About 503B
Manufactured Products

Consistent quality in every batch.

Defining 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 (Stokes Pharmacy) is a traditional compounding pharmacy that formulates compounded medications based on a prescription for a specific patient
  • A 503B outsourcing facility (Epicur Pharma) 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.

Read our white paper for a deeper look at 503A versus 503B. Download Your Copy. 

Epicur Pharma: A Stokes Healthcare 503B Outsourcing Facility

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

Expanding to include Epicur allows us to meet the evolving needs of veterinary practices as regulations and laws changed, including GFI 256 and USP Guidelines, and serve the needs of many of your patients with standardized and tested bulk medications while still serving individual patients through Stokes Pharmacy.

Epicur Pharma® manufactures drugs with consistent potency, sterility, and purity from batch to batch, raising the standard in animal drugs. Our commitment to drug consistency and quality emphasizes our devotion to patient safety.

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.

Why Our Partners Love Epicur

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