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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
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  3. Guidance, Compliance, & Regulatory Information
  4. Laws, Acts, and Rules
  5. FDA’s Labeling Resources for Human Prescription Drugs
  6. Prescription Drug Labeling Contact Information
  1. FDA’s Labeling Resources for Human Prescription Drugs

Prescription Drug Labeling Contact Information

For specific application or supplement questions, please contact

For general questions about the Prescribing Information or this website contact the Labeling Policy Team in CDER. 

*For the purposes of these webpages, references to drugs include drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act and biological products licensed under section 351 of the Public Health Service Act that are regulated as drugs.  Not every resource on this website will be applicable to every prescription drug. 

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