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:

        Drug Supply Chain Integrity

Drug Supply Chain Security Act (DSCSA)

                        
                Drug Supply Chain Security Act (DSCSA) Portal in CDER NextGen
          Drug Supply Chain Security Act Law and Policies
          Drug Supply Chain Security Act Public-Private Partnership
          The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions
          Drug Supply Chain Security Act (DSCSA) Assessment of Small Dispensers
          Drug Supply Chain Security Act Public Meetings
          Drug Supply Chain Security Act Webinars and Presentations
          Pharmacists: Utilize DSCSA Requirements to Protect Your Patients
          What do I need to know about supply chain security requirements under the Drug Supply Chain Security Act (DSCSA)?
          Drug Supply Chain Security Act Resources for State Officials Home
          Drugs
          Drug Safety and Availability
          Drug Supply Chain Integrity
          Drug Supply Chain Security Act (DSCSA)Drug Supply Chain Integrity Drug Supply Chain Security Act (DSCSA)
  	
        Share
    Post
    Linkedin

    Email
    Print**Notify FDA of Illegitimate Products**

Manufacturers, repackagers, wholesale distributors, and dispensers are required to notify FDA within 24-hours after determining a product is illegitimate.


**Submit Annual Report for Licensure**

The law requires wholesale distributors and third-party logistics providers to report licensure and other information annually to FDA.

Sign up for email updates on the Drug Supply Chain Security Act.

The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. These requirements will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually.

Latest Activity

December 7, 2023: Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
	November 20, 2023: Federal Register Notice: Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements; Request for Information and Comments
	November 3, 2023: Implementing DSCSA: Stabilization Period and Expectations SBIA Webinar
	September 5, 2023 - DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry
	August 30, 2023 - Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies (read the announcement here)
	August 30, 2023 - Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act
	August 25, 2023 - Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies (read the announcement here)
	August 10, 2023 - Federal Register Notice: Development of Small Dispensers Assessment Under the Drug Supply Chain Security Act; Request for CommentsResources

Read an overview of key supply chain requirements: What do I need to know about supply chain security requirements under the Drug Supply Chain Security Act (DSCSA)?
	Read the law Drug Supply Chain Security Act
	Find a list of DSCSA policy documents
	Get involved with DSCSA issues through FDA’s public meetings
	Find more information through webinars on various requirements
	View resources for state officials
	Browse answers to questions on product tracing requirements
	Learn about the DSCSA Pilot Project Program
	Decision tree graphic: Should this drug package or case have a product identifier under the DSCSA?
	Understand the public health emergencies and DSCSA requirementsContact FDA

If you have questions related to wholesale distributor and third-party logistics provider requirements, email us WDD3PLRequirements@fda.hhs.gov.

If you have other DSCSA-related questions, such as those related to product tracing information, waivers, exceptions and exemptions, and trading partner requirements, email us at drugtrackandtrace@fda.hhs.gov.

                                                                                  Content current as of:
      12/13/2023
                  
                   
Regulated Product(s)
		 DrugsDrug Supply Chain Security Act (DSCSA)                
                          

                        Drug Supply Chain Security Act (DSCSA) Portal in CDER NextGen
          Drug Supply Chain Security Act Law and Policies
          Drug Supply Chain Security Act Public-Private Partnership
          The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions
          Drug Supply Chain Security Act (DSCSA) Assessment of Small Dispensers
          Drug Supply Chain Security Act Public Meetings
          Drug Supply Chain Security Act Webinars and Presentations
          Pharmacists: Utilize DSCSA Requirements to Protect Your Patients
          What do I need to know about supply chain security requirements under the Drug Supply Chain Security Act (DSCSA)?
          Drug Supply Chain Security Act Resources for State Officials
 
 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