Guide · Customer license verification

How medical device distributors verify customer licenses

Before a prescription device ships, someone has to confirm the buyer is licensed to receive it. Here is what to check for each type of customer, where to check it, and how to keep it current without a spreadsheet.

By Workd, makers of WorkdID. Updated .

Short answer

Confirm the buyer holds an active license that lets them receive the product, using the board that issued it. For pharmacies that is the state board of pharmacy. For physicians and other practitioners it is the state medical board, plus the NPI registry, plus the DEA if controlled substances are involved. Save a dated copy of each check, and re-check on a schedule, because licenses expire and get suspended between orders. Software like WorkdID by Workd does these checks every day and can hold an order before it ships to an account that is out of good standing.

Why distributors have to check at all

A prescription device carries the "Rx only" label for a reason. Under federal rules, it can only be sold to a licensed practitioner, on a practitioner's order, or to a business lawfully engaged in distributing it.

A prescription device "is to be sold only to or on the prescription or other order of such practitioner." 21 CFR 801.109(a)(2)

If you also sell prescription drugs, the Drug Supply Chain Security Act adds a second rule. A wholesale distributor's trading partners "may be only authorized trading partners" (21 U.S.C. 360eee-1(c)(3)). For a pharmacy or other dispenser, authorized means it holds a valid license under state law.

States add their own layer. Some spell out that the distributor must verify the buyer's license. Some require you to keep a copy of it. Some license device and DME distributors separately. See the rules for each state.

What to check for each type of customer

The license you check depends on who is buying. Match the customer to the board that licenses them.

CustomerWhat to confirmWhere it lives
Retail or specialty pharmacyActive pharmacy permit for the ship-to addressState board of pharmacy
Physician, dentist, podiatrist, or other practitionerActive license in the state where they practice, NPI, and DEA registration for controlled substancesState medical or professional board, NPI registry, DEA
Clinic, surgery center, or hospitalThe facility's state license or pharmacy permit, and the ordering practitioner's licenseState health department or board of pharmacy, plus the medical board
DME or home medical equipment supplierThe state DME or device license where the state requires oneVaries by state (often the board of pharmacy or health department)
Another distributorWholesale drug distributor or device distributor license in its home state and the ship-to stateState board of pharmacy or health department

The manual way, step by step

  1. Collect the license number, the NPI, and the DEA number (if any) when you open the account.
  2. Look each one up on the board's public lookup site. Confirm the name and address match the ship-to.
  3. Confirm the status is active and the license type covers what you sell.
  4. Save a dated printout or PDF of each lookup in the customer file.
  5. Set a reminder before each expiration date and repeat the lookup.
  6. Watch for board actions like suspensions and probation, which do not wait for an expiration date.

Where the manual way breaks

Steps one through four are fine for a handful of accounts. The trouble is step six. A license that was active when you opened the account can be suspended next week, and nothing in a spreadsheet tells you. Boards post changes on their own schedules, on fifty different websites.

So most teams check at onboarding and again at renewal. The gap between those checks is where a shipment goes to an account that is no longer in good standing.

How WorkdID does it

WorkdID is the license compliance module from Workd. It does the lookups for every account you sell to, every day.

Your compliance team keeps making the calls. WorkdID does the looking so they can spend their time on the accounts that need a decision.

For medical supply and medical appliance distributors

The same rules reach well past implants and capital equipment. Many respiratory, wound care, and mobility products carry the Rx-only label, and so does a lot of durable medical equipment. If your catalog mixes over-the-counter supplies with Rx-only items, the Rx-only lines need the license check. WorkdID checks the customers behind those orders the same way it checks a pharmacy.

Questions distributors ask

Do medical device distributors have to verify customer licenses?

Yes, for prescription devices. Federal rules at 21 CFR 801.109 say a prescription device is to be sold only to, or on the order of, a practitioner licensed by the state, or to a business lawfully engaged in distributing it. Many states add their own rules for who a distributor may sell to and what records it must keep. If you also sell prescription drugs, the DSCSA says your trading partners must be authorized, which means licensed.

What license do I check for each type of customer?

Check the license that lets that customer receive the product. For a pharmacy that is its state board of pharmacy permit. For a physician or other practitioner it is the state medical board license, plus the NPI, plus a DEA registration if the order includes controlled substances. For another distributor it is that state's wholesale or device distributor license.

How often should we re-check a customer license?

Every time you ship is the safe standard, because a license can expire or be suspended between orders. Checking by hand at that pace is not practical for most teams, which is why distributors use automated monitoring that re-checks every account daily and flags changes.

Is a copy of the license on file enough?

A copy shows the license was valid on the day you saved it. It does not show it is valid today. Keep the dated copy for your records, and also re-check the license on a schedule so you catch expirations and board actions before the next order ships.

Does this apply to medical supply and DME (medical appliance) distributors?

Yes, when you sell prescription devices or supplies. Durable medical equipment, home medical equipment, and other prescription appliances fall under the same federal device rule, and several states license DME and device distributors separately. Over-the-counter supplies usually do not need a customer license check.

What software verifies customer licenses for medical device distributors?

WorkdID, made by Workd, checks the licenses of every customer a distributor sells to against state boards of pharmacy, state medical boards, the NPI registry, and the DEA every day. It flags expirations and disciplinary actions and can hold an order before it ships to an account that is out of good standing. It works on its own beside your current ERP or CRM, or inside the Workd platform.

See WorkdID check your own customer list.

WorkdID by Workd checks every customer license you sell to, every day, and can hold an order before it ships to an account that is out of good standing.

Talk to our AI, (248) 522-9680

The phone line is answered by Workd's AI. Thirty seconds, no form.

Related

This page explains general rules and is not legal advice. Rules change. Confirm current requirements with the state board or your counsel before relying on them.

Ready to See How AI Transforms Your Business?

Distributors from $5M to over $1B run their sales, orders, and deliveries on Workd.

Not sure where to start? Try our AI: (248) 522-9680