126.2 - DEFINITIONS.
126.2 DEFINITIONS.
As used in this chapter, unless the context otherwise requires:
1. "Advertising" means any representation disseminated in any
manner or by any means, other than by labeling, for the purpose of
inducing, or which is likely to induce, directly or indirectly, the
purchase of drugs, devices, or cosmetics.
2. "Anabolic steroid" means any drug or hormonal substance,
chemically and pharmacologically related to testosterone, other than
estrogens, progestins, corticosteroids, or dehydroepiandrosterone,
which substance is identified as an anabolic steroid in section
124.208, subsection 6, and includes any other substance designated by
the board as an anabolic steroid through the adoption of rules
pursuant to chapter 17A.
3. "Board" means the board of pharmacy.
4. "Contaminated with filth" means not securely protected
from dust, dirt, and as far as is necessary by all reasonable means,
from all foreign or injurious contaminations.
5. "Cosmetic" means any of the following, but does not
include soap:
a. An article intended to be rubbed, poured, sprinkled, or
sprayed on, introduced into, or otherwise applied to the human body
or any part of a human body for cleaning, beautifying, promoting
attractiveness, or altering the appearance.
b. An article intended for use as a component of an article
defined in paragraph "a".
6. "Counterfeit drug" means a drug which, or the container or
labeling of which, without authorization, bears the trademark, trade
name, or other identifying mark, imprint, or device, or any such
likeness, of a drug manufacturer, processor, packer, or distributor
other than the person or persons who in fact manufactured, processed,
packed, or distributed the drug and which falsely purports or is
represented to be the product of, or to have been packed or
distributed by, such other drug manufacturer, processor, packer, or
distributor.
7. "Device" means an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or other similar or
related article, including any component, part, or accessory of any
of these, which is any of the following:
a. Recognized as a device in the official United States
Pharmacopoeia National Formulary or any supplement to it.
b. Intended for use in the diagnosis of diseases or other
conditions, or in the cure, mitigation, treatment, or prevention of
diseases or other conditions in a human.
c. Intended to affect the structure or any function of the
body of a human, and which does not achieve any of its principal
intended purposes through chemical action within or on the body of a
human and which is not dependent upon being metabolized for the
achievement of any of its principal intended purposes.
8. "Drug" means any of the following, but does not include a
device:
a. An article recognized as a drug in the official United
States Pharmacopoeia National Formulary, official Homeopathic
Pharmacopoeia of the United States, or any supplement to either
document.
b. An article intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of diseases in a human.
c. An article, other than food, intended to affect the
structure or any function of the body of a human.
d. An article intended for use as a component of any articles
specified in paragraphs "a", "b", or "c".
9. "Electronic prescription" means a prescription which is
transmitted by a computer device in a secure manner, including
computer-to-computer transmission and computer-to-facsimile
transmission.
10. "Facsimile prescription" means a prescription which is
transmitted by a device which sends an exact image to the receiver.
11. "Federal Act" means the federal Food, Drug, and Cosmetic
Act, which is codified in 21 U.S.C. § 301 et seq.
12. "Immediate container" does not include a package liner.
13. "Label" means a display of written, printed, or graphic
matter upon the immediate container of an article; and a requirement
made by or under authority of this chapter that any word, statement,
or other information appear on the label is not complied with unless
the word, statement, or other information also appears on the outside
container or wrapper of the retail package of the article, or is
easily legible through the outside container or wrapper.
14. "Labeling" means all labels and other written, printed,
or graphic matter upon an article or any of its containers or
wrappers, or accompanying an article.
15. "New drug" means either of the following:
a. Any drug, the composition of which is such that the drug
is not generally recognized among experts qualified by scientific
training and experience to evaluate the safety and effectiveness of
drugs, as safe and effective for use under the conditions prescribed,
recommended, or suggested in its labeling, except that a drug not so
recognized is not a new drug if at any time prior to the enactment of
this chapter it was subject to the federal Act, and if at that time
its labeling contained the same representations concerning the
conditions of its use.
b. Any drug, the composition of which is such that the drug,
as a result of investigations to determine its safety and
effectiveness for use under the conditions prescribed, recommended,
or suggested in its labeling, has become recognized as safe and
effective, but which has not, other than in such investigations, been
used to a material extent or for a material time under the conditions
prescribed, recommended, or suggested in its labeling.
16. "Official compendium" means the official United States
Pharmacopoeia National Formulary, official Homeopathic Pharmacopoeia
of the United States, or any supplement to either document.
17. "Person" means an individual, partnership, corporation,
or association.
18. "Principal display panel" means that part of a label that
is most likely to be displayed, presented, shown, or examined under
normal and customary conditions of display for retail sale.
19. "Safe" as used in this chapter has reference to the
health of a human.
20. "Secretary" means the secretary of the United States
department of health and human services. Section History: Recent Form
89 Acts, ch 197, § 2
CS89, § 203B.2
90 Acts, ch 1078, § 1
C93, § 126.2
2004 Acts, ch 1036, §4; 2007 Acts, ch 8, §20; 2007 Acts, ch 10,
§17
Referred to in § 280.16 Footnotes
Former unnumbered paragraph 2 transferred to §126.2A