| Customer verification | Must verify the buyer's license |
|---|---|
| Records to keep | 6 years |
| Separate device or DME distributor license | In some cases |
What Kentucky requires before you ship
Wholesalers must keep an ongoing list of verified persons or businesses they deal with. They may sell prescription drugs and drug-related devices only to currently licensed or permitted buyers on a set list. That list covers wholesalers, third-party logistics providers, pharmacies, outsourcing facilities, practitioners, repackagers, hospitals (for their own use), research labs, and other properly licensed facilities. These duties appear in the rule's recordkeeping section for products exempt from the DSCSA.
Who counts as an authorized buyer: A currently licensed wholesaler, third-party logistics provider, outsourcing facility, practitioner, or hospital (for use in that hospital); a currently permitted pharmacy or repackager; a lab head (for research use in that lab); or any other facility appropriately licensed or permitted where it is located. For controlled substances, KRS 218A.170(1) also allows sales to persons registered under federal controlled substance law.
"Wholesalers shall maintain an ongoing list of verified persons or businesses with whom they do business." 201 KAR 2:105, Section 5(3)(c) and (d)
Records to keep
Records of receipt and distribution of prescription drugs and drug-related devices must be kept and ready for inspection for 6 years. Each record shows product name, dosage, container size and count, lot number, the names and addresses of all parties back to the manufacturer, and dates. Off-site records that cannot be pulled up electronically must be produced within 2 working days.
Source: 201 KAR 2:105, Section 5(3)(a) and (b); KRS 315.402(2)
Licenses a distributor needs in Kentucky
Prescription drug wholesale distributor
A wholesale distributor must be licensed by the Board of Pharmacy before it distributes prescription drugs in Kentucky. Each facility needs its own license. A surety bond of at least $25,000 is required unless the Board waives it, for example for publicly held companies or distributors already bonded in another state.
Source: KRS 315.402(1); 201 KAR 2:105, Section 2
Medical device and DME distributors
Kentucky's wholesaler rule covers prescription drugs and drug-related devices. A device wholesaler handling those products falls under the Board of Pharmacy wholesaler license and its customer rules. Separately, any business that provides home medical equipment and services in Kentucky needs a license from the Kentucky Board of Durable Medical Equipment Suppliers unless an exemption applies.
Source: 201 KAR 2:105; KRS 309.400 to 309.422; 201 KAR 47:010, Section 1
Controlled substances
Kentucky's old state license for controlled substance manufacturers and wholesalers (KRS 218A.150) was repealed in 2018. We found no separate state controlled substance registration for wholesalers. DEA registration still applies. KRS 218A.170(1) limits licensed distributors to selling controlled substances to manufacturers, wholesalers, pharmacies, practitioners, hospitals, research labs, and DEA registrants.
Source: KRS 218A.150 (repealed 2018); KRS 218A.170(1)
Where to look up a Kentucky license
- Pharmacies and pharmacy permits: Kentucky Board of Pharmacy
- Physicians and other practitioners: Kentucky Board of Medical Licensure
- 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 Kentucky accounts
WorkdID by Workd checks every Kentucky 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 Kentucky file is ready when someone asks for it.
Other states
Alabama · Alaska · Arizona · Arkansas · California · Colorado · Connecticut · Delaware · Florida · Georgia · Hawaii · Idaho · Illinois · Indiana · Iowa · Kansas · Louisiana · Maine · Maryland · Massachusetts · Michigan · Minnesota · Mississippi · Missouri · Montana · Nebraska · Nevada · New Hampshire · New Jersey · New Mexico · New York · North Carolina · North Dakota · Ohio · Oklahoma · Oregon · Pennsylvania · Rhode Island · South Carolina · South Dakota · Tennessee · Texas · Utah · Vermont · Virginia · Washington · West Virginia · Wisconsin · Wyoming