Indiana Code 25-26-14-11. “Wholesale distribution”
(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;
Terms Used In Indiana Code 25-26-14-11
- blood: means whole blood collected from a single donor and processed either for transfusion or further manufacturing. See Indiana Code 25-26-14-2
- board: refers to the Indiana board of pharmacy established under IC 25-26-13-3. See Indiana Code 25-26-14-4
- co-licensed products: means pharmaceutical products:
Indiana Code 25-26-14-4.1
- distribute: means to sell, offer to sell, deliver, offer to deliver, broker, give away, or transfer a legend drug, whether by passage of title or physical movement, or both. See Indiana Code 25-26-14-4.7
- health care entity: means any organization or business that provides diagnostic, medical, surgical, dental treatment, or rehabilitative care. See Indiana Code 25-26-14-6
- legend drug: has the meaning set forth in IC 16-18-2-199. See Indiana Code 25-26-14-7
- manufacturer: means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a legend drug. See Indiana Code 25-26-14-8
- Month: means a calendar month, unless otherwise expressed. See Indiana Code 1-1-4-5
- practitioner: has the meaning set forth in IC 16-42-19-5. See Indiana Code 25-26-14-9.2
- sale: includes purchase, trade, or offer to sell, purchase, or trade. See Indiana Code 25-26-14-10
- Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
(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 C.F.R. § 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.