Challenges of USP 800 Compliance

2019-05-01 16:09:00
Tags: challenges,compliance,compounding,Retail,usp 800



Dana Saffel, PharmD, CGP, CPh, FASCP, CEO of PharmaCare Strategies, is certified in geriatric pharmacy. In this video, filmed during the American Society of Consultant Pharmacists Forum in Washington, DC, she relays the challenges to USP 800 compliance.  

Dana Saffel, PharmD, CGP, CPh, FASCP: So, with regards to any of the USP standards, the length it takes for a state board of pharmacy to make the decision about whether they are going to enforce all or a part of the language of the USP is a challenge for us right now. We know that the standard becomes official for USP 800 and the revised 797 December 1, 2019 – just this year, 7 months from now. Boards of pharmacy though could take another year or 2 before they actually rule 1 way or the other on USP 800.

If they made a ruling, the pharmacies would, number 1, have time to get their affairs in order if they had to buy new equipment, change standards. In long term care, we use a lot of prepackage machines because we package things in punch-card packaging, compliance packaging, unit-dose packaging that we utilize automated machines to do. In particular with USP standard 800, if we are to comply with that, then we could not continue to put USP hazardous drugs through a common-channel dispensing funnel in an automated machine. We would have to change procedures, that certain drugs would have to be packaged in a different type of packaging or packaged separately through a different machine. We would have to implement policies and procedures that if we are packaging–let’s just pick on warfarin, because that happens to be one of the most commonly used NIOSH drugs in long-term care–we would have to. Theoretically, we would need to make sure that we were packaging all the warfarin with a separate packaging system because of the dust that could be created from the warfarin tablet, and we don’t want to contaminate any other medication.