| Customer verification | May sell only to licensed buyers |
|---|---|
| Records to keep | 2 years |
| Separate device or DME distributor license | Yes |
What Michigan requires before you ship
Michigan lets distributors sell prescription drugs only to buyers who are licensed or authorized to receive them, which means checking the license first. A wholesale distributor may sell or transfer prescription drugs or devices only to persons licensed to distribute, prescribe or dispense them, in or outside Michigan. The rule has no separate verification step, but you cannot follow it without confirming each customer's license.
Who counts as an authorized buyer: Persons the board licenses to distribute, prescribe or dispense prescription drugs or devices, in or outside Michigan. Examples are pharmacies, prescribers and other wholesale distributors.
"may supply, distribute, sell, barter, or otherwise transfer prescription drugs or devices only to persons who are licensed by the board" Mich. Admin. Code R 338.565
Records to keep
Wholesale distributors must keep inventories and records of receipts and distributions of prescription drugs or devices. Records must show the source, the identity and quantity of items, and the dates. Keep them at least 2 years after the products are disposed of. Wholesale distributor-brokers must keep DSCSA transaction history, information and statements for at least 7 years. Records kept off site must be produced within 2 working days.
Source: Mich. Admin. Code R 338.569
Licenses a distributor needs in Michigan
Prescription drug wholesale distributor
A manufacturer, wholesale distributor or wholesale distributor-broker must be licensed to operate in Michigan, whether or not it is located in Michigan. Licenses renew every 2 years. A pharmacy needs a wholesale distributor license once its distributions to any one person go over 5 percent of its dosage units in 12 months.
Source: MCL 333.17748(1); Mich. Admin. Code R 338.561
Medical device and DME distributors
Michigan defines a wholesale distributor as one that supplies a 'drug or device salable on prescription only'. So prescription device distributors need the same wholesale distributor license. A business that handles only prescription devices does not need a pharmacist in charge. The 'licensed persons only' sales rule covers devices too.
Source: MCL 333.17709(8); MCL 333.17748(2); Mich. Admin. Code R 338.565
Controlled substances
Anyone who manufactures, distributes, prescribes or dispenses controlled substances in Michigan must have a state controlled substance license. A distributor that closes must return both its wholesale distributor license and its controlled substance license.
Source: MCL 333.7303; Mich. Admin. Code R 338.575
Where to look up a Michigan license
- Pharmacies and pharmacy permits: Michigan Board of Pharmacy (LARA, Bureau of Professional Licensing)
- Physicians and other practitioners: Michigan Board of Medicine (LARA, Bureau of Professional Licensing)
- 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 Michigan accounts
WorkdID by Workd checks every Michigan 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 Michigan file is ready when someone asks for it.
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