Is your Compounding Pharmacy renovation taking longer than expected? Are you worried you won’t meet the new USP regulations by December 1, 2019 and are afraid to be shut down?
Don’t let this happen to you. Odulair has established solutions for your Compounding Pharmacy needs. Our rental fleet of Mobile USP 800 Certified Mobile Pharmacy Trailers are guaranteed to meet the new guidelines. These new USP 800 guidelines go well beyond the previous hazardous drug guidelines established by USP 797.
The United States Pharmacopeia (USP) 800 drafts regulations for compounding pharmacies. 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. Odulair’s team of professionals has completed research in order to have our Mobile Compounding Pharmacy Trailers pass CETA Certification. We are the only manufacturing company who will guarantee our rental USP 800 Mobile Pharmacy Trailers meets the new standards.
It’s important to note that USP 800 replaces USP 797 for Compounding Pharmacies. USP 800 regulations are designed to integrate procedures and engineering controls which minimize worker and environmental exposure to hazardous drugs. The new codes 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 meticulous emphasis on worker safety and sets detailed requirements for “negative pressure” environments in Compounding Pharmacies.
Don’t be fooled by other rental compounding trailers. If the Mobile Compounding Pharmacy facility is built to USP 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 by the beginning of December. All Mobile and Modular Compounding Pharmacies by Odulair are compliant with the new requirements in USP 800 clean room guidelines. We have USP 800 Pharmacy Trailers in Mobile or Modular options for rental in the USA.
If you want to skip the time consuming renovation of your facility, Odulair offers Modular USP 800 Units for sale as well. Don’t need both? Odulair specializes in custom design and manufacturing to provide efficient solutions to complex problems.