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How can your company prepare for USP <800>?

What is USP <800>?

In the 1980’s, several scientific publications began demonstrating antineoplastic drugs, used for treating cancer and most often compounded on site at a hospital or out-patient treatment facility, could be considered hazardous to individuals who came in contact with them. As a result, special handling would be required to manipulate these drugs during processes such as compounding, dispensing, and disposal. These antineoplastic drugs would become known as hazardous drugs (HDs); and, as noted by Zhao and Radwick1, it wasn’t until 2010 that clear support for linking HDs to health risk in healthcare workers was established.

In 2014, United States Pharmacopeia (USP) proposed the Hazardous Drugs – Handling in Healthcare settings chapter, also known as USP <800> to supplement USP <795> and USP <797>, which outline the safe handling and compounding of non-sterile and sterile compounds. In its current form, USP <800> is informational only and not compendially enforceable, unless an entity with legal authority over a hospital or practice decides to enforce the regulations. Read more >>

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USP <800> Compliance