MPhA Town Hall - Duluth

Understanding USP 800 and potential changes coming in 795 and 797

View & download the Town Hall slides here.

Description

USP Chapter 800 Hazardous Drugs was published in February of 2016, with a twice-delayed implementation date. We will discuss the specific steps you need to take to be compliant, including the Assessment of Risk, facility requirements, personal protective equipment and staff training requirements. Major revisions of both USP Chapter 795 Nonsterile Compounding, and USP Chapter 797 Sterile Compounding were published in June of this year. Significant revisions we will discuss include changes in categories of compounds, beyond-use dating, environment, sampling, and harmonization with USP Chapter 800.

Objectives

1. Describe the process to construct a hazardous drug (HD) list and perform and assessment of risk for your pharmacy
2. Define the key engineering controls, and the types and specifications of personal protective equipment (PPE) required for compliance with USP Chapter <800>
3. List the elements required in your HD training program and personnel competency assessments.
4. Identify the major changes to USP Chapter <795> including beyond-use dating.
5. Identify the major changes to USP Chapter <797> including beyond-use dating, environment and sampling.

Agenda

Speaker

Denise M. Frank, BPharm, RPh, FACA

Denise Frank is a registered pharmacist in Minnesota with a BS degree in Pharmacy from the University of Minnesota and is a fellow with the American College of Apothecaries (ACA). She has more than 30 years of experience as a pharmacist. She is the owner of Frank Consulting, LLC and a Senior Associate with Gates Healthcare Associates. Her consulting is in the areas of pharmacy practice, technician training, compounding, USP 795/797/800, pharmacy accreditations, and operational and regulatory compliance.

Where

Pickwick Restaurant & Pub
508 E Superior St
Duluth, MN 55802