Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Center for Drug Evaluation and Research | CDER

Center for Drug Evaluation and Research | CDER
            
                        CDER Offices and Divisions
          Meeting Presentations | Drugs
          CDER Exclusivity Board


                        Accelerating Rare disease Cures (ARC) Program
          CDER Contact Information
          CDER Manual of Policies & Procedures | MAPP
          Frequently Asked Questions about CDER
          Reports & Budgets | CDER Home
          About FDA
          FDA Organization
          Center for Drug Evaluation and Research | CDER
          Office of ComplianceCenter for Drug Evaluation and Research | CDER Office of Compliance

    
Share
    Post
    Linkedin

    Email
    PrintWho We Are:

The Office of Compliance (OC) shields patients from poor quality, unsafe, and ineffective drugs through compliance strategies and risk-based enforcement actions. OC makes strategic and risk-based decisions that are guided by law and science to foster global collaboration, promote voluntary compliance and takes decisive and swift actions to protect patients.

Office of Compliance 2023 Annual Report Cover
Office of Compliance Annual Report FY 2023 (PDF - 8 MB)

What We Do:

Address patient health risks that arise from violations of FDA regulations and law. Develop risk-based enforcement and communication strategies to reduce and prevent patient harm associated with these violations.
	Work to protect consumers from unsafe compounded drugs.
	Protect the integrity of the legitimate drug supply chain and minimize consumer exposure to dangerous products marketed outside the legitimate supply chain.
	Monitor the quality of human drugs through facility inspections, product testing, and other pre- and postmarket compliance activities.
	Ensure drugs in FDA approval system have reliable evidence of safety and effectiveness, human subjects in clinical trials are protected, and drugs meet postmarket safety requirements.
	Develop policies and compliance strategies to help ensure that over-the-counter and prescription drugs are properly labeled and meet drug approval requirements.
	Coordinate evaluation and classification of drug recalls, and work with FDA offices globally to implement recalls.
	Monitor and assist with alleviation of drug shortages involving compliance issues.
	Provide support and guidance on developing potential investigations and regulatory actions to FDA offices around the world.
	Maintain the electronic drug registration and listing database and work to ensure the information in the database is up to date and accurate.Organization:

Office of Compounding Quality and Compliance
	Office of Drug Security, Integrity, and Response
	Office of Manufacturing Quality
	Office of Program and Regulatory Operations
	Office of Scientific Investigations
	Office of Unapproved Drugs and Labeling ComplianceFor More Information:

Office of Compliance Annual Report FY 2023 (PDF - 8 MB)
	Office of Compliance Annual Report FY 2022 (PDF - 7 MB)
	Office of Compliance Annual Report 2021 (PDF - 11 MB)
	Office of Compliance Annual Report 2020 (PDF - 6 MB)
	Office of Compliance Annual Report 2019 (PDF - 5 MB)
	Office of Compliance Annual Report 2018 (PDF - 1 MB)Contact Us:

Email: CDERCompliance@fda.hhs.gov

Phone: 301-796-3100
Fax: 301-847-8747

Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Rm 5271
Silver Spring, MD 20993-0002

                                                                                  Content current as of:
      01/11/2024Center for Drug Evaluation and Research | CDER
            
          
                        CDER Offices and Divisions
          Meeting Presentations | Drugs
          CDER Exclusivity Board


                        Accelerating Rare disease Cures (ARC) Program
          CDER Contact Information
          CDER Manual of Policies & Procedures | MAPP
          Frequently Asked Questions about CDER
          Reports & Budgets | CDER
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop