Kan. Admin. Regs. § 68-14-2 - Definitions
As used in this article of the board's regulations and the pharmacy practice act, each of the following terms shall have the meaning specified in this regulation:
(a)
"Blood" means whole blood collected from a single donor and processed either
for transfusion or for further manufacturing.
(b) "Blood component" means that part of
blood separated by physical or mechanical means.
(c) "Common ownership and 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 by other means.
(d)
"Drug sample" means a unit of a prescription-only drug that is not intended to
be sold, is intended to promote the sale of the drug, and is distributed on a
gratuitous basis.
(e) "Device" has
the meaning specified in K.S.A. 65656, and amendments thereto.
(f) "Emergency medical reasons" shall include
transfers of prescription-only drugs by a retail pharmacy to another retail
pharmacy to alleviate a temporary shortage, except that the gross dollar value
of these transfers shall not exceed five percent of the total prescription-only
drug sales revenue of either the transferor or transferee pharmacy during any
period of 12 consecutive months.
(g) "Excursion" means a deviation from the
range of temperatures specified by the manufacturer for storage or transport of
a prescription-only drug or device based on stability data.
(h) "Intracompany sales" and "intracompany
distribution" mean any transaction or transfer between any division,
subsidiary, parent, affiliated, or related company under the common ownership
and control of a corporate entity.
(i) "Primary owner" means any person owning
or controlling more than 50 percent of the wholesaler's business.
(j) "Room temperature" means a temperature
that is maintained thermostatically and meets the following requirements:
(1) Encompasses the usual and customary
working environment of 20° to 25°C (68° to 77°F);
(2) results in a mean kinetic temperature
calculated to be not more than 25°C (77°F); and
(3) allows for excursions between 15° and
30°C (59° to 86°F) experienced in facilities, such that the
allowable calculated mean kinetic temperature remains in the allowed
range.
(k) "Virtual
wholesale distribution" means arranging for the distribution of a drug or
device, which may include taking actual possession of the drug or device and
shall include contracting with another entity for the distribution, purchase,
and sale of the drug or device.
(l)
"Virtual wholesale distributor" means a business entity that arranges for the
distribution of a drug or device, with or without taking actual possession of
the drug or device, and contracts with others for the distribution, purchase,
and sale.
(m) "Wholesale
distribution" means distribution of prescription-only drugs or devices to
persons other than a consumer or patient and shall include virtual wholesale
distribution and virtual wholesale distributors, but this term shall not
include either of the following:
(1) The
distribution of drug samples by manufacturers' representatives or
representatives of the authorized distributor of record, in accordance with
21
U.S.C. 353; or
(2) the sale, purchase, or trade of blood and
blood components intended for transfusion.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.