FDA is issuing new guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2).
FDA is concerned that large volume of saleable returns coupled with the challenges of establishing reliable and robust technology may disrupt the distribution of prescription drugs in the United States.
FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product. This is a 3-year delay from the current date of enforcement.
FDA also does not intend to take action against dispensers who do not verify the product identifiers of suspect product as required by DSCSA before November 27, 2023.
Instead the FDA believes that the delay in enforcement will allow manufacturers, repackagers, wholesale distributors and dispensers to focus resources and efforts on implementing secure, interoperable, electronic tracing of products at the package level.
“We envision that, along with other enhanced drug distribution security requirements, wholesale distributors can increase their efficiency by incorporating the saleable return verification requirements into the enhanced verification required by 2023 instead of developing separate processes or infrastructures.”
This delay does not affect other aspects of DSCSA. Manufacturers are still obligated to conduct product verification according to section 582(b)(4)(C) of the FD&C Act upon receiving a request for verification from an authorized wholesale distributor. Furthermore, a wholesale distributor may engage in transactions involving a product only if such product is encoded with a product identifier.
Please contact us if you have additional questions on this policy and the impact on DSCSA deliverables.
Gary Lerner, president and founder of Gateway Checker and expert on supply chain integrity, will be discussing the future of pharmaceutical traceability at the GS1 Connect virtual conference, taking place June 16-17, 2020. Gary, together with Jeff Denton of AmerisourceBergen, will present “Bridging the Gap to Pharmaceutical Traceability” as an On Demand session, which will be available throughout the two-day event.
During their session, Gary and Jeff will explore how the drug industry as a whole is adjusting to the requirements outlined in the Drug Supply Security Act of 2013 and what companies can do today to prepare for the new traceability standards that will be required by 2023. These requirements aim to help the FDA understand what product is in the supply chain, where it has been, where it is going, and who is handling it; and to ensure that only legitimate, safe products end up on the market.
Currently, much of the data collected along the drug supply chain is either inadequate or not interoperable according to accepted industry guidelines. Many organizations have developed their own proprietary solutions or workarounds that don’t play well together. Gary will address how agreeing upon and employing a “common language” across the pharmaceutical industry is vital in preparing for the upcoming regulations and requirements.
FREE Registration for GS1 Connect is open through Friday, June 12 at gs1connect.gs1us.org.
About Gateway Checker
Gateway Checker provides software to help the pharmaceutical industry quickly, accurately and thoroughly ensure data accuracy and integrity about the products moving through the drug supply chain. Gateway Checker is a GS1 Certified Conformance Testing Service, and can attest to full conformance with the GS1 US Rx EPCIS traceability requirements.
About GS1 Connect
GS1 Connect is an annual event hosted by GS1 US for the purpose of bringing trading partners together to network and learn about the value of using standards-based business processes and best practices for optimum efficiencies in managing the supply and demand sides of their value chain. Due to COVID-19, this year’s event will be virtual.
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We will be presenting at this year’s GS1 Connect Conference.
GS1 US has created a digital conference experience that brings you the best of both worlds: highly curated program content and the flexibility for when and where you choose to engage. Join on June 16-17, 2020 to hear why the role of supply chain and unique identification have never been more important. Learn about trends from industry leaders and keynote speakers. Get up to speed on ways GS1 Standards are helping organizations adapt and accelerate to re-invent their supply chains to match shifting customer experiences. Participate in cross-industry and track sessions for Retail, Grocery, Foodservice, Healthcare, Tech, and Innovation. Explore emerging technologies with the Startup Lab Pitch Competition to be better prepared for the future of commerce. There will be no charge to attend allowing for more of our community to participate. Stay tuned as we share additional agenda details in the coming weeks.
Date: 16-17 June 2020
Location: Denver, CO, United States