On July 12th, 2024, the FDA announced an exemption for small dispensers from the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026.
However, the FDA will not extend further enforcement discretion for other parts of the supply chain.
Trading partners who are not prepared to meet the DSCSA’s enhanced traceability requirements by Nov. 27, 2024, are urged to seek individual waivers, exceptions, and exemptions (WEEs). However, the FDA has emphasized there’s no guarantee they will grant or deny these requests by the deadline, and the recommended deadline to submit these requests has already passed.
Furthermore, broad-scale WEEs could complicate DSCSA implementation and stabilization, particularly impacting those diligently preparing for interoperable traceability.
Gateway Checker is here to help you navigate these quickly approaching requirements. As the leading GS1 Conformance Testing Platform, Gateway Checker has a suite of services designed to help you protect the integrity of your supply chain and conform to necessary DSCSA Standards.
Blog Archives
How Ozempic Counterfeits Demonstrate the Urgent Need for a Secure Supply Chain
When demands soars for prescription pharmaceuticals and supply falls short, drug pirates get to work.
The bad actors manufacture and package fake drugs to look just like the legitimate brand-name medication. And many times, these counterfeits make their way into legitimate supply chains.
Counterfeit versions of Novo Nordisk’s diabetes drug Ozempic pose severe risks to patients worldwide, prompting CEO Lars Fruergaard Jorgensen to collaborate with authorities in various countries to address the issue.
Various reports reveal instances of patient harm, including dangerous drops in blood sugar, after consuming fake Ozempic, highlighting the urgent need for action.
Only a secure supply chain that is under constant surveillance can keep fraudulent drugs out of the legitimate supply chain. The FDA is protecting patients from adulterated or counterfeit medications through the Drug Supply Chain Security Act (DSCSA).
See how Gateway Checker can help you get there.
FDA Allows Florida to Import Prescription Drugs from Canada to Alleviate High Prices
Florida marks a milestone as the FDA authorizes the state to import prescription drugs from Canada to alleviate high drug prices.
This decision, resulting from bipartisan discussions and executive orders, grants Florida a two-year period to implement its drug importation program, potentially saving the state up to $183 million in the first year.
However, obstacles remain, requiring Florida to fulfill additional FDA requirements, conduct quality testing, and address potential Canadian restrictions. The FDA’s approval is a political triumph, yet the program’s impact on overall drug prices for Floridians is uncertain.
Furthermore, what will the impact be on supply integrity? Will Canadian medications imported to the US be required to comply with the enhanced traceability requirements of DSCSA? What mechanisms will be implemented to ensure authenticity of the medication? With many domestic partners struggling to adhere, its interesting to see how Canadian entities will navigate this process.
Will other states explore similar strategies to combat high drug costs? What will happen to prices as demand shifts from domestic supply to Canada?
FDA: Additional Time to Refine Systems and Processes for Interoperable Electronic Tracing
Effective August 25, 2023: FDA issues new compliance policies to help supply chain stakeholders attain enhanced traceability under DSCSA.
FDA recognizes that additional time beyond November 27, 2023 is necessary to “stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange.”
FDA is issuing this compliance policy to provide additional time, beyond November 27, 2023, to attain compliance without hindering access to prescription pharmaceuticals.
While FDA is strongly urging supply chain stakeholders to continue their efforts to deploy enhanced traceability solutions, FDA does not intend to take action to enforce enhance drug traceability until November 27, 2024.
Per FDA:
“This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.”
Gateway Checker Introduces Gateway CertifiedTM Program to Support DSCSA Interoperability Requirements
Lexington, MA, August 28, 2023 – Gateway Checker, the industry’s leading GS1-certified conformance testing service, today announced the introduction of the Gateway Certification program. A “Gateway CertifiedTM” drug transaction report enables organizations to be confident that they are compliant, interoperable, and fully conform to industry and regulatory requirements.
In November, all pharmaceutical trading partners will need to be compliant with DSCSA. Compliance requires electronic tracing of item-level product through interoperable systems. Although trading partners may be able to exchange records, there is no way to know if these transaction records are accurate, compliant, and interoperable, until problems emerge. Proactive identification of conformance issues minimizes surprises and time-consuming, costly exception handling, rework, and reverse logistics that can disrupt safe and secure access to essential medicines.
The Gateway Certification program leverages Gateway Checker’s TraceReady application for drug transaction quality assurance. Transaction records that pass TraceReady’s rigorous conformance testing requirements are eligible to be Gateway Certified. The Gateway Certified seal of approval means all trading partners can be confident in the data’s quality, ensuring integrity across the entire supply chain.
“Today most trading partners are operating in the dark when it comes to DSCSA record conformance. Problems are discovered too late and can be very costly and time-consuming,” commented Gary Lerner, CEO of Gateway Checker. “The only way to know is to test. Gateway Checker’s fact-based approach to testing and certification allows users to quickly understand and address areas of non-conformance and dramatically improve supply chain efficiency.”
“As a distributor, we literally have to connect with 100,000 customers using varied DSCSA solutions. It is not efficient or effective for us to negotiate the file transmission and completeness with every single one of those connections,” emphasized Scott Mooney, Vice President of Distribution Operations at McKesson Corporation. “For that reason, we are firmly committed to following the GS1 DSCSA implementation guide and Gateway Checker is the best tool for us to be able to validate that our EPCIS files are conformant. Having our transactions Gateway Certified puts us in an affirmative position and significantly minimizes conflicts when we start sending data to our customers who may claim that our files are in error.”
Certification is available for manufacturers, distributors, wholesalers, and solution providers. Gateway Checker also offers Gateway Certification for validation of VRS product verification systems. Click here to learn more about the Gateway Certified program, or contact our team with any questions.
Gateway Checker will be at the HDA 2023 Traceability Seminar, Washington DC, Aug 29-31, 2023.
Media Contact: Gary Lerner, glerner@nullgatewaychecker.com, 781-254-9987
About Gateway Checker
Gateway Checker™ is a Software as a Service platform that facilitates product traceability, DSCSA compliance, and unambiguously verifies the interoperability readiness of serialized pharmaceutical transaction records. Drug manufacturers, repackagers, and distributors can quickly and continuously test, validate, and certify adherence to GS1 US Rx EPCIS and VRS product verification application standards. Gateway Checker is certified by the GS1 US RX EPCIS Testing Service Certification Program and is owned and operated by the Gateway Checker Corporation, a wholly-owned subsidiary of BrandSure, LLC.