503B Facilities were created to produce sterile human compounded drugs for in-hospital/clinic use
As states began adopting laws pertaining to clinic-use veterinary compounding, the need was realized to build a 503B
Planning for Atlas Pharmaceuticals began in March 2016
Purpose is to provide cGMP quality sterile and non-sterile products for practitioners for use in their facilities
As a newly constructed FDA registered 503B facility, we implement the Current Good Manufacturing Practices (cGMPs) set forth by the rules and regulations designed for compounding in this type of facility. The 503B compounding facility came into existence after the passing of the Drug Quality and Security Act (DQSA) of 2013. DQSA set forth provisions to create two different types of compounding facilities. A 503A pharmacy is a traditional compounding pharmacy that prepares compounded medications pursuant to a prescription for a specific patient and does not make large quantities for office-use. A 503B facility may prepare medications pursuant to a prescription and has the ability of preparing large batches of medications for office-use. In order to maintain the quality and integrity of large batch compounding, 503B facilities are required to follow cGMPs as followed by the pharmaceutical manufacturing industry. This is a new regulatory arena for pharmacy and one in which quality is built in to each step during batch production to ensure the defined standards are met on a consistent basis from batch to batch.