Are you aware of the dates for USP 800 relating to your state? You may want to check if your Compounding Pharmacy facility was built to USP 797 code or is USP 800 compliant. By December 1, 2019 all Compounding Pharmacies in the United States will have to be in compliance with USP 800 sterile compounding design and clean room guidelines.
It’s important to highlight that USP 800 replaces USP 797 for Compounding Pharmacies performing hazardous drug compounding and sterile compounding processes. Compounding Pharmacies will have to be in compliance with the new 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.
These changes will take time to implement at any size facility. Don’t wait to renovate, Odulair can transform your existing pharmacy environment and provide a fully compliant USP 800 Pharmacy facility. Our Mobile Compounding Pharmacy Trailers are guaranteed to meet code. Odulair offers Mobile Compounding Pharmacy Trailers, USP 800 Mobile Pharmacy Trailers, and Mobile Cleanroom Trailers for sale and rental in the USA. Odulair Mobile Pharmacy Trailers can be installed virtually anywhere and can be relocated and expanded to meet multiple site demands for small or large hospitals, healthcare systems, businesses and government agencies.