USP Compounding Chapters: Understanding the Latest Revisions
September 14, 2023 | 12:30-2:30 PM CT
On November 1, 2022, United States Pharmacopeia (USP) published updates to USP General Chapters <795> and <797> on compounding nonsterile and sterile preparations. The revisions to the chapters, including updates to the beyond-use dates (BUDs), reflect advancements in science and clinical practice, clarify topics that were not consistently understood, and incorporate input from stakeholder engagements and comments received during the public comment period. These chapters will become official on November 1, 2023, to allow for increased flexibility and engagement for adoption. This webinar will include a brief presentation and then provide an opportunity for attendees to hear questions regarding the compounding General Chapter revisions answered by members of the USP Compounding Expert Committee.
Please note that the webinar capacity is 1,000 participants; registration does not guarantee entry. Those who are unable to join the meeting may purchase the webinar recording that will be posted online in a few weeks.
The complimentary webinar is eligible for Accreditation Council for Pharmacy Education (ACPE)-accredited continuing pharmacy education (CPE) credit. More details regarding the presentation, CPE activity credits, and browser requirements can be found in the CPE Activity Information Guide.
Brenda Jensen, CPhT, CNMT, MBA, is the current chair of the USP Compounding Expert Committee; and previously was a member of the 2015-2020 Compounding Expert Committee. She also participates on the Radiopharmaceutical Standards Expert Panel. Ms Jensen is an independent consultant and owner of Compounding Consultants, LLC. She helps facilities improve compounding quality and safety by providing gap analyses, on-site training, and customized standard operating procedures. Her previous experience includes sterile and nonsterile compounding in hospital, clinic, and community pharmacy settings. Her sterile compounding experience includes oncology, nuclear, and high-risk level compounding. Ms Jensen is a member of multiple pharmacy organizations, president of the American College of Veterinary Pharmacists, and a member of the American Pharmacists Association (APhA) House of Delegates.
Vanessa Pinheiro, MS, BS Pharm, is the current vice chair of the USP Compounding Expert Committee. Mrs Pinheiro is a compounding pharmacist with over 20 years of experience. She received her master’s degree in science from the University of São Paulo and taught at the College of Pharmacy at the University Suprema and UNIPAC in Brazil. Additionally, she was the owner of RX Pharmaceutica and Petfarma Compounding Pharmacies in Brazil, where she was responsible for compounding, quality control of raw materials and final products, training pharmacists and technicians, and counseling patients. She was a Surveyor and Standards Committee member of the Brazilian National Association of Compounding Pharmacies (ANFARMAG), a nonprofit organization that oversees customized pharmaceutical preparations. She has specialty training in nonsterile compounding, pharmaceutical technology, cosmetology, and veterinary compounding. She is also the author of the veterinary formulary book, Formulário Veterinário Farmacêutico, and co-author of the Helou, Cimino, Daffree: Farmacotécnica book, for which she was responsible for developing a chapter about veterinary compounding.
Mrs Pinheiro is currently working as a manager for compounding services, development, and consulting at Medisca, focusing primarily on the development, design, and implementation of formulations, standard operating procedures, compounding tools, compounding support, consultation, analytical services, and more for the compounding community. She manages the on-site operations of LP3 Network at Aventura, FL, and she facilitates various training programs beneath LP3. She is also a resource to external customers who are experienced compounders or new to the industry, with the primary goal of assisting them to expand the practice of compounding in their business. Additionally, she has been interfacing with various departments and key stakeholders on the global compounding landscape while identifying new threats and new opportunities.
Gus Bassani, PharmD, currently serves as chief scientific officer for PCCA, a Houston-based supplier of active pharmaceutical ingredients and excipients and formulation and drug information consulting to pharmacies, health care institutions, and outsourcing facilities. He has been with PCCA since 2002. Before that, he was a formulation pharmacist in the product development lab of a veterinary pharmaceutical company. Dr Bassani has worked in multiple pharmacy practice settings in Alaska, Iowa, and Kansas, and has taught extemporaneous compounding principles to pharmacy students in Drake University’s Pharmaceutics Laboratory course. He received his doctor of pharmacy degree from Drake University College of Pharmacy and Health Sciences. He is a member of the 2020-2025 USP Compounding Expert Committee and chairs the <795> Subcommittee. Previously, he was a member of the 2010-2015 and 2015-2020 USP Compounding Expert Committees. Gus served on the 2012-2014 Drake University College of Pharmacy and Health Sciences National Advisory Council and is a member of the APhA, the Alliance for Pharmacy Compounding, the American Association of Pharmaceutical Scientists, and the National Community Pharmacists Association.
Connie Sullivan, BS Pharm, is the president and chief executive officer of the National Home Infusion Association (NHIA). Ms Sullivan has over 25 years of home infusion industry leadership, management, and clinical practice experience. She is responsible for NHIA’s legislative and regulatory advocacy initiatives and developing resources that support the infusion industry to foster innovation and promote the delivery of high-quality patient care. Ms Sullivan also oversees the National Home Infusion Foundation, a not-for-profit subsidiary of the association devoted to research, leadership development, and education programs. She is a member of the 2020-2025 USP Compounding Expert Committee and chairs the <797> Subcommittee. Before joining NHIA, Ms Sullivan served for 15 years as the national director of infusion for a national home health and skilled nursing provider. She earned her bachelor’s degree in pharmacy from The Ohio State University College of Pharmacy in 1994.