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What's New In USP <795>: Non-sterile Compounding

On June 1, 2019, the United States Pharmacopeia (USP) published a revised version of USP General Chapter <795>, which contains the standards for non-sterile compounding. This revision is meant to reflect new available evidence and to clarify topics that are a frequent source of questions and confusion. Two of the major revisions in this chapter are the emphasis on ‘must’, indicating that compliance is mandatory, and the exclusion of compounding hazardous drugs.

In this webinar, participants will revisit the history that led to the current regulatory framework for non-sterile compounding, highlighting the major revisions. Throughout the webinar, comparisons will be made between the current and revised versions of USP <795> with focus on personnel requirements (designated person, training and proficiency, health and hygiene, garb and glove), facility and component requirements (building, equipment, cleaning and sanitization), and compounding process requirements (documentation, beyond-use date, labeling, quality control and assurance programs, and outcome measure). The compare-contrast approach with this webinar will serve as a valuable reference for compounding pharmacists and pharmacy technicians as they move forward with aligning their practice and pharmacy with the new standards. The practical information highlighted in this webinar will further assist in the compounder’s path toward compliance.

Intended audience

  • Pharmacists
  • Pharmacy Technicians
  • Pharmacy Managers
  • Auditors and Inspectors
  • Compliance Specialists



Learning Objectives

  1. Learn the history that led to the current regulatory framework for non-sterile compounding.
  2. Enumerate the major revisions in the revised USP General Chapter <795>.
  3. Compare the standards specified in the previous and revised USP <795>.
  4. Discuss the most important changes in the revised chapter, especially with regards to personnel and training; facilities, equipment and components; documentation, beyond-use dates, and quality assurance and quality control programs.
  5. Identify what compounding pharmacists must do to ensure compliance with the revised standards.


Hardware/software requirements

High speed internet connectivity and an updated internet browser is required to attend the webinar. The broadband recommended is 1 Mbps or better. The minimum browser requirements to attend the webinar are:

  • Google Chrome v39 or later
  • Mozilla Firefox v34 or later
  • Internet Explorer v8 or later
  • Microsoft Edge
  • Apple Safari v6 or later
Course summary
Available credit: 
  • 1.50 Contact Hours

Facilitator, LP3 Network; Vice President, Compounding Compliance, Gates Healthcare Associates; Surveyor and Accreditation Expert, Accreditation Commission for Health Care (ACHC/PCAB); Fellow, International Academy of Compounding Pharmacists (IACP); Fellow, American College of Apothecaries (ACA); Professor of Pharmacy Practice (retired), University of Findlay

Disclosure: Surveyor, Accreditation Commission for Health Care (ACHC/PCAB); Consultant, Gates Healthcare Associates; 

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).


There are no refunds, returns or transfer upon purchase of the webinar.



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