DSCSA FOR PHARMACIES

DSCSA Authorized Trading Partners: How to Check a License

Supplier invoices ready for a DSCSA authorized trading partner check.

The DSCSA authorized trading partner rule rarely feels urgent until an offer shows up. Picture it. An email lands from a supplier you've never heard of. It has a drug that's been short for weeks, at a price well below your wholesaler's, and the paperwork, it says, will follow after payment.

You probably already feel that something is off. The question is what to check, and where. That check is the heart of this rule, and it takes a few minutes once you know where to look.

So let's go through it. First we'll look at what "authorized" means for each kind of supplier. Then we'll cover where to confirm it, and how to keep proof that you did.

DSCSA Requirements for Pharmacies: What Applies Today

Why does this rule apply to you today?

The Drug Supply Chain Security Act (DSCSA) is the federal law that tracks prescription drugs from the maker to your shelf. One of its oldest rules for pharmacies is simple. Buy only from authorized trading partners, and sell only to them. It has applied since January 1, 2015, under section 582(d)(3) of the FD&C Act. It's one of the duties in our guide to DSCSA pharmacy requirements in 2026.

A trading partner is any company you buy product from or sell product to. For most independents, that means your main wholesaler, a secondary or two, a few drug makers that ship to you directly, and the pharmacy down the road. This check is yours to do, even if your wholesaler gives you a portal, as we explain in what the wholesaler portal covers.

Here's the part that trips people up. The small dispenser exemption doesn't touch this rule. FDA's exemption covers the electronic, package-level tracing that small pharmacies need by 2027. Checking your partners is not part of it, so it applies to every pharmacy right now. Our post on what the exemption covers has the full split.

The DSCSA authorized trading partner definition, by partner type

"Authorized" means something a little different for each kind of partner. The definition sits in section 581(2) of the FD&C Act, and it has four parts.

Partner type"Authorized" meansWhere to check
Manufacturer or repackagerA valid registration with FDAFDA's drug establishment registration database
Wholesale distributorA valid license, plus filing the required annual report with FDAThe state license, then FDA's annual reporting database
Third-party logistics provider (3PL)A valid license, plus filing the required annual report with FDAThe state license, then FDA's annual reporting database
Another pharmacyA valid license under state lawThe state board of pharmacy or other licensing agency

The two middle rows are the ones you'll use most. FDA spells out a two-step check on its page about how to check the licensure of wholesale distributors and 3PLs. First, confirm a valid license in the state where the company does business. That page links to the state agencies. Then, confirm the company filed its annual report in FDA's database.

Listed is not licensed

This is the detail most people miss, and it matters. Finding a wholesaler in FDA's database is a good first step, but it isn't proof on its own.

FDA says so plainly on its annual licensure reporting page. A report in the database does not mean FDA licensed or approved the facility. It also doesn't mean the facility follows state and federal rules. That's why the state license check comes first.

Drug makers have a similar catch. Registration is what makes them authorized, but FDA's rules say that registration does not mean FDA approval (21 CFR 207.77). So you're confirming that a valid registration exists, and nothing more.

DSCSA Compliance for Small Pharmacies: Free Training (2026 Rules). Short video lessons + a printable checklist → Get free access

Let's walk through a real-looking check

Example (fictional): Dana owns two pharmacies. Her main wholesaler covers most orders, but she also buys from a smaller regional wholesaler, and one drug maker ships a specialty item to her directly.

Dana starts with the regional wholesaler. She looks up its license on her state agency's site, and the license is active. Next, she searches FDA's annual reporting database and finds a line for that facility. She writes down the license number, the state, and the date she checked.

Then she checks the drug maker in FDA's registration database and finds an active registration. Both partners pass, and the whole thing takes her about fifteen minutes.

Now go back to the email from the opening. Dana searches for that supplier and finds no license in any state. That answers the question. She doesn't buy, and she doesn't need to argue about the price.

What happens when nobody checks

This isn't only a paperwork rule. In April 2026, FDA sent a warning letter to a medical spa in Texas that it treated as a DSCSA dispenser. FDA cited the spa for buying from unauthorized sources. It also cited the spa for handling product without a product identifier, the 2D barcode many pharmacists call the "QR code."

One line in that letter is worth reading twice. FDA faulted the spa's response for having no written procedures for checking trading partner status. In other words, checking matters, and so does being able to show how you check. We cover what's at stake in DSCSA enforcement and penalties.

Turn the check into a simple routine

You don't need software for this part. A one-page supplier file does the job, and it's easy to keep up.

  1. List every partner. Include your main wholesaler, every secondary, each drug maker that ships to you directly, and any pharmacy you buy from or sell to.
  2. Check each one in the right place. Use the table above to match the partner type to the right database or agency.
  3. Write down what you found. Note the license or registration number, the state, and the date you checked.
  4. Check before the first order. A new supplier gets checked before you buy, not after the box arrives.
  5. Check again on a schedule. Once a year is a sensible habit, and also whenever a license may have lapsed.

Keep a short written procedure next to the file, so anyone on your team can follow it. Lesson 6 of the free training walks through it with the other duties that apply today. If a product from an unknown source is already on your shelf, treat it with care. Our guide to suspect product and Form FDA 3911 explains the next steps.

That same partner list helps later, too. In 2027, these are the companies you'll exchange electronic data with. A DSCSA connector, such as Connect RX by Maltexi, connects your pharmacy to your trading partners for electronic DSCSA data.

FAQ

What is an authorized trading partner under DSCSA? It depends on the partner. A drug maker or repackager needs a valid FDA registration. A wholesaler or 3PL needs a valid license and must file its annual report with FDA. A pharmacy needs a valid state license.

How do I verify a wholesaler's license? Check the license with the state agency where the wholesaler does business. Then confirm it filed its annual report in FDA's database. FDA describes both steps on its licensure page.

If a wholesaler is in FDA's database, is it licensed? Not necessarily. FDA says that being listed in its reporting database does not mean FDA licensed or approved the company. Always confirm the state license.

Do I really need to check the Big 3? The rule covers every partner, and no wholesaler is excluded by name. Checking a large wholesaler takes a few minutes, and it gives you a complete file.

Is this rule part of the small dispenser exemption? No. It has applied since January 1, 2015, and FDA's exemption doesn't cover it.

The short version

Buy only from authorized trading partners, and sell only to them. For wholesalers and 3PLs, check the state license and then FDA's annual reporting database, because listed is not licensed. For drug makers, check the registration, and for pharmacies, check the state license. Then write it all down, so you can show your work if anyone asks.

Check every partner, and keep the proof. → 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

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