What Isn’t Included in the Recent Exemption

Posted by bryan hanley On November 27, 2024 at 2:16 pm | Comments Closed

Published November 26th, 2024

Who Does It Apply To?

Recently, I shared that eligible trading partners were temporarily exempted from specific components of the Drug Supply Chain Security Act, “Latest DSCSA Exemption”. However, considering the stabilization period ends tomorrow, I thought I’d share some further insights on what isn’t part of the recent exemption.

First, as noted in my previous posts, the recent exemption doesn’t apply to everyone. As the FDA emphasized in their release, trading partners who are eligible for the exemption include “those who have initiated their systems and processes by successfully completing data connections with their immediate trading partners”, and “those who initiated processes including documentation of efforts to establish data connections but were not able to fully complete them with all immediate trading partners.” In other words, now is not time for trading partners to start initiating their systems and processes (that ship has sailed)—it’s time for trading partners to refine them.

Progress Necessary

The FDA wants to see progress made toward finalizing systems and processes capable of exchanging DSCSA transaction information and transaction statements with one another. Key enablers of this progress include:

Reconciling receipts of digital and physical representations of Serialized Information

Investigating suspect process

Verifying product for saleable returns

Responding to a trace request

In addition to documentation of progress, the FDA expects trading partners who plan to rely on the extension to communicate their intentions with immediate trading partners.

The FDA, similarly to when they announced their decision to implement the stabilization period, does not want trading partners to view this exemption as a “justification for delaying efforts to implement enhanced drug distribution security requirements.”

The deadline for compliance will come sooner than many expect, especially for manufacturers. In fact, there are only 129 working days until the May 27th, 2025 EDDS deadline.

Risks of Noncompliance

For those who haven’t initiated these systems and processes, punishments could be severe, and include:

Regulatory Risks: Potential for regulatory actions like warning letters, import alerts, or product seizures.

Operational Disruptions: Potential for supply chain disruptions and delays in product acceptance.

Market Exclusion: Risk of being completely excluded from the supply chain

Partners who do not meet the exemption criteria will need to submit a Waiver, Exception, or Exemption, or will more than likely face the consequences outlined above.

Stabilization Behind Us

Navigating DSCSA compliance amidst the constant changes to legislation can be tricky. However, one thing is for sure: if your business lacks systems and processes in place to implement EDDS requirements, the business is at risk.

With stabilization behind us, let Gateway Checker put you on the fast path towards supply integrity and regulatory compliance. Visit our website to view our services, or contact our team with any questions.

7 Things to Know About DSCSA Enhanced Drug Distribution Security Requirements

Posted by bryan hanley On October 9, 2024 at 12:17 pm | Comments Closed

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:

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.
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.
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.
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.
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).
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.
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.

Louisiana Board Report Sheds Light on DSCSA Compliance

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

A survey conducted by the Louisiana Board of Drug and Device Distributors (published on October 1st) 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

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

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

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.

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