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 […]
Tag Archives: USP 800
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 […]
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 […]
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 […]
What is a Negative Pressure Room?
Prior to USP 800 , third party testing of wipe/swab samples revealed contamination problems both inside the lab and, more troubling, in general areas like break rooms and retail space. Similar results found in compounding pharmacies throughout the USA. To prevent that, USP 800 has as requirement negative pressure rooms in order to eliminate the […]
USP 800
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 800 guidelines developed by the United […]