[6/10/14] FDA today, issued its first guidance under the Drug Supply Chain Security Act seeking public comment on its proposal for how prescription drug supply chain stakeholders should identify suspect drug products in the supply chain and notify the agency when illegitimate drug products are found.
Suspect or illegitimate drug products may pose risks to consumers because they may be counterfeit, diverted, stolen, the subject of a fraudulent transaction or otherwise unsafe. The guidance, “Draft Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification,” describes potential signs of suspect drug products, including:
- Product labeling that contains misspelled words or looks different from the standard labeling;
- The finished product is a different shape or color from the standard product or has an unusual odor;
- The packaging is missing identifying information such as the lot number or expiration date;
- The original packaging seals have been opened, damaged, repaired or altered.
FDA also advises supply chain stakeholders to be vigilant in certain situations that could increase the risk of receiving potentially dangerous drugs, including:
- Purchasing drugs from a new source;
- Responding to an unsolicited offer, usually with a significantly lower price, that comes through an advertisement, email, fax or telephone call;
- Purchasing a product on the Internet from an unknown source; and
- Purchasing a product that is in high demand or one that is on the drug shortage list.
This draft guidance also provides information for supply chain stakeholders about how to quickly notify FDA when they determine that they have an illegitimate product, and it sets forth a process for stakeholders to follow when terminating previously made notifications.
The Drug Supply Chain Security Act further enhances the safety of the U.S. supply chain and protects consumers from potentially unsafe drugs. The Drug Supply Chain Security Act outlines critical steps to build an electronic, interoperable system over the next 10 years capable of identifying and tracing the path of certain prescription drugs as they travel through the U.S. distribution chain. This draft guidance is one of the first steps to implement this new law.
Stakeholders and interested parties may submit comments to the public docket and view the Federal Register notice here.