Practice Pearls for Line Pharmacists and Technicians: USP 795, 797, and 800 | August 19, 2024
POWERED BY LP3 NETWORK
This webinar will be live on August 19th, 2024 at 6:00pm Eastern Daylight Time (EDT).
Overview
On November 1, 2023, the United States Pharmacopeia (USP) published quality standards for non-sterile compounding (USP <795>) and sterile compounding (USP <797>). This brought hazardous drug compounding (USP <800>) to the forefront as well. Combined these three USP chapters make up the standards of practice for compounding in the United States and beyond.
This webinar explores the infrastructure and nuance to these standards bringing clarity and precision to the manner in which compounding needs to be practiced. However, it is not without the need for professional judgement, evidence-based decision-making, and reliance on additional USP chapters that the compounding community must move forward.
Join us as we talk to the responsibilities outlined, the quality assurance and quality control needed, and the standard operating procedures necessary to practice compounding as we endeavor to bring an explanation and clarity to these new standards of practice.
Intended audience
- Pharmacists & Pharmacy Technicians
Learning Objectives
Pharmacists & Pharmacy Technicians
1. Outline the roles and responsibilities of the Designated Person(s) and other compounding personnel.
USP <795>
2. Explain significant changes in non-sterile compounding standards of practice.
3. Relate water activity and stability to non-sterile compounded preparation (CNSP) beyond-use dating.
USP <797>
4. Explain significant changes in sterile compounding standards of practice.
5. Relate Category 1, Category 2, and Category 3 Compounded Sterile Preparation (CSP) requirements to beyond-use dating.
USP <800>
6. Outline requirements of the Hazard Communication Program.
7. Describe hazardous drug handling and compounding.
8. Perform an assessment of risk to determine alternative containment strategies and/or work practices.
Hardware/software requirements
We will be using Zoom for this webinar - full system requirements can be found here. You can download the Zoom client here.
Web browser |
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Internet connection |
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Misc |
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Hardware | Minimum | Recommended | |
Processor | Single-core 1Ghz or higher | Dual-core 2Ghz or higher (Intel i3/i5/i7 or AMD equivalent) | |
RAM | N/A | 4 GB |
COPYRIGHT
This webinar is Copyright © Alliance for Pharmacy Compounding 2024.
Michael Shafor, PharmD, RPh |
Dr. Mike Shafor is a fourth-generation pharmacist specializing in sterile compounding and hazardous drug handling. Dr. Shafor attained his Doctorate in Pharmacy, from Nova Southeastern University (2006).
Dr. Shafor spent the first few years of his career working as a staff pharmacist, and then Pharmacy Manager of a large regional home infusion pharmacy (Ft. Myers, Florida), where he prepared IV antibiotics and TPNs for homecare. In 2008, Dr. Shafor became manager and then owner of a sterile compounding pharmacy (Tampa, Florida), which prepared large batch sterile vitamin, hormone, and peptide injectable preparations. In 2014, Dr. Shafor became Quality Control Manager of a hazardous sterile compounding outsourcing facility that specialized in preparing cytotoxic medications and MABs for chemo-therapy protocols. He supervised the preparation of cytotoxic medications to be dispensed to the Oncology departments of over 60 different hospitals throughout Florida and Georgia. In 2016, Dr. Shafor started Osmotic International, a pharmaceutical consultation and formulation services practice specializing in pharmaceutical and dietary supplement formulation and manufacturing process development, as well as compounding personnel training.
Dr. Shafor is speaking at Educon on behalf of Medisca Networks and LP3 Network, where he has worked for the last 11 years as a consultant for technical support services, and a writer and facilitator of sterile and non-sterile compounding training programs for Canada, the United States, and Australia.
This activity is eligible for ACPE credit; see final CPE activity announcement for specific details.