Tenn. Comp. R. & Regs. 1140-16-.02 - THIRD-PARTY LOGISTICS PROVIDER LICENSING

(1) Before any 3PL provides or coordinates warehousing or other logistics services within this state for a prescription drug and/or prescription device on behalf of a manufacturer, wholesale distributor, or dispenser the 3PL shall be licensed by the Board in accordance with this Chapter whether physically located within this state or outside this state. Where operations are conducted at more than one location, each such location shall be licensed by the Board. A warehouse provided by a 3PL shall be inspected by the Board's inspector(s) or inspectors of the state where the warehouse is physically located prior to providing services.

(2) A 3PL that coordinates with facilities that are engaged in the act of wholesale drug distribution and are also located outside of this state, shall provide documentation to the Board within 60 days of issuance of a 3PL license that each facility used by the 3PL has received either:

(a) A Verified-Accredited Wholesale Distributors accreditation from the National Association of Boards of Pharmacy;

(b) A manufacturer, wholesaler, or distributor license issued by the Board, including any license modifiers and/or additional registrations; or

(c) A manufacturer, wholesaler, or distributor license issued by the state where the facility is physically located, including any license modifiers and/or additional registrations.

(3) Failure to provide the required documentation within 60 days of the issuance of a 3PL license or within 60 days from any change in status of any previously submitted documentation may result in disciplinary action.

(4) Each manufacturer, wholesaler, or distributor that ships prescription drugs and/or prescription devices into or from the State of Tennessee shall be licensed by the Board accordingly and shall comply with all requirements of Tenn. Comp. R. & Regs. 1140-01-.08 and 1140-09-.01 et. seq.

(5) Each wholesale distributor, who is also engaged in providing 3PL services, as defined in Tenn. Code Ann. § 63-10-204(46), shall obtain a license to operate as a wholesale distributor issued by the Board and shall obtain a separate license to operate as a 3PL issued by the Board.

(6) An applicant with physical facilities located in this state must obtain and display prominently a separate license for each principal place of business where the applicant manufactures or distributes prescription drugs and/or prescription devices.

(7) Any 3PL that obtains controlled substances shall obtain the Board's controlled substance registration in accordance with Tenn. Comp. R. & Regs. 1140-01-11.

Notes

Tenn. Comp. R. & Regs. 1140-16-.02

Original rules filed September 12, 2018; effective 12/11/2018.

Authority: T.C.A. §§ 63-10-204, 63-10-304, and 63-10-306.