Drug Supply Chain Security Act (DSCSA) was first enacted in 2013 by the US Food and Drug Administration (FDA) to boost the ability to increase patient safety. DSCSA outlines the necessary steps to build an electronic, interoperable system to identify and trace prescription drugs through the supply chain to eliminate drug counterfeiting. This enabled the government to identify any stolen, diverted, or counterfeit medicine and remove it from the market before the patients consumed it. Also, it is made sure that drugs and medicines subject to DSCSA are safely stored and transported to avoid any entry of harmful products.
Under the DSCSA, trading partners – primarily manufacturers, wholesale distributors, dispensers, and repackagers – are subject to certain requirements for enhanced drug distribution security.
The DSCSA, enacted in 2013, outlines steps to achieve interoperable, electronic tracing of products to identify and trace certain prescription drugs as they are distributed throughout the U.S. The DSCSA requires trading partners to provide, receive and maintain documentation about prescription drugs and their chain of ownership from manufacturer to dispenser as the drugs are distributed in the U.S. supply chain. Currently, these entities can choose to provide such information either electronically or in paper format.
Those DSCSA requirements are scheduled to change on November 27, 2023, and will include requiring trading partners to provide, receive and maintain documentation about products and ownership only electronically. The stabilization period will accommodate an additional year, until November 27, 2024, to allow trading partners to implement, troubleshoot and mature their electronic interoperable systems. The stabilization period is intended to avoid disruption to the supply chain and ensure continued patient access to drug products as trading partners work to fully implement the enhanced drug security requirements.
With that, on 25th August 2023, the FDA extended the guidelines enforcement from November 27, 2023 to November 27, 2024.
The FDA issued two different draft guidelines and announced that “these documents are critical steps toward implementing the DSCSA enhanced drug distribution security requirements that will go into effect on.”
The first one “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs” describes the use of electronic standards for tracing products throughout the pharmaceutical supply chain. It is an update of the version issued in 2014. The guidance is primarily for manufacturers, wholesale distributors, dispensers, and repackagers; delayed enforcement pertains to product identifiers at the package level; saleable returns; interoperable, electronic product tracing; and investigating suspect and illegitimate products
To provide and maintain the data associated with the transaction information and transaction statements, the FDA strongly recommends trading partners use the Electronic Product Code Information Services (EPCIS) standard. EPCIS is a global GS1 standard that allows trading partners to capture and share information about products as they are transacted through the supply chain. FDA firmly believes that EPCIS is an appropriate globally recognized standard and there is considerable agreement amongst the stakeholders.
The second one “Identifying Trading Partners Under the Drug Supply Chain Security Act” will help industry, state, and local governments categorize the entities in the drug supply chain in accordance with the DSCSA. It is a revised version of the guidance issued in 2017. FDA announced that in the revised draft, it has added or revised its current thinking on the status of certain entities as trading partners, such as private label distributors, salvagers, returns processors, and reverse logistics providers.
The draft also includes clarification on how trading partners in the supply chain can be categorized. A clarification is also given on some drug distribution scenarios which include distribution for emergency medical use, office use, non-human research purposes, and research in humans under an investigational new drug application.
FDA also announced that until some rules are finalized and issued regarding the licensing standards for 3PL providers, these providers will be considered licensed trading partners if they are certified by the state.
Kevision Systems, part of the Kevin group, is a leading provider of complete solutions and services to protect your products and supplies. We are also a leading Solutions Provider for Vision-Based Inspection Systems for products, especially in the Healthcare, Food & Beverage as well as Automobile Industries. With Global Trade becoming seamless, the need for increased security & traceability of products is imperative for product authenticity. Kevision partners with clients to provide a robust & secure solution to meet product & client safety as well as regulatory compliance.
