About FDA

Office of Unapproved Drugs and Labeling Compliance (OUDLC)

OUDLC’s Mission

To promote and protect public health through science driven, comprehensive, strategies and actions that communicate potential risks about drug products and minimize exposure to unsafe, ineffective, or poor quality unapproved or misbranded drugs.  

OUDLC’s Vision

Using scientific, risk based strategies, and comprehensive compliance, we are global leaders in the effort to eliminate exposure to unapproved or misbranded drugs.   

Immediate Office

Office Director: Carolyn Becker, J.D.

Deputy Office Director: Kathleen Anderson, Pharm.D.

Senior Advisor for Policy: Huascar Batista

Regulatory Counsel: Lesley Frank, Ph.D., J.D.

Senior Advisor for Market Surveillance and Data Analysis: Meghan Murphy, Ph.D.

Senior Medical Advisor: Arthur Simone, M.D., Ph.D.

Director, Division of Prescription Drugs: Gail Bormel, J.D., R.Ph.

Director, Division of Non-Prescription Drugs and Health Fraud: John (Brad) Pace, J.D. (acting)


Mailing Address

Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance
Office of Unapproved Drugs and Labeling Compliance
10903 New Hampshire Ave.
Silver Spring, MD 20993
Ph:  (301) 796-3110
Fax: (301) 847-8745
Email: OUDLCMail@fda.hhs.gov





Page Last Updated: 03/29/2018
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