New Era Global 503B Pharmacy is an FDA-registered outsourcing facility based in San Juan, Puerto Rico, committed to advancing pharmaceutical quality, safety, and accessibility.
We specialize in the large-scale compounding of ready-to-use sterile medications for hospitals, surgical centers, clinics, and healthcare systems across Puerto Rico and the mainland United States.
Every formulation produced at New Era Global follows the strictest Current Good Manufacturing Practice (cGMP) standards set by the U.S. Food and Drug Administration, ensuring sterility, potency, and consistency in every batch.
Full regulatory compliance
ISO-classified cleanrooms
Independent verification
Automated systems
Through continuous research, innovation, and a steadfast commitment to regulatory integrity, New Era Global is setting a new standard for trusted 503B outsourcing—from Puerto Rico to the world.
A 503B facility is authorized to compound large-batch, "office-use" medications for hospitals, clinics, and physician offices—without the need for a patient-specific prescription.
The FDA established this designation to raise the national standard for quality, safety, and consistency in compounded medications.
Built from the ground up for full 503B compliance and FDA standards.
Providers choose New Era as their compounding pharmacy of choice because they are confident in the quality of our medications and appreciate the personalized service we provide.
Through custom compounding, we prepare prescribed formulations for wellness solutions, pellet implants, and other medications for a wide range of conditions. We combine superior quality and expertise to protect your patients and your practice.