Blog Archives

HDA DSCSA Guidance

Posted by bryan hanley On October 9, 2024 at 12:36 pm | Comments Closed

Following the recent HDA Traceability Seminar between August 26th-28th, I had the opportunity to lead a conversation amongst dozens of pharmaceutical partners and solution providers; we discussed various important topics related to the DSCSA, from Waiver, Exception, and Exemptions, to Verification Routing Services, and more. Emphasizing the importance of transparency and open conversation, I thought I’d highlight some important insights.  

It’s All About the Data

The FDA understands there are conflicts in terms of data quality and integrity. Downstream integrity is impossible without manufacturers ensuring their data and products align with updated standards. The FDA has stressed the importance of pharmaceutical partners, particularly manufacturers, meeting these standards by the end of the stabilization period (next month). However, for certain exceptions, including product/no data, WEEs must be considered.  

Waivers, Exceptions, Exemptions

Since mid-June, there have been over 324 requests for package-level requirements WEEs, with more likely to be submitted as we approach the deadline. Dispensers are most frequently requesting WEEs, followed by wholesalers, manufacturers, and repackages. The issue many partners are experiencing is that downstream partners cannot get accurate data from suppliers without upstream partners providing it to them efficiently. The FDA believes it is adequately staffed to handle WEEs, and if they find consistent requests for handling WEE scenarios, they will announce how partners should handle them.  

Easier Said than Done

Navigating the complexities of Waivers, Exceptions, and Exemptions is oftentimes easier said than done. While the FDA has provided various recommendations for handling tricky exceptions, oftentimes, partners still find themselves facing challenges in practice.  

VRS on the Rise

VRS is gaining popularity as an effective means to ensure interoperability between supply chain partners, helping pharmaceutical partners conform to product identification and authorization requirements under the DSCSA. Apart from saleable returns for pharmaceutical partners, VRS can provide additional verification in medical emergencies, though it’s not intended to bypass EPCIS verification.  

If you have any questions about these insights, please don’t hesitate to contact us.

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.

The Importance of Anti-Counterfeiting Solutions

Posted by bryan hanley On January 11, 2024 at 11:00 am | Comments Closed

Published January 11th, 2024

The global pharmaceutical industry faces a significant challenge with counterfeit medicines, estimated to be one in 10 medical products in low- and middle-income countries, leading to a $30.5 billion spending on substandard drugs.

Counterfeit medicines, often indistinguishable from genuine ones, pose severe risks, including toxic ingredients that can be life-threatening.

The US pharmaceutical supply chain is among the safest and most secure especially when medicines are exclusively supplied through authorized trading partners. Nonetheless, recent counterfeit Ozempic and Muro 128 products remind us that risks from fake medicines remain.

To combat this, healthcare and pharmaceutical organizations must embrace innovative anti-counterfeit technology solutions, prioritizing simplicity, ease of deployment across the supply chain, and adherence to standards.

Mapping the supply chain, leveraging digital tracking, financial transaction analysis, and evaluating delivery infrastructure can identify vulnerabilities, while trusted champions in the supply chain can be crucial in verifying authenticity.

While you can’t prevent counterfeiting, you can make it harder to do, and criminals easier to catch. And this all starts with implementing a traceability solution that protects the integrity of your supply chain.

See how Gateway Checker makes this possible.