understand what position your state board is adopting, and how aggressively they intend to enforce these new standards. If you are an organization that must hold an accreditation with the Joint Commission (TJC) or another accreditation body, you may be held to these standards either way, as the TJC has already announced their intention to survey against the new standards.
4. Impacts outside pharmacy
Some of the new changes will have an impact in areas beyond pharmacy. For example, your nursing department will need to be aware of the requirement under USP <800> for the use of closed-system transfer devices for cytotoxic drug administration. So you should have a plan to work with impacted departments outside pharmacy to support USP compliance.
5. Documentation requirements
The new standards call for increased documentation in order to demonstrate USP compliance. To help manage these requirements, organizations should consider a comprehensive documentation system that provides easy information retrieval, such as the Compounding 360 platform from Pharmacy Stars.
Expert guidance on USP compliance
Visante has compiled two briefings to help your organization navigate the new USP standards and ensure compliance. These briefings provide a summary of the work that must be completed as part of a USP compliance program.
- USP <795> Pharmaceutical Compounding – Non-Sterile Preparations Briefing
- USP <797> Pharmaceutical Compounding – Sterile Preparations Briefing
Is your organization ready?
The magnitude of these changes will have a significant impact on quality and compliance for many health systems. That’s why we recommend conducting a final organizational readiness review prior to the USP go-live date on Nov. 1. Contact us today to schedule your review! Email solutions@visanteinc.com or call (866) 388-7583 to speak to one of our team members.
