Notify FDA of Illegitimate Products
Notify FDA within 24 Hours
The Drug Supply Chain Security Act (DSCSA) requires certain trading partners — manufacturers, repackagers, wholesale distributors and dispensers — to notify FDA and all appropriate immediate trading partners within 24 hours after determining a product is illegitimate. Manufacturers also are required to notify FDA and appropriate trading partners within 24 hours after determining a product is at high risk for illegitimacy.
Notify FDA of Illegitimate Products: 3911 Platform in CDER NextGen
Illegitimate Products
An illegitimate product is a product for which credible evidence shows the product:
- is counterfeit, diverted or stolen;
- is intentionally adulterated and would result in serious adverse health consequences or death;
- is the subject of a fraudulent transaction; or
- appears otherwise unfit for distribution and would be reasonably likely to result in serious adverse health consequences or death.
Visit the Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act guidance for more information.
Notifying FDA
Submit illegitimate product notifications through the 3911 platform in CDER NextGen, which is the agency’s preferred method, or complete Form FDA 3911 and submit via email. Trading partners should provide information:
- about the person or entity initiating the notification,
- the product that has been determined to be illegitimate and subject of the notification and
- a description of the circumstances surrounding the event that prompted the notification.
Notify FDA Using the 3911 Platform in CDER NextGen
- Log in to your CDER NextGen account or create a new account using the “Sign Up” link.
- On the CDER NextGen homepage, click the “3911 Platform” link to make a new submission.
- Review the “Getting Started” information. More detailed instructions are available in the Reference Guide. This guide also is available in CDER NextGen on the 3911 platform, which you can access from the Help Center link in the “Need Help?” box on the left side of the screen.
Notify FDA Using Email
- To complete Form FDA 3911, download the form. Open the form, and either save a copy to your computer or download it as a fillable PDF form. Do not attempt to fill out the form and submit it via FDA’s website.
- Visit Drug Notifications Frequently Asked Questions and the Form FDA 3911 instructions supplement for detailed instructions.
- Submit the completed Form FDA 3911 using the “Submit by Email” button on the form or email the completed form to drugnotifications@fda.hhs.gov with the subject line: “Illegitimate Product Notification Submission.”
- FDA will acknowledge receipt of the notification and provide an incident number to the notifier. This incident number should be referenced in all future correspondence about the illegitimate drug, including a request for termination.
Visit the Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification guidance for more information about submitting a notification of illegitimate product to FDA.
Trading partners must quarantine and disposition the illegitimate product to prevent further distribution and remove it from the supply chain. Continue to coordinate with other trading partners to protect the supply chain from illegitimate products.
Visit the Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription guidance for more information.
Products that are at High Risk of Illegitimacy
Only manufacturers are required to notify FDA no later than 24 hours after determining or being notified that there is a high risk a product is an illegitimate product. Visit our Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification guidance for more information about notifying FDA of product with a high risk of illegitimacy.
One example of a product that poses a “high risk” of illegitimacy is if there is a specific high risk that increases the likelihood that an illegitimate product will enter the U.S. drug supply chain. Manufacturers should review section III of FDA’s guidance for additional scenarios and examples of products at high risk of illegitimacy.
Manufacturers should use the same process – the 3911 platform, which is the preferred method, or complete the Form FDA 3911 and submit it via email to FDA – to submit notifications of drugs that are at high risk of illegitimacy (using the instructions above).
Terminating a Notification
DSCSA requires:
- manufacturers, repackagers, wholesale distributors and dispensers consult with FDA before terminating a notification of illegitimate product
- manufactures consult with FDA before terminating a high-risk notification
The guidance Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification addresses the process by which trading partners must terminate notifications in consultation with FDA. This process must be used when trading partners believe that a notification they made to FDA regarding an illegitimate product or, for a manufacturer, a notification of a product that is at high risk of illegitimacy is no longer necessary.
The process for terminating notifications in consultation with FDA is:
- The trading partner making a notification to FDA is responsible for making the request for termination. Trading partners must include the FDA-assigned incident number associated with the initial notification in the request for termination.
- Submit the request using the 3911 platform in CDER NextGen or by email (using the instructions above). Trading partners must provide information about the person or entity initiating the request for termination, the illegitimate product or the product with a high risk of illegitimacy, the notification that was issued and an explanation about which actions have taken place or what information has become available that makes the notification no longer necessary.
- Continue to use the 3911 platform to terminate a request if the initial notification was submitted via the 3911 platform.
- After logging in to CDER NextGen, click on “3911 Platform” to access your landing page. Choose the incident number to request termination and enter the requested information.
- Continue using email to terminate the request if the initial notification was submitted by email (review “notify FDA using email” above).
- FDA considers a request to terminate the notification by a trading partner as a request for consultation, as required in section 582 of the Federal Food Drug and Cosmetic Act. FDA may request additional information to complete the consultation.
- FDA reviews the request and consults with the trading partner. The response time depends on the number of requests for termination and the circumstances surrounding the requests.