FDA’s New Drug Tracking System May Be Going Off the Rails


The FDA may be falling behind its schedule for implementing a national drug tracking system intended to prevent counterfeit and substandard medicines from entering the supply chain.

Drug distributors and pharmacists told me the implementation of the tracking system has been slow and the Food and Drug Administration is behind on issuing guidance needed by industry. The Drug Supply Chain Security Act (DSCSA) outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs within the U.S. by 2023. The DSCSA is part of the Drug Quality and Security Act (Pub. L. No. 113-54), signed into law in November 2013.

As well as keeping counterfeit drugs from entering the supply chain, the system also is intended to prevent the diversion of legitimate drug products for illegal use and the importation of unapproved drugs. The goal is to keep dangerous drugs that could harm patients from entering the drug supply chain. This is a big challenge as about 4 billion prescriptions were filled at U.S. retail pharmacies in 2016, according to the FDA’s website.

The Healthcare Distribution Alliance (HDA) is concerned about whether the 2023 deadline for implementation will be met without specific directions from the FDA on how to do it, Patrick Kelly, executive vice president of government affairs at the HDA, told me. The HDA represents wholesale distributors that purchase drugs from manufacturers and sell them to pharmacies, hospitals, and others.

Also, Jenna Ventresca, director of health policy at the American Pharmacists Association (APhA), told me she doesn’t think the 2023 deadline “is reasonable anymore. The compliance time is very short given the size of the task, issues that have arisen in current compliance efforts, and delays that have already occurred.”

Lyndsay Meyer, an FDA press officer, told Bloomberg BNA in a Sept. 25 email that “implementation of DSCSA is a high priority in the agency and we have no concerns about being able to implement the system by 2023.” The agency has issued some guidance documents on topics such as how to exchange product tracing information and identifying suspect products. Also, in July, the FDA announced plans to hold three public meetings intended to give pharmaceutical supply chain members an opportunity to provide input on strategies and issues related to the enhanced drug distribution security provisions of the DSCSA. The agency held the first meeting in August, and will hold two additional meetings in December and in February 2018.

But Kelly said wholesale distributors are still waiting for more guidance that the agency was supposed to issue in 2015. Specifically, he said the FDA was supposed to provide guidance on how pharmaceutical distributors should be licensed by the states and how to handle drug products that don’t have serial numbers.

All pharmaceutical distributors must be licensed by the state in which they are located. Under the DSCSA, the FDA is statutorily required to publish model state licensure standards that factor in requirements pertaining to serialized products, obligations to keep and maintain records of transaction information, product storage, and other appropriate specifications.

The second guidance deals with how to handle grandfathered products that don’t have serial numbers, Kelly said. “After the serialized products come on the market, you’re still going to have a marketplace full of unserialized product that is valid, legitimate product but is essentially noncompliant” with the DSCSA. Pulling all of those products off the market could create drug shortages, he said.

Read my full article here.

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