With the Drug Supply Chain Security Act (DSCSA) enforcement deadline recently pushed forward (again), Authorized Trading Partners (ATP) in the pharmaceutical supply chain might be letting out a collective sigh of relief. While the immediate pressure to be fully compliant might be reduced, this relief is temporary. ATPs should keep moving forward by focusing on workflows, training, education, teams and standard operating procedures.
It is important to note that while enforcement may be delayed, the existing rules remain in effect. Compliance efforts must continue.
Where we are today
The DSCSA had several requirements due by November 27, 2024, but delays were announced in October 2024. However, the law has technically been in effect since November 27, 2013, with requirements rolling out in stages since then.
These delays are like so many other delays in the industry. An example is the United States Pharmacopeia Chapter 797 where many healthcare systems waited patiently to see the results of the delay prior to investing in high-cost cleanrooms or authoring lengthy policies and procedures.
What was delayed?
Let’s look at some of the original expectations and delays that were originally in place and will be enforced by this time next year. Some of the original expectations and delays include:
Electronic tracking
All trading partners must use electronic systems to track prescription drugs. This includes manufacturers, wholesale distributors, repackagers and dispensers.
Unique product identifiers
Each drug package must have a unique serial number, lot number, expiration date and National Drug Code (NDC).
Stabilization period
The FDA had established a one-year stabilization period from November 2023 to November 2024 to allow trading partners to implement their electronic systems. During this time, the FDA would not enforce certain DSCSA requirements.
Small dispensers
The FDA granted small dispensers a two-year extension to meet the enhanced tracking requirements for drugs, based on the understanding that they would not be ready for the November deadline. This applies only to those with fewer than 25 employees.
Transaction history
The transaction history would be sunset at the end of the stabilization period in November 2024.
Most recent delays:
- Manufacturers and repackagers: May 27, 2025
- Wholesale distributors: August 27, 2025
- Dispensers with 26 or more full-time employees: November 27, 2025
DSCSA enforcement: Myth vs. fact
These most recent delays have led to some myths and misnomers as ATPs continue towards these new deadlines. Below, we will explore (and dispel) some myths that evolved from these delays for some of the major ATPs, including dispensers, manufacturers and wholesalers.
Myth: The DSCSA has been delayed to 2025, with varying deadlines for different ATPs.
Fact: The law is in effect as of November 2024 after the one-year stabilization period. Enforcement will begin in 2025.
Myth: ATPs can slow down or even pause their compliance efforts until the new deadlines approach.
Fact: ATPs are still required to adhere to DSCSA regulations. They should use the enforcement grace period to audit their systems and processes.
Myth: Health system dispensers, manufacturers and wholesalers can rely on upstream partners to ensure that products received have the proper tracking and tracing information.
Fact: ATPs must prioritize DSCSA readiness by understanding the law, staying updated on changes and training their teams. They should ensure upstream partners are prepared, communicate compliance plans to downstream customers and set clear vendor expectations. Engaging only with licensed trading partners, managing product tracing, identifying suspicious products and knowing how to report them to the FDA are critical steps. Lastly, ensure all transaction data is securely exchanged via an interoperable electronic system.
Myth: Our company can just rely on the waiver, exceptions and exemption (WEE) process since we will not be fully ready for implementation by May 2025.
Fact: Over-relying on WEE systems could jeopardize medication access, drive up prices and worsen shortages. Trading partners must continue readiness efforts to meet the delayed 2025 DSCSA deadlines.
The FDA must efficiently review and approve legitimate WEEs while rejecting those filed due to inadequate preparation to prevent major supply chain disruptions.
Myth: As long as some data is flowing across, even with errors or missing datapoints, we can continue to refine our process and it should be good enough.
Fact: Concerns about data quality and incomplete transmission were raised at an August meeting hosted by the Healthcare Distribution Alliance (HDA). Issues included inconsistent data aggregation, lack of standardization, trading partner communication challenges and potential disruptions from the new NDC format.
Industry leaders reported that only 25% to 50% of prescription drug products arrive with complete EPCIS data, leaving some pharmacies without serialized data or with inaccurate information from up to 20% of manufacturers. The impact on essential and shortage medicines remains unclear, but all medications are vital to patient safety.
The FDA must act quickly to process legitimate WEEs while holding companies accountable for unfulfilled DSCSA compliance steps to prevent supply chain disruptions.
The journey forward
As ATPs, assemble a compliance preparedness team with representatives from pharmacy, IT, compliance and legal. This team should evaluate current standards, assess technological needs and determine your readiness for 2025 and beyond.
The goal is full implementation of interoperable, enhanced electronic unit-level drug traceability including serialized identifiers and verification of saleable returns. Consider drug shortages, supply chain disruptions and trends like modernization and patient-first strategies.
Next steps for ATPs
Continue working toward compliance by collaborating with both your upstream and downstream partners to gain clarity on their preparedness and how it may affect you. Here are some key questions to ask:
- Does your wholesale distributor transact serialized products?
- How are you preparing for DSCSA compliance?
- Are you prepared for full prescription pharmaceutical product traceability in a secure, electronic, interoperable manner?
- What will you expect from dispensers?
- Which of your key vendors (inventory vendor, EMR vendor, tracing data vendor, etc.) have these on their radar?
Together authorized trading partners can hold each other accountable, learn from each other and set expectations to meet these goals and keep patients and the supply chain safe and secure.
The DSCSA journey is not over. While delays provide some breathing room, ATPs must stay focused on progress. Keep building your compliance team, working with partners and refining traceability and data quality to keep on track for the upcoming deadlines.
Stay proactive to protect patient safety, strengthen the supply chain and meet regulatory expectations. The work you do now will set you up for success when enforcement begins. It will help you thrive in the evolving pharmaceutical landscape.