Course contents

Business Essentials - Winds of Change: USP <797> 2008 Becomes 2022 (2.5hr CE)

Pharmacists

USP Guideline

Welcome to our Business Essentials series. This series is designed to educate pharmacists and other professionals on topics that will help them to operate their pharmacies in a way compliant with current guidelines and help get them ready for upcoming guidelines. In this installment we review USP <797>: Pharmaceutical Compounding - Sterile Preparations. We will discuss who it impacts, what the guideline addresses, and how to get your pharmacy ready for these guideline changes.

 English only
  Pharmacists 
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Why should I take this course?

  • Recall the historical development of USP <797>
  • Recognize the types of pharmaceutical preparations to which it applies
  • Differentiate between Category 1, 2, and 3 preparations
  • Recognize changes that apply to Personnel Management
  •  Recognize changes that apply to Facility Management
  • Recognize changes that apply to Sterile Preparation Management
  • Recognize changes that apply to Quality Management
  • Describe how these changes can be applied to BUD of formulations
  • Evaluate variables involved in implementing change in their practice
  • Identify the testing requirements outlined in the new version of USP <797> for establishing and extending BUDs, and for batch release
  • Describe some of the microbiological, biological, and analytical tests utilized in the extension of BUDs for CSPs
  • Describe a stability study design where all design factors are tested at all time-points, and recognize where a reduced study design may be implemented
  • Recognize the importance of testing the CSPs to ensure the safety and efficacy of the products through the BUD

Course Lesson

Meet your instructor

Kerry Earlywine 

Kerry Earlywine is a Doctor of Pharmacy and a graduate of Nova Southeastern University, College of Pharmacy. After graduating, Kerry completed a Psychopharmacology Specialty Residency, also at Nova Southeastern University. He has more than 28 years of experience, having specialized since 2004 in the practice of compounding pharmacy. His experience in various areas, including but not limited to hormone replacement, autoimmune disorders, Lyme disease, autism, nutrition, and various forms of alternative medicine, provide him a wholistic approach to the care of the body and the numerous variables that affect its perfect function.

As an assistant professor and adjunct at Nova Southeastern University, College of Pharmacy, and preceptor for students at various United States Colleges of Pharmacy, Dr. Earlywine has assisted with the training and development of other pharmacists and pharmacist students and was part of the team that first developed the University’s on-campus pharmacy and pharmaceutical care services. Further, he routinely speaks on the topics of health, nutrition and compounding pharmacy, and serves as a consultant to numerous clients in Colombia, Brazil, Canada, Mexico and the United States.

Meet your instructor

Wayne DeHaven

Wayne DeHaven earned his bachelor’s degree from the University of Florida (Gainesville, FL) and his Ph.D. in Pharmacology and Therapeutics from the University of South Florida (Tampa, FL). After earning his doctorate degree, Wayne completed an NIH fellowship investigating cellular signaling through ion channel activation. He joined the Food and Drug Agency (FDA) (White Oak, MD) in 2009 where he continued to work until 2015 when he left as Acting Director of the Division of Bioequivalence I to join Pharmetric Laboratory as Director of Quality. Pharmetric Laboratory is a contract laboratory that focuses on quality testing for compounded pharmaceuticals.