FDA Drug Shortage Products
Ensuring a reliable supply of critical medications when they're needed most. Sterile compounded medications manufactured to address drugs listed on the FDA Drug Shortage List.
Become a Provider
Addressing Critical Medication Shortages
Sterile compounded medications manufactured by our 503B outsourcing facility to address drugs listed on the FDA Drug Shortage List. These products are developed and manufactured in full compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act and current Good Manufacturing Practices (cGMP).
The purpose is to support hospitals, emergency departments, surgery centers, and clinics by ensuring a reliable supply of critical medications that are temporarily unavailable or insufficient in the commercial market.
FDA Compliance & Quality
Production is initiated only when a drug is officially listed on the FDA Drug Shortage List or when otherwise permitted under FDA guidance. Products are prioritized based on clinical necessity, patient safety, and public health impact.
This category is dynamic and responsive, meaning product offerings may be added or discontinued based on changes to the FDA Drug Shortage List, regulatory guidance, and healthcare system needs.
What We Manufacture
Sterile Injectables
Ready-to-use sterile injectable medications for immediate clinical application.
Ready-to-Use Syringes
Pre-filled syringes designed for rapid administration in emergency and acute care settings.
IV Bags
Intravenous solutions for hydration, nutrition, and therapeutic support.
Preservative-Free Formulations
Specialized formulations for sensitive applications in acute care and emergency settings.
Emergency Medications
Critical medications for emergency departments and urgent care scenarios.
Acute Care Products
Formulations commonly used in hospitals, surgery centers, and clinical environments.
Supporting Healthcare Systems
At New Era Global, we understand that medication shortages can have life-or-death consequences. Our FDA Drug Shortage Products program is designed to be responsive and dynamic, ensuring healthcare providers have access to the critical medications their patients need.
- Full compliance with Section 503B regulations
- cGMP manufacturing standards
- Third-party laboratory testing
- Prioritized based on clinical necessity
Need FDA Shortage Medications?
Contact our team to learn about current availability and how we can support your healthcare institution.