Office of Unapproved Drugs and Labeling Compliance
Who We Are
Office of Unapproved Drugs and Labeling Compliance (OUDLC) oversees drugs that are not approved by the agency, taking regulatory actions and developing 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
Resources For You
- FDA Warning Letters
- CDER Office of Compliance
- Guidance, Compliance and Regulatory Information