Indiana Code
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; or
(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.
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.

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