Meeting New Requirements for Sterile Compounding Webinar
Learn about new and upcoming state regulations and federal standards, and how to comply

Webinar Recorded Live June 28, 2016


The California State Board of Pharmacy (BoP) and United States Pharmacopeia (USP) Convention are planning changes that will significantly impact hospital pharmacy compounding of hazardous and non-hazardous medications and facility structures.

The BoP regulations are being finalized now and will become effective Jan. 1, 2017. In addition to cleaning, testing and personnel training, a significant anticipated change is the requirement that hospital pharmacies have a physically separate room for hazardous sterile compounding that meets specific ventilation requirements.

USP standards serve as a professional guide for compounding practices and medication administration. USP standard 797 will be finalized in February 2018 and will be used for survey purposes. USP standard 800, which was finalized in February 2016, is focused entirely on employee safety when handling hazardous medications.

Hear California State Board of Pharmacy Executive Officer Virginia Herold and Supervising Inspector Michael Ignacio, and hospital pharmacists from CHA’s Medication Safety Committee, explain the new regulations and standards, and the impact on hospital procedures and operations.

Learn what the changes will mean for your hospital. Take home helpful tools and resources to ready your facility for compliance.

Recommended for:

Pharmacists in charge, chief operating officers, chief compliance officers, facilities managers and building engineers, CNOs, quality and infection control managers.


Where it all started, and why regulations and standards have been revised

  • High-profile lapses in process, increased industry scrutiny

Federal changes

  • USP Convention changes to 797 and 800 — what this means for operations
  • CMS Conditions of Participation

California State Board of Pharmacy updates

  • Upcoming sterile compounding regulations
  • Extension options for hospitals — the waiver process

Vital tools and resources

  • Sterile compounding matrix tools for lab testing, temperature monitoring, documentation, plant requirements
  • Regulation confusion? Check the new federal and state regulation crosswalk
  • And more resources


Virginia Herold, Executive Officer, California State Board of Pharmacy

Michael Ignacio, PharmD, Supervising Inspector, California State Board of Pharmacy

Jeannette Hanni, RPh, MPA, FCSHP, Bay Area Executive Director of Pharmacy Services, Sutter Health

Doug O’Brien, PharmD, Regional Director for Inpatient Pharmacy Services, Kaiser Permanente

Lynn Paulsen, PharmD, Director, Pharmacy Practice Standards, University of California, San Francisco

BJ Bartleson, RN, NEA-BC, Vice President, Nursing and Clinical Services, California Hospital Association (moderator)