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About 503B

In 2013, the federal Drug Quality and Security Act (DQSA) was signed into law. It established provisions to create two different kinds of drug compounding facilities:

  • A 503A pharmacy is a traditional compounding pharmacy that formulates compounded medications based on a prescription for a specific patient
  • A 503B outsourcing facility not only can prepare personalized compounded medications for specific patients, but also large batches of medications for use by doctors and veterinarians in their offices

In order to be registered as a 503B outsourcing facility by the U.S. Food and Drug Administration (FDA), compounding pharmacies must meet stringent rules and regulations to ensure the consistent quality and integrity of their compounding from batch to batch. Referred to as current good manufacturing practices (cGMPs), these rules and regulations are the same as those followed by the traditional pharmaceutical manufacturing industry.

To facilitate compliance with these strict practices and processes—which Stokes Pharmacy has voluntarily done for decades, before 503B regulations were promulgated—we built a state-of-the-art manufacturing facility in Mount Laurel, New Jersey, where our compounded medications are produced.

Bottom line, it means that doctors and patients alike can rely on the quality, safety, and integrity of the medications we produce, knowing they’ve been formulated under exacting manufacturing standards for sterility and purity. Read more here.

It’s precision compounding at its best—something few compounding pharmacies in the nation can achieve.

To learn more, visit Stokes 503B website.
https://www.stokes503b.com