2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-11. "Wholesale Distribution"

Sec. 11. As used in this chapter, "wholesale distribution" means to distribute legend drugs to persons other than a consumer or patient. The term does not include:
(1) a sale or transfer between a division, a subsidiary, a parent, an affiliated, or a related company under the common ownership and control of a corporate entity;
(2) the purchase or acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug for the hospital's or health care entity's own use from the group purchasing organization or from other hospitals or health care entities that are members of the organization;
(3) the sale or transfer of a drug by a charitable organization described in Section 501(c)(3) of the Internal Revenue Code, to:
(A) a nonprofit affiliate of the organization; or
(B) a nonprofit entity described in Section 501(c)(3) of the Internal Revenue Code that is not affiliated with the organization;
to the extent otherwise permitted by law;
(4) the sale of a drug among hospitals or other health care entities that are under common control;
(5) the sale of a drug for emergency medical reasons, including transfers of legend drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage, if the gross dollar value of the transfers does not exceed five percent (5%) of the total legend drug sales revenue of either the transferor or transferee pharmacy during any twelve (12) consecutive month period;
(6) the sale of a drug or the dispensing of a drug pursuant to a prescription;
(7) the distribution of drug samples by manufacturers' representatives or distributors' representatives;
(8) the sale of blood and blood components intended for transfusion;
(9) the sale of a drug by a retail pharmacy to a practitioner (as defined in IC 25-26-13-2) for office use, if the gross dollar value of the transfers does not exceed five percent (5%) of the retail pharmacy's total legend drug sales during any twelve (12) consecutive months;
(10) the sale of a drug by a retail pharmacy that is ending its business and liquidating its inventory to another retail pharmacy;
(11) drug returns by a hospital, health care entity, or charitable institution conducted under 21 CFR 203.23;
(12) the sale of minimal quantities of drugs by retail pharmacies to licensed practitioners for office use;
(13) the distribution of prescription drugs by the original manufacturer of the finished form of the prescription drug or the distribution of the co-licensed products by a partner of the original manufacturer of the finished form of the prescription drug;
(14) drug returns that meet criteria established by rules adopted by the board;
(15) the sale of a drug for research or clinical trial purposes, provided the seller is authorized by the federal Food and Drug Administration to sell the drug for research or clinical trial purposes; or
(16) the donation, acceptance, distribution, or dispensing of a legend drug as part of the prescription drug donation repository program under IC 25-26-26.
As added by P.L.182-1991, SEC.3. Amended by P.L.33-1993, SEC.47; P.L.212-2005, SEC.45; P.L.246-2019, SEC.19; P.L.264-2019, SEC.8; P.L.143-2022, SEC.72; P.L.208-2023, SEC.4.