
DRUG SHORTAGES & 503B SOLUTIONS
When the Drug Supply Breaks, 503B Facilities Step In
Hospitals and clinics depend on 503B outsourcing facilities to fill the gap when commercial drugs are in shortage. But outdated policies are keeping them on the sidelines.
The U.S. faces chronic drug shortages — from cancer medications to IV nutrition. 503B outsourcing facilities were created to solve this. They can produce large volumes of critical therapies quickly, safely, and at scale.
But FDA restrictions and procurement red tape often prevent these facilities from supplying hospitals until it’s too late — or never.
Who’s Being Harmed
Preemptive contracts to stock high-risk shortage medications
Bulk purchasing without naming individual patients
Hospital confidence in using 503B suppliers
National coordination on emergency drug needs
WHAT NEEDS TO CHANGE
We need policy that activates 503B capabilities before crises hit — not after shelves are empty. That means empowering outsourcing facilities, cutting red tape, and treating them like the national asset they are.
Copyright 2025