Sec. 14. (a) Subject to subsection (h), a person may not engage in wholesale distributions of legend drugs without:
(1) obtaining and maintaining accreditation or certification from the National Association of Boards of Pharmacy's Verified Accredited Wholesale Distributor or an accreditation body approved by the board under subsection (g);
(2) obtaining and maintaining a license issued by the board; and
(3) paying any reasonable fee required by the board.
(b) The board may not issue or renew the license of a wholesale drug distributor that does not comply with this chapter.
(c) The board shall require a separate license for each facility or location where wholesale distribution operations are conducted.
(d) An agent or employee of any licensed wholesale drug distributor does not need a license and may lawfully possess pharmaceutical drugs when acting in the usual course of business or employment.
(e) The issuance of a license under this chapter does not affect tax liability imposed by the department of state revenue or the department of local government finance on any wholesale drug distributor.
(f) The board may adopt rules that permit out-of-state wholesale drug distributors to obtain a license on the basis of reciprocity if:
(1) an out-of-state wholesale drug distributor possesses a valid license granted by another state and the legal standards for licensure in the other state are comparable to the standards under this chapter; and
(2) the other state extends reciprocity to wholesale drug distributors licensed in Indiana.
However, if the requirements for licensure under this chapter are more restrictive than the standards of the other state, the out-of-state wholesale drug distributor must comply with the additional requirements of this chapter to obtain a license under this chapter.
(g) The board may adopt rules under IC 4-22-2 to approve an accreditation body to:
(1) evaluate a wholesale drug distributor's operations to determine compliance with:
(A) professional standards;
(B) this chapter; and
(C) any other applicable law; and
(2) perform inspections of each facility and location where wholesale distribution operations are conducted by the wholesale drug distributor.
(h) The board may issue a provisional wholesale drug distributor license to an applicant that is located in Indiana and in the process of obtaining accreditation or certification from:
(1) the National Association of Boards of Pharmacy's Verified Accredited Wholesale Distributor; or
(2) an accreditation body approved by the board under subsection (g).
As added by P.L.182-1991, SEC.3. Amended by P.L.90-2002, SEC.456; P.L.212-2005, SEC.46; P.L.180-2018, SEC.25.