FDA Issues Draft Guidance for Implementing Drug Supply Chain Security ActBy
The US Food and Drug Administration (FDA) has issued two draft guidances to further 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 US.
This system, which is expected to be fully implemented by 2023, seeks to enhance the FDA’s ability to protect consumers from drugs that may be counterfeit, stolen, adulterated, or otherwise harmful. The system is also expected to improve detection and removal of potentially dangerous drugs from the drug supply chain.
“[W]e 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,” said FDA Commissioner Scott Gottlieb, MD, in a February 28, 2018 statement. “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 US.”
The first draft guidance, Standardization of Data and Documentation Practices for Product Tracing, outlines the standards for the interoperable exchange of transaction information,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. The FDA says this is currently 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The second draft guidance, Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act, describes the FDA’s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”.
The FDA also held on February 28, 2018 its third public 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.
Source: FDA (Standardization of Data and Documentation Practices for Product Tracing) and FDA (Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act)