USP <797> BEST PRACTICES – IT’S NOT JUST SOPs (PART 1): FROM PERSONNEL TO FACILITIES & EQUIPMENT (PFM ON-DEMAND)
AN APC WEBINAR POWERED BY LP3 NETWORK
This is the on-demand version of the webinar for APC Pharmacy/Facility Members.
The webinar was recorded on September 14th, 2023.
Overview
In a survey of best practices in over 600 compounders, only little more than half indicated to define and always follow standard operating procedures (SOPs) during sterile compounding processes (ISMP, 2020). While SOPs are crucial to ensuring best practices in sterile compounding, they are often times not regularly reviewed and updated to reflect areas experiencing significant change or new regulations to remain compliant with USP Chapter <797>.
This activity aims to highlight key areas of sterile compounding practices that are important to recognize as best practices to implement in your SOPs in order to remain compliant with USP <797>. In Part 1 of this 2-Part series, Amy Summers, PharmD, BCSCP, highlights best practices in your personnel, facilities & equipment.
To access Part 2 of this 2-Part series, click here.
Institute for Safe Medication Practices (ISMP). ISMP Survey Provides Insights into Pharmacy Sterile Compounding Systems and Practices. October 22, 2020. https://www.ismp.org/resources/ismp-survey-provides-insights-pharmacy-sterile-compounding-systems-and-practices
Intended audience
- Pharmacists & Pharmacy Technicians
Learning Objectives
Pharmacists
- Describe the importance of remaining compliant with the latest USP sterile compounding standards.
- Review USP <797> requirements for personnel training and competency.
- Identify USP standards to ensure that sterile compounding is performed in a suitable facility and under controlled environmental conditions.
Pharmacy Technicians
- Recall the value of complying with the most up to date USP standards for sterile compounding.
- Recognize the importance of the implementation of USP <797> requirements for personnel training and competency.
- Define sterile facility and environmental conditions according to latest USP standards.
Hardware/software requirements
| Web browser | Google Chrome (most recent 2 versions) Mozilla Firefox (most recent 2 versions) Internet Explorer v11 Apple Safari (most recent 2 versions) Microsoft Edge (most recent 2 versions) |
Internet connection | Computer: 1 Mbps or better (broadband recommended) Mobile device: 3G or better (WiFi recommended) |
Software | No additional software needed |
Hardware | 2GB of RAM (minimum), 4GB or more of RAM (recommended) |
COPYRIGHT
This webinar is Copyright © Alliance for Pharmacy Compounding 2023.
| Amy Summers, PharmD, BCSCP | ![]() |
Amy Summers, PharmD, BCSCP, is an independent consultant, specializing in business, operations, quality assurance, and regulatory compliance matters for the pharmaceutical compounding industry. Dr. Summers earned her PharmD degree from the University of California San Francisco and was among the first pharmacists in the nation to earn a Board Certified Sterile Compounding Pharmacist (BCSCP) credential.
Dr. Summers has spent her entire career as a pharmacist in various settings centered around non-sterile and sterile compounding. She has formerly served as Director of Operations and Pharmacist in Charge at organizations engaged in compounding and also as Managing Director of a FDA-registered 503B outsourcing facility. With extensive experience in USP standards, accreditation, cGMP, and regulatory compliance, Dr. Summers has also served as an expert witness for matters related to compounding.
The accreditation period for this webinar has expired.
By registering for this Alliance for Pharmacy Compounding (APC) webinar, you confirm that your information, including contact information, will be shared with APC for direct marketing purposes.
CANCELLATION AND REFUND POLICY
There are no refunds, returns or transfers upon purchase of the webinar.

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