503B Outsourcing
FDA-registered 503B outsourcing facilities backed by a national network of 503A compounding pharmacies serving all 50 states.
Bulk sterile products for the floor. Patient-specific compounds for the individual. One network behind both.
503A and 503B: Different Roles, Same Goal
503A Compounding Pharmacy
Compounds medications to individual prescriptions. Regulated by state boards of pharmacy. The right fit when a patient needs a tailored formulation.
503B Outsourcing Facility
Manufactures compounded medications in large batches under FDA oversight and cGMP. Distributed to hospitals and health systems without requiring individual prescriptions.
Neither replaces the other. The strongest compounding strategy uses both.
Eagle Pharma Outsourcing
FDA Registered
503B Outsourcing Facility, Est. 2015
cGMP Compliant
Validated and inspection-ready
Last FDA Inspection
February 2025
ISMP-Compliant Labeling
On every product we ship
Triple-Validated BUDs
Stability-supported dating
Pre-Release Batch Testing
Sterility, endotoxin, potency
The Medications Your Teams Count On
- Acute Care: L&D, ICU, and surgical formulations. Oxytocin, phenylephrine, heparin, ropivacaine.
- Dermatology: Topical compounds for dermatology practices. Benzocaine/Lidocaine/Tetracaine and Lidocaine/Tetracaine formulations.
- Medical Office: Corticosteroid injections and seasonal allergy treatments for clinic and office settings.
- IV Nutrition: Injectable nutrition for clinical and wellness settings. Glutathione, NAD+, Sermorelin, and more.
Strict Adherence to cGMP Standards
Aseptic Processing
Qualified cleanroom environments. Validated techniques. Every batch, every time.
Environmental Monitoring
Continuous viable and non-viable monitoring. Not periodic spot checks.
Personnel Qualification
Ongoing media fill simulations. Sterility verified through testing, not assumption.
Supplier Qualification
Every vendor risk-assessed before a single raw material enters the facility.
Deviation and CAPA
Any unexpected event triggers documented investigation and corrective action. Systematically, not informally.
Full Documentation
Every stage of production documented, traceable, and reviewable. Always.