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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
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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.

Related Keywords: Joe Cabaleiro, RPh, FACA, BCSCP, Difficult to Compound list, U.S. Food, Drug and Cosmetic Act, FDCA, drug safety, Drug Products Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness list, negative list, Code of Federal Regulations, CFR, biologics, biological agents, protein, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food Drug and Cosmetic Act, Drug Quality and Security Act, DQSA, Bulk Drug Substances That Can be Used to Compound Drug Products in Accordance with Section 503A of the Federal Food Drug and Cosmetic Act, Bulks list, tetrahydrobioptermin deficiency, BH4, oxitriptan, domperidone, diethylstilbestrol, USP-NF Monograph, flowchart, investigational drugs


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