Compounding Pharmacies by PharmaSalon

USP 800: Budgeting for People, Place & Practices


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As many of us have, I've been discussing USP 800. For what feels like years now, which is saying something because I've not been in the compounding space for that long. There's so many issues involved. The one I hear most often probably because it's the most expensive is how does a pharmacist who doesn't know anything about construction, carpentry, plumbing, electrical or HVAC begin to even create a lab that is compliant. Then there's the point that USP 800 includes OSHA and NIOSH, and they are under the banner of the Department of Labor. Because at its core, USP 800 is about a labor problem. And if you don't spend any money, whether you're a hospital or community pharmacy, or even a doctor's office, and you're dealing with these drugs and not making improvements, you run the risk of an employee picking up the phone to OSHA and saying, I'm being wronged here. And that's when the fines start to fly. And then there's a piece I just learned about the involvement of CMS, the organization that controls Medicare and Medicaid, this is huge for hospital pharmacies, because non compliance is a real risk to that very important revenue stream and it could be cut off. 

If you're thinking that sounds like a lot of information, how are they going to touch on all that in 20 minutes? We're not. This is a long episode. So get a cup of coffee, some comfortable headphones, and let's begin.

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Compounding Pharmacies by PharmaSalonBy Vivian Juter Frankel