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;

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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.
(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 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.

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