Verification Router Services: A Solution to Drug Shortages? 

The Importance of Collaboration to Address Drug Shortages

On October 31st, 2024, I listened to a compelling LinkedIn conversation hosted by Chip Davis of the Healthcare Distribution Alliance, titled “Working Collaboratively to End Drug Shortages.” Joined by Laura Bray of Angels for Change and April Gile of the End Drug Shortages Alliance (EDSA), the panelists emphasized the crucial role of collaboration in addressing the issue of drug shortages. Both of their organizations have taken tremendous strides in addressing the issue of drug shortages, an issue adversely impacting millions of Americans every single year. 

When organizations work as individuals, rather than cooperating, little is accomplished to address the drug shortage crisis. In the conversation, Bray stressed “I have so many examples of times where 3 people in a room did way more than 30 individual organizations trying to solve [the drug shortage crisis]. 30 people in a room working to the same goal can truly solve the crisis and save lives.” The complexity of supply chains and other communication barriers make cooperation more difficult; however, its organizations like theirs that are helping make this process easier. 

To address shortages, we must bring together supply chain partners who typically don’t interact with each other. As April highlighted in the conversation, transparency and proactiveness are the keys to success. She noted: 

“How do we identify shortage risks in a preventive way, ahead of a shortage vs. behind it? How do we think about promoting transparency between these partners who have really never worked (together) before around inventory awareness, and really create an effective collaboration approach to prevent disruptions ahead of time vs. being responsive after a disruption occurs.”  

Pharmaceutical partners must invest in systems and processes that encourage greater transparency across the supply chain; one of these solutions is product verification through the Verification Router Service (VRS). 

Could VRS Help Solve the Problem?

Though most understand VRS as a means to handle saleable returns, product verification through VRS could provide other benefits. VRS can help proactively address drug shortages in a variety of ways, assuming supply chain partners verify product both at the time of order receipt and delivery.  By identifying replenishment rates to better address supply and demand, authenticating sources to prevent improper disposals, and providing up-to-date product information to support inventory turnover, there is a major role VRS can play in addressing shortages. 

Traceability is currently limited to a one-up, one-back system, where partners only track drugs one partner before (direct supplier) and one partner after them (direct buyer). However, as drugs make their way from manufacturers to end consumers, there are usually 4-5 stops they make along the way; these stops include wholesalers, distributors, third-party logistic providers, and/or other partners. It’s clear to see how supply chain visibility and transparency can be limited from start to finish; product verification through VRS systems, if used effectively, can help address the drug shortage crisis. 

The challenge? Making VRS data available for every supply chain partner. Currently, VRS data goes directly back to the manufacturer. However, in consideration of the role VRS could play in proactively addressing the drug shortage issue, could we consider making the data available to all supply chain partners? Could centralizing this data for analysis address the root cause of drug shortages better than current methods? While industry partners would need to collaborate extensively for this to work, the added transparency and visibility integral to resolving the drug shortage crisis would make it well worth it. 

What do you think? Do you see a future where VRS helps prevent and resolve drug shortages?  

DSCSA Exemptions from Section 582 and Other Requirements of the FD&C Act for Certain Trading Partners

The FDA announced on October 9th that they are granting eligible pharmaceutical trading partners exemptions from Enhanced Drug Distribution Security (EDDS) requirements of the FD&C Act. Eligible trading partners include those who have initiated systems and processes and successfully completed data connections with immediate trading partners, or those who have initiated processes (with documentation) to establish data connections, but were unable to fully complete them with all of their immediate trading partners, by November 27th, 2024.

Specifically, eligible trading partners will be exempt from key portions of Section 582 of the FD&C Act. These exemptions and their respective sections of the FD&C include:

  • Enhanced drug distribution requirements– section 582(g)(1)
  • Verification requirements for wholesale distributors concerning saleable returned product– section 582(c)(4)(D)*
  • Verification requirements for dispensers concerning illegitimate or suspect product– sections 582(d)(4)(A)(ii)(II) and (d)(4)(B)(iii)**

*Eligible wholesale distributors are still obligated to meet all other verification requirements of section 582(c)(4) of the FD&C Act, including package-level product verification to investigate suspect/illegitimate product.

**Eligible dispensers are still obligated to meet all other verification requirements of section 582(d)(4) of the FD&C Act, including package-level product verification to investigate suspect/illegitimate product.

The FDA has implemented these exemptions based on pharmaceutical trading partner feedback. Particularly, trading partners have described challenges resolving issues related to missing or erroneous data in electronic DSCSA transactions, without delaying drug movement downstream. This, partners have argued, could contribute to drug shortages and prevent pharmacies and patients from receiving the drugs they need.

