Louisiana Board Report Sheds Light on DSCSA Compliance 

Posted by bryan hanley On October 2, 2024 at 12:28 pm | 0 Comments

A recent survey conducted by the Louisiana Board of Drug and Device Distributors found that a majority of trading partners have the necessary electronic systems to exchange data with other trading partners under the updated DSCSA compliance standards. The survey was sent to designated responsible persons (DRPs) at facilities that distribute drugs to Louisiana between August 13th and September 23rd. The survey received a response rate of 273 different firms across 40 states and Canada. 

According to the results, 77% of firms reported having processes in place for identifying suspect and illegitimate products, 75% have procedures in place for verifying products, and 74% have implemented data exchanges between partners. While the results of firms having policies for managing exceptions (45%), procedures for identifying ATPs (43%), and policies for managing WEEs (29%) didn’t indicate as strong of results, the significant majority of firms are taking the necessary steps to protect the integrity of our pharmaceuticals, and accordingly, to protect the health of consumers. 

Executive director of the Louisiana Board of Drug and Device Distributors, George Lovecchio, believes the results of the survey withhold positive implications. Besides calling to action the importance of the policies and procedures that need to be in place for DSCSA, the results show that “we can make this November (DSCSA) deadline”, but can only “do it if we work together.” 

Lovecchio added, “The survey shows that the time for excuses is over and it’s time for implementing (DSCSA guidelines).” For the integrity of our supply chains, trading partners failing to meet compliance requirements must prioritize their efforts. 

Contact us to learn how Gateway Checker can help you navigate the DSCSA compliance process.

Far From Compliant: Much Improvement Still Necessary for DSCSA Compliance

Posted by bryan hanley On September 26, 2024 at 11:31 am | Comments Closed

Many Manufacturers are Failing to Meet DSCSA Requirements

The November 27th deadline for DSCSA Compliance is just two months away. While many pharmaceutical partners have made tremendous efforts to adhere to updated guidelines, many remain far from compliant. DSCSA Compliance is a team effort; if certain trading partners fail to meet these new guidelines, the entire supply chain could be adversely impacted.

Pharmacies and the organizations that represent them, in particular, are discovering that manufacturers are behind when it comes to meeting updated traceability requirements. According to Jillanne Schulte Wall, Senior Director of Health & Regulatory Policy at the Alliance for Safe Online Pharmacies (ASOP), many manufacturers are only providing 20% to 30% of the data necessary for supply chain traceability. She believes this gap can be attributed not to purposeful noncompliance, but rather, to the various enforcement discretion periods and the complexities of the DSCSA itself.

Further Proof, and What it Could Mean for Consumers

These concerns align with the results of a recent survey conducted by the FDA and the Partnership for DSCSA Governance: close to one-third of pharmacies surveyed reported they are routinely receiving serialized data from 20% or less of their suppliers, and only 10% of them said they were receiving serialized data routinely from 95% to 100% of their suppliers.

The National Association of Chain Drug Stores (NACDS) gave their own input on DSCSA preparedness. The organization believes a phased, renewed approach to compliance is necessary, considering the number of manufacturer-level trading partners who are failing to provide complete and accurate EPCIS data consistently. Relying on the Waiver, Exception, and Exemption process alone could withhold negative implications for consumers, including higher prices and drug shortages.

The American Society of Health-System Pharmacists (ASHP) is communicating around the clock with the FDA as the end of the stabilization period approaches. “We are very concerned about the lack of preparedness we are seeing upstream, and whether or not there should be a continuation of the stabilization period,” Ms. Schulte Wall added. Nonetheless, the FDA hasn’t provided any reason for pharmaceutical partners to expect another stabilization period.

FDA: No More Stabilization

The FDA has made it clear they have no intention of continuing the stabilization period past November 27th. With this in mind, partners across the supply chain need to meet these updated requirements promptly. Though various organizations are pushing for modified compliance procedures or extensions to stabilization, the FDA has emphasized that this is not a likely scenario.

Pharmaceutical partners must focus on meeting updated compliance standards or risk consequences, including legal penalties, product seizures, downstream supply chain disruptions, and reputational damages.

How Gateway Checker Can Help

Gateway Checker has a variety of services intended to help pharmaceutical partners adhere to these updated DSCSA requirements. Our traceability platform, TraceReady™,  provides comprehensive drug transaction quality assurance, proactively identifying and remediating conformance and interoperability issues. Additionally, transaction records that pass TraceReady’s rigorous conformance testing requirements are eligible to be Gateway Certified™, our seal of approval verifying that your transactions are interoperable and meet updated DSCSA guidelines.

