USP 800 Mandatory Requirements and Changes for 2017

USP <800> Mandatory Requirements and Changes for 2017

Learning Objectives

United States Pharmacopeial Convention (USP)

USP and Professional Practice

Purpose - <797> vs. <800>

USP Abbreviations & Jargon ISO air quality classifications ISO-5 ISO-6 ISO-7

USP - Should versus Shall/Must

Why <800>?

Why <800>?

<800> - Big Spotlight to Speed Progress

<800> broader than <797>

Chapter <800> Impact

Chapter <800> Impact

New Jersey “Hazardous Drug Safe Handling Act” – A 837

New Jersey “Hazardous Drug Safe Handling Act” – A 837

New Jersey “Hazardous Drug Safe Handling Act” – S 468

New Jersey “Hazardous Drug Safe Handling Act” – S 468

Chapter <800> Impact

Physical Environment Typical Current State

<800> Impact Physical Environment

<800> Impact Physical Environment

<800> Impact Physical Environment

<800> Impact Physical Environment

<800> Impact Physical Environment

<800> Impact SOPs and Quality Program

<800> Impact SOPs

<800> Impact SOPs

<800> Impact SOPs

<800> Impact SOPs

<800> Impact SOPs

<800> Impact SOPs

<800> Impact SOPs

<800> Impact SOPs

<800> Impact SOPs

<800> Impact SOPs

<800> Impact SOPs

<800> Impact SOPs

<800> Impact SOPs

<800> Impact Personnel Training/Competency

<800> Impact – Disposable supplies

<800> Impact Surveillance - Environment

<800> Impact Surveillance - Environment

<800> Impact Surveillance - Medical

<800> Impact Surveillance - Medical

<800> Impact Surveillance - Medical

Who wrote <800>

Who were conspicuously absent from writing <800>?

<797> and <800> How to Implement?

<797> and <800> How to Push Back?

Dialogue

Willis C Triplett, Pharm. D.

Background Reading

Off-Label Use Disclosure(s)

Financial Disclosure(s)