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503B History and Timeline
The Drug Quality and Security Act, signed into law on
November 27, 2013, created a new section 503B in the
Federal Food, Drug, and Cosmetic Act. Under section 503B,
a compounder can become an outsourcing facility.
SCA Pharmaceuticals became the first FDA
registered 503B compounding facility.
753 patients in 20 states were diagnosed with
a fungal infection after receiving contaminated
methylprednisolone acetate from New England
Compounding Center. The CDC reported 64 deaths,
with a total of 793 patients affected nationwide.
2013
2012
2016
2018
Prescription Requirement is added under Section
503A of the Federal Food, Drug, and Cosmetic Act.
2019
Industry guidelines are created by registered
outsourcing facilities on the Compounding and
Redistribution of Radiopharmaceuticals.
Section 503A Bulks List Final Rule Questions and
Answers; Small Entity Compliance Guide is established.
2023
Prohibition on Wholesaling is added under Section
503B of the Federal Food, Drug, and Cosmetic Act.
2020
Biological products that were approved under
the Federal Food, Drug, and Cosmetic (FD&C)
Act transitioned to being licensed under
the Public Health Service (PHS) Act.
2024
FDA established Modernization Initiatives to
create a unified human foods program, revamp
field operations, and introduce additional reforms.
2025
Interim Policy on Compounding Using Bulk
Drug Substances is added under Section 503A
of the Federal Food, Drug, and Cosmetic Act
As of March 31, 2025, a total of 89 503B
companies are registered.