503B Outsourcing Facilities

503B Outsourcing Facilities are specialized manufacturing facilities approved by the FDA that produce large batches of sterile medications, often for hospitals and clinics. They operate under strict quality standards to ensure safety, consistency, and compliance with regulations. These facilities allow for the timely supply of compounded medications, especially during shortages or emergencies, by licensing them separately from traditional pharmacies. Essentially, they produce bulk sterile drugs in a controlled, regulated environment, helping healthcare providers deliver safe and effective treatments to patients.