We have known for a few months now that the official active date for USP General Chapters <795>, <797>, and <800> will be postponed from its original date of December 1, 2019. While further consideration is being given to certain aspects of Chapters <795> and <797>, the new official date is yet to be determined. The appeals in question cover details concerning beyond-use dating provisions as well as questions regarding alternative technology. The previous iterations of Chapter <795> (2014) and Chapter <797> (2008) remain official during this postponement.
Interestingly, USP Chapter <800>, which is not expected to change as a result of these appeals, is “official” as of this past December 1, although it is considered to be informational at this point, and its compendial applicability will not be established until the remaining Chapters are made official. That said, once those chapters are approved, USP <800> will be enforceable as well.
While we may have come to expect some unsettledness with the creation and establishment of these complex guidelines and standards, the fact remains that the tenets of these Chapters should have been part of implementation plans for several years now (particularly those of <795> and <797>). As adherence to USP standards remains a vital aspect of hospital pharmacy practice, we plan to continue devoting editorial coverage to this important topic. As always, it is beneficial to learn from your peers about strategies for offsetting the lack of official guidance during this time. Fortunately, there are many best practices in place, which are detailed on the pages of Pharmacy Purchasing & Products, on our website at pppmag.com, and via other outlets, such as our webinar series.
The next installment in our To The Point webinar series:
Automating Preparations of Hazardous CSPs will debut on Friday, January 31.
Visit pppmag.com/tothepoint to sign up today.
All the best,
R. Mitchell Halvorsen
Correction: In our November 2019 cover story, USP Enforcement Status Update, page 30, the top bullet should state “The surface sampling action level for ISO Class 8 is now defined at >50 CFU/sample, which requires that any microorganism recovered be identified.” PP&P regrets the error.
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