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

Posted by bryan hanley On October 10, 2024 at 5:18 pm | Comments Closed

Published October 10th, 2024

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?

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.

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: 

  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.

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. 

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

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.