126.3 - PROHIBITED ACTS.
126.3 PROHIBITED ACTS.
The following acts and the causing of the acts within this state
are unlawful:
1. The introduction or delivery for introduction into commerce of
any drug, device, or cosmetic that is adulterated or misbranded.
2. The adulteration or misbranding of any drug, device, or
cosmetic in commerce.
3. The receipt in commerce of a drug, device, or cosmetic that is
adulterated or misbranded, and the delivery or proffered delivery
thereof for pay or otherwise.
4. The introduction or delivery for introduction into commerce of
a drug, device, or cosmetic in violation of section 126.12.
5. The dissemination of any false advertising.
6. The refusal to permit entry or inspection, or to permit the
taking of a sample or to permit access to or copying of any record as
authorized by section 126.18; or the failure to establish or maintain
any record or make any report required under section 512(j), 512(l),
or 512(m) of the federal Act, or the refusal to permit access to or
verification or copying of any such required record.
7. The manufacture within this state of a drug, device, or
cosmetic that is adulterated or misbranded.
8. The giving of a guaranty or undertaking referred to in section
126.5, subsection 2, if the guaranty or undertaking is false, except
by a person who relied upon a guaranty or undertaking to the same
effect, signed by, and containing the name and address of, the person
residing in this state from whom the person received the drug,
device, or cosmetic in good faith.
9. The removal or disposal of a detained or embargoed drug,
device, or cosmetic in violation of section 126.6, subsection 1.
10. The alteration, mutilation, destruction, obliteration, or
removal of the whole or any part of the labeling of, or the doing of
any other act with respect to a drug, device, or cosmetic, if the act
is done while the article is held for sale, whether or not it would
be the first sale, after shipment in commerce; and if the action
results in the article being adulterated or misbranded.
11. Forging, counterfeiting, simulating, or falsely representing,
or without proper authority using a mark, stamp, tag, label, or other
identification device authorized or required by rules or regulations
adopted under this chapter or the federal Act.
12. Making, selling, disposing of, or keeping in possession,
control, or custody, or concealing a punch, die, plate, stone, or
other thing designed to print, imprint, or reproduce the trademark,
trade name, or other identifying mark, imprint, or device of another
trademark, trade name, mark, imprint, or device or a likeness of any
trademark, trade name, mark, imprint, or device upon a drug or drug
container or the labeling thereof so as to render the drug a
counterfeit drug.
13. The doing of an act which causes a drug to be a counterfeit
drug, or the sale or dispensing, or the holding for sale or
dispensing, of a counterfeit drug.
14. The use by a person to the person's own advantage, or the
revealing, other than to the board or to the person's authorized
representative or to the courts when relevant in a judicial
proceeding under this chapter, of any information acquired under
authority of this chapter concerning any method or process which as a
trade secret is entitled to protection.
15. The use, on the labeling of a drug or device or in
advertising relating to a drug or device, of a representation or
suggestion that approval of an application with respect to the drug
or device is in effect under section 126.12 or section 505, 515, or
520(g) of the federal Act, or that the drug or device complies with
the provisions of any of those sections.
16. The use, in labeling, advertising, or other sales promotion
of a reference to a report or analysis furnished in compliance with
section 126.18 or section 704 of the federal Act.
17. If a prescription drug is distributed or offered for sale in
this state, the failure of the manufacturer, packer, or distributor
of the prescription drug to maintain for transmittal, or to transmit,
to any practitioner licensed by applicable law to administer the drug
who makes written request for information as to the drug, true and
correct copies of all printed matter which is required to be included
in any package in which that drug is distributed or sold, or such
other printed matter as is approved under the federal Act. This
subsection does not exempt any person from a labeling requirement
imposed by or under this chapter.
18. a. Placing or causing to be placed upon any drug or
device or container thereof, with intent to defraud, the trademark,
trade name, or other identifying mark or imprint of another
trademark, trade name, mark, or imprint or any likeness of such a
trademark, trade name, mark, or imprint.
b. Selling, dispensing, disposing of; causing to be sold,
dispensed, or disposed of; or concealing or keeping in possession,
control, or custody, with intent to sell, dispense, or dispose of, a
drug, device, or container thereof, with knowledge that the
trademark, trade name, or other identifying mark or imprint of
another trademark, trade name, mark, or imprint or any likeness of
any trademark, trade name, mark, or imprint has been placed thereon
in a manner prohibited by paragraph "a".
c. Making, selling, disposing of; causing to be made, sold,
or disposed of; keeping in possession, control, or custody; or
concealing with intent to defraud any punch, die, plate, stone, or
other thing designed to print, imprint, or reproduce the trademark,
trade name, or other identifying mark, imprint, or device of another
trademark, trade name, mark, or imprint or any likeness of any
trademark, trade name, mark, or imprint upon a drug or container or
labeling thereof so as to render the drug a counterfeit drug.
19. The failure to register in accordance with section 510 of the
federal Act, the failure to provide any information required by
section 510(j) or 510(k) of the federal Act, or the failure to
provide a notice required by section 510(j)(2) of the federal Act.
20. a. The failure or refusal to:
(1) Comply with a requirement prescribed under section 518 or
520(g) of the federal Act.
(2) Furnish any notification or other material or information
required by or under section 519 or 520(g) of the federal Act.
b. With respect to any device, the submission of any report
required by or under this chapter that is false or misleading in any
material respect.
21. The movement of a device in violation of an order under
section 304(g) of the federal Act or the removal or alteration of any
mark or label required by the order to identify the device as
detained.
22. The failure to provide the notice required by section 412(b)
or 412(c) of the federal Act, the failure to make the reports
required by section 412(d)(1)(B) of the federal Act, or the failure
to meet the requirements prescribed under section 412(d)(2) of the
federal Act.
23. Selling, dispensing, or distributing; causing to be sold,
dispensed, or distributed; or possessing with intent to sell,
dispense, or distribute, an anabolic steroid to a person under
eighteen years of age, with knowledge that the anabolic steroid is
not necessary for the legitimate treatment of disease pursuant to an
order of a physician. Section History: Recent Form
89 Acts, ch 197, § 3
CS89, § 203B.3
90 Acts, ch 1078, §2
C93, § 126.3
Referred to in § 126.4, 126.5, 232.52, 321.215, 901.5