Enhanced FDA Tracking System to Monitor for Counterfeits, Contamination

Posted March 31, 2014 at 5:06pm

One of the Food and Drug Administration’s newest tools in trying to protect consumers from counterfeit or contaminated drugs is a system to enhance tracking of products throughout the distribution chain.

The agency is currently developing a schedule for implementing the system, which was included in a 2013 law to clarify the FDA’s oversight of compounding pharmacies (PL 113-54). The goal is to provide an easier way to trace drug packages as they move throughout the supply chain — from manufacturers to distributors to pharmacies.

Supporters say the system will help the FDA and groups along the supply chain detect and remove potentially dangerous drugs, including those that could be counterfeit or contaminated. The FDA says it will also help make for more efficient recalls of drug products.

As Sen. Michael Bennet, D-Colo., often said before the provision became law, “Right now, we know more from the barcode on a gallon of milk than we do from the barcode on a bottle of pills.”

The law would create a national, interoperable, electronic tracking system of prescription drugs over the next 10 years. Groups within the supply chain — including manufacturers, wholesale distributors, repackagers and pharmacies — will be required to maintain detailed records of every transaction.

Within 10 years of the law’s enactment, the system will allow entities to exchange information at the individual package level about where a drug has been in the supply chain.

Each entity within the supply chain will have additional responsibilities, as will the FDA. Drug manufacturers and repackagers will have to put a unique product identifier — for example, a bar code that can be scanned — on prescription drug packages. And groups throughout the supply chain will be required to set up systems to verify that product identifier for every package that comes through.

Manufacturers, wholesale drug distributors, repackagers and many dispensers will be required to provide information about who handled the drug package. They also must quarantine and investigate any drug that has been identified as suspect, and notify the FDA and other stakeholders if an illegitimate drug is found in the supply chain.

In February, the FDA designated 13 companies to participate in its Secure Supply Chain Pilot Program, which is meant to help the agency focus resources on preventing the entry of high-risk drugs that pose a great risk to consumers. If the program is successful, the FDA may establish a more permanent program and expand it to include more companies.