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. Additionally, manufacturers are also required to notify FDA and appropriate trading partners within 24 hours after determining a product is at high risk for illegitimacy.
Q1. What is the definition of an illegitimate product?
A1. The term “illegitimate product” means 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.
Q2. How do I notify FDA about illegitimate product?
A2. To notify FDA of illegitimate products, trading partners should:
- Complete FDA Form 3911. 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.
- To complete the form, open it and save a copy to your computer or download the form as a fillable pdf form. Do not attempt to fill the form and submit from FDA's website.
- See Drug Notifications Frequently Asked Questions and the FDA Form 3911 Instructions Supplement for specific details and instructions on how to fill out the form.
- Submit the completed FDA Form 3911 using the “Submit by Email” button on the form or email the completed form to firstname.lastname@example.org and include “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 any request for termination.
Learn more by watching an FDA webinar about illegitimate product notifications.
Q3. What should do after I notify FDA and trading partners about illegitimate product?
A3. After notifying FDA and other trading partners about illegitimate product, a trading partner must quarantine and disposition the illegitimate product to remove it from the pharmaceutical distribution supply.
For more information, see the guidance Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription.
High-Risk of Illegitimacy
Q4. What products are considered at high-risk for illegitimacy?
A4. For suspect products that pose a high-risk of illegitimacy, a ‘high risk’ may include a specific high risk that could increase the likelihood that illegitimate product will enter the pharmaceutical distribution supply chain and other high risks as determined by FDA in guidance. Manufacturers should review section III. C. in FDA’s guidance for more specifics scenarios and examples of high-risk of illegitimacy.
Learn more by watching an FDA webinar that includes information about high-risk of illegitimacy notifications.
Q5. Who needs to submit notifications to FDA about products at high-risk of illegitimacy?
A5. Manufacturers only must notify FDA no later than 24 hours after determining or being notified there is a high risk that a product is an illegitimate product. For more information about notifying trading partners, see Guidance for Industry, the Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF - 1.2MB).
Q6. How are notifications about high risk of illegitimacy submitted to FDA?
A6. See question two for information on how to notify FDA of a product with high risk of illegitimacy using Form FDA 3911.
Q7. Do I need to submit a notification to FDA about suspect product?
A7. No. Notifications to FDA are required for product determined to be illegitimate and for product determined to be at high-risk for illegitimacy. For more information, see the guidance Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry and Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry
For more information on verifications steps related to suspect product please see, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
Q8. How do I terminate a notification?
A8. The law requires manufacturers, repackagers, wholesale distributors, and dispensers consult FDA before terminating a notification.
The Guidance for Industry, the Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF - 1.2MB) 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 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 the FDA is responsible for making the request for termination.
- Trading partners must follow the instructions to access and complete Form FDA 3911. Using this form, trading partners must provide to FDA 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 what actions have taken place or what information has become available that makes the notification no longer necessary. Trading partners must include the FDA-assigned incident number associated with the notification in the request for termination.
- Submit the 3911 form by using the “submit” button or by emailing DrugNotifications@fda.hhs.gov. The trading partner’s submission of a request for termination of a notification will be viewed as a request for consultation with FDA, as required in section 582 of the FD&C Act. FDA may request any additional information it determines necessary to complete the consultation.
- FDA will review the request and consult with the trading partner. The response time will depend on the number of requests for termination and the circumstances surrounding the requests for termination that are received by FDA.
Please email DrugNotifications@fda.hhs.gov for questions about drug notifications, suspect product, terminations, and high-risk of illegitimacy product.