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Compounding-Workflow-Unintended-Consequences-of-USP800

Unintended Consequences of USP <800>: Additional Costs for the Professional Stamps

There are definitely some unintended consequences of USP <800> implementation for certain pharmacies that I don’t believe the expert committee anticipated. I’m not trying to lay the blame at their feet because admittedly construction can be a fickle animal. I tell my pharmacy clients to go ahead and brace themselves because construction rarely finishes on schedule and on budget. Unfortunately these reasons that we dissect further into this blog are why independent community compounding pharmacies are getting out of the business of compounding. These are community pharmacies  that passionately and professionally serve their communities and now they have decided not to offer these services.  If they are a retail pharmacy they’re already getting kicked on those reimbursements and now to find out the budget for a USP 800 remodel project has ballooned to a place they are not financially willing to go because it is difficult to make a capital investment with a five plus year return on investment.  

Here is the simple explanation to the above statement, but we will examine this a little deeper in just a moment.  When a pharmacy takes on remodeling for USP 800, more times than not they (usually handled by the general contractor) have to apply for a building permit from the local city or municipality building department.  To apply for a building permit, most of the time, you need a set of drawings to submit for review so they building department knows the size and scope of the project.  Those official project drawings have to prepared and stamped by an architect licensed in that state.  

The process goes a little further.  If a make up air unit (or other appropriately designed air handling system) is being ordered to supply the 12 air changes per hour (refer to Table-2 for nonsterile requirements in the chapter) or 30 air changes per hour (refer to Table-3 for sterile requirements) requirements in the chapter) to the secondary engineering control (C-SEC), which is the negative pressure hazardous drug room, now you have new mechanical equipment being drawn and specfiied on the construction documents (e.g. blueprints). If a state licensed mechanical engineer has to design the new mechanical equipment, then they will also have to professionally stamp the drawings. 

Taking this a little further… Sometimes with new mechanical requirements comes possible structural requirements and even new electrical requirements.  An example is, a make up air unit weights 900 to 3000 pounds which requires structural support if placed on top of the building. If there are concerns about roof load, then a structural engineer is going to get invited to the project team to inspect the situation and give a professional opinion.

New mechanical equipment really likes 3-phase power to operate efficiently.  You can run it off of single phase power, but probably not the best use of energy. The air handling equipment needs an electrical wiring diagram for the electrical contractor and that drawn diagram will require a professional stamp.

What if the project requires putting in a new wash sink or hand hygiene sink not near an existing plumbing access point. It is possible that the building’s concrete slab has to be “trenched” to run new water and drain lines. This will most likely require a set of drawings to be submitted in the blueprint set going to the building permit office, which will require an engineer to professionally stamp. 

Just so you understand the implications of the construction drawing process, every professional stamp on the drawings is a charge to you and reflected in the overall project budget. Listed in the previous paragraph was five professional stamps: Architect, Mechanical Engineer, Structural Engineer, Electrical Engineer, and Plumbing Engineer. Sometimes the “MEP” stamp is from the same engineer or firm, but still a set of drawings to correspond with the construction detail.

A little over a year ago I consulted for a pharmacy that took up multiple bays (individual units) in a commercial strip center and it was revealed during permitting that they were required to undergo complete asbestos remediation. This process required hiring a very specific contractor to do investigative work and the final report revealed tens of thousands of dollars in unforeseen cost to remove and remediate the asbestos. On top of that they would have had to install new sprinkler systems in all the bays.  These issues can surface because when the commercial strip center was originally built some twenty years prior, those specific building code requirements didn’t exist. However those building codes exist today which requires all new building permits to be built to the most up to date building standards.  Very rarely will a building get “grandfathered” under older building codes. Based on the unforeseen costs the pharmacy sought out new real estate in the area that had already built to current standards.  This scenario has played out with my pharmacy clients quite a few times actually.

Now I don’t’ tell you this to scare you out of compounding, so please-please don’t misinterpret what I’m saying here.  My goal here to help you understand and prepare you for the unintended financial consequences I have encountered on previous USP 800 projects. My good friends at the ACHC/PCAB call me “bad news Bryan” and although I’m not flattered by the description, someone has to be honest here with the bumps and bruises of construction and its harsh reality.  I grew up with a blue collar construction family that built houses and even started off in that industry as a professional in the late 90’s through 2006, so there’s something that I’ve learned and shared with my pharmacy clients: Construction is not a pretty process.  Remember my earlier comment, construction is most always overbudget and rarely finished in the anticipated timeline.  I don’t mean to be “bad news Bryan” all the time, but there are unintended consequences for compliance with USP standards. 

My real hope for this blog post is that this gave you information you need to have real conversations with your bank, your contractors, architects, engineers, or whomever decides to join your USP 800 project-design-budgeting team.