§328-112 - Definitions.
[§328-112] Definitions. As used in
this part:
“Blood” means whole blood collected from a
single donor and processed either for transfusion or for further manufacturing.
“Blood component” means that part of blood
separated by physical or mechanical means.
“Common control” means the power to direct or
cause the direction of the management and policies of a person or an
organization, whether by ownership of stock, by voting rights, by contract, or
otherwise.
“Department” means the department of health except
when otherwise provided.
“Drug sample” means a unit of a prescription
drug that is not intended to be sold and is intended to promote the sale of the
drug.
“Manufacturer” means anyone who is engaged in
manufacturing, preparing, propagating, compounding, processing, packaging,
repackaging, or labeling a prescription drug.
“Prescription drug” means any human drug
required by federal or state statutes, regulations, or rules to be dispensed
only by a prescription, including finished dosage forms and active ingredients
subject to section 328-16 or to section 503(b) of the federal Food, Drug, and
Cosmetic Act.
“Wholesale distribution” means the distribution
of prescription drugs to persons other than a consumer or patient, but does not
include:
(1)Â Intracompany sales, defined as any transaction or
transfer between an entity and any division, subsidiary, parent, or affiliated
or related company under common ownership and control;
(2)Â The purchase or other acquisition, by a hospital
or other health care entity that is a member of a group purchasing
organization, of a drug for the entity’s own use, from the group purchasing
organization or from other hospitals or health care entities that are members
of the group purchasing organization;
(3)Â The sale, purchase, or trade of a drug or an
offer to sell, purchase, or trade a drug by a charitable organization described
in section 501(c)(3) of the Internal Revenue Code of 1986, as amended, to a
nonprofit affiliate of the organization to the extent otherwise permitted by
law;
(4)Â The sale, purchase, or trade of a drug or an
offer to sell, purchase, or trade a drug among hospitals or other health care
entities that are under common control;
(5)Â The sale, purchase, or trade of a drug or an
offer to sell, purchase, or trade a drug for emergency medical reasons; for
purposes of this definition the term “emergency medical reasons” includes, but
is not limited to, transfers of prescription drugs by a retail pharmacy to
another retail pharmacy to alleviate a temporary shortage, except that the
gross dollar value of such transfers shall not exceed five per cent of the
total prescription drug sales revenue of either the transferor or transferee
pharmacy during any period of twelve consecutive months;
(6)Â The sale, purchase, or trade of a drug, or an
offer to sell, purchase, or trade a drug, or the dispensing of a drug, pursuant
to a prescription;
(7)Â The distribution of drug samples by
manufacturers’ representatives or distributors’ representatives; or
(8)Â The sale, purchase, or trade of blood and blood
components intended for transfusion.
“Wholesale distributor” means any person or
entity engaged in wholesale distribution of prescription drugs, including, but
not limited to, manufacturers; repackers; own-label distributors; jobbers;
private label distributors; brokers; warehouses, including manufacturers’ and
distributors’ warehouses, chain drug warehouses, and wholesale drug warehouses;
independent wholesale drug traders; prescription drug repackagers; physicians;
dentists; veterinarians; birth control and other clinics; individuals;
hospitals; nursing homes and their providers; health maintenance organizations
and other health care providers; and retail and hospital pharmacies that
conduct wholesale distributions. The term “wholesale distributor” shall not
include any carrier for hire or person or entity hired solely to transport
prescription drugs. [L 1992, c 196, pt of §2]
Cross References
 Wholesale prescription drug distributor licenses, see
§461-8.6.