Section 25-26-14-11 - "Wholesale distribution"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.Amended by P.L. 208-2023,SEC. 4, eff. 7/1/2023.Amended by P.L. 143-2022,SEC. 72, eff. 7/1/2022.Amended by P.L. 264-2019,SEC. 8, eff. 7/1/2019.Amended by P.L. 246-2019,SEC. 19, eff. 7/1/2019.As added by P.L. 182-1991, SEC.3. Amended by P.L. 33-1993, SEC.47; P.L. 212-2005, SEC.45.