What's New In USP <797>: Sterile Compounding
Fifteen years after it was first enacted, the United States Pharmacopoeia (USP) General Chapter <797> for Sterile Compounding has been revised. Expected to be published on June 1, 2019, this chapter has been amended to respond to the feedback received, to expand on topics that may need clarification, and to align with the updates made to USP <800> for Hazardous Drug Compounding and USP <795> for Non-sterile Compounding.
This webinar will review the major revisions in USP <797>, including the definition, scope, and categories of compounded sterile preparations (CSPs). Details on personnel training, assessment and qualification, hand hygiene, garbing and gloving will be addressed. The specific requirements for facilities for sterile compounding will also be outlined, including: the two types of cleanroom layouts permitted; the mandated requirements for certification; environmental control, including ventilation and airflow; guidelines for construction, equipment and supplies; indications and conditions for environmental sampling; and cleaning and disinfection schedules.
Finally, standards for compounding sterile preparations will be identified. The discussion will encompass the following: sterilization methods; sourcing, receiving and handling components, including conventionally manufactured products and CSPs; determination of beyond-use dates (BUDs); labeling; release testing; quality assurance and quality control programs; and documentation, including standard operating procedures (SOPs), master formulation records (MRFs) and compounding records (CRs). Changes in the preparation of allergenic extracts will also be considered.
- Pharmacy Technicians
- Pharmacy Managers
- Auditors and Inspectors
- Compliance Specialists
- Learn the history that led to the current regulatory framework for sterile compounding.
- Enumerate the major revisions in the revised USP General Chapter <797>.
- Compare the standards specified in the previous and revised USP <797>.
- Discuss the most important changes in the revised chapter, especially with regards to personnel and training; facilities, equipment, supplies and components; documentation; beyond-use dates; sterilization methods; quality assurance and quality control programs; and preparation of allergenic extracts.
- Identify what compounding pharmacists must do to ensure compliance with the revised standards.
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KEN SPEIDEL, BS Pharm, PharmD, RPh, FIACP, FACA
Dr. Ken Speidel is recognized for his broad experience in pharmacy practice and education, including his national recognition as a pharmacotherapeutic specialist in endocrinology and pain management. In addition, Dr. Speidel provides expert training in sterile and non-sterile compounding processes in the acute care, community, outpatient, and 503A/503B practice sectors. He has been instrumental in the development of national standards for pharmacy compounding practices and provides consulting services to many organizations, including boards of pharmacy as well as hospitals and health systems in the United States and abroad.
In addition to his worldwide consulting and educational work, Dr. Speidel is a retired Professor of Pharmacy Practice from the University of Findlay. He has also assisted in the development and facilitation of many nationally recognized educational programs, approved by the Accreditation Council for Pharmacy Education (ACPE). Moreover, Dr. Speidel was an advisor for the development of the Pharmacy Compounding Accreditation Board (PCAB) and remains a surveyor and accreditation expert for PCAB/ACHC (Accreditation Commission for Health Care). Dr. Speidel has served as multi-term president of the National Home Infusion Association (NHIA) as well as president of the Hospice of Portage, a large hospice program in the United States.
Dr. Speidel received a Bachelor of Science and Doctor of Pharmacy from Ohio Northern University and has completed postdoctoral training in nutritional support and functional medicine. He has been awarded Fellowship status with the International Academy of Compounding Pharmacists (IACP) as well as the American College of Apothecaries (ACA).
CANCELLATION AND REFUND POLICY:
There are no refunds, returns or transfer upon purchase of the webinar.