Form 3911 Instructions - Drug Notification
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3INSTRUCTIONS FOR COMPLETION OF FORM FDA 3911 – DRUG NOTIFICATION
(The item numbers below correspond to the numbered areas on Form FDA 3911)
1. Type of Report – Indicate the type of report by checking the appropriate box.
•
Initial Notification – Your first notification to the FDA of an illegitimate product or product with a high risk of
illegitimacy
•
Follow-up Notification – subsequent notification to FDA, related to an initial notification already submitted
to FDA
•
Request for Termination – request for consultation with FDA to terminate a notification of an illegitimate
product or product with a high risk of illegitimacy
2. Incident Number – This number will be assigned by FDA when the initial notification is received by FDA
and sent to the reporter with the FDA receipt acknowledging the initial notification. Please utilize the incident
number that corresponds to the initial notification in all future correspondence with the FDA about the
notification, including the request for termination.
3. Date of Initial Notification – Enter the date that you are submitting the initial notification. For follow-up
notifications or a request for termination, enter the date the initial notification was submitted to FDA. Use the
calendar function or enter the date in MM/DD/YYYY format. If you do not have the incident number, then
providing the date of initial notification will allow FDA to associate any follow-up notification or request for
termination with the initial notification.
4. Date Illegitimate Product Was Determined by Company – Use the calendar function or enter the date in
MM/DD/YYYY format that the product was determined to be illegitimate or to have a high risk of illegitimacy
(manufacturers only).
5. Classification of Notification – Select the appropriate classification of the illegitimate product or product
with a high risk of illegitimacy (manufacturers only).
•
Counterfeit – A product is determined to be counterfeit, or has a high risk of being counterfeit.
•
Diverted – A product is determined to be a diverted product, or has a high risk of being a diverted product.
•
Stolen – A product is determined to be a stolen product, or has a high risk of being a stolen product.
•
Intentional adulteration – A product is determined to be intentionally adulterated such that use of the
product would result in serious adverse health consequences or death to humans, or has a high risk of it.
•
Unfit for distribution – A product appears otherwise unfit for distribution such that use of the product would
be reasonably likely to result in serious adverse health consequences or death to humans, or has a high
risk of it.
•
Fraudulent transaction – A product in your possession or control is determined to be the subject of a
fraudulent transaction, or has a high risk of it.
Description of Product
6. Name of Product as it appears on the label– Indicate the name of the product as it appears on the label.
7. Primary Ingredient(s) – List active pharmaceutical or biological ingredient(s) if known and not listed in item
6 above.
8. Drug Use – Select the approved use of the product. If “other” is selected, please provide a description in
your response to item 17 or 18. Note: Section 582 of the FD&C Act notifications are for human-use products
only
•
Human use
•
Other
FORM FDA 3911 SUPPLEMENT (12/15) – FORM INSTRUCTIONS
Page 1 of 3
EF
PSC Publishing Services (301) 443-6740
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Parent category: Financial