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.

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.

FDA Announces Small Dispenser Exemption

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

On July 12, 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.

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?

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