USP Issues a Decision on: 795, 797, and 825
USP has published a notice communicating the final decisions from the Appeals Panel in relation to USP <795>, <797>, and <825>.
The chapters which address the compounding of nonsterile (<795>) and sterile preparations (<797>) have now been remanded to the Compounding Expert Committee (CMP EC) for further engagement on the issues raised concerning the beyond-use-dating (BUD) provision.
Recap of the BUD Dating Changes in the Proposed Chapters
The proposed chapters which have been remanded to the CMP EC would change the system for assigning BUDs. In the case of <797> Compounded Sterile Preparations (CSPs) would no longer be assigned the maximum allowable BUD based on the risk level of the preparation. Instead, the proposed chapter would follow a new system for assigning BUDs based on several different factors related to achieving and maintaining sterility. Category 1 CSP’s would be allowed a BUD of 12 hours at controlled room temperature and 24 hours if refrigerated. Category 2 CSP’s would be allowed longer BUD’s, especially those that are terminally sterilized, prepared using only sterile components, tested for sterility, or stored in refrigerated or frozen storage conditions.
What the USP Decision Means for Compounders
The USP’s decision means the current official versions of the chapters will remain as follows:
- USP <795> Pharmaceutical Compounding – Nonsterile Preparation – Last revised in 2014
- USP <797> Pharmaceutical Compounding – Sterile Preparations – Last revised in 2008
Eagle will continue to follow the proceedings related to the chapters and publish more information as soon as it’s made available.
Read the Notice on the USP website for detailed information.
The Total Solution for all Your Compliance Needs
Eagle provides analytical and microbiological testing services, as well as consulting to help you ensure compliance with compounding standards and regulations. Eagle consultants are helping compounding facilities implement successful quality systems. Our team has over 200 years of combined experience in the FDA-regulated pharmaceutical industry and can provide guidance in establishing the systems and processes that will help your facility meet and exceed regulatory expectations. Follow the link below to learn more about our consulting services.
- Central Drug Compounding & Wellness Recommends Eagle Plates - April 16, 2021
- Paperless Sample Submissions – Effective May 3, 2021 - April 8, 2021
- The Woodlands Compounding Pharmacy Recommends Eagle Plates - April 7, 2021