| Customer verification | Federal rules apply |
|---|---|
| Records to keep | 2 years |
| Separate device or DME distributor license | Yes |
What Montana requires before you ship
We did not find a Montana rule beyond federal law that spells out how a distributor must verify its customers. Federal rules still require it. Montana law bars licensed wholesale distributors from dispensing or distributing prescription drugs or devices directly to patients, unless the distributor is also licensed to dispense. It also bars buying drugs or devices from unlicensed sources. We found no Montana rule that expressly requires a distributor to verify a customer's license before selling. Federal DSCSA trading-partner rules still apply.
"may not dispense or distribute prescription drugs or devices directly to patients" MCA 37-7-603
Records to keep
Facilities must have written policies for receipt, recordkeeping, security, storage, inventory and distribution, and must comply with federal 21 CFR 205 and track-and-trace rules. Inventories and records must be available for inspection for two years after distribution. Off-site paper records must be produced within two working days.
Source: ARM 24.174.1211
Licenses a distributor needs in Montana
Prescription drug wholesale distributor
Every person engaged in wholesale distribution of drugs or prescription devices, including reverse distribution and medical gases, and every third-party logistics provider, must be licensed by the board each year. A separate license is needed for each location that stores and ships into Montana. Montana facilities must pass an inspection, and wholesale distributors must post a surety bond.
Source: MCA 37-7-604; ARM 24.174.1201
Medical device and DME distributors
Wholesale distribution of prescription devices requires the same board wholesale license as drugs. Since December 6, 2025, a facility that only dispenses devices, durable medical equipment or medical gas directly to Montana patients under a prescription drug order needs a separate device facility license instead of a pharmacy or wholesale license. Medical gas suppliers also need an endorsement.
Source: MCA 37-7-602; ARM 24.174.1201(1); ARM 24.174.2001 and 24.174.2002 (eff. 12/6/2025)
Controlled substances
Wholesale distributors that distribute controlled substances must register with the Board of Pharmacy.
Source: ARM 24.174.1201(7)
Where to look up a Montana license
- Pharmacies and pharmacy permits: Montana Board of Pharmacy
- Physicians and other practitioners: Montana Board of Medical Examiners
- NPI: NPPES NPI Registry
- DEA registrations: DEA Diversion Control Division
Federal rules that apply in every state
- A prescription device "is to be sold only to or on the prescription or other order of such practitioner," or to a business lawfully distributing it (21 CFR 801.109).
- A prescription drug wholesale distributor's trading partners "may be only authorized trading partners," which for a pharmacy means one licensed under state law (21 U.S.C. 360eee-1(c)(3)).
How WorkdID handles Montana accounts
WorkdID by Workd checks every Montana customer you sell to against the state's pharmacy and medical boards, the NPI registry, and the DEA, every day. It flags an expiration or a board action within a day of posting, and in Workd order entry it can hold the order until your compliance team clears the account. Every check is saved with the date and the board record, so your Montana file is ready when someone asks for it.
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