| Customer verification | May sell only to licensed buyers |
|---|---|
| Records to keep | 2 years |
| Separate device or DME distributor license | In some cases |
What Minnesota requires before you ship
Minnesota lets distributors sell prescription drugs only to buyers who are licensed or authorized to receive them, which means checking the license first. Minnesota makes it unlawful to sell or distribute a legend drug except as the pharmacy chapter allows. The chapter then lists who may lawfully receive legend drugs. A wholesaler may not sell drugs to a person in Minnesota except as the chapter provides, and may not ship drugs directly to patients. No separate verification step is written, but you cannot follow these rules without confirming each customer is licensed.
Who counts as an authorized buyer: Licensed drug wholesalers, licensed manufacturers, registered pharmacies, local detoxification centers, licensed hospitals, animal hospitals, and licensed pharmacists and practitioners acting within their practice.
"Nothing in this chapter shall prohibit the sale to, or the possession of, a legend drug by licensed drug wholesalers, licensed manufacturers, registered pharmacies" Minn. Stat. §§ 151.37, subds. 1 and 5; 151.47, subd. 3; 151.46
Records to keep
Wholesalers must keep inventories and records of every receipt and distribution of drugs. Records must show the source, the identity and quantity of drugs, and the dates. Keep them at least 2 years and make them available to the Board on request. Records kept off site that cannot be pulled up electronically must be produced within 2 working days. Wholesalers must also follow federal DSCSA rules.
Source: Minn. Stat. § 151.47, subd. 1a(h)(4); Minn. R. 6800.1440, subp. 8
Licenses a distributor needs in Minnesota
Prescription drug wholesale distributor
No one may act as a wholesale distributor without a Board license. A separate license is needed for each Minnesota facility and for each out-of-state facility that ships drugs into Minnesota. Facilities must pass an inspection or hold accreditation the Board approves. Applicants must post a surety bond, $100,000 or $25,000 for smaller firms, and pass background checks. Licenses renew every year. Selling drugs to a person in Minnesota is unlawful except as the pharmacy chapter allows.
Source: Minn. Stat. § 151.47, subds. 1a, 3; Minn. R. 6800.1400
Medical device and DME distributors
No general Minnesota license for prescription device or DME distributors was found. The Board regulates medical gas. Retail sellers of legend medical gases who are not otherwise licensed must register with the Board every year. The statute also defines medical gas manufacturers, wholesalers and dispensers.
Source: Minn. R. 6800.9921; Minn. Stat. § 151.01, subds. 29a to 29c
Controlled substances
Wholesale drug distributors that handle controlled substances must register with the Board of Pharmacy as well as with the DEA.
Source: Minn. R. 6800.1440, subp. 11
Where to look up a Minnesota license
- Pharmacies and pharmacy permits: Minnesota Board of Pharmacy
- Physicians and other practitioners: Minnesota Board of Medical Practice
- 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 Minnesota accounts
WorkdID by Workd checks every Minnesota 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 Minnesota file is ready when someone asks for it.
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