USP <800> refers to a new set of standards designed to protect patients and healthcare workers from exposure to hazardous materials, including the controlled storage of pharmaceutical drugs. The regulation is named "General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings", and it was released by USP (United States Pharmacopeia).
The USP <800> standards go into effect on December 1, 2019, and all companies must be in compliance at that time. Failure to comply can result in fines, suspensions or loss of licensure. Achieving compliance is a significant challenge for healthcare facilities, as implementing the type of structural upgrades and refurbishments required to meet compliance can cost up to hundreds of thousands of dollars.
At a high level, the guidelines state that when compounding hazardous drugs:
Environmental chambers are required to operate at negative pressure.
Pass-through refrigerators are no longer permissible.
Conventional (compressor-based) refrigerators must vent outside the cleanroom.
Dedicated refrigeration must be maintained.
USP <800> and Refrigeration
According to the USP <800> guidelines, refrigerators must be placed physically near an exhaust and/or a low wall return in order to allow any particulates created by the compressor to be swept from the cleanroom. The guidelines recommend that exhausts should be adjacent to the compressor, behind the refrigerator.
Phononic & USP <800>
Phononic aims to help healthcare companies prepare to meet USP <800> compliance by providing compressor-free, solid-state medical-grade refrigerators that are "out of the box" cleanroom-ready, eliminating the need for expensive renovations or ventilation. Solid-state technology eliminates contamination by getting rid of the mechanical vibrations that lead to particulates, as well as the need for grease or oil. Our cleanroom-ready medical-grade refrigerators are available in two sizes to meet your space needs: countertop and undercounter.
Defining Hazardous Drugs
NIOSH (National Institute for Occupational Safety and Health) defines a hazardous drug as one that exhibits one or more of "carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs." (source: https://www.usp.org/compunding/general-chapter-hazardous-drugs-handling-healthcare)
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