FDA In Brief: FDA takes steps to enhance drug supply chain security; setting new recommended data standards to identify, trace packages

For Immediate Release: Feb. 28, 2018

Media Inquiries

"The U.S. drug supply system is among the safest in the world. But we need to remain vigilant to protect patients from harmful or illegitimate drugs, such as counterfeits, by evolving our practices to use the latest technologies to thwart increasingly more sophisticated threats. To further secure the supply chain, the FDA is implementing a series of measures to enhance our supply chain’s electronic infrastructure. The new steps will reduce the risk of harmful drugs reaching patients by allowing us to identify and trace certain prescription drugs as they are distributed throughout the U.S.," said FDA Commissioner Scott Gottlieb, M.D. "Establishing a truly interoperable system requires setting standards and using consistent terms to ensure the data is captured and shared in a way that allows various systems involved in the supply chain – from manufacturers to pharmacies – to communicate with one another. The FDA and supply chain stakeholders must continue working together to get this right. Today, the agency is issuing two new draft guidances and holding a public meeting to advance this goal of establishing an interoperable, electronic product tracing system at the package level."

The U.S. Food and Drug Administration today issued two draft guidances furthering the agency’s implementation of the Drug Supply Chain Security Act (DSCSA), which outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This system, which will be fully implemented by 2023, will enhance the FDA’s ability to help protect consumers from drugs that may be counterfeit, stolen, adulterated or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

The "Standardization of Data and Documentation Practices for Product Tracing" draft guidance elaborates on the standards for the interoperable exchange of transaction information, transaction history and transaction statements (product tracing information). The FDA has said that “interoperability” encompasses the ability to exchange product tracing information accurately, efficiently and consistently among trading partners. Currently, this is being done in paper and electronic form, but beginning in 2023, it will be exchanged only electronically. The agency intends for this guidance to assist trading partners in the drug supply chain, from manufacturers to pharmacies, by providing recommendations for standardizing the data in the product tracing information that they must provide, capture and maintain. In addition, this guidance recommends documentation practices a trading partner can use to meet its product tracing obligations, including in situations where they are legally allowed to omit certain product tracing information they give to other trading partners.

The "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act" draft guidance describes the FDA’s interpretation of terms used in the definitions of "suspect" and "illegitimate" products in the DSCSA to help trading partners meet their verification obligations, which include notifying the FDA. The draft guidance presents the FDA’s current understanding of the terms counterfeit, diverted, fraudulent transaction and unfit for distribution.

Today, the FDA is also holding the third meeting in its series titled "Enhanced Drug Distribution Security under the Drug Supply Chain Security Act" to discuss strategies and issues related to the enhanced drug distribution security provisions of the DSCSA.

# # #

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.