FDA Publishes Draft Guidance On Identifying, Reporting Fake Drugs

The U.S. Food and Drug Administration (FDA) has published its first draft guidance under the Drug Supply Chain Security Act. The FDA is asking for public opinion regarding its proposal on suspect drugs identification in the supply chain.

The guidance entitled “Draft Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” lists the following possible signs of suspect drug products:

• Misspellings or errors in product labeling compared to standard labels
• Different shape, odor, or color compared to standard product
• Errors or missing information such as lot numbers or expiration date on the drug packaging
• Tampered, damaged, or altered original drug packaging seals

The guidance describes specific scenarios where supply chain stakeholders are at increased risk of purchasing suspect drugs, and in which situations they are advised to practice greater vigilance. These include buying drugs from untried sources, buying drugs online from an unknown source, or paying for high demand drugs or products on the drug shortage list. Replying to unsolicited offers touting a lower price, usually seen in ads, emails, faxes, or telephone calls also puts supply chain stakeholders at higher risk of product fraud.

Should a stakeholder suspect a product of being counterfeit, stolen, or unsafe, they are advised to notify the FDA through the following process:

• Access the FDA’s webpage
• Fill up FDA Form 3911 which asks details about the informant, the suspect drug, and the circumstances surrounding the event that prompted the reporting
• Submit completed FDA Form 3911 using directions on the FDA website

The published draft guidance is one of the initial steps to implementing the Drug Supply Chain Security Act, which was established as a counter effort against the dangers of illegitimate and unsafe drugs.