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FDA 503a Bulks List

Meaning

The FDA 503a Bulks List is a regulatory compilation by the U.S. Food and Drug Administration (FDA) that identifies bulk drug substances permissible for use by traditional compounding pharmacies under Section 503A of the Federal Food, Drug, and Cosmetic Act. A substance must meet one of three criteria to be compounded: having a USP/NF monograph, being a component of an FDA-approved drug, or being explicitly included on this “positive list.” The list provides a legally compliant pathway for pharmacists to prepare custom medications, including certain hormonal compounds, when an FDA-approved alternative is not suitable for a patient.