When a product looks wrong, hold it and prove it.
In fiscal 2024, US Customs seized 3,743,413 counterfeit pharmaceutical items worth $129.6 million at retail. Under DSCSA, a suspect product is one where there is reason to believe it may be counterfeit, diverted, stolen or otherwise unfit; an illegitimate product is one where credible evidence shows it. The duties to investigate and to respond apply to every trading partner, including small dispensers.
For: DSCSA trading partners (manufacturers, repackagers, wholesalers, dispensers) and brand teams in other industries. Sources: CBP, IPR seizure statistics FY2024; FDA, suspect product guidance.
What to do
Law a legal requirement, with its source. Good practice recommended by the regulator or industry, not required.
Spot and hold
- Law Buy and sell only with authorized trading partners, and check a new partner's licence or registration before the first order. FD&C Act 582, via FDA guidance
- Good practice Screen for FDA's red flags: an unknown or unsolicited source, a partner slow to provide transaction history, a price too good to be true, a shortage or often-counterfeited product, a missing lot number or security feature, tampered or repaired seals, misspellings, or off-standard colours and fonts. FDA, identification of suspect product
- Law Quarantine suspect product, physically and in your systems. A verification request from FDA or a trading partner also triggers quarantine. FDA, identification of suspect product
Investigate
- Law Review the transaction information and statement, and verify the product identifier with the manufacturer or repackager. Dispensers verify at least 3 packages or 10% of the suspect product, whichever is greater, or every package if there are fewer than 3. FDA, verification systems guidance
- Good practice Bring in the manufacturer and your trading partners. The manufacturer is the authority on whether a product is genuine. FDA, identification of suspect product
- Good practice Preserve the evidence: photographs, chain of custody, and no destruction until FDA, the manufacturer or law enforcement agrees. FDA, counterfeit medicine
- Law If the product clears, document the investigation and release it. FDA, identification of suspect product
Notify and close
- Law If it is illegitimate, file Form FDA 3911 within 24 hours of the determination and notify your immediate trading partners. Stolen product counts as illegitimate. FDA, notify FDA of illegitimate products
- Law Find every matching product in your possession or control, including stock that arrives later. FDA, verification systems guidance
- Law Ask FDA to terminate the notification, quoting the FDA incident number, once the matter is resolved. FDA, notify FDA of illegitimate products
- Law Keep investigation and disposition records for at least 6 years after the investigation ends. FDA, verification systems guidance
- Good practice Other industries: report imported counterfeits to CBP through e-Allegations and to the IPR Center. CBP e-Allegations
One-page checklist
- Partner's licence or registration verified
- Red-flag screen done for new sources and offers
- Packaging compared with earlier shipments
- Suspect product quarantined, physically and in the system
- Transaction information and statement reviewed
- Product identifier verified with the manufacturer
- Dispensers: at least 3 packages or 10% verified
- Manufacturer and trading partners consulted
- Determination documented
- Form FDA 3911 filed and partners notified within 24 hours
- Other affected stock identified
- Termination requested with the FDA incident number
- Records kept for 6 years or more
- Evidence preserved; nothing destroyed
Who to contact
- FDA, Form 3911 · [email protected] · fda.gov
- FDA Office of Criminal Investigations · accessdata.fda.gov
- FDA MedWatch · adverse events · fda.gov
- The manufacturer's verification contact
- CBP e-Allegations · cbp.gov
- IPR Center · 1-866-477-2060 · iprcenter.gov
Where Aeroz fits
A printed code can be photographed and reprinted. The secure chip in an Aeroz tag answers a cryptographic challenge and is designed to be clone-resistant, so anyone can tap the product with a phone and see whether it is genuine.
Take it with you
The PDF has the full guide and the one-page checklist to print and post by the dock or in the quality office.
A practical guide, not legal advice. Checked 14 Oct 2026; each step links to its source.
From the Aeroz blog
- Fake Vials Carried QR Codes. They Did Not Scan.
- In Counterfeit Raids, the Packaging Often Outnumbers the Product
More answers: DSCSA questions in the compliance FAQ
A kit covers one incident. A call covers your chain.
In a free 20-minute call we look at your products, partners and handoffs and where a verifiable record would close the gaps.