Using Form FDA 3911 for Drug Notifications under the Drug Supply Chain Security Act (DSCSA)
To comply with the notification requirements of the DQSA, trading partners – manufacturers, wholesale distributors, dispensers, and repackagers – should use Form FDA 3911 to notify FDA about illegitimate product and, for manufacturers, products that are at high risk of being illegitimate.
The incident number is an FDA-assigned number. Trading partners should leave this field blank when making an initial notification. When you submit an initial notification, the contact identified in field 23 of the Form FDA 3911 will receive an acknowledgement email from FDA that will contain the incident number associated to that specific notification. Provide this incident number in field 2 for all subsequent submissions related to that notification, including the request for termination.
The classification of notification in field 5 provides a dropdown menu and only allows the submitter to select one choice. Choose the classification that best describes the situation of the notification. If you think that other classifications apply, please indicate it in the Description of Event/Issue section in field 17.
If multiple drugs are involved in a single notification then write “Multiple” in field 6, Name of the Product as it appears on the label, in field 7, Primary Ingredients(s), and in field 10, Strength of Drug. Select “Multiple” from dropdown menu in field 9, Drug Description, if drugs fitting multiple descriptions are involved. Select “Multiple” from dropdown menu in field 11, Dosage Form, if multiple dosage forms are involved.
We recommend that you create a pdf version of a table that lists all of the drug names, ingredients, etc., and attach the file to the email generated when the “Submit by Email” button on the form is activated.
If your response exceeds the space provided for fields 17 or field 18, select the “Add Page for Item 17” or “Add Page for Item 18” as appropriate. This step will generate an extra page for field 17 or 18 as applicable. If the response exceeds the space provided by the extra page, please create a pdf version of the description and attach the file to the email generated when the “Submit by Email” button on the form is activated.
The “Submit by Email” button will generate an email addressed to the correct mailbox at FDA to receive the notification. After the email is generated, attach any additional files as needed, and send the email as you would normally.
Attach the photograph file to the email generated when the “Submit by Email” button on the form is activated.
If this occurs, the form is having difficulty communicating with your email program. Use the following steps for an alternative way to submit the notification to FDA:
- Save the form as a pdf version
- Open your email system
- Put firstname.lastname@example.org in the “To:” field of the email
- Put “Illegitimate Product Notification Submission” in the subject line
- Attach the form and any other documentation
The person identified as the contact in field 23 of the Form FDA 3911 will receive the acknowledgement. If you do not receive a response within 24 hours please check your spam filter. If the acknowledgement has not been received send an email to email@example.com, with “no response” in the subject line. In the body of the email, include the name of the product, date of submission to FDA, type of notification, and the contact name if different from the person sending the email. Do not resend the Form FDA 3911 unless contacted to do so.
The Date of Initial Notification field is the date you are submitting the initial notification to FDA.
Please email DrugNotifications@fda.hhs.gov if you have additional questions.