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USP <797> Compliance

Although USP <797> sounds like an obscure regulation for compounders and manufacturers, it's actually something surgery centers need to maintain compliance with, as well. If you're not sure what USP <797> is, I'm confident you're familiar with it's standards. In fact, you're probably practicing them everyday. For example, have you heard of the "one hour rule"? Or syringe labeling requirements? These regulations have been taken directly out of USP General Chapter <797>. CMS, AAAHC, and Joint Commission (just to name a few), have all adopted USP <797> standards. If you're wondering how this affects your organization, take a look at the USP <797> must know info below.


Immediate Use Compounding If you happen to read USP <797> you'll notice that there are at least 4 different types of compounding: Immediate Use, Low Risk, Medium Risk, and High Risk. Without a hood or clean room, facilities are limited to Immediate Use Compounding. This is where the One Hour Rule comes from. To be compliant:

  1. You may mix a maximum of 3 products, from their original manufacturer's packaging, and enter each package no more than twice. Yes, sterile water or NSS would be considered one of those 3 products.

  2. The prepared mixture must be used within 60 minutes of preparation.

  3. The mixture must be under supervision or be used immediately.

  4. The mixture MUST include a label with the patient information, names and amounts of all ingredients, name or initials of preparer, and exact 1 hour beyond use date and time.

Reconstituting USP <797> clearly states that reconstituting a drug, or mixing for use, per manufacturer's instructions, is NOT considered compounding. These reconstitutions must still be used within 60 minutes of preparation if prepared outside of a sterile environment such as a hood. Manufacturer beyond use and storage information may include information about storage beyond 60 minutes,and could even reference storage for days or weeks. This information most likely refers to the stability of the product and longest possible storage time, assuming the drug was prepared in a controlled environment such as a hood. These extended storage times or conditions are not intended for mixtures prepared on a counter or medication preparation area outside of a hood.

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