The last stage of DSCSA implementation has arrived bringing changes to how pharmacies and distributors share product details. Though the legislation passed in 2013, the updated rules being phased in by 2026 need a higher level of package tracking digital data exchanges, and verification steps. Pharmacies’ current systems often aren’t equipped for these demands. The way you work with your distributors will shift . Knowing what they need to do and how that affects your operations will determine how well your pharmacy adapts.
Knowing What Distributors Must Do
Wholesalers have tight deadlines to follow. By August 27, 2025, they are required to:
- Accept only products that have unique serial numbers.
- Check returned drugs before distributing them again.
- Send electronic transaction records with every shipment.
- Share data using EPCIS (Electronic Product Code Information Services).
Now, every package comes with a unique ID that includes the NDC number serial number, lot information and expiration date. The system maintains an electronic record which follows the products throughout their journey from manufacturers to distributors and finally to pharmacies.This isn’t just extra paperwork. It’s a required tracking process enforced by law.
How This Affects Electronic Data Exchange
Your distributor now has to send serialized transaction records to you . This is a big change in how things work. Instead of just batch numbers on an invoice, you’ll get detailed information about each package in every drug shipment.
Some wholesale pharmacy distributors started sharing this data back in late 2025. Large pharmacies those with 26 or more full-time pharmacists and techs, need to meet compliance by November 27, 2025. Smaller pharmacies have until November 27, 2026 to comply. The important detail states that your distributor’s rules will impact your work even when your pharmacy qualifies for an exemption.
Key detail: You must answer FDA product tracing questions. Distributors can’t handle this for you. This means your systems need to be ready to store, manage, and find transaction data whenever it’s needed.
How the New Returns Verification Works
Processing returns has changed a lot now. When you return saleable products to distributors, they have to confirm the product identifier before they can take them back. This confirmation happens through two ways:
- Directly connecting with the manufacturer
- Using Verification Router Services to match serial numbers with manufacturer databases
If the serial number is not confirmed, the product won’t be accepted. This rule became mandatory for distributors in August 2025, which means every pharmacy, whether exempt or not, is affected in their everyday processes.
Systems for Data and Integration
Big distributors such as McKesson, AmerisourceBergen, and Cardinal Health have their own portals where you can find transaction data. There are also third-party tools like Pulse by NABP you can use. Whatever setup you choose, make sure it follows GS1 standards and works with EPCIS files.
These files are more than just simple spreadsheets. They hold transaction details tied to various invoices and purchase orders. Often, this information gets grouped at the tote or pallet level during work at distribution centers. Your pharmacy management tools must store and look up this data.
When Distributors Lack Complete Information
What if a pharmaceutical distribution company does not have the right serialized data? The FDA guidelines require them to set those products aside until they get the correct details. They are prohibited from distributing products that do not meet compliance once the exemptions are no longer valid. This can lead to real problems such as temporary shortages, if systems fail to stay aligned.
Steps Pharmacies Need to Take Now
Even though there’s an exemption lasting until 2026, you should not delay getting ready:
- Tell your distributors in writing about your exemption status
- Make sure your pharmacy system can handle and store serialized data
- Check if you can access transaction details on distributor portals or third-party tools
- Improve your scanners so they can read 2D barcodes with GS1 technology
- Teach your staff how to handle quarantine steps for questionable or fake products
The FDA has made it clear that exemptions aim to avoid supply chain issues, not stall proper preparation. After exemptions end, enforcement will start. Fines could go up to $500,000 for each violation. Serious violations might lead to criminal penalties. Licenses might also get canceled.
Why Staying Compliant Matters
DSCSA establishes a seamless custody chain for prescription drugs. It strengthens the supply chain to stop fake medications tainted products, and stolen stock. Distributors and pharmacy suppliers who apply these safety measures can find and pull harmful items from the market . This process keeps patients safe and adds confidence to the pharmaceutical supply system.
Working with a Reliable Distributor
Drugzone Pharmaceutical Inc. put a lot of resources into building serialization systems and electronic data exchange tools to meet DSCSA requirements without any issues. Independent and small-chain pharmacies often struggle with limited resources while dealing with these tough rules. Our team is here to assist you by making it easier to get transaction data set up verification steps in your current processes, and meet regulatory deadlines on time. We aim to make this shift simple so you can prioritize taking care of patients over worrying about compliance challenges.
FAQs
Q1. How does EPCIS data sharing work between pharmacies and distributors?
EPCIS follows the GS1 standard to record electronic transactions whenever a product changes ownership. Your distributor provides EPCIS files with serialized shipment data, which you need to receive, store, and access if the FDA requests it.
Q2. Does DSCSA serialization apply to every prescription drug?
No, it does not. Some items are excluded, like over-the-counter drugs, animal medications, blood products radioactive and imaging drugs specific IV products medical gases homeopathic remedies, and compounded drugs. Prescription drugs in their final dosage form are included.
Q3. What do I do if my distributor sends a product missing the required serialization data?
Distributors need to set aside products without correct serialization data and are not allowed to sell them after DSCSA exemptions end. If you get these products, reach out to your distributor right away to fix the missing data issue.