In April of 2014, Premier Pharmacy Labs registered with the FDA as a 503B Outsourcing Facility under the new Drug Quality and Security Act (DQSA). This voluntary registration is made available to large-scale facilities engaged in non-prescription anticipatory compounding as stated in the 503B section of the federal Food, Drug, and Cosmetic (FDC) Act.
“The FDA urges providers to purchase from 503B registered compounders.”
As a partner of choice for many hospitals and clinics alike, Premier Pharmacy recognizes the need for a higher level of scrutiny and oversight of our industry. Premier’s registration as a 503B facility serves as a commitment to patient safety and improved quality.
To that end, we have significantly changed our internal processes to better align with GMP regulations and improve the efficiency of all operations. Premier hired GMP consultants to rewrite protocols, validate equipment, improve lab operations, train staff, and establish a continuous quality monitoring system.
Premier has also expanded and streamlined compounding operations by adding new clean rooms and designing the latest IT infrastructure system to scale easily with our growth and customer demands.
All the changes have us working hard around the clock, but we welcome the excitement and possibilities this new regulatory designation affords our market. As the Drug Quality and Security Act (DQSA) continues to be clarified, Premier Pharmacy Labs will be at the forefront, meeting or exceeding these new regulations.