§ 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.

Legislative History

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.