What are the requirements of USP 797?
Designed to protect both patients and pharmacists, USP 797 requires attention to three main areas to ensure compliance: staff training and ongoing guidance, determination of categories, and development and implementation of appropriate policies and procedures.
What is a Category 1 CSP?
Category 1 CSPs are defined as “CSP that is assigned a BUD of 12 hours or less at controlled room temperature or 24 hours or less refrigerated that is compounded in accordance with all applicable requirements for Category 1 CSPs in this chapter.” Category 1 CSPs may be prepared in an unclassified Segregated Compounding …
What is a C Pec?
Containment Primary Engineering Control (C-PEC): A ventilated device designed and operated to minimize worker and environmental exposures to HDs by controlling emissions of airborne contaminants. Examples of C-PECs include Class I, II, or III BSCs, CACIs, and CVE (e.g., powder hood).
Who does USP 797 protect?
USP 797 is designed to protect both patients and pharmacists, USP 797 classifies sterile compounding into three risk groups: low, medium, and high. It applies to all pharmacies that produce compound sterile preparations including those in hospitals and retail settings.
How do you do fingertip 797?
Using a separate sampling device for each hand, collect samples from all gloved fingers and thumbs from both hands by rolling finger pads and thumb pad over the agar surface. Incubate the sampling device at a temperature of 30° -35° for no less than 48 hours and then at 20° -25° for no less than 5 additional days.
What is the difference between CAI and CACI?
When working with non-hazardous material, a compounding aseptic isolator (CAI) is used to create a positive pressure controlled environment. When handling hazardous material, a compounding aseptic containment isolator (CACI) is used to create a negative pressure controlled environment.
Is Botox a hazardous drug?
“One highlight is that botulinum toxin (Botox), which had been added to the proposed hazardous drug list in 2018, has now been removed,” notes Patton. “Hospitals that struggle to be compliant with this medication in many outpatient settings will find that removal not adding to their existing regulatory burdens.”
Is USP 797 updated?
USP provisionally published their latest proposed revisions on Chapter 797–Sterile Preparations in September 2021. The proposed changes are currently open for pharmacies’ feedback and will not be implemented until the March 17, 2022, deadline.
What is USP General Chapter <797>?
Developing USP General Chapter <797>. USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards.
Do USP 797 and 800 training recommendations support safe sterile-compounding practices?
This study found that developing training programs to fit the recommendations provided in USP 797 and 800 helps ensure safe sterile-compounding practices with a focus on patient safety. « Click here to return to Compliance Update.
What is the role of USP?
United States Pharmacopeia (USP) –Non-governmental non-profit organization –Primary activities are creation of standards, patient safety, healthcare information, and verification of products Quality and consistency of medicines –Prescription –Non-prescription –Dietary supplements –Veterinary drugs –Healthcare products
What is the USP compounding expert committee responsible for?
The USP Compounding Expert Committee is responsible for the development of General Chapter <797>. Review their work plan and past meeting summaries. Your participation is integral to the standard setting process.