Blog - Mobile Pharmacy Trailers by Odulair

USP800 New Regulations: Why Upgrade Hospital Pharmacies?

The USP 800 is a new regulation to promote patient health, worker safety, and address environmental concerns. USP 800 applies to all pharmacies, hospitals, patient treatment centers, patient treatment clinics, physician practice facilities, surgical centers, veterinarians, home health centers, and skilled nursing facilities that handle or compound hazardous drugs. Hazardous drugs pose a threat to the safety of patients and employees due to the ability to cause cancer, affect fertility, damage DNA or cause organ damage. All facilities compounding hazardous drugs will be required to utilize these specific kinds of pharmaceutical powder containment hoods starting December 1, 20191. Odulair provides mobile compounding pharmacy trailers that are fully compliant with USP 800 regulations.

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.

USP 800 Standards and Guidelines

USP 800 standards compliance significantly impacts existing compounding pharmacies infrastructure requirements. The new USP 800 is a catalyst demanding new cleanroom build-outs to higher standards. While renovation or expansion of existing compounding pharmacies are intricate and can be highly disruptive to a health-system pharmacy, Odulair delivers a complete free-standing pharmacy that is immediately operational, allowing for seamless sterile and hazardous drug compounding during any construction project. Hazardous drugs must be handled in separate negative pressure buffer rooms vented to the outdoors.

USP 800 & USP 797 Defined

The United States Pharmacopeia (USP™) is the only independent, non-profit, and non-governmental organization responsible for establishing an inventory of drug and supplement standards. United States Pharmacopeia introduced the USP 800 guidelines were created to protect the working environment of pharmacists and technicians when dealing with compounding Hazardous Drugs. This was first published in 9/29/2017, becoming official on 7/1/2018. USP 800 guidelines and standards can vary by State. USP 800 is specific for Compounding Hazardous Drugs, while the USP 797 is specialized for Non-Hazardous Drugs. The United States Pharmacopeia (USP) published standards in 2016 to protect workers who handle hazardous drugs. The requirements go into effect in December 2019. The changes reflected in the USP regulations follow more than three decades of research in the safety of the pharmacy and healthcare workers.

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.

USP 800 & USP 797 Definition

Pharmaceutical compounding, a job performed by compounding pharmacies, is the creation of a particular pharmaceutical product to fit the unique need of a patient. To do this, compounding pharmacists combine appropriate ingredients using various tools and processes. The United States Pharmacopeia (USP™) is the only independent, non-profit, and non-governmental organization responsible for establishing an inventory of drug and supplement standards. Their main function is to maintain a global catalog of over 4,500 monographs for prescription and over-the-counter (OTC) drugs, dietary supplements, and medical devices. The USP sets the bar for patient and worker safety and environmental protection. The standard was developed based on published reports of adverse effects in healthcare personnel from occupational exposure to hazardous drugs. Basically, the risk involved in handling hazardous drugs and exposing the staff too said compounds were known, but there was no regulation to minimize the potential risk of exposure.

All Mobile Pharmacy Trailers by Odulair as well as, Mobile Compounding Pharmacy Trailers, USP 800 Mobile Pharmacy Trailers, and Mobile Cleanroom Trailers by Odulair are available for sale and rental in the USA and are in compliance with USP 800 guidelines and standards.

Rent USP 800? Learn How To

Perhaps you have heard of the newly introduced regulations regarding healthcare employee safety: USP 800. Currently, the deadline to comply is December 1, 2019. Your compounding facility will have to seize operation past that date if it does not meet the safety standard. Odulair offers rental or lease units. If you would like to acquire an Odulair Mobile Pharmacy Clean Room – USP 800 Mobile Compounding Pharmacy – USP 800 Mobile Compounding Pharmacy Trailer by Odulair, please read below. The Odulair Mobile USP 800 Compounding Pharmacy and Mobile USP 800 Cleanrooms can be swiftly dispatched, planted on-site, and adjusted to be operable in record time. Odulair Mobile Pharmacy Clean Room – USP 800 Mobile Compounding Pharmacy – USP 800 Mobile Compounding Pharmacy Trailer by Odulair is perfect for renovations, new constructions, and disaster relief and emergency response situations.

