[ HOW-TO GUIDE ]
How to Investigate a DSCSA Suspect Product
Take a possibly counterfeit, diverted, stolen or unfit drug from first suspicion to clearance or illegitimate-product notification within the statutory clocks.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
Under section 582 of the FD&C Act, every trading partner must be able to quarantine and investigate a suspect product and, if it proves illegitimate, notify FDA and the affected trading partners within 24 hours of that determination. The investigation is where the time is lost. This sequence keeps it moving and leaves the record FDA will ask for.
- 1
Recognise it as suspect
A product is suspect when there is reason to believe it is potentially counterfeit, diverted or stolen, intentionally adulterated, the subject of a fraudulent transaction, or otherwise unfit so as to risk serious harm. Typical triggers are a package identifier that does not verify, mismatched transaction information, damaged or altered packaging, an unusual source or price, or an FDA or trading-partner alert.
- 2
Quarantine immediately
Separate the product physically or by system status from product intended for distribution, and record the quantity, location, lot and serial numbers. Nothing ships while the investigation is open.
- 3
Investigate with your trading partners
Verify the product identifier at package level, including the standardised numerical identifier, with the manufacturer or repackager, which must answer a verification request within 24 hours. Review the transaction information and statements, and ask upstream partners what they hold. Record every contact and answer.
- 4
Decide: cleared or illegitimate
If the product is not illegitimate, record the determination and release it from quarantine; a manufacturer notifies FDA of the clearance where applicable. If credible evidence shows it is illegitimate, the decision starts the 24-hour clock.
- 5
Notify and disposition
Within 24 hours of determining a product is illegitimate, notify FDA and the immediate trading partners you believe may have received it. Keep it quarantined, disposition it, retain a sample for examination if FDA asks, and help partners disposition product outside your control.
- 6
Close and keep the record
End the notification only after determining, in consultation with FDA, that it is no longer needed, and tell the partners you notified. Keep investigation and disposition records for at least six years.
- !No named decision-maker, so an investigation sits open and the product is neither cleared nor reported.
- !Starting the 24-hour clock from the first suspicion rather than the illegitimate determination — or, worse, not starting it at all.
- !Releasing a cleared product without recording why it was cleared.
- !Investigating alone without contacting the manufacturer or upstream partners who hold the facts.
How to Investigate a DSCSA Suspect Product: frequently asked questions
Common questions on investigate a dscsa suspect product.
Is a suspect product the same as an illegitimate product?
No. A suspect product is one there is reason to believe is potentially counterfeit, diverted, stolen, intentionally adulterated, fraudulently transacted or unfit. An illegitimate product is one for which credible evidence shows that. The investigation moves a product from the first category to cleared or to the second.
When does the 24-hour notification clock start?
When the trading partner determines that a product in its possession or control is illegitimate. Notification goes to FDA and to the immediate trading partners it has reason to believe may have received the product.
How long must investigation records be kept?
At least six years after the investigation, or after the disposition of an illegitimate product, concludes.
WHERE NEXT
- DO ITOpen the DSCSA Product Tracing Implementation Plan template →The structure these steps fill in.
- UNDERSTAND ITDSCSA: US Drug Supply Chain Security →The principles behind the procedure.
- ALL GUIDESBrowse all 127 how-to guides →
A free account keeps what you save, remembers where you are across devices, and can send you the weekly regulatory briefing. Create a free account