Blog Archives

FDA: No More Delay for Updated DSCSA Guidelines

Posted by bryan hanley On September 12, 2024 at 2:01 pm | Comments Closed

The FDA has reaffirmed its commitment to the November 27, 2024, deadline for pharmaceutical partners to adhere to upcoming DSCSA regulations. With time running out, pharmaceutical stakeholders must assess their readiness and address any outstanding challenges.

Ensuring accurate and complete data exchange between trading partners is critical for DSCSA compliance. Yet many partners remain unprepared to meet these guidelines.

Helping You Become Compliant

Gateway Checker offers comprehensive solutions to address the challenges of DSCSA compliance. We specialize in helping you assess whether your pharmaceutical transactions comply with upcoming DSCSA regulations.

Are you prepared for the DSCSA deadline? See how Gateway Checker’s EPCIS and VRS Conformance Testing Platforms can give you and your supply chain partners the confidence that upcoming requirements are met.

 

FDA Announces Small Dispenser Exemption

Posted by bryan hanley On July 12, 2024 at 5:38 pm | Comments Closed

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.

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How Ozempic Counterfeits Demonstrate the Urgent Need for a Secure Supply Chain

Posted by bryan hanley On March 8, 2024 at 11:30 am | Comments Closed

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

Posted by bryan hanley On January 12, 2024 at 12:21 pm | Comments Closed

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

Posted by rebecca On August 28, 2023 at 10:44 am | Comments Closed

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.”

> Read Updated FDA Guidelines