| Customer verification | Federal rules apply |
|---|---|
| Records to keep | 2 years |
| Separate device or DME distributor license | Yes |
What Tennessee requires before you ship
We did not find a Tennessee rule beyond federal law that spells out how a distributor must verify its customers. Federal rules still require it. We found no Tennessee rule that tells a wholesaler to verify a customer's license or limits sales to licensed buyers. The wholesaler rules require following federal, state, and local law, so the federal DSCSA authorized trading partner rule still applies. Tennessee's general legend drug law makes it unlawful to sell legend drugs outside the prescription system, which in practice points sellers toward licensed buyers.
Source: Tenn. Comp. R. & Regs. 1140-09-.05(9); Tenn. Code Ann. § 53-10-104
Records to keep
Licensees must keep inventories and records of all receipts and distributions of prescription drugs and prescription devices, showing the source, the item and quantity, and the dates. Records must be available for two years after disposition. Off-site records must be produced within two working days.
Source: Tenn. Comp. R. & Regs. 1140-09-.05(6)
Licenses a distributor needs in Tennessee
Prescription drug wholesale distributor
Every manufacturer, outsourcing facility, oxygen supplier, or wholesaler/distributor must be licensed by the Board of Pharmacy before it makes, sells, or distributes prescription drugs and prescription devices in Tennessee. Applicants with facilities in Tennessee need a separate license for each principal place of business.
Source: Tenn. Comp. R. & Regs. 1140-09-.01
Medical device and DME distributors
The same Board license covers prescription devices, and the operating and recordkeeping rules apply to prescription devices as well as drugs. Device manufacturers and wholesalers/distributors also have a yearly December filing tied to inspections.
Source: Tenn. Comp. R. & Regs. 1140-09-.01; 1140-09-.05; 1140-09-.07
Controlled substances
Manufacturers and wholesalers/distributors that handle controlled substances must register with the Board of Pharmacy and with DEA.
Source: Tenn. Comp. R. & Regs. 1140-09-.05(9)(b)
Where to look up a Tennessee license
- Pharmacies and pharmacy permits: Tennessee Board of Pharmacy (Tennessee Department of Health)
- Physicians and other practitioners: Tennessee Board of Medical Examiners (Tennessee Department of Health)
- 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 Tennessee accounts
WorkdID by Workd checks every Tennessee 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 Tennessee file is ready when someone asks for it.
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