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As the final phase of the Drug Supply Chain Security Act (DSCSA) takes effect, the method for delivering compliance information is changing. T3 data previously included in Advance Ship Notices (ASNs) is now replaced by serialized T2 data transmitted via EPCIS transactions.
However, ASNs remain a critical supply chain requirement. The customers of life sciences manufacturers—including wholesalers, health systems, and retail pharmacies—rely on ASNs to streamline receiving processes, support inventory management processes and reduce manual data entry errors.
By mandating that DSCSA T3 information be included in the ASN, the industry was able to drive digitalization of the transaction—not only to support compliance, but also to enable more efficient receiving, improved inventory management, and reduced manual data entry. It was a significant win for the industry.
Now, with the DSCSA compliance information moving from the ASN to a dedicated EPCIS transaction, pharmaceutical manufacturers are also being asked to continue sending the ASN. It would be a costly step backwards if the industry lost the benefits it currently receives from exchanging ASNs.
Industry Requirements are Varied
We have established that the business value the ASN provides to wholesalers and dispensers is significant. The majority of pharmaceutical manufacturers are sending DSCSA EPCIS files as of May 27, 2025, in line with the FDA requirements.
As of now, many wholesalers and dispensers are continuing to receive both the ASN with DSCSA information and the DSCSA EPCIS transaction. However, several wholesalers and dispensers have stated that they expect to require pharmaceutical manufacturers to remove the DSCSA information from the ASN.
This is not surprising because the DSCSA information in the ASN includes information and legal attestations that would—at best—create confusion, and at worst, create unnecessary liability. While it is not clear when the requirement to remove DSCSA information from ASNs will go into effect, the intentions of wholesalers and dispensers are clear.
Two Paths Forward—But Only One That Scales
As manufacturers transition from DSCSA-compliant ASNs to operational ASNs, there are two options: build and manage the infrastructure internally, or continue relying on TraceLink to handle both the complexity and scale of ASN delivery. Let's take a closer look at both options:
Option 1: Build It Internally
Managing ASN delivery in-house requires significant investment in systems and resources:
- Developing and maintaining a standard internal ASN generation process
- Providing support for 50+ unique ASN wholesaler and dispenser formats
- Building custom EDI integrations for each trading partner—potentially hundreds
- Managing delivery across multiple methods, including EDI, API, and portals
- Continuously onboarding and supporting new partners, formats, and updates
- This approach introduces long-term cost, complexity, and operational risk.
Option 2: Continue Relying on TraceLink
With TraceLink MINT for Commerce, customers use the same integration they use today and TraceLink manages the rest. This includes:
DSCSA Compliance:
- Creates and maintains the serialized T2 information and assembles the DSCSA EPCIS transaction
- Formats the DSCSA EPCIS transaction to the trade partners' specific requirements
- Sends the DSCSA EPCIS transaction to the trade partner via the pre-existing B2B configurations
- Makes required DSCSA serialized T2 information available in a portal
- Ongoing maintenance and support for trading partner B2B and file format requirements
ASNs for Operational Efficiency
- Route information from U.S. Compliance to MINT for Commerce
- Format transformation based on each trading partner’s specifications
- Routing and delivery via the partner’s preferred method
- Ongoing maintenance of all B2B maps and profiles
- Free onboarding and support for 100% of trading partners
This model ensures continued DSCSA support and ASN coverage across your trading partner network. All of this without having to reimplement and revalidate your business system integration.
MINT for Commerce and the Power of the Network
With TraceLink MINT for Commerce, manufacturers use the same Business-to-Network (B2N), Integrate-Once™ approach that enabled DSCSA compliance. DSCSA data is removed and operational ASNs are delivered to 100% of trading partners in the exact format required—without changes to existing integrations or added IT overhead. The free conversion program transitions current DSCSA ASN setups into a fully orchestrated operational ASN process. This proven, network-powered approach eliminates complexity, speeds onboarding, and preserves the operational benefits of ASN exchange.
Get Started—Without Disruption or Cost
Your customers still want ASNs. You still need operational efficiency. TraceLink MINT for Commerce ensures you deliver both—without the pain of costly integration projects.
Let us show you how easy it is to get started. Schedule a 15-minute call with a TraceLink expert today.
