USP <800> drafts regulations for compounding pharmacies, which are set to take effect on December 1, 2019. USP <800> guidelines are designed to integrate procedures and engineering controls which minimize worker and environmental exposure to hazardous drugs. Regulations are clearly designed to implement safe handling of hazardous drugs. Where USP <797> fails to thoroughly address worker safety and allows for vague terminology pertaining to handling of hazardous drugs, USP <800> places a greater emphasis on worker safety and sets specific requirements for “negative pressure” environments in compounding pharmacies. It’s important to note that USP <800> replaces USP 797 for compouding pharmacies. If your compouding pharmacy facility is built to <797> code, then check the dates that apply to your state, as compounding pharmacies will have to be in compliance with USP <800> design guidelines. All Mobile Compounding Pharmacies and Modular Compounding Pharmacies by Odulair are compliant with the new requirements in USP <800> guidelines. These new USP <800> guidelines go well beyond the previous hazardous drug guidelines established by USP <797>. Among those changes, the new USP <800> design guidelines are different in respect to negative pressure environments, requires a dedicated space for any hazardous drug compounding, warning signs and demarcation lines for hazardous areas, labeling requirements, and pass thru requirements between areas.
Rental of Compounding Trailers, Mobile Pharmacy Trailers, Mobile Compounding Pharmacy Trailers, USP 800 Certified Mobile Pharmacy Trailers, and Mobile Cleanroom Trailers by Odulair are available for sale and rental in the USA.