About Eagle Pharmacy
Eagle Pharmacy is proud to be the only 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. Each product is personalized to fit the specific needs of the physician’s office. This means maintaining rigorous quality standards, exceeding FDA regulations, and making sure 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 503B in the Federal Food, Drug, and Cosmetic Act. Under section 503B, a compounder can become an outsourcing facility. 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 of the 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.
- 503B outsourcing facilities may manufacture for office use.
- Frequent Monitoring: Environmental monitoring must be performed per production shift in primary compounding areas and weekly in secondary compounding areas.
- Quality Control: 503B outsourcing facilities are required to maintain their own quality department as its own autonomous entity 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 they became 503B
Here at Eagle Pharmacy, we are a 503B outsourcing facility and can be found on the exclusive FDA shortlist. Our pharmacy complies with all current good manufacturing practice requirements, inspections by FDA according to a risk-based schedule, and meets all conditions set forth by the FDA. We proudly underwent rigorous drug quality testing procedures in order to become a 503B registered outsourcing facility under The Drug and Security Act.
Every product that leaves our pharmacy is guaranteed to have gone through our strict quality control procedures. This is key so our providers can rest easy knowing they have the best available product on the market.
Here at Eagle Pharmacy, we strive to provide healthcare providers with the highest quality products. Our specialty is in our sterile compounding and we are well known for delivering the best sterile corticosteroid injections on the market. We also provide a wide range of compounded sterile 503b products including sterile injectables and excel at all forms of compounding.
What is Sterile Compounding
The preparation of compounded sterile medications in compliance with federal, state, and industry standards is a key to the success of Eagle Pharmacy’s practice. Sterile compounding involves creating a medication in an environment 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.
Where We Ship
Currently, we are proud to serve health care providers in 28 states and counting, plus Puerto Rico.
A quality-based program is vital in every compounding pharmacy to ensure that each preparation is compounded properly and meets FDA standards and guidelines. It has never been more important to understand the rules and regulations governing safety and quality assurance. This is where a 503B compounding pharmacy like Eagle Pharmacy comes into play.
Every vial of medicine is put through a rigorous multi step process to ensure the product is absolutely the best and safest it can be. Because of our state-of-the-art manufacturing processes and unsurpassed quality control, medical facilities and professionals know they can trust us to deliver a stellar product to their practice.
Besides the quality you will receive from Eagle Pharmacy, we are also required to send all compounding products to an FDA approved lab for additional testing. Every step we take not only meets Eagle Pharmacy standards but also overseen by the FDA and meets their rigorous standards for 503B compounding.