Demystifying Immediate Use: What’s NOT Category 1, 2, or 3

Patricia C. Kienle, RPh, MPA, BCSCP, FASHP, is Director of Accreditation and Medication Safety for Cardinal Health. She received her pharmacy degree from Philadelphia College of Pharmacy and Science and a Master in Public Administration degree from Marywood University in Scranton, Pennsylvania. She is author of The Chapter <795> Answer Book, The Chapter <797> Answer Book, and The Chapter <800> Answer Book and co-author of Meeting Accreditation Standards: A Pharmacy Preparation Guide. With over 600 invited presentations and 100 publications, she has special interests in medication safety, compounding sterile preparations, accreditation, and regulatory issues. 

Glen Gard CPhT-Adv, CSPT, FNHIA is the national director of compounding & pharmacy compliance for Option Care Health and is a member of the State of Illinois Board of Pharmacy. Mr. Gard is an inaugural member of the PTCB’s CSPT exam development committee. He is an active member of ASHP having served as the chair of the Pharmacy Technician Forum Executive Committee and is a current member of the Education and Workforce Development Committee. Additionally, Mr. Gard has been an active member of NHIA and currently serves as Vice Chair of the Sterile Compounding Practice Committee.

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.

Michael Ganio, PharmD, MS, BCSCP, FASHP joined the staff at ASHP as Director of Pharmacy Practice and Quality in January of 2018. As a member of the Center on Medication Safety and Quality team, his responsibilities span the practice of pharmacy and include drug shortages, pharmaceutical quality, sterile and non-sterile drug compounding practices, hazardous drug handling, and the ASHP Standardize 4 Safety initiative. Dr. Ganio earned his PharmD from the Rutgers University Ernest Mario School of Pharmacy and his Master’s degree in Health-System Pharmacy Administration from The Ohio State University College of Pharmacy. He completed a PGY1 Pharmacy Practice residency at The Ohio State University Wexner Medical Center. Dr. Ganio is a Board Certified Pharmacotherapy Specialist (BCPS) and a Board Certified Sterile Compounding Pharmacist (BCSCP).

Relevant Financial Relationship Disclosures

The following persons in control of this activity’s content have relevant financial relationships:

• Patricia C. Kienle: BD – Speaker’s Bureau

All other persons in control of content do not have any relevant financial relationships with an ineligible company. As defined by the Standards of Integrity and Independence in Accredited Education definition of ineligible company. All relevant financial relationships have been mitigated prior to the CE activity.

Resources

• Mind the Gaps: Assessing Your Institution’s Compliance with USP Chapter <797>
• Elevating Compliance: Navigating USP <797> with Technology and Standardization
• Frontline Conversations: Enhancing Compliance with USP Chapter <797> in Small and Rural Hospitals
• Frontline Conversations: Targeting Compliance Gaps with USP Chapter <797>

More in this Series

• Compliance with USP Chapter <797> in Small and Rural Hospitals