In a notice posted last Friday, USP announced its intention to postpone the official date of USP Chapter <800> — Hazardous Drugs — Handling in Healthcare Settings.
According to the notice: “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 original date for USP <800> to take effect was July 1, 2018.
This is good news for many as the July 1, 2018 date has created chaos in pharmacies across the country as they attempt to update their cleanrooms to become compliant. With that said, it’s a bit irresponsible for USP to wait this long to announce the postponement. Many acute care pharmacies are in the middle of lengthy and expensive cleanroom renovations.
Not to mention that many state boards of pharmacy have hung their hats on USP <800>. For example, California has already made significant changes to their regulations around hazardous drug compounding. As I’ve written previously, California made significant — and reckless — changes. Unfortunately, this postponement of USP <800> will make matters worse. It’ll be interesting to see how the California Board of Pharmacy handles the postponement.
Leave a Reply