The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States. This is essential to enhance the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, 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 DSCSA directs the FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually. DSCSA traceability requirements in effect from 2015 to 2023 generally require drug supply products to be traceable at the lot level. The final phase of requirements will go into effect November 27, 2023, to allow the interoperable, electronic tracing of products at the package level.
The Healthcare Distribution Alliance (HDA) breaks down the essential pillars of enhanced traceability, such as with utilizing an Enterprise Resource Planning (ERP) solution designed for the pharmaceutical industry. Pharma ERP systems include functionality to identify, investigate, and handle suspect and illegitimate products as well as use processes to address and reconcile transactional errors. (Read the full HDA report)
Breaking it Down
DSCSA comprises multiple milestones throughout several years and requires all steps of the drug supply chain to be traceable and verifiable. It began with requiring labeling and tracking and culminates November 2023 where tracing moves from lot to package level. An example of this is tracing a prescription drug throughout the world from its manufacturing stage to consumer purchase. Each container of this drug will have its own serial number. The lot level is one form of tracing, and each bottle is another, and stands to create large bottlenecks in the supply chain, which is where technology must come in to help alleviate that. Deploying an ERP that encompasses the different compliance aspects all under “one roof” and helping your company stay in compliance while eliminating manual work, is arguably the best route.
Concern is mounting
Some smaller drug supply chain players are still unaware of the DSCSA milestones ahead, along with a general lack of assuredness among distributors, manufacturers, and dispensers regarding full implementation of Federal Drug Administration (FDA) required phase II regulations. The FDA will not grant immunity after November 27, 2023, to drug supply companies who are not phase II ready. This means that companies who are not compliant will no longer be allowed to distribute drug products.
Action required, NOW!
As the November 23 deadline approaches combined with the in-depth and time-consuming work that must be done, it’s important to develop a timeline starting now, to November 2023. Your action list should include highlights, guidance, and outlines the solution development, testing, and ramp up phases.
Join us for a complimentary webinar
If you are a drug supply company in need of compliance assistance, VAI and LSPediA will help you get ready and prepare. Join our complimentary webinar, November 2023 DSCSA Requirements: What You Must Do NOW to Prepare. Pharmaceutical technology experts from VAI and LSPediA will focus on compliance with the DSCSA 2023 Requirements and offer a step-by-step approach on how you will get there. Visit our events page to for more information and to register.