USP 800 and Community Pharmacy
So you don’t compound…….
Does USP 800 apply to you?
“USP who? 800?… How many chapters do they have?
I haven’t compounded since that rotation in ‘99 with that cute little pharmacy…. I wonder if they are still open…”
If that thought just passed through your mind:
KEEP READING…. Because, YES, this applies to you.
WHAT is USP 800?
It is a chapter of the United States Pharmacopeia that creates guidelines for good manufacturing practices and compounding. This particular chapter applies to the handling of hazardous drugs. The purpose of the chapter is to create policies and procedures that minimize your staff’s risk of exposure to hazardous drugs. The hazardous drug list come from the NIOSH list published by the CDC. First published in 2016, it created A LOT of discussion and concern across the pharmacy world, resulting in implementation dates getting pushed back. The latest revision was posted at the end of May 2019 and will become official December 1, 2019.
WILL this affect you?
USP itself does not enforce any of its chapters. That decision comes from your state board of pharmacy, department of health, and the FDA. Unfortunately, a lot of states boards have yet to decide if they will adopt all, part, or none of USP 800 into their regulations.
But the bottom line is this: If your pharmacy dispenses any of these medications, this chapter applies to you.
Not sure if you have hazardous drugs on your shelf? Link to the full list is below. But here’s just a few examples.
HOW will this affect you?
You can chose to “wait and watch” like we all have been for the last few years: crossing your fingers and cogitating with other owners at conferences, balking at the inundation of regulations now-a-days.
OR you can look at what this really is: Protecting your staff.
Just how robust do the policies and procedures need to be is up to you, though there are minimal requirements with which you will need to be compliant.
If you don’t compound, there’s not as much that you need to do.
But rather than have a looooooong article, I’m going to break it down into sections.
Hopefully, easier to digest so I don’t lose you out there.
Stay tuned for the next episode. Same bat time, same bat place…
800 CHAPTER BREAKDOWN-
Cliff notes user over here!
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ASSESSMENT OF RISK-
Even though I despise Excel more than you.
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SOPS & SUPPLIES-
Simple solutions for you.
Don’t be the trampled by the bull,
grab it buy the horns.
REFERENCES: (for your reading pleasure)
Download your copy of USP 800- its free. Don’t let anyone charge you for it