USP<800> Now What? Building a Plan for Compliance

At this year’s American College of Apothecaries annual conference in Ponte Vedra, Florida, Bryan Prince (Compliance Workflow and Design Specialist) is speaking on the topic of “USP <800> – Now What? Building a Plan for Compliance.” The United States Pharmacopeia (USP) announced on September 30,  2017 that the implementation deadline for USP chapter <800> would be pushed back from its original date of July 1, 2018 to December 1, 2019. Compounding pharmacies handling hazardous drugs now have an additional sixteen months to build a plan and implement the necessary engineering standards and procedural standards. The additional sixteen months may seem like a significant reprieve from the overwhelming task, but Bryan will detail why compliance planning should start sooner than later.

Bryan’s ACA conference talk on Friday, March 2nd will clarify and outline a minimum achievable timeline for chapter <800> implementation.   Bryan has consulted on and designed approximately thirty different compounding pharmacy projects and has established that a minimum timeline for full implementation of the chapter is seven months. “Seven months is achievable with a consistent effort. The downside of being a pharmacy owner who wears a lot of different hats on a daily basis, is that it will be difficult to consistently focus on this multifaceted project.” During the ACA presentation Bryan will show a visual GANNT chart, which is a useful project management tool, that details the compliance process step by step with a defined timeline.

Are there exceptions to the timelines that Bryan has outlined in the presentation? “There have been two projects that were completed in six months, but a lot of engineering and infrastructure pieces were already in place at those pharmacies. Additionally, the laborious task of writing dedicated SOPs for hazardous drug handling was outsourced to a consulting group which alleviated the burden away from the pharmacy staff. So actually a more realistic timeline is seven to twelve months because running our pharmacy’s daily business takes priority and time never seems to be on our side.”

The takeaway advice Bryan is offering to our readers here is, “don’t wait until 2019 to start the planning process”. The benefit of planning your pharmacy’s <800> compliance project is to build a timeline that is not rushed.” The advice seems wise because we all know that rushed projects are stressful, not efficient, and can be riddled with costly mistakes.

Bryan Prince is an exclusive lead consultant for Encore Scientific and offers our customers a free 30-minute consultation to discuss their pharmacy’s unique USP <800> challenges. We recommend you utilize his knowledge to help start your compliance planning project. Schedule a time that is convenient for you to talk with Bryan: