As you know, the FDA recently extended saleable returns verification until 2023.
Please join Gateway Checker CEO and Founder Gary Lerner at the HDA 2020 Virtual Traceability Seminar where he is hosting a VRS System Verification roundtable on Tuesday, November 3 at 10:00 AM ET.
We will address the FDA’s saleable returns verification extension and have a lively discussion on data integrity challenges facing drug manufacturers, wholesalers, and dispensers as the deadline extends out to 2023.
During the session we will address a key industry question:
How are pharmaceutical manufacturers, distributors, and dispensers viewing the need to establish, test, and deploy VRS given the extended FDA enforcement discretion for saleable returns verification?
Topics for discussion:
What are your plans for VRS given the recent FDA announcement?
What factors are driving your decision?
What actions would you like to see from the VRS solution providers?
If there are additional topics you’d like us to cover, please contact us.
Click here to register.
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.
Pharmaceutical Commerce | July 3, 2020 | Updated: July 28, 2020
By Gary Lerner, Gateway Checker Corp
Within the next 30 months, some US pharmaceutical wholesalers are planning to be traceability-ready in accordance with the Drug Supply Chain Security Act (DSCSA). To some that might sound like plenty of time. To those of us with years of experience in the industry, it sounds more like a sprint to the finish line rather than a pleasant jog. Even now, the US drug supply network is struggling with electronic, interoperable traceability without alignment around a common set of application standards. A report from the Office of Inspector General of HHS, while evaluating the current status of DSCSA traceability, recommended that “FDA offer educational outreach to trading partners about required drug product tracing information and data standardization guidelines.” 
There is a broadly (but not universally) accepted standard for trading-data communication: the EPCIS standard of the GS1 organization. But to ensure that EPCIS is being effectively employed by pharma trading partners, and the software vendors serving them, a testing protocol has been developed and sanctioned by GS1. This article will explain its justification and application.
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3 EPCIS Data Exchange Issues in Pharma Traceability
Keren Sookne | Healthcare Packaging | Jun 16th, 2020
Conformance testing services have emerged to cut down on wasted back-and-forth between manufacturers and trading partners to get efficient data exchange up and running.
Gary Lerner, president at Gateway Checker Corporation, presented at GS1 Connect.
Pharma companies continue to make inroads to meet the DSCSA 2023 requirement for unit-level traceability at each change of ownership between trading partners. “Capturing and exchanging information at this level of specificity requires a common information framework,” explained Gary Lerner, president at Gateway Checker Corporation, at the GS1 Connect: Digital Edition (virtual) conference this week.
“This information framework captures what happens in the physical world with an electronic twin, essentially an information encoded representation of packing and shipping events that can be exchanged with trading partners. What’s needed to accomplish that is a common vocabulary and structure that enables trading partners to then share and exchange essential trading information in a consistent, accurate and interoperable manner,” said Lerner. Without a common standardized approach, there will be considerable waste in time and effort with trading partners negotiating the structure and content in each point of connection.
Lerner pointed to the value of the global GS1 standard EPCIS (Electronic Product Code Information Services), which enables the common information exchange language that can be shared. “However, EPCIS is a general purpose exchange standard. Application-specific standards are therefore necessary to tailor EPCIS to suit a specific industry and application. In 2015, the GS1 US Healthcare working group recruited more than 50 companies representing a cross section of the pharmaceutical industry to adapt EPCIS to address DSCSA specific requirements. And in 2016, the application standards governing DSCSA traceability were published. Adopting these standards therefore helps different businesses within the drug supply chain to more efficiently and effectively connect and share information,” he said.
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Healthcare Packaging | Jun 16th, 2020
Join Jeff Denton (AmerisourceBergen) and Gary Lerner (Gateway Checker) as they discuss how to bridge the gap to US Drug traceability at the GS1 Connect Digital Conference, June 16 and 17.
GS1 Connect: Bridging the Gap to Pharmaceutical Traceability
FDA regulations mandates interoperable, electronic tracing of medicines at the item level to enhance the security of the US Drug supply chain by 2023.
Establishing traceability requires accurate and complete data sharing among trading partner within the drug supply network.
Closing the gap to traceability is essential for major US pharmaceutical wholesalers. See the challenges AmerisourceBergen faces as they prepare to onboard more than 500 drug manufacturers and accept serialized electronic transactions from nearly 25,000 drugs Learn how they utilize new tools and technology from Gateway Checker to test, evaluate and certify conformance to GS1 US traceability standards.
Conformance to the GS1 Electronic Product Code Information Services (EPCIS) standards specific to the Drug Supply Chain Security Act allows trading partners within the supply chain to enable compatible connections: first-time, every-time.
Register for complimentary attendance to the GS1 Connect Digital conference.