We recently published a blog post on USP Chapter <800> on how LTC pharmacies can prepare for this change. However, there are some additional changes and developments being reported related to the state of this standard.
The upcoming revisions of USP chapters <795> and <797> seem to have been postponed until further notice. During the time of postponement and pending the resolution of Chapters <795> and <797>, USP <800> has been labeled as “informational and not compendially applicable.”
This new information raises some questions and has caused some uncertainty among pharmacies and the state boards that are tasked with enforcing the USP <800> standards for handling hazardous drugs.
In the interest of keeping our long-term care pharmacy customers up to date with the status of this regulatory development, we reached out to the various state boards of pharmacy for clarification on how they were handling this matter.
Enforcement of USP<800>
Enforcement of USP <800> is left to the individual state boards of pharmacy. Most have planned to implement the regulations fully, while some have delayed the date of enforcement.
Some states have indicated that they will not enforce USP <800> at all. Nearly all the state boards we contacted indicated that they were watching and waiting to see what happens with USP <795>, <797>, and <800>.
We recommend that our customer pharmacies reach out to their individual state boards, as applicable, for clarification on when and how USP <800> will be enforced in their state.
While enforcement may be delayed, the guidelines set forth in USP <800> can help protect healthcare workers from exposure to hazardous drugs. Pharmacies should still work towards achieving compliance with USP <800>, in accordance with their respective state boards and other regulatory bodies.
FrameworkLTC Supports USP<800>
But good news is that FrameworkLTC supports the current USP <800> requirements related to identification of hazardous drugs starting from our September 2019 release. Reach out to SoftWriters Support or review the document “What's New in FrameworkLTC Suite of Products in Sept 2019 Release” available on SoftWriters’ Customer Engagement Zone to know more.
SoftWriters will continue to educate our LTC pharmacies as future developments unfold with the goal of helping you stay up-to-date and compliant.
Mark Fulton is a Clinical Product Manager at SoftWriters, a Pittsburgh-based company that offers pharmacy management solutions to pharmacies serving the long-term care community. Mark applies his 16 years of pharmacy expertise to the software development process, creating value by building a more efficient linkage between customers and the development channel.
