About FDA

Office of Unapproved Drugs and Labeling Compliance

Who We Are

The Office of Unapproved Drugs and Labeling Compliance (OUDLC) develops policies and compliance strategies to aid in ensuring that over-the-counter and prescription drugs are properly labeled and meet drug approval requirements. OUDLC engages in strategic, risk-based, compliance activities to minimize consumer exposure to unsafe fraudulent and compounded drugs.

What We Do

  • Develop and implement compliance policies, strategies, and actions to ensure that prescription drugs marketed in the United States meet applicable new drug approval requirements and are properly labeled.
  • Work to protect consumers from unsafe compounded drugs.
  • Implement the compounding provisions of the Federal Food, Drug and Cosmetic Act.
  • Identify and address fraudulent and dangerous drugs that pose a direct or indirect health hazard and alert U.S. consumers of these dangers.
  • Provide guidance on prescription drug labeling requirements and the regulatory status of drug products marketed in the United States.
  • Evaluate product ingredients and labeling of over-the-counter drug products to determine compliance with scientific and legal standards.


Contact Us
Email: CDEROUDLCPMTRACK@fda.hhs.gov

Phone: 301-796-3110

Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Room 5186
Silver Spring, MD 20993-0002




Page Last Updated: 09/24/2018
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