Have you ever stopped to think about where your prescription drugs come from? As a pharmacist, you play a critical role in ensuring that every product you dispense is safe, legitimate, and fully traceable. With the U.S. drug supply chain continuing to evolve, confidence in your upstream partners—and in your own compliance processes—has never been more important.
The Drug Supply Chain Security Act (DSCSA), enacted in 2013, established a nationwide system to prevent harmful drugs from entering the supply chain, detect them if they do appear, and enable rapid response when they are discovered. Now, with the final interoperability requirements in effect, the expectations for pharmacies are clearer—and more essential—than ever.
At Outcomes, we understand the challenges pharmacies face in keeping up with DSCSA requirements. That’s why we provide technology solutions that help ensure compliance, protect your patients, and streamline your daily workflow.
Key DSCSA Requirements Pharmacies Must Follow
1. Confirm All Trading Partners Are Authorized
Pharmacies may only work with trading partners who hold valid state or federal licensure or registration. This includes:
- Manufacturers and repackagers (check FDA registration)
- Wholesale distributors and 3PLs (verify state or federal licensing)
- Pharmacies (verify through your state board of pharmacy)
Always confirm that partners maintain active status—your supply chain is only as strong as the entities within it.
2. Receive, Store, and Provide Product Tracing Information
Pharmacies must only accept prescription drugs that arrive with complete product tracing data. This includes:
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Transaction Information (TI)
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Transaction Statement (TS)
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Transaction History (TH) – Note: TH requirements evolved under the enhanced system, but historical documentation must still be retained.
You must:
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Obtain complete documentation before accepting a product
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Store tracing data for six years (paper or electronic)
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Provide TI and TS when transferring ownership to another trading partner (Not required when dispensing to a patient or transferring to another pharmacy for a specific, identified patient)
3. Investigate and Handle Suspect and Illegitimate Products
Pharmacies must have procedures to identify, quarantine, and investigate any product that appears:
If a product is confirmed illegitimate:
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Quarantine it immediately
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Notify the FDA and affected trading partners
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Coordinate with the manufacturer
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Prevent the product from reaching patients
Robust procedures are not just regulatory requirements—they are essential protections for patient safety.
The DSCSA “Enhanced System” Is Now Real—Is Your Pharmacy Ready?
The final phase of DSCSA implementation—often referred to as “DSCSA 2023”—introduced package-level serialization, electronic interoperable exchange, and verification requirements. While industry-wide stabilization extended well past 2024, full compliance expectations are active in 2026.
That means dispensers must use systems capable of:
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Receiving and storing serialized, EPCIS-based electronic data
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Verifying product identifiers at the package level
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Exchanging tracing data electronically with trading partners
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Supporting investigations with reliable, retrievable digital records
Failure to comply may result in regulatory penalties, supply chain disruptions, or loss of access to key trading partners.
At Outcomes, our Pharmacy Management Systems—ComputerRx and Rx30—are designed to support the enhanced DSCSA requirements and provide seamless interoperability. We continuously update our platforms to align with evolving FDA guidance, industry best practices, and trading partner standards.
Your 2026 DSCSA Compliance Prep Guide: A Fun (But Serious) Look at Pharmacy Compliance
Hey there, pharmacy superheroes! As the DSCSA landscape continues to evolve, it’s time to suit up and make sure your pharmacy is operating like the compliance champion it was destined to be. Here are five refreshed tips to help you stay DSCSA-ready in 2026.
1. Get Your Compliance Prescription Filled
Know the rules before the rules know you. Familiarize yourself with:
The only thing you should improvise is your customer-service smile—not your compliance plan.
2. Tech Upgrades: Enter the Pharma Matrix
Outdated tech is the true supervillain of 2026. Your pharmacy needs a system that can:
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Manage serialized products
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Exchange EPCIS files
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Maintain clean, searchable histories
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Verify products electronically
Luckily, Outcomes’ Rx30 and ComputerRx have your back—no black trench coat required.
3. Superhero Squad: Choose Trusted Trading Partners
Even the best heroes need reliable allies. Make sure every trading partner in your supply chain is:
No Jokers allowed.
4. Training Academy: Build Your Compliance Ninjas
Your team is your shield. Regular training helps staff:
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Spot suspicious products
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Handle quarantines correctly
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Manage electronic tracing data
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Understand their DSCSA responsibilities
Every great superhero has an origin story—make DSCSA training part of yours.
5. Audits: They’re No Laughing Matter
Mock audits are like superhero training simulations. Use them to:
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Test your tracing documentation
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Practice verifications and recalls
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Identify gaps in workflow or technology
Keep the atmosphere positive, collaborative, and focused on continuous improvement.
Stay Compliant. Stay Confident. Stay Protected, Pharmacy Owners.
Preparing for DSCSA requirements may feel overwhelming, but with the right systems, partners, and processes, your pharmacy can navigate 2026 with ease. Outcomes is committed to helping you stay ahead of regulatory changes so you can focus on what matters most—protecting your patients.
Contact Outcomes today to learn how our Pharmacy Management Systems can help your pharmacy remain compliant, efficient, and prepared for the future.