To learn more about our TraceReady™ Platform, and our Gateway Certified™ EPCIS and VRS conformance testing services, view our services or contact us.


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.

 

The Importance of DSCSA Compliance

Posted by bryan hanley On September 4, 2024 at 12:30 pm | Comments Closed

Many Unprepared for New Guidelines

With the stabilization period deadline approaching quickly, pharmaceutical partners must be ready to adhere to new traceability and interoperability requirements. But a troubling number of partners haven’t made enough progress to reach these new standards, a statistic troubling to partners, the FDA, and one that should trouble consumers as well.

While Phase 2 of the Drug Supply Chain Security Act was supposed to come into effect last November, a stabilization period has granted pharmaceutical partners an extra year to adhere. However, the November 27th deadline is quickly approaching, and FDA officials announced that this deadline is firm. Manufacturers, distributors, and healthcare providers must be prepared to exchange EPCIS interoperable, product-level data across the supply chain… and the truth is, many aren’t ready.

In June, the Partnership for DSCSA Governance (PDG) hosted a joint public meeting discussing DSCSA implementation and stabilization efforts, allowing industry leaders to discuss progress made to adhere to these standards. While progress has certainly been made since June, many pharmaceutical players remain unprepared, including major wholesalers and manufacturers. However, making progress simply by adhering to requirements isn’t the only issue.

Why Updated Regulations Matter… and How to Be Prepared

Counterfeits remain a real threat throughout the United States. Recent reports found Ozempic counterfeits infiltrating the supply chain, with counterfeit boxes containing the same serial number on all packages. A third-party review of the product detected this complication, exhibiting the lack of quality systems and processes within that particular supply chain. Instances like this are far from uncommon, highlighting the importance of DSCSA Compliance and working with a trusted solution provider to help you comply.

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.  

Keep your supply chain safe. Take a look at our traceability platform and conformance testing solutions, to see how we can help you prepare for the upcoming DSCSA regulations. 

Or, feel free to contact us to learn more.

 

HDA Traceability Seminar Insights

Posted by bryan hanley On August 28, 2024 at 11:41 am | Comments Closed

The 2024 HDA – Healthcare Distribution Alliance Traceability Seminar was an amazing opportunity for pharmaceutical industry leaders to discuss DSCSA compliance challenges, and present innovative solutions to help partners remediate these challenges. Below, we discuss some important HDA Traceability Seminar Insights. One of the major takeaways from the conference was the role of Waivers, Exceptions, and Exemptions (WEEs) on DSCSA deployments.

DSCSA Compliance Clock is Ticking

With the deadline for compliance less than 3 months away, the compliance clock is ticking, and ticking fast; however, many appear unprepared. Despite reasonable efforts, many pharmaceutical supply chain partners are far from fully compliant, and likely won’t be by the time the stabilization period ends this November 27th.

The FDA has exempted small dispensers (25 or fewer full-time employees for the corporate entity owning the dispenser) from upcoming DSCSA electronic and data-driven requirements; these small dispensers account for about 1/3rd of total dispensers. What remains unclear is whether distributors who ship to these dispensers will also be exempt for those specific transactions.

Furthermore, the FDA cannot guarantee all of those who apply for WEEs will be answered by the end of the stabilization period, and the recommended deadline to submit these requests ended nearly a month ago.

The ambiguity over who is and who isn’t exempt and the indefiniteness of WEE approval could have detrimental implications on pharmaceutical supply chain integrity. Furthermore, handling common exceptions has proven difficult for big wholesalers and other partners, likely to further inhibit pharmaceutical supply chain security.

How Gateway Checker Can Help

The good news? Gateway Checker’s services provide wholesales, distributors, dispensers, and logistics providers the capabilities necessary to handle a variety of common exceptions, including:

  • Resending of a file with corrections (even after acceptance)
  • Reconciliation of partial shipments/short shipments
  • Digital instantiation of products with no corresponding EPCIS data (only to be used in accordance with SOPs)
  • Visibility into EPCIS errors

See for yourself how Gateway Checker simplifies DSCSA Compliance. Explore our features for yourself, or contact us to discuss your specific needs.

Gayr Lerner representing Gateway Checker at the 2024 HDA Traceability Seminar in Washington, DC.