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The FDA 503A and 503B refers to sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which created two separate regulatory pathways for compounded medications: “503A” comes from Section 503A - Pharmacy Compounding of the FD&C Act, and it defines the 503A compounding pharmacy pathway “503B” comes from Section 503B - Outsourcing Facilities of the FD&C Act and it defines the 503B outsourcing facility pathway Section 503B was established following the 2012 New England Compounding Center (NECC) tragedy, a nationwide fungal meningitis outbreak leading to over 50 deaths, caused by contaminated injectable steroid medications

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