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503B Facility

We are an FDA-registered and licensed 503B outsourcing facility.

503B Outsourcing Facility That Manufactures the Highest Quality Injectable Medications

The Food and Drug Administration (FDA) is responsible for ensuring the safety and efficacy of all human and veterinary drugs and biological products, whether large pharmaceutical companies, contract research organizations, or outsourcing facilities produce them.

The Drug Quality and Security Act was signed into law in November 2013. This law outlines specific regulations and guidelines that must be followed by outsourcing facilities engaged in non-prescription anticipatory manufacturing to ensure that the products they prepare and distribute are safe and of high quality. The FDA has urged healthcare providers to use only registered and approved outsourcing facilities.

Section 503B of this law states that:

  • All drugs must be produced in compliance with cGMP by or under the supervision of a licensed pharmacist in a registered facility;
  • The facility must report specific information about the products it generates, including the source of the ingredients used and all products produced in the last 6 months;
  • All adverse events must be reported;
  • All products must be labeled with adequate directions for use.

Axia Pharmaceutical is an FDA-registered and licensed 503B outsourcing facility that is an industry leader. We provide services to clients across the United States, and our quality is second-to-none.

Mission Statement

"Axia Pharmaceutical‘s core values — patient safety, flawless quality, operational excellence, top-notch customer service, and a respectful and collaborative work environment —best define our organization and our people. They also form the nucleus of what differentiates Axia Pharmaceutical from others in our industry."
- Chief Executive Officer