With USP <800> and revisions to USP <797> becoming official on November 1, 2023, sterile compounding experts have received numerous questions from hospital pharmacy leaders inquiring about the new standards. In this podcast, we answer the top 10 questions received across the country providing valuable information regarding current sterile compounding hot topics including: procedural areas, competencies, cleaning, lab reporting, COA (Certificate of Analysis) and DVO (Dose Vial Optimization).
REFERENCES/RESOURCES
- ASHP Compounding Resource Center
- ASHP Compounded Sterile Preparations Certificates (RpH & Tech)
- Joint Commission DVO Standards
- ASHP Policy 1813 – Use of CSTD to reduce drug waste
- USP – Role & applicability of USP <800> related to safe handling of hazardous drugs [PDF]
Abby Roth, CMQ/OE, founder of Pure Microbiology, has been supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries since 2004. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring. Abby served as a USP Compounding EC member during the 2015-2020 cycle. She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of four CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations. 
Annie Lambert (she/her) is the clinical program manager for Simplifi+ Pharmacy Compliance Solutions at Wolters Kluwer Health. She received her PharmD from Washington State University and has over 20 years of experience in health systems pharmacy operations and consulting. Lambert enjoys partnering with leaders and colleagues to educate and share best practices for USP compounding compliance. 
Melanie Horn (she/her) serves as the subject matter expert for compounding for Sutter Health and brings extensive experience in project management, personnel management, clinical practice, and staffing in her 10 years working with Sutter. She specializes in system compounding compliance within a complex healthcare system. Horn enjoys collaborating with professionals to develop system initiatives that leverage current technology for enhanced patient safety. Her professional focus includes sterile compounding training, compounding workflow optimization, hazardous medication production protection. 
Sara Carey (she/her) is the pharmacist coordinator for medication-use safety and policy at UNC Health Rex. She earned a PharmD from Purdue University (Boiler Up!) followed by a postgraduate year 1 residency at the University of Louisville Health - Jewish Hospital and a postgraduate year 2 residency in Medication-Use Safety and Policy at UNC Medical Center. She is passionate about improving safety outcomes for patients, staff, and providers throughout various settings and evolving healthcare environments. 
