TLDR DSCSA | May 2025 🌻
May Brings More Than Flowers
April showers bring May flowers but in 2025, May also brings the Drug Supply Chain Security Act (DSCSA) enforcement deadline for manufacturers and repackagers.
What’s Required of Manufacturers and Repackagers?
Serialization: Each package of prescription drugs must have a unique identifier, including the National Drug Code (NDC), serial number, lot number, and expiration date.
Electronic Data Exchange: Transaction information (TI) and transaction statements (TS) must be exchanged securely and in a standardized, interoperable format.
Verification Capabilities: Systems must be in place to verify the legitimacy of products and respond promptly to verification requests.
Record Retention: Accurate transaction records must be maintained to support investigations and audits.
Deadlines for Other Supply Chain Entities
Other stakeholders have a little more time:
Wholesalers: August 27, 2025
Dispensers (>25 employees): November 27, 2025
So... How Will DSCSA Be Enforced?
While the mandates are clear, the FDA’s enforcement playbook remains vague. There’s been no formal announcement outlining how inspections will be conducted or penalties applied. And if you’ve been following DSCSA for any length of time, you already know that most guidance from the FDA requires significant interpretation.
The FDA’s enforcement history has also been... flexible. The original full enforcement deadline of November 27, 2023, was pushed to November 27, 2024, and subsequent extensions followed for other supply chain roles.
This pattern of delays set a precedent where waiting seemed, at times, more rewarding than preparing early.
But What If Enforcement Comes From Within?
Regardless of whether the FDA starts issuing fines or strongly worded letters, a self-regulating industry has already emerged.
Many 3PLs and distributors now refuse to accept shipments that lack serialization data. They are enforcing compliance in real time, because they have to.
The next DSCSA phase?
Auditing the data...
...and service providers who created it.
From Gatekeepers to Inspectors
Initially, 3PLs and wholesalers acted as gatekeepers who were checking for the presence of serialized data. They issued score cards and deadlines to push us to the current state of compliance. This was a big, smart, and noble effort IMHO.
Now, under DSCSA, downstream parties must become inspectors responsible for verifying product legitimacy.
That means asking questions like:
Is the GTIN valid and properly formatted?
Does the EPCIS file reflect a real shipping event that matches a PO or ASN?
Do the serialized products exist in the correct quantity?
Are the event types logically sequenced and accurately timestamped?
Currently, most EPCIS data is accepted at face value. As long as a file exists and it's in the right schema, we're good. But that’s a fragile approach. It creates risk: mismatches go undetected, bad data slips through, and organizations face regulatory exposure.
That’s why auditing is the logical next step. If it’s not already underway, it soon will be.
And when it is, we’ll see product turned away or quarantined more frequently. Product won’t go to market and that means dollars lost.
The Self-Enforcing Ecosystem Is Growing Up
This ecosystem is maturing from document validation to data integrity enforcement. It’s not a stretch to understand why: 3PLs and distributors don’t want to be liable for data they didn’t validate.
Manufacturers and repackagers who can’t back up their EPCIS data with accuracy and integrity will lose trust and possibly, contracts. Also, it should be noted this isn't just an intra United States issue. Contract organizations moving product into and then throughout the United States are also in this boat.
The CDMO boat, by the way, is worth billions alone.
I’d worry less about the FDA and more about whether my partners will shut the door before regulators ever knock.
DSCSA May TLDR:
From preparation to Compliance: DSCSA Implementation Takes Big Steps in 2025
TLDR ⚡: The DSCSA is entering its final phase of implementation in 2025, with key exemption periods expiring for manufacturers (May), wholesalers (August), and large dispensers (November), signaling a transition to near-full compliance. While most trading partners are ready, potential issues such as aggregation data quality and increased verification demands could strain systems and staffing. Despite political pressures and regulatory uncertainty, the DSCSA framework has remained largely stable and is delivering real benefits, such as detecting counterfeit drugs like GLP-1 medications.
TLDR ⚡: Fusion Health has partnered with MMCAP, a national group purchasing organization, to offer its DSCSA compliance platform, Fusion360, to over 26,000 government-affiliated healthcare facilities across the U.S. Fusion360 streamlines traceability, verification, and reporting tasks to help public pharmacies and healthcare systems meet DSCSA requirements efficiently. The partnership enhances supply chain security and patient safety while ensuring audit-readiness.
Tech Solutions Can Fight the Surge in Counterfeit Medicine
TLDR ⚡: Counterfeit medicines are a growing threat, especially online, with drug crime now estimated at $75 billion annually and impacting everything from HIV medications to diabetes test strips. While the DSCSA provides a legal framework for traceability, gaps remain in product-level tracking, online pharmacy regulation, and packaging security. The article advocates for advanced tech solutions like blockchain, RFID tagging, and tamper-proof packaging, alongside better oversight of online pharmacies and domain-level enforcement.
DSCSA Job Openings:
Supply Chain Analyst : A-Line Staffing Solutions (Remote)
DSCSA Analyst : Aquent (Remote)
Senior Business Analyst, Track & Trace DSCSA Compliance: Walgreens (On-site / IL)
Analyst-Pharmacy Strategic Value (DSCSA and Reverse Distribution) : Indiana University Health (On-site / IN)