§ 25-26-14-14 — Accreditation and license for wholesale distribution of legend drugs; provisional license

Indiana § 25-26-14-14

• Jurisdiction: Indiana
• Title 25: PROFESSIONS AND OCCUPATIONS
• Art. 26: PHARMACISTS, PHARMACIES, DRUG STORES
• Ch. 14: Wholesale Legend Drug Distributors and Third Party

Text

(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).

Legislative History

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.