1. ENSURING YOUR PRACTICE IS USP 800 COMPLIANT
John Dodd, CMPE
Director, Business Optimization and Clinical Consulting

2. Agenda Acronyms Why USP 800? Benefits of USP 800 Challenges of USP 800
How to make USP 800 work for your Patients and your Practice

3. Acronyms There are 30 acronyms in USP 800. Examples:
BSC – Biological Safety Cabinet (Hood)
CACI – Compounding Aseptic Containment Isolator (Hood with gloves)
C-SCA – Containment Segregated Compounding Area (Negative Pressure Room)
Other confusing factors – USP 795 –

4. Why USP 800? History Studies began in the last 1970s
Federal Government Involvement
OSHA published the first set of guidelines in 1986 for the handling of antineoplastic drugs
They followed that up with the publication of the Hazard Communication Standard concerning all hazardous drugs in 1994, revised in 2014
NIOSH publishes the tables that lay out the hazardous drugs based on specific criteria (Currently in revision)
USP Published in February 2016 but pending enforcement until December 1, 2019
Patient and Staff Safety

5. Benefits of USP 800 Safety – Patient and Staff Protection Training
Enforcement

6. Challenges of USP 800 Cost Space Documentation Training
New requirements on PPE, CSTDs, negative pressure room, etc.
Enforcement
Inspections
Unknowns

7. How to make USP 800 work for your patients and your practice
Understand the requirements
Appoint an HDDP that will be your Champion
Practice leadership has to step up and embrace the program
Use available ION resources

8. USP 800 Consulting Offering
USP 800 Gap/Risk Analysis
Three part offering
14 Question Questionnaire
Onsite Visit
Written report
For more information on this, contact:
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