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The USP standard for Pharmacies has gone through rapid changes in the past couple of years, leaving pharmacy owners buried in requirements, renovations, and above all questions. Chapters 795 and 797 of the USP standard were developed out of necessity, in response to recurring tragedies linked to drug compounding practices. And since USP 797 was first adopted by the industry in 2008, rapid changes have been added to the drug compounding standard. Pharmacy owners have found themselves renovating building spaces only to be chasing changes to the latest standards.
To keep up with the fast pace of standard changes Fitzemeyer & Tocci wrote a guide “Pharmacy Designs and Standards: The Past, Present, and Future”. The purpose of the guide is to draw attention to the importance of the USP standards as well as highlight the difficulties compounding Pharmacies are experiencing with required renovations. Below is a table of the changes that occurred between the USP chapter updates for reference.
The changes listed above do not replace or supersede one another and all regulations must be followed. USP 797 regulates the compounding of hazardous and nonhazardous material, while USP 800 regulates the handling of hazardous material. Compounding pharmacies have to keep track of all USP requirements that regulate their specific practice, and the list is long. Everything from floor plan spacing requirements to equipment available, to employee training, and even building system operation are all covered under USP.
The safety of drug compounding facility workers as well as the safety of pharmacy customers is extremely important and following the USP standard isn’t a suggestion - it’s a requirement. The building renovations required to keep a compounding pharmacy operational can be expensive and extensive, never mind trying to hit a moving target with seemingly constant updates to the standards. But the engineering team at Fitzemeyer & Tocci understands what it takes to keep these spaces safe, provide unique solutions to minimize the cost of renovation, and look to the future to reduce the need for constant renovation.
Download the full guide here.
Zach DiSalvo Samantha Oliver
Plumbing Project Engineer Electrical Design Engineer