| Customer verification | Must verify the buyer's license |
|---|---|
| Records to keep | 3 years |
| Separate device or DME distributor license | Yes |
What North Dakota requires before you ship
A manufacturer or wholesaler may supply prescription drugs only to persons licensed by the right state authority. Before the first sale to a new customer, you must contact the state licensing authority and confirm the customer can legally receive the drugs. Ship only to the address on the customer's license. Open accounts only in the licensee's name.
Who counts as an authorized buyer: Persons licensed by the appropriate state licensing authorities to receive prescription drugs, such as pharmacies, practitioners, hospitals, and other licensed distributors. Delivery must go to the premises listed on the license.
"Before furnishing prescription drugs to a person not known to the manufacturer or wholesale distributor, the manufacturer or wholesale distributor shall affirmatively verify" N.D. Cent. Code § 43-15.3-05(2), (3), (5)
Records to keep
Keep records of all prescription drug receipts and distributions, showing the source, identity, quantity, and dates. The Board rule requires two years after disposition. The statute requires pedigree records to be kept for three years from the date of sale and produced within five business days of a request. DME retailers keep prescriptions for five years.
Source: N.D. Cent. Code § 43-15.3-06(4); N.D. Admin. Code § 61-10-01-09(6)
Licenses a distributor needs in North Dakota
Prescription drug wholesale distributor
Wholesale distributors of prescription drugs, medical gases, or medical equipment need a Board of Pharmacy license for each facility. Prescription drug wholesalers must also hold NABP accreditation (formerly VAWD) or another approved accreditation. Out-of-state distributors must also register with the Secretary of State.
Source: N.D. Cent. Code §§ 43-15.3-03, 43-15.3-04; N.D. Admin. Code ch. 61-10-01
Medical device and DME distributors
The state's definition of wholesale distribution covers medical equipment and medical gases, so wholesale distributors of these need a Board license. Medical equipment means equipment prescribed or distributed by a practitioner for home care treatment. The Board says a wholesale DME licensee may ship only to other licensees. DME retailers selling to patients need a separate retail license and may buy only from state-licensed manufacturers or wholesalers.
Source: N.D. Cent. Code §§ 43-15.3-01(14), (28), (29); 43-15.3-03; 43-15.3-11
Controlled substances
Wholesale distributors that handle controlled substances must register with the state controlled substances board and with the DEA.
Source: N.D. Admin. Code § 61-10-01-09(9)(b)
Where to look up a North Dakota license
- Pharmacies and pharmacy permits: North Dakota Board of Pharmacy
- Physicians and other practitioners: North Dakota Board of Medicine
- 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 North Dakota accounts
WorkdID by Workd checks every North Dakota 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 North Dakota file is ready when someone asks for it.
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