DSCSA Wholesaler Portal: What It Covers for Your Pharmacy
Your rep mentions the DSCSA wholesaler portal on a call, and it sounds like the answer to everything. Your orders are already in there, the data is in there, and the wholesaler is a big, careful company. So it's tempting to think DSCSA is handled.
Part of that is true. The other part is still on you. Let's sort out which is which, so you know exactly what the portal does for your pharmacy and what it can't do.
Does your wholesaler handle DSCSA for you?
Here's the part that's true. FDA lets each company choose the technology it uses for electronic DSCSA data. In its 2023 standards guidance, it names web portals that use the EPCIS standard as one example. EPCIS is a shared data format that lets different companies' systems read the same DSCSA records. FDA recommends it, but the law doesn't require it.
So your wholesaler's portal can be one way to receive and store your data. That's a real help, and for many small pharmacies it's where the records already live.
But a portal stores data. It doesn't check that every supplier you use is authorized. It doesn't quarantine a suspect bottle on your shelf, and it doesn't answer FDA for you. Those duties stay with the pharmacy.
What the DSCSA wholesaler portal covers, and what stays with you
It helps to see the split side by side. The left column is what a portal can do. The right column is what the law still puts on you.
| What a wholesaler portal can do | What stays with your pharmacy |
|---|---|
| Receive the TI and TS for what you bought from that wholesaler | Make sure every supplier is an authorized trading partner (§582(d)(3)) |
| Store those records for you, under a written agreement | Keep a copy of that agreement, and stay responsible for the records (§582(d)(1)(B)) |
| Let you search and download past records | Answer FDA or state requests in a recall or investigation within two business days (§582(d)(1)(D)) |
| Hold data only for that wholesaler's sales | Get TI and TS from every other supplier too |
| Show you data after the sale | Quarantine and investigate suspect product, and report illegitimate product (§582(d)(4)) |
A quick note on terms. Transaction information (TI) is the record of what you bought, from whom, and when. The transaction statement (TS) is the seller's statement that it's authorized and followed the rules. For what to do with a bottle that looks wrong, see our post on suspect product and Form FDA 3911.
The written agreement most pharmacies skip
This is the detail people miss most. Section 582(d)(1)(B) lets a third party, including an authorized wholesaler, keep your DSCSA records for you. But it has to be under a written agreement. You keep a copy of that agreement, and the law says you are not relieved of your duties.
In plain terms, the portal can hold the records, but they are still your records. If FDA asks for them, the request comes to you. So it's worth checking whether your account terms include such an agreement. Ask how long the wholesaler keeps the data, too. You need at least six years. Then file a copy of the agreement with your DSCSA records.
The suppliers the portal doesn't see
Most pharmacies don't buy from just one place. Secondary wholesalers and drop-ship orders from manufacturers each send their own data. Each one also has to be an authorized trading partner.
Example (fictional): Dan owns one pharmacy. He buys about 85% of his stock from his primary wholesaler. The rest comes from a secondary wholesaler and from drop-ship orders with two manufacturers. His primary's portal shows 85% of his records. The other 15% arrive as emails, PDFs and a second portal login. If FDA asks about a drop-ship item, the main portal has nothing on it.
That doesn't mean Dan is doing anything wrong. It means his records live in four places, and he needs to know where each one is. FDA's page on checking a distributor's license is the place to start for every supplier, and our post on authorized trading partners walks you through it.
DSCSA Compliance for Small Pharmacies: Free Training (2026 Rules). Every duty in one place, one short video per step → Get free access
Three questions to ask your wholesaler this week
You don't need a meeting. A short email works. Ask these three questions, and save the answers with your DSCSA records.
1. What DSCSA data do you send me, and how? Find out whether it's in the portal, in a file, or both. Ask whether it includes lot numbers today.
2. Do you store it for me, and for how long? Ask whether a written agreement covers it, and get a copy. Make sure the answer is at least six years.
3. What will change before 2027? Ask when they'll send package-level electronic data, and what they'll need from you. Some wholesalers ask for a GLN, a location number used in EPCIS data. DSCSA does not require a GLN, but your wholesaler may ask for one as a business requirement.
While you're at it, ask about returns. For saleable returns, the partner taking them back must be able to match them to the original TI. During the small dispenser exemption, FDA lets your trading partners keep using their current methods to accept your saleable returns. Your wholesaler's own return policy may still ask for more, such as serial numbers, so check it.
Getting ready for 2027
If you're a small dispenser, you have some extra time. FDA's August 6, 2026 letter lets you and your partners keep using current methods for TI and TS until November 27, 2027. After that, your data needs to arrive electronically from every partner, not just your primary. Our post on the small dispenser exemption explains who qualifies.
That's where one place for all of it starts to matter. A DSCSA connector, such as Connect RX by Maltexi, connects your pharmacy to your trading partners for electronic DSCSA data. Whatever you choose, these seven questions help you compare options.
FAQ
Is my wholesaler's portal enough for DSCSA? Not on its own. It can receive and store your records, but checking suppliers, handling suspect product and answering FDA stay with your pharmacy.
Do I need a written agreement with my wholesaler? If a third party, such as your wholesaler, stores your DSCSA records, the law calls for a written agreement. Keep a copy, because you remain responsible.
Does the portal cover drop-ship and secondary orders? Usually not. Each supplier sends its own data, and each one has to be an authorized trading partner.
Do I need a GLN for DSCSA? DSCSA does not require a GLN. Your wholesaler may ask for one as a business requirement for electronic data exchange.
Can I keep using paper or PDFs until 2027? If you're a small dispenser, FDA lets you and your partners keep using current methods for TI and TS until November 27, 2027. Your other duties apply today.
The short version
Your wholesaler's portal can receive and store your DSCSA records, and that's a real help. But it covers one supplier, and the duties stay with you. Get the written agreement on file, track down data from every other supplier, and ask your wholesaler three questions this week. Then use our DSCSA compliance checklist to make sure nothing else slips.
Know what to do today. Be ready for 2027. → Get the free DSCSA training
DSCSA rules can change. Always confirm the latest requirements on FDA.gov. This is educational content, not legal advice.
Sources
- FDA guidance, DSCSA standards for the interoperable exchange of information for tracing (Sep 2023).
- FD&C Act §582, 21 U.S.C. 360eee-1.
- FDA, DSCSA exemptions for small business dispensers until Nov 27, 2027 (Aug 6, 2026).
- FDA, DSCSA product tracing requirements: FAQ (Aug 14, 2024).
- FDA, Check licensure of wholesale drug distributors and 3PLs (Mar 6, 2026).