These exemptions vary in length based on trading partner type:

  • Manufacturers and Repackagers: May 27, 2025
  • Wholesale Distributors: August 27, 2025
  • Dispensers with 26 or more full-time employees: November 27, 2025

It will be interesting to see how these exceptions are enforced, and how eligible trading partners will be identified:

  1. What “documentation of evidence to establish data connections” will make a trading partner exempt?
  2. How will the FDA ask for this “documentation”, and how will they check for progress?
  3. What will this mean for those who haven’t made efforts to comply?

7 Things to Know About DSCSA Enhanced Drug Distribution Security Requirements

The Image introduces what the article will discuss, the 7 key things you need to know about enhanced drug distribution security as required by the Drug Supply Chain Security Act

The DSCSA: A Phased Approach to Implementation

Published October 10th, 2024

Over a decade ago, the FDA established the Drug Supply Chain Security Act to help protect consumers from potentially counterfeit, stolen, contaminated, or otherwise harmful prescription drugs as they’re distributed throughout the United States. The legislation focuses on establishing procedures for achieving interoperable, electronic product tracing at the package level, improving detection and removal of potentially dangerous drugs from supply chains, and providing a licensing system for wholesale drug distributors and 3PLs. 

The legislation mapped out a 10-year phased timeline, beginning with Product Tracing, followed by Verification, Authorized Trading Partner Establishment, Product Identifier Implementation and Verification, and finally, Enhanced Drug Distribution Security requirements (EDDS). EDDS requirements were supposed to go into effect on November 27th, 2023. However, in August of the same year, the FDA announced a stabilization period, delaying enforcement until a year after the original deadline. This stabilization period provides trading partners additional time to “build and validate interoperable systems and processes, manage products and data, and ensure continuity of the supply chain and product availability to patients.” Despite requests from various trading partners and organizations, the FDA has indicated frequently that it will not extend the stabilization period any further. 

7 Things to Know About EDDS Requirements

With the stabilization period ending in November, what exactly are the EDDS requirements trading partners must adhere to? Here are 7 things you need to know about Enhanced Drug Distribution Security requirements: 

  1. Product Identifiers are required at the package level. Each Product Identifier must contain a Standardized Numerical Identifier (Serialized GTIN), a Lot Number, an Expiration Date, and human-readable and machine-readable data carriers. 
  2. Systems must be in place to ensure electronic, interoperable-traceability. This is enabled by capturing “who buys what from whom” in Drug Transaction Records (DTRs), and assuring these records meet DSCSA regulations and industry application standards. 
  3. DTRs must be exchanged at each level of ownership as drugs make their way across the supply chain. Tracing information must be provided at the individual serialized level. Capturing and exchanging information at this level requires a common information framework; this “information framework” captures what happens in the physical world, and is essentially an information-encoded representation of packing and shipping events. EPCIS is the only FDA-recommended standard to support and enable electronic traceability. 
  4. Systems need to securely exchange, capture, and maintain the electronic DTR accurately, efficiently, and consistently among trading partners. Processes and systems need to be more accountable, transparent, and responsive to regulatory oversight. 
  5. Trading partners shall reconcile transactions; they must ensure product tracing information received electronically (Transaction Record) accurately reflects the packages of product the purchasing trading partner physically received (digital representation of the physical shipment). 
  6. Reporting and communication are necessary for true, accurate, and complete traceability. Errors and discrepancies need to be identified, communicated, and resolved within three business days. For recalls and suspect products, the DTR must be promptly generated upon request by the FDA. Additionally, partners must allow saleable returns only if they can be associated with the initial DTR. 
  7. The consequences of non-compliance are seismic, both at the business and personal levels. As we’ve already seen with counterfeit Ozempic, enhanced drug distribution security procedures can save lives. Punishments for non-compliance include seizure of goods, loss of license, civil and criminal violations, and imprisonment. 

It’s Time to Take Action

With the final phase of the DSCSA coming November 27th, ensuring you are prepared for enforcement is essential.  

See how Gateway Checker’s solutions can help you comply with updated guidelines, or contact our team with any questions.

Far From Compliant: Much Improvement Still Necessary for DSCSA Compliance

Many Manufacturers are Failing to Meet DSCSA Requirements

Published September 26th, 2024

The November 27th, 2024 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 in June: 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.


The Importance of DSCSA Compliance

Many Unprepared for New Guidelines

Published September 4th, 2024

With the November 27th, 2024 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.