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Keeping You Current with USP 〈795〉 & 〈797〉 Published Revisions
🔺USP PUBLISHED REVISIONS – WHAT CHANGED?
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On November 1st, 2023, the United States Pharmacopeia (USP) published its new compounding standards for <795> Pharmaceutical Compounding – Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations. These published chapters make USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings compendial 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 updates since 2008. This update includes changing the CSP categories from 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 help you meet your regulatory requirements.
USP REVISIONS Video Series
An informational video series created to assist you in understanding the revisions to the United States Pharmacopeia compounding standards <795> and <797>. Save this page to your favorites for quick access to new USP videos and content. Play the video and click plus icon for detailed information concerning the revisions.
USP Antimicrobial Effectiveness Revisions
Antimicrobial Effectiveness
Antimicrobial effectiveness should be demonstrated for all products containing preservatives including injections and other aqueous-based, multiple–dose products not limited to ophthalmics, topicals, and oral dosage forms.
USP Beyond-Use Dates Revisions
Beyond-Use Dates
The USP published updates to the USP General Chapters on compounding nonsterile (USP 795) and sterile (USP 797) preparations. Included in these revisions were updates to the beyond-use dates (BUDs) to clarify topics that were not consistently understood. Most of the revisions involved guidance on stability and sterility considerations for nonsterile and sterile preparations.
USP Cleanroom Certification Revisions
Cleanroom Certification
Cleanroom certification shall be performed prior to initiating sterile operations and must be repeated at least every six months and/or after any changes to the classified area including construction, replacement, or relocation of any primary engineering control (PEC), and any reconfiguration of the room and major equipment.
Classified areas and engineering controls are certified by performing airflow testing, HEPA filter integrity testing, total particle count testing, differential pressure testing, dynamic airflow smoke patterns test, and by having viable environmental monitoring.
Facility Design and Construction Revisions
Facility Design and Construction Requirements
It is important to note that there have been significant changes made to the regulations governing nonsterile preparations and sterile preparations. These changes are outlined in USP General Chapters <795> and <797>, and they came into effect on November 1st, 2023. To remain compliant with the new regulations, facilities must understand these changes.
USP Sterility Testing Revisions
Sterility Testing
The updated revisions to USP Chapters <795> Pharmaceutical Compounding – Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations are official as of November 1st, 2023, and regulatory bodies will enforce the established conditions. Both chapters have undergone significant changes, thus it is imperative for compounders to understand expectations to ensure compliance. In this article and video, we will examine the requirements for sterility testing.
USP Water Activity Revisions
Water Activity
The new practice of using water activity as a tool for establishing the BUD of a CNSP is described in Section 10.3 of the to-be-official USP <795> chapter. Water activity testing in accordance with USP <922> is not required but is highly recommended to support the established BUD of the CNSP. Water activity testing should be considered in cases where there is an absence of a USP-NF Compounded Preparation Monograph and/or CNSP-specific stability information.
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 learn more about USP revisions and Eagle services. EAGLE IS HERE TO HELP your business implement the published revisions.
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.
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