FDA Pushes to Prevent Drug Counterfeiting

Bottle packaging

For many years, manufacturers and distributors of pharmaceutical products have attempted to keep the pharmaceutical supply chain secure. Concerns about contamination and counterfeit medication have necessitated a system to track where shipments of medication go between manufacturer and distributor. Thus, track and trace pharmaceutical shipping was born.

Track and trace pharmaceutical shipping utilizes e-pedigree serialization. Each time a shipment of products changes hands, the products are formed into groups, authenticated, and serialized. This occurs when the product enters custody and when it is shipped out again. Trading partners along the supply chain all have access to the serialization data. In the event of an issue, federal regulators should be able to look at the serialization data and determine when the problematic product entered the supply chain.

One of the biggest issues with the e-pedigree track and trace pharmaceutical system is that serialization only occurs when the product changes custody. A shipment of specific products may be passed through various company distribution centers without ever changing custody, leaving plenty of opportunity for counterfeit medication or contaminants to enter the group without being caught immediately.

The United States Food and Drug Administration (FDA) will soon be implementing a new program for track and trace pharmaceuticals. Within the next four years, packages will be required to include a serial number for tracking at the lot level. Six years after that, the same requirements will be executed at the package level. Each individual along the supply chain will also be required to keep transfer serialization data for at least six years.

The FDA tracking system will only apply to prescription drugs intended for human consumption. Over-the-counter drugs, veterinary medicine, blood, intravenous products, medical gases, homeopathic drugs, radioactive drugs, compounded pharmaceuticals, and other non-consumables will be exempt from the pharmaceutical serialization policy.

The FDA policy was scheduled to enter into effect January 1st, 2015, but, due to the release of new guidance documents by the FDA, has been pushed back to May 15th.