138 RXINSIDER | 2026 PHARMACY500 PLATINUM PAGES
MANUFACTURING
• 503B Outsourcing Facilities, Compounding Services
• Contract Manufacturing, Drug Shortage Mitigation
• Generics, Brand Name, Biotech
• Injectables
OVERVIEW
Pharmacy manufacturing encompasses the production of
brand-name, generic, injectable and compounded medications
to ensure the availability of safe and effective treatments. 503B
outsourcing facilities produce bulk compounded medications
for healthcare providers under FDA oversight. Pharmacy
manufacturing increasingly relies on contract manufacturing
organizations (CMOs) and drug shortage mitigation strategies
to ensure a steady supply of medications.
KEY TERMS
• Pharmacy 503B outsourcing refers to a specific type of
pharmaceutical outsourcing facility regulated under Section
503B of the Federal Food, Drug, and Cosmetic Act (FDCA).
It involves the outsourcing of compounded medications by
a pharmacy facility that is registered with the U.S. Food and
Drug Administration (FDA). These pharmacies are authorized
to produce large quantities of compounded drugs for
hospitals, clinics, and other healthcare providers.
• Drug shortage mitigation refers to the strategies and
processes implemented by healthcare providers, pharmacies,
manufacturers, and regulatory agencies to prevent, manage,
and alleviate the impact of drug shortages on patient care.
• Branded pharmaceutical manufacturers are companies that
develop, produce, and market pharmaceutical products under
a proprietary brand name, while generic drug manufacturers
are companies or entitities that produce generic versions of
branded pharmaceutical products once the original drug’s
patent protection expires.
• Injectables include antibiotics, pain management drugs, and
anesthetics administered intravenously or via injection.
Source: U.S. Dept. of Health and
Human Services
of U.S. hospitals report shortages.
99%
of U.S. hospitals obtain
compounded drugs exclusively
from registered 503B
outsourcing facilities.
89%
of pharmaceutical
manufacturing sites are
located in the U.S.
42%
Source: FDA
Source: American Hospital
Association