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Stay informed with information and education from CriticalPoint's compounding experts
USP Healthcare Quality & Safety published revised USP Chapters <797> and <795> in the USP-NF and USP Compounding Compendium on November 1, 2022. This update affects the requirements and recommendations for how pharmacists, technicians, and others working in and with compounding pharmacies do their work.
As the leaders in training and education for sterile compounding, the team at CriticalPoint, a TRC Healthcare company, is preparing to support customers throughout the implementation of any new standards with our products and virtual training programs.
Sign up for email notifications related to upcoming webinars, trainings, and education opportunities covering the latest updates on the new chapter releases.
FAQS
When will I need to be compliant with the updated chapters?
According to the announcement, USP expects compliance with <797> and <795> chapters by November 1, 2023.
How significant are the changes?
The changes are numerous and detailed. Teams will need to be equipped with resources to enable a smooth, thorough transition to the new standards. There are increased expectations around training, adjustments to facility requirements, and more detailed garbing requirements among others.
CriticalPoint sterile compounding experts will host a free webinar to cover the high-level updates that align to the new USP expectations. Sign up on this page to be invited to upcoming webinars.
Sign Up for Chapters <797> & <795> Updates
What does the update mean for USP <800>?
USP <800> sets the standards that must be followed for handling hazardous drugs (HDs) where there is risk of exposure to patients, healthcare workers, and the environment. <800> became official in 2019; however, it was not enforceable because there were conflicts between it and <797>. Now that the updates to the chapters are published, those discrepancies are resolved.
Is <800> enforceable now?
<800> is official. USP will make it enforceable on November 1, 2023 at the same time as <797> and <795>. However, some jurisdictions are expecting pharmacies to be compliant with <800> immediately. Pharmacies should check with their local regulatory agency to confirm the compliance expectations.
How can I prepare my team to be compliant?
CriticalPoint will include content from the updated chapters in our virtual trainings and online learning products. The 2023 virtual training sessions featuring the updated USP information include:
- Sterile Compounding Inspector Training
- Nonhazardous Sterile Compounding Training
- Hazardous Sterile Compounding Training
- Environmental Monitoring
- Designated Person Training (coming soon)
- Updates and Best Practices for new USP guidelines
How can I get more information?
TRC Healthcare is committed to helping customers smooth the implementation transition with the tools and resources you need to succeed. Sign up to be updated with resources, webinars, and other information about the chapter updates.
USP References: https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare
USP Timeline: https://go.usp.org/Proposed_2021_Revisions_795_797
