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Business · 01/09/2009Updated: 10/17/2026 · 1 min read

FDA Releases Guidance on Labeling Nonprescription Human Drugs Sold Without FDA Approval

Summary

The Food and Drug Administration (FDA) has released a guidance document to help the pharmaceutical industry correctly label nonprescription human drugs sold without FDA approval, as mandated by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. This guidance complements a separate document addressing dietary supplement labeling requirements.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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