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Keeping You Current with USP 〈795〉 & 〈797〉 Published Revisions 

🔺USP PUBLISHED REVISIONS – WHAT CHANGED?

 

On November 1st, 2022, the United States Pharmacopeia (USP) published its final versions revisions of the USP compounding standards <795> Pharmaceutical Compounding – Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations after incorporating public feedback received in response to draft proposed USP revisions published in September 2021.  These chapters become official on November 1st, 2023, and USP encourages early implementation. The publishing of these chapters makes USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings compendially applicable.

The General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations revision marks the first major update since 2014 and includes more details about the compounding environment and cleaning requirements.

General Chapter <797> Pharmaceutical Compounding—Sterile Preparations received its first major update since 2008. This update changes the CSP categories from a three termed format of low-risk, medium-risk, and high-risk to a three termed format of Category 1, Category 2, and Category 3 and corresponding beyond-use dates (BUD). This newly published version also includes updates to environmental monitoring frequencies, facility requirements, use of alternative technologies, personnel qualifications, garbing requirements, personnel training, and more.

EAGLE is here to answer your questions and guide you through the implementation process.  We can assist you with meeting your regulatory requirements.

OUR EXPERTS, ON YOUR BEHALF

It is our commitment to provide your organization with the tools to operate and maintain compliance with the USP revisions. In support of this commitment, Eagle is home to professionals spanning the science and pharmaceutical industry, including experts in chemistry, microbiology, engineering, CGMP, QA/QC, and high-level USP experience.

REVISIONS

Eagle is uniquely positioned to provide service offerings that meet these revisions to USP compounding standards <795> Pharmaceutical Compounding – Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations. Click the following icons to see how Eagle can help your business implement the published revisions.

Beyond-Use Dating (BUD) and Water Activity Testing
Environmental MONITORING SOLUTIONS
Alternative Sterility Testing
Alternative Sterility Testing
Environmental MONITORING SOLUTIONS
Smoke Studies
Terminal Sterilization Cycle Development And Qualification
Antimicrobial effectiveness testing
Sterility and Endotoxin Testing (Release Testing)
Stability Studies
SOP Development

DEDICATED TO HELPING YOU

Eagle helps facilities utilize fact-based decision-making to create science-based solutions. Eagle is an FDA and DEA-registered A2LA ISO 17025 accredited laboratory founded in 2003 that provides analytical and microbiological testing, consultation services, and other technical services for pharmacies, healthcare professionals, highly regulated industries, clinical and research organizations, educational institutions, and more to support their compliance needs.

WE ARE HERE FOR YOU. Contact us and let us assist you with meeting your unique needs and regulatory requirements.

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503A Compounding Pharmacies

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Hospitals

503B CGMP Outsourcing Facilities

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Clinical/Research and Development Organizations

Pharmaceutical Manufacturers and Repackagers

Universities

Get Started Today

Call the Eagle Client Care Team at 800.745.8916 to request an initial consultation and discuss your operation’s specific needs.

Your Future Awaits

Our talents vary — but we all have the same drive: to find better ways to improve the lives around us. If you are looking to become part of a company that is growing and innovative, Eagle may just be what you are looking for.

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