How can suspected counterfeit medications be reported?

How can suspected counterfeit medications be reported?

• A. Call the manufacturer directly with no other steps
• B. Email the FDA with your concerns but no phone number
• C. Call 1-800-551-3989 or email DrugSupplyChainIntegrity@fda.hhs.gov
• D. Report to local postal service

Answer: (C)

Reporting suspected counterfeit medications to the right authorities is essential for patient safety and rapid regulatory action. The FDA provides a dedicated path for this through its Drug Supply Chain Integrity program, designed specifically to collect and action reports about counterfeit drugs. The best way to report is to call the FDA’s hotline at 1-800-551-3989 or to email DrugSupplyChainIntegrity@fda.hhs.gov. These channels connect you directly with the team responsible for investigating counterfeit drugs, and they can guide you on what details to provide—such as the product name, manufacturer, lot or NDC numbers, where the product was obtained, and any packaging or labeling images. This information helps the agency verify concerns and take appropriate actions to protect the supply chain and public health. Other options aren’t appropriate for formal reporting. Reaching out to the manufacturer directly may not initiate the regulatory investigation or reporting workflow needed to address counterfeit risk. Emailing the FDA without a specific reporting channel can lead to delays or misrouting. Reporting to the local postal service doesn’t connect to the regulatory mechanisms that track counterfeit drugs, so it wouldn’t trigger the official investigation.

Reporting suspected counterfeit medications to the right authorities is essential for patient safety and rapid regulatory action. The FDA provides a dedicated path for this through its Drug Supply Chain Integrity program, designed specifically to collect and action reports about counterfeit drugs.

The best way to report is to call the FDA’s hotline at 1-800-551-3989 or to email DrugSupplyChainIntegrity@fda.hhs.gov. These channels connect you directly with the team responsible for investigating counterfeit drugs, and they can guide you on what details to provide—such as the product name, manufacturer, lot or NDC numbers, where the product was obtained, and any packaging or labeling images. This information helps the agency verify concerns and take appropriate actions to protect the supply chain and public health.

Other options aren’t appropriate for formal reporting. Reaching out to the manufacturer directly may not initiate the regulatory investigation or reporting workflow needed to address counterfeit risk. Emailing the FDA without a specific reporting channel can lead to delays or misrouting. Reporting to the local postal service doesn’t connect to the regulatory mechanisms that track counterfeit drugs, so it wouldn’t trigger the official investigation.