We’re an FDA registered 503B Outsourcing Facility

PharMEDium’s three compounding facilities are registered with the FDA as 503B Outsourcing Facilities. Our facilities that process controlled substances are registered with the U.S. Drug Enforcement Administration (DEA). In addition, our three Outsourcing Facilities are registered with the State Board of Pharmacy in their resident states of New Jersey, Tennessee and Texas. We maintain approximately 300 licenses in the U.S. and have been inspected by regulatory agencies over 60 times since 2003. As a long-time advocate for clearer FDA authority and stronger oversight, PharMEDium has been voluntarily registered with the FDA since its inception – more than two decades before the passage of the Drug Quality and Security Act (DQSA). PharMEDium is an active and vocal supporter of stronger oversight and accountability outlined in section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act. This new category was created when President Obama signed into law the DQSA in November 2013. The law, which calls for large-scale entities engaged in anticipatory outsourcing of sterile compounds to voluntarily register with the FDA and comply with guidelines under the newly created section 503B of the FD&C Act, has been recognized for the potential to improve patient safety. Our support of this Federal oversight continues today with the ongoing development of innovative solutions and processes to comply with 503B requirements. From supply chain integrity and rigorous quality control testing to labeling and delivery, stringent controls guide our processes. We hope this commitment to transparency and accountability reinforces your confidence in our pledge to being your trusted partner.


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