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