Accreditation University workshops are specifically designed to prepare healthcare organizations for the initial or renewal accreditation process.


USP <800> Compliance Workshop sponsored by PCAB


Upcoming Workshop Dates:

July 26, 2017

Fairleigh Dickinson School of Pharmacy and Health Sciences

Florham Park, NJ



The Madison Hotel, Morristown, NJ

Call for special rate (973) 285-1800

Since the highly-anticipated release of USP <800> there has been much discussion among pharmacies about the interpretation of these new guidelines---and what that will mean for their operations once implementation takes full effect in 2018. During this workshop participants will examine the new standards and discover practical applications. This workshop will offer 6.5 CEs.


USP <800> has been recently approved, and all pharmacies should be in compliance by July 1, 2018. Though implementation is not until 2018, the standards are comprehensive and may require significant facility updates. Due to this, the time to start planning is now.

Key items addressed include:

Facility design

Creating an OSHA compliant HD List

Shipping HDs

OSHA Hazardous Communications Programs

Respiratory protection

Workflow considerations

Personnel training

Primary Engineering Controls (PECs)

Deactivation and decontamination

Increasingly, regulators are looking for pharmacies to use a thorough root cause analysis to address out-of-spec results or other issues. Part of the program will consist of interactive exercises with participants developing a root cause analysis and plan of correction for sterile and non-sterile events.


In addition, USP <797> has issued a revision draft.
We will cover key differences that are critical to your practice including:

Changes to how BUDs (Beyond-Use Dates) may be assigned

Testing requirements

Revised facility requirements

Gowning and garbing requirements

Learning Objectives:

Define what is considered a hazardous drug

Provide strategies to achieve USP <800> compliance

Review proposed changes to USP <797>

Discuss and perform a mock root cause analysis

Intended Audience:

Your Instructor(s):

Jon Pritchett, Pharm.D., RPh.

Bryan Prince, MBA

Associate Director,

 Compounding Safety, Workflow, and Design Consultant

This workshop is relevant to sterile and non-sterile compounders.

USP <800> Compliance Workshop Agenda - (8am - 4:30pm)

Registration/Continental Breakfast

Introductions/Agenda/PCAB Update

Intro to USP <800> – Protection Not New

How To Read SDS/HD List/What Should be on the List


The Environment – Sterile and Non-Sterile

Lunch Break -Questions




Receiving and Shipping

OSHA Communication Plan

HD Waste


USP <797> Update