ABOUT EAGLE PHARMA OUTSOURCING
Eagle Pharma is a 503B compounding facility in the state of Alabama that has been serving the compounding community for over a decade. Our goal is to produce exceptional medicine that allows healthcare professionals to provide the best quality medications to their patients. This means complying with FDA Current Good Manufacturing Practices and maintaining rigorous quality standardsto ensure that our products are safe and effective.
503B OUTSOURCING FACILITY
What is it?
Becoming a 503b compounding facility is no easy feat. The Drug Quality and Security Act, signed into law on November 27, 2013, created a new section referred to as 503B in the Federal Food, Drug, and Cosmetic Act. Under section 503B, a compounder can choose to become an outsourcing facility, however, the process for becoming certified is long and thorough.
The law defines an outsourcing facility as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all requirements of section 503B.
- Must comply with CGMP requirements.
- Are inspected by FDA according to a risk-based schedule; and
- Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
- Can compound for office use.
- Require Rigorous Monitoring: Environmental and personnel monitoring must be performed per production shift in primary compounding areas and weekly in secondary compounding areas.
- Have a Designated Quality Control Unit: 503B outsourcing facilities are required to maintain an autonomous quality department to conduct investigations.
No matter what compounded sterile 503B products you are looking for we promise a commitment to excellence. Nothing means more to us than providing our providers with the medication they need in a safe, cost-effective, and reliable manner.
How we became 503B
Eagle Pharma can be found on the exclusive FDA list of 503B Outsourcing Facilities. We strive to comply with all current good manufacturing practice requirements and are routinely inspected by the FDA according to a risk-based schedule. We underwent rigorous drug testing procedures in order to provide safe products of exceptional quality.
Every product that leaves our pharmacy is guaranteed to have gone through our strict quality control procedures and has passed all product testing requirements. This is key so our providers can rest easy knowing they have the best available product on the market.
Here at Eagle Pharma, we strive to provide healthcare providers with the highest quality products. We specialize in our sterile compounding and are well known for our corticosteroid injections that have filled a gap during ongoing shortages.
What is Sterile Compounding?
The preparation of compounded sterile medications in compliance with federal, state, and industry standards is key to the success of Eagle Pharma’s practice. Sterile compounding involves creating a medication in a controlled environment that is essentially free from bacteria, viruses, or any other potentially infectious microorganisms. This type of compounding is used for medications that will be administered either through an injection, an IV, or directly into the eyes. Eagle Pharma currently specializies in the compounding of sterile injections only.