The U.S. FDA Drug Supply Chain Security Act, often referred to as DSCSA, is a regulation designed to improve and ensure the safety of the U.S pharmaceutical supply chain.
Signed into law as part of the Drug Quality and Security Act (DQSA) in November of 2013 by Congress, DSCSA aims to address the dangers of counterfeit, contaminated, stolen, or otherwise harmful drugs. Largely created in response to keeping illicit and counterfeit drugs out of the U.S. drug supply chain and protect public health, the act outlines steps for electronically tracking and tracing prescription drugs at the packaging level. It requires manufacturers, wholesalers, healthcare providers, and pharmacies to maintain and share certain prescription drug data in a secure format that can be transmitted between each of their systems.
Maximizing patient safety by protecting patients from receiving incorrect or harmful drugs is the main driver of the regulation, while also enhancing the security of our country’s drug supply. Additionally, this regulation aims to enable a more seamless flow of data between supply chain partners by ‘marrying’ the physical product with its digital twin. In other words, every product will have a dual state—a digital version, represented by the data encoded in the barcode and the product’s transaction event data, and the physical version of the product with the product identifier data in a human readable format on the label. This will help the pharmaceutical industry with inventory accuracy and create many other operational efficiencies.
Important: All GS1 Standards and solutions are voluntary, not mandatory. It should be noted that use of the words “must” and “require” relate exclusively to technical recommendations for the proper application of the standards to support the integrity of your implementation.
While meeting the DSCSA requirements will help you comply with the law, it will also improve your relationship with trading partners and help your products seamlessly move through the supply chain.
The entire pharmaceutical supply chain could unlock benefits from the increased visibility brought by these regulatory requirements – but only if every stakeholder carries out their responsibility. Due to the requirement that DSCSA requires the electronic exchange of data in an interoperable manner, without the necessary product information or the ability to receive, verify, or share it, obstacles will be created in the pharmaceutical supply chain that may ultimately lead to a patient's inability to receive the medicine they need when they need it, which can harm their safety.
Stated as the “Prohibited Act” in section 206 of the law, not meeting DSCSA requirements can have severe impacts on not only your business, but also patient safety across the country. Failure to meet DSCSA requirements could result in penalties, fines, and suspensions from the U.S. FDA.
When signed into law, the DSCSA was given a 10-year implementation timeline. Different milestone dates were set with requirements to help stakeholders prepare in a phased approach.
Under the DSCSA, the dispenser’s responsibility is to verify that all incoming receipts meet the applicable regulation requirements.
Working with supply chain leaders, GS1 US® developed the below step-by-step guide to aid you and other dispensers in meeting requirements. For additional details on how to implement GS1 Standards, please review our Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability Release 1.3.
A GLN is a globally unique identification number that gives you the ability to know who is involved in transactions and where things are located throughout the supply chain. Having and sharing GLNs with your trading partners will help you manage saleable returns and other requirements of the DSCSA.
Helpful Hint: A GLN may have been enumerated for you by your Group Purchasing Organization (GPO) or wholesaler partner. If they have not, you can set up your own GLN(s) for your corporate and site locations. Review our DSCSA quick start guides to learn how to determine if you have a GLN or how you can get your own.
Helpful hint: Under the regulation, there are three different types of transactional data:
Transaction Information (or TI) includes the proprietary or established name/names of the product, the strength and dosage form, the NDCs, the container size, the number of containers, the lot number, the date of the transaction, the date of the shipment (if more than 24 hours after the date of the transaction), the business names and address of the person from whom ownership is being transferred, and the business name and address of the person to whom ownership is being transferred.
Transaction Statement (or TS) states the partner is authorized, received the product from an entity that is authorized, received the TI and TS from the prior owner of the product, did not knowingly ship a suspect or counterfeit product, had systems and processes in place to comply with verification requirements under section 582, did not knowingly provide false TI data, and did not knowingly alter the TH data.
Transaction History (or TH) includes the transaction information for each prior transaction going back to the manufacturer of the product and sunsets on November 27, 2023.
Helpful hint: EPCIS is a data sharing standard that helps provide the “what, when, where, why and how” of products and other asset. The U.S. FDA recommends EPCIS to provide a standard language to express required DSCSA information in an interoperable manner.
Helpful hint: You can utilize tools including GS1 US DataHub or GS1 GEPIR to search and retrieve your trading partner GLNs.
The GS1 Lightweight Messaging Standard provides a simple, standardized lightweight messaging framework for asking verification questions and receiving actionable information by defining a verification Request message and a corresponding Output Response message. Review our Guideline for Supporting Verification of Product Identifiers for DSCSA to learn more.
Helpful hint: A Verification Router Service (VRS) refers to using a third-party routing system to send product information back and forth between distributors and manufacturers.
