Abstract

Determining Whether a Substance is Legal to Compound with Under Section 503A of the FDCA

Author(s): Cabaleiro Joe

Issue: Sep/Oct 2021 - Volume 25, Number 5

Page(s): 358-362

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Abstract

In the U.S., determining whether it is legal to compound with a particular substance for human patients is governed by a patchwork of laws, regulations, and U.S. Food and Drug Administration guidance. Furthermore, there is no single, unified source where a compounder can determine whether a particular substance is legal to compound with. This article provides 503a compounders a step by- step tool to evaluate the legality of compounding with a particular substance for human patients. It does so in a systematic way that considers the patchwork of law, regulations, and U.S. Food and Drug Administration guidance documents that must be considered.

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