When a product looks wrong.
Under the Drug Supply Chain Security Act, a suspect product is quarantined and investigated, and a product found to be illegitimate is reported to FDA and immediate trading partners within 24 hours on Form FDA 3911.
Every DSCSA trading partner needs a working process for a product it has reason to doubt. Quarantine it and investigate with your trading partners. If it is cleared, release it. If it is illegitimate, notify FDA and your immediate trading partners within 24 hours of deciding so, using Form FDA 3911. Keep the investigation records for six years.
DSCSA suspect product, in three facts.
US DSCSA · §582 verification · quarantine and investigate · Form FDA 3911 within 24 hours · records for six years.
A trading partner that determines a product is illegitimate notifies FDA and its immediate trading partners within 24 hours, using Form FDA 3911.
Source: FDA, Notify FDA of illegitimate productsRecords of a suspect-product investigation are kept for at least 6 years after the investigation ends.
Source: FDA, Verification Systems Under the DSCSA (guidance)Manufacturers and repackagers answer a verification request from an authorized trading partner within 24 hours.
Source: 21 U.S.C. §360eee-1(b)(4)(C) and (e)(4)(C)
Four steps, one deadline.
Quarantine
Separate the product physically or electronically so it cannot be sold or dispensed while you look into it. This applies to manufacturers, repackagers, wholesale distributors and dispensers alike.
Investigate
Work with the trading partner you bought from. Check the transaction data, verify the product identifier with the manufacturer, and inspect the package. Manufacturers and repackagers answer verification requests within 24 hours.
Notify within 24 hours
The 24 hours start when you determine the product is illegitimate. FDA takes notifications through its 3911 platform in CDER NextGen, or by emailing the completed Form FDA 3911.
Keep the records
Keep investigation records for at least six years after the investigation ends, and disposition records for six years after the product is disposed of. Ending a notification also requires consulting FDA.
The timeline, as it stands.
These duties have applied for years and no current exemption pauses them. FDA's small-dispenser exemption is limited to certain requirements. Quarantine, investigating suspect product and notifying FDA of illegitimate product still apply.
Three moves that de-risk the deadline.
Name the people
Write down who can quarantine, who investigates and who files the 3911, with a backup for each. The 24-hour deadline does not pause for weekends or holidays.
Define what counts as suspect
Give staff concrete triggers: a broken or missing seal, a label that differs from the last lot, a serial number that fails verification, a seller you have not bought from before, a price far below market.
Run a drill
Take one real unit through the whole process, up to the point of filing. Time each step and fix whichever one took longest.
An answer in seconds, on record.
Most of an investigation is finding out whether this unit is the one the manufacturer made and the one you were sent. Aeroz answers that with a read of the unit against its record, and logs who checked, when and what the result was. That log is the start of your six-year investigation file.
DSCSA suspect product, answered.
What is the difference between suspect and illegitimate product?
Suspect product is one you have reason to believe may be counterfeit, diverted, stolen, intentionally adulterated, the subject of a fraudulent transaction, or otherwise unfit for distribution. Illegitimate product is one where credible evidence shows that it is.
When does the 24-hour clock start?
When you determine the product is illegitimate, or are told so by FDA or a trading partner. It does not start at the first suspicion. Manufacturers must also notify within 24 hours when they find a high risk that a product is illegitimate.
How do I file Form FDA 3911?
Through the 3911 platform in FDA's CDER NextGen portal, which FDA prefers, or by completing the form and emailing it to FDA. The same form is used to request termination of a notification.
Do small pharmacies have to do this?
Yes. The small-dispenser exemption that runs to 27 November 2027 is limited to certain requirements. Quarantine, investigation and notification of illegitimate product still apply.
Know exactly where you stand — in 14 days.
A fixed-fee Aeroz audit maps your products against DSCSA suspect and illegitimate product procedures and returns a written readiness assessment, a data-mapping review, and a scoped pilot plan with cost and timeline.