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 the manufacturer determines or is notified by FDA or a trading partner that there is a high risk that a product is illegitimate. DSCSA also requires manufacturers, repackagers, wholesale distributors, and dispensers consult FDA before terminating the notification of an illegitimate product.
Notifications can be made by sending the information using Form FDA 3911. Form FDA 3911 must also be used to request a notification be terminated in consultation with FDA. To complete the form, open it and save a copy to your computer or download the form as a fillable pdf form. Do not fill the form and submit from FDA's website. See Drug Notifications Frequently Asked Questions for information about filling out the form
- the identification of a suspect product, and recommendations how to identify a suspect product;
- the concept of high risk of illegitimacy; and
- the processes for notifying FDA of an illegitimate product or product with high risk of illegitimacy and for requesting termination of a notification which includes using Form FDA 3911.
FDA has also posted a webinar that provides an overview of the guidance.