| Customer verification | Federal rules apply |
|---|---|
| Records to keep | 2 years |
| Separate device or DME distributor license | In some cases |
What Maine requires before you ship
We did not find a Maine rule beyond federal law that spells out how a distributor must verify its customers. Federal rules still require it. Maine's wholesaler rules cover licensing, storage, security, records and written procedures. They do not say who a wholesaler may sell to, and they include no step to verify a customer's license. They require wholesalers to follow 21 U.S.C. 353(e) and other federal rules, so federal DSCSA trading partner rules still apply.
Source: 02-392 C.M.R. ch. 16, § 2 (reviewed; no customer verification rule found)
Records to keep
Wholesalers must keep inventories and records of every receipt and distribution of prescription drugs. Records must show the source (seller name and address, and the ship-from address), the identity and quantity of drugs, and the dates of receipt and distribution. They must be open to inspection for 2 years after the drugs are disposed of. Records kept off site that cannot be pulled up electronically must be produced within 2 working days.
Source: 02-392 C.M.R. ch. 16, § 2(7)
Licenses a distributor needs in Maine
Prescription drug wholesale distributor
Any manufacturer or wholesaler whose products are distributed in Maine, in any manner, must be licensed by the Board, whether it is located in Maine or not. Distributing prescription drugs in Maine without this license is unlawful. The license is renewed every year. The law says the Board should not set rules for out-of-state companies with no Maine facility that are stricter than federal law.
Source: 32 M.R.S. § 13758; 32 M.R.S. § 13751(1); 02-392 C.M.R. ch. 12
Medical device and DME distributors
No general Maine license for prescription device or DME distributors was found. Maine does license retail suppliers of medical oxygen. A supplier inside or outside Maine that sells medical oxygen to Maine consumers needs this license, and oxygen for a specific person may be sold at retail only on a prescription. A licensed pharmacy does not need it.
Source: 02-392 C.M.R. ch. 34, § 2
Controlled substances
Maine has no state controlled substance registration like the federal DEA one, according to the Maine Drug Enforcement Agency. Board rules say wholesalers that handle controlled substances must register with the DEA and follow DEA rules. We did not find a separate rule for wholesalers.
Source: 02-392 C.M.R. ch. 16, § 2(10)(C); Maine DEA FAQ
Where to look up a Maine license
- Pharmacies and pharmacy permits: Maine Board of Pharmacy
- Physicians and other practitioners: Maine Board of Licensure in 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 Maine accounts
WorkdID by Workd checks every Maine 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 Maine file is ready when someone asks for it.
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