503(a) and 503(b) Identification Regarding Compounding Pharmacies

Mobile Pharmacy Clean Room by Odulair
Mobile Pharmacy Clean Room by Odulair

There are some notable differences between 503(a) and 503(b) identifications. 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. A USP 800 is specifically designed to accommodate the specifications of the standard. There are three main components – rooms in the build. The Odulair USP 800 Mobile Compounding Pharmacy Trailer and USP 800 Clean Room Trailer implements 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. Odulair Mobile Pharmacy Trailers are fully compliant with USP 800 guidelines and standards, and are equipped with HVAC units specially designed by Odulair to meet all USP 800 HVAC requirements.

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