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  1. CDER Offices and Divisions

Office of Unapproved Drugs and Labeling Compliance


Who We Are

The Office of Unapproved Drugs and Labeling Compliance (OUDLC) develops and implements surveillance activities, compliance strategies and policies related to unapproved prescription and OTC drugs, fraudulent drugs and drug registration and listing. OUDLC engages in strategic, risk-based, compliance and enforcement activities to minimize consumer exposure to unsafe unapproved new 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.
  • 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.
  • Oversee FDA’s drug registration and listing database (eDRLS), manage associated regulatory and policy issues and conduct stakeholder outreach regarding eDRLS issues.
  • Publish the drug establishment current registration site (DECRS) list of all currently registered drug establishments and National Drug Code (NDC) directory for all finished and unfinished drug products available in the United States.

Organization

  • Division of Unapproved Drugs and Labeling
  • Division of Labeling, Registration, and Unapproved Drugs

Contact Us

Email: CDEROUDLCPMTRACK@CDER.FDA.GOV

Phone: 301-796-3110

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




 
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