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  1. Drug Supply Chain Security Act (DSCSA)

Notify FDA of Illegitimate Products

What’s New

Trading partners and manufacturers can use the 3911 platform in FDA’s CDER NextGen Portal (CDER NextGen) to notify FDA of illegitimate products. Question 2 includes instructions.

Although the 3911 platform is now available for new submissions, all follow-up notifications and termination requests related to an existing Form FDA 3911 that has already been submitted via email must also occur by email, not through the platform.

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 are also 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 Product

1. What is the definition of an illegitimate product?

An illegitimate product is a product for which credible evidence shows that the product:

  • is counterfeit, diverted or stolen;
  • is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
  • is the subject of a fraudulent transaction; or
  • appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.

Visit the guidance Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.

2. How do I notify FDA about an illegitimate product?

Complete Form FDA 3911 using the 3911 platform in CDER NextGen (preferred) or email. Trading partners should provide information about the person or entity initiating the notification, the product determined to be illegitimate that is the subject of the notification to FDA and a description of the circumstances surrounding the event that prompted the notification.

3911 platform in CDER NextGen

  • Log in to your CDER NextGen account or set up 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.

Email

  • To complete Form FDA 3911 via email, download the form here: Form FDA 3911. 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 from the FDA's website.
  • For details and instructions, visit Drug Notifications Frequently Asked Questions and the Form FDA 3911 instructions supplement.
  • 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 “Illegitimate Product Notification Submission” in the subject line.
  • FDA will acknowledge receipt of the notification and assign an incident number. This incident number should be referenced in all future correspondence about the illegitimate product, including a request for termination.

3. If I initially submitted Form FDA 3911 via email, may I submit related follow-ups and termination requests through the 3911 platform in CDER NextGen?

No. Subsequent follow-up notifications or termination requests should also be sent by email so that this information can be associated with your initial notification.

4. What should I do after I notify FDA and trading partners about an illegitimate product?

Continue to coordinate with other trading partners to protect the supply chain from illegitimate products. Trading partners must quarantine and disposition the illegitimate product to prevent further distribution and remove it from the supply chain.

Visit the guidance Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription for more information.

High Risk of Illegitimacy

5. Which products are at high risk of illegitimacy?

For suspect products that pose a high risk of illegitimacy, a “high risk” may include a risk that increases the likelihood that an illegitimate product will enter the pharmaceutical distribution supply chain, as well as other high risks as determined by FDA. Manufacturers should review section III(c) of FDA’s guidance for specific scenarios and examples of products at high risk of illegitimacy.

6. Who needs to submit notifications to FDA about products 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 the guidance Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification for more information about notifying trading partners.

7. How are notifications about high risk of illegitimacy submitted to FDA?

The same process used to submit notifications for illegitimate products is used to submit notifications about products at high risk of illegitimacy. Review question 2 above for information on how to use Form FDA 3911 to notify FDA about a product with high risk of illegitimacy.

Suspect Product

8. Do I need to submit a notification to FDA about a suspect product?

No. Notifications to FDA are required for products determined to be illegitimate and for products determined to be at high risk of illegitimacy. Visit the following guidance documents for more information:

Additionally, visit Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs for more information on verification steps related to suspect product.

Terminating a Notification

9. How do I terminate a notification?

The law requires that manufacturers, repackagers, wholesale distributors and dispensers consult with FDA before terminating a 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 high risk of illegitimacy, is no longer necessary.

The process for terminating notifications in consultation with FDA is as follows:

  • 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.
  • Follow the instructions in question 2 to submit the request using the 3911 platform in CDER NextGen or by email. 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.
  • If the initial notification was submitted via CDER NextGen, the portal must be used for the termination request. After logging in to the portal, click on “3911 Platform” to access your landing page. Choose the incident number to request termination and enter the requested information.
  • If the initial notification was submitted by email, then email must be used for the termination request (review question 3 above).
  • The trading partner’s submission of a request for termination of a notification will be viewed as a request for a consultation with FDA, as required in section 582 of the Federal Food Drug and Cosmetic Act. FDA may request additional information to complete the consultation.
  • FDA will review the request and consult with the trading partner. The response time depends on the number of requests for termination and the circumstances surrounding the requests for termination.

Contact FDA

Email DrugNotifications@fda.hhs.gov for questions about drug notifications of illegitimate products and products at high risk of illegitimacy and requests for a termination of a notification.

 
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