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Washington State Requests USP 797 Input By March 22nd

Friday, March 18, 2016   (0 Comments)
Posted by: Dagmar Anderson
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The Washington State Pharmacy Quality Assurance Commission is seeking comments on the U.S. Pharmacopeial Convention (USP) General Chapter <797> revisions. Please click here to view.  

For the past three months the Pharmacy Quality Assurance Commission (Commission), Department of Health (DOH) and stakeholders have been actively developing a Sterile Compounding [USP <797>] Self-Assessment Compliance Checklist. Over 90 stakeholders provided comments or attended two workshops to develop this checklist. In addition, the Commission’s Sterile Compounding committee and DOH staff extensively reviewed and researched stakeholder input to best reflect sterile compounding’s current requirements and recommendations. 

They are seeking final comments on the attached Sterile Compounding [USP <797>] Self-Assessment Compliance Checklist. These comments will be considered before the checklist is presented to the Commission for approval at the April 14, 2016, meeting. Please note:

•         The first part of the checklist includes the “shalls” and verbatim language form USP <797>.
•         The last part of the checklist includes best practice recommendations addressing isolators.

Please forward your comments to SterileCompoundingRules@doh.wa.gov by March 22, 2016.


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