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USP Postpones Chapter <800>

November 2017 - Vol.14 No. 11 - Page #1

While certainly notable, it makes sense that USP has announced its intent to postpone the official date of General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings. Per USP:

The intent of this postponement is to align the official date of General Chapter <800> with the official date of the next revision of General Chapter <797> Pharmaceutical Compounding - Sterile Preparations, to provide a unified approach to quality compounding. The next revision to General Chapter <797> is anticipated to be published in the Pharmacopeial Forum 44(5) September-October 2018 for a second round of public comment and is expected to become official on December 1, 2019. Sections of the revised <797> may have longer implementation dates that will allow time for adoption of the standard.

The new expected official date for USP <800> is December 1, 2019. This is a delay of 17 months from the previous deadline. Both USP General Chapters <797> and <800> are in concert on several topics given the overlap in certain product areas. With this in mind, it is certainly reasonable to align the two in terms of official release.

Although many pharmacy directors may be releasing a sigh of relief, there is no reason to slow or diminish plans to implement the tenets of both chapters. The threats posed by mishandling and misuse of hazardous and sterile compounds are constant, and a delay such as this should have little bearing on plans to bolster safety efforts. This alignment of USP chapters provides the opportunity for your pharmacy to bring its operations into agreement with both documents. With this goal, even more effort should be given to USP compliance than before.

All the best,

R. Mitchell Halvorsen

P.S. The annual ASHP Midyear Clinical Meeting & Exhibition (Orlando, December 3 – 7) is a perfect time to discuss both successes and challenges of USP compliance with your colleagues. There will be numerous education opportunities, as well as insight into the latest technologies to assist in gaining and maintaining compliance. We hope you will stop by Booth 806 and say hello to PP&P.


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