503B Outsourcing Facilities Report 2025

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©2025 RXinsider | RXinsider Market Intelligence Group | 2025

89

FDA-registered 503B

facilities in the U.S.

12

503B facilities are listed on the

Pharmacy500.

50+%

of shortages are due

to manufacturing and

supply chain issues.

99%

of U.S. hospitals report

drug shortages.

60%

of shortages involve

injectable medications.

6,093

hospitals in the

U.S. as of 2025

The Drug Quality and Security Act (DQSA) was signed into law in 2013.

Source: U.S. Senate Homeland Security Report

on Drug Shortages

SCA Pharmaceuticals

became the first registered

503B company

Source: FDA

Source: American Hospital

Association

Source: RXinsider

Source: FDA

EXECUTIVE SNAPSHOT

503B

OUTSOURCING

FACILITIES

Source: FDA

271

drug shortages reported

as of December 2024.

Source: FDA

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