Creating a New System to Improve the Security of the Drug Supply

By: Ilisa Bernstein, Pharm.D., J.D.

FDA is committed to protecting consumers from potentially dangerous drugs, including those that are counterfeit, stolen or tainted. We are taking steps to create a system that will help identify and trace certain prescription drugs as they are distributed within the United States.

Ilisa BernsteinThe Drug Supply Chain Security Act (DSCSA), signed into law last November, outlines the path to building this electronic tracking system. We are working now to develop standards for this new system and we can’t do it alone. Stakeholders – including drug manufacturers, wholesaler distributors, repackagers, and many dispensers (mainly retail and hospital pharmacies) – will be working with us.

The ultimate goal is to identify each individual prescription drug package in a way that will enable rapid and accurate verification of the legitimacy of the product, which will be an important tool in the fight against counterfeit drugs. If a counterfeit or other harmful drug is discovered in the supply chain, we can immediately notify patients, health care professionals, hospitals and others about the public health risk.

This system, which will include a history of the transactions involving each drug product, will also help to enable more efficient recalls to remove drugs from the market that are considered potentially dangerous.

It will be an “interoperable” system, meaning that different stakeholders in the drug supply chain will be able to communicate with each other and share information about the drug and its location.

We have posted our implementation plan at fda.gov and have opened a docket in the Federal Register with questions that we’d like these stakeholders to answer about any practices or systems they may be using to exchange information related to prescription drug transactions, in paper or electronic format. The docket is open until April 21, 2014.

We will be reviewing all information that comes into the docket as we work on establishing standards for the interoperable exchange of tracing information. On May 8 and 9, 2014, FDA is hosting a public workshop for interested parties to discuss what standards may work, what makes sense and what can be done quickly. We encourage you to participate.

Time is of the essence because the law requires FDA to issue a draft guidance document with initial standards by Nov. 27, 2014, and for many stakeholders to establish systems and processes that will enable them to comply by Jan. 1, 2015.

Experts from all over FDA are working to implement this important law. Provisions of this law will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful through improved detection and removal of potentially dangerous drugs from the drug supply chain. U.S. consumers deserve safe, effective and high-quality medications.

Ilisa Bernstein, Pharm.D., J.D., is Deputy Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research

For more information please visit the following Web links:

Drug Supply Chain Security Act (DSCSA) Implementation Plan

Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format; Establishment of a Public Docket

Public Workshop: Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format

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