Mobile Pharmacy Trailers, Mobile Compounding Pharmacy Trailers, USP 800 Mobile Pharmacy Trailers, and Mobile Cleanroom Trailers by Odulair are available for sale and rental in the USA.

USP 800 Mobile Pharmacy Trailer Rental

Mobile Clean Room Trailer Rental by Odulair

Rent or lease an Odulair Mobile Pharmacy Clean Room – USP 800 Mobile Compounding Pharmacy – USP 800 Mobile Compounding Pharmacy Trailer by Odulair. The Odulair Mobile USP 800 Compounding Pharmacy and Mobile USP 800 Cleanrooms can be quickly delivered, installed on-site, and ready to operate in record time. Odulair Mobile Pharmacy Clean Room – USP 800 Mobile Compounding Pharmacy – USP 800 Mobile Compounding Pharmacy Trailer by Odulair is perfect for renovations, new constructions, and disaster relief and emergency response situations.

Mobile Pharmacy Trailers, Mobile Compounding Pharmacy Trailers, USP 800 Mobile Pharmacy Trailers, and Mobile Cleanroom Trailers by Odulair are available for sale and rental in the USA.

USP 800 Compounding Pharmacy: Mobile Compounding Pharmacy by Odulair

The Odulair USP 800 Mobile Compounding Pharmacy Trailer and USP 800 Clearn Room Trailer include a positive pressure Ante Room, negative pressure Hazardous Drug (HD) Buffer Room and a mechanical room housing the Heating Ventilation Air Conditioning (HVAC) system and back-up generator with automatic transfer switch. Mobile medical trailers by Odulair are perfect for USP 800 compouding pharmacy renovations. The Odulair USP 800 Mobile Compounding Pharmacy Trailer is a mobile medical facility built on 53 ft long trailer chassis.

Mobile Pharmacy Trailers, Mobile Compounding Pharmacy Trailers, USP 800 Mobile Pharmacy Trailers, and Mobile Cleanroom Trailers by Odulair are available for sale and rental in the USA.

USP 800 Compliance: Hospitals and Facilities Upgrade

Transform your existing pharmacy environment into a fully compliant USP 800 Pharmacy facility. Odulair’s USP 800 sterile compounding pharmacies can be installed virtually anywhere and can be moved and enlarged. USP 800 Pharmacy Trailers by Odulair are available for acquisition, rental or lease. They are especially valuable for hospitals refurbishing their current facilities in order to to meet the new USP 800 standard’s deadline, Mobile Compounding Pharmacies by Odulair include ready-to-go Compounding Pharmacies and Cleanrooms that can be built on trailers and modular buildings and can perform as temporary or permanent USP 800 compliant pharmacies and clean rooms. 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. USP 800 compliant Mobile Compounding Pharmacies and Cleanrooms by Odulair are available in the US for sale, rental, or lease.

Mobile Pharmacy Trailers, Mobile Compounding Pharmacy Trailers, USP 800 Mobile Pharmacy Trailers, and Mobile Cleanroom Trailers by Odulair are available for sale and rental in the USA.

Hazardous Drugs Compounding: Differences between USP <800> and USP <797>. Why does <800> replace <797>

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.

USP 800 Compouding Pharmacies Identification: 503(a) and 503(b)

Compounding pharmacies are identified as a 503(a) traditional compounding pharmacy or a 503(b) outsourcing facility. USP standards and State Board of Pharmacy regulations, including USP 795 are applicable to all non-sterile compounding, USP 797 applies to all sterile compounding, and USP 800 applies to all compounding that uses hazardous drugs.

Mobile Pharmacy Trailers, Mobile Compounding Pharmacy Trailers, USP 800 Mobile Pharmacy Trailers, and Mobile Cleanroom Trailers by Odulair are available for sale and rental in the USA.