General Chapter USP <797> and USP <800>
This has been updated in our 26 SEP 2019 posting. On June 1, 2019, the United States Pharmacopeia (USP) released updates to the General Chapter USP <797> Pharmaceutical Compounding - Sterile Preparations. The official date for the revised standard was set for December 1, 2019 but formal appeals to the revision require postponement of the official date until further notice (https://www.uspnf.com/notices/compounding-chapters-postponement). In the meantime the 2008 version of General Chapter USP <797> remains official.
The USP General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings, which was published in February 2016 is on track to go into effect on December 1, 2019.
Eurofins EMLab P&K are currently preparing to adjust our services to accommodate the new requirements. Below is our Frequently Ask Questions [FAQ] to start a series of communication and updates with our USP clients to make sure that we capture everything and share it with you.
We are also hosting a Webinar on this topic on Oct.23rd, presented by Dr. Michael Berg. To register for this webinar, click here.
Frequently Asked Questions
Q: Do I need to make changes in my environmental sampling procedures and when do I need to make those changes?
A: The revision of the chapter <797> was published on June 1st, 2019 and the effective date has been postponed until further notice due to formal appeals. We will work with our clients to make any needed adjustments but we recommend caution against any pre-mature changes.
Q: What are the changes in the new revision of USP Chapter <797>?
A: We recommend downloading a copy of the revised chapter at USP.org for a review and/or to participate in the training program at USP for details and a comprehensive assessment. Some of the changes affecting the environmental monitoring program are listed below:
Q: How is Eurofins EMLab P&K going to support USP <797> testing going forward?
A: As leader in this industry Eurofins EMLab P&K is committed to provide highest quality service and data. We are in the process of implementing operational and IT changes to accommodate the changing needs of our USP <797> clients. For more details and questions please contact our client service team or Dr. Michael Berg at (firstname.lastname@example.org).