Wednesday, July 2, 2014

Article on Proposed new guidelines for compounding non-sterile hazardous drugs USP 800

 


Our compounding pharmacy customers are reviewing proposed new guidelines, USP <800> Hazardous Drugs—Handling in Healthcare Settings, for compounding hazardous drugs (HD).
Hazardous drugs are a category of pharmaceutical products that can harm the people who prepare them even though they are designed to have a therapeutic effect on the patients who use them.
Included are drugs that are carcinogenic, genotoxic, teratogenic, have reproductive toxicity, or are toxic to organs.
HDs may require either sterile or non-sterile compounding.
Our customers use our Ductless Containment Hoods for non-sterile compounding.
“No acceptable level of personnel exposure to HDs” – USP <800>
USP <800> proposes a separate room for non-sterile HD compounding. No matter which type of hood is used, it must have HEPA filtration and be exhausted to the exterior of the building.
The block diagram below uses the terminology of the proposed USP <800> document.

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