Why 503B of the FD&C Act matters

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).

Advancing the science behind what we do.

PharMEDium performs real-time stability verification through independent FDA-registered laboratories who utilize current Good Manufacturing Practices (cGMPs) when testing our final formulations. We maintain a comprehensive set of technical reports and quality compounding reports available 24/7 available within our Customer Resource Center (CRC).

Our testing includes:

  • Storage conditions including temperature cycling
  • Homogeneity
  • Particulate matter
  • Active ingredient drug profiles
  • Shifts in pH
  • Specific container and drug manufacturer
  • Packaging and shipping studies
  • Light sensitivity
  • Sterility integrity of each container/closure combination
  • Bactericidal and fungicidal sterility validation testing

 

In-House vs Outsourced Compounding