126.9 - DRUGS AND DEVICES -- ADULTERATION.
126.9 DRUGS AND DEVICES -- ADULTERATION.
A drug or device is adulterated under any of the following
circumstances:
1. a. If it consists in whole or in part of any filthy,
putrid, or decomposed substance.
b. If it has been produced, prepared, packed, or held under
insanitary conditions whereby it may have been contaminated with
filth, or whereby it may have been rendered injurious to health.
c. If it is a drug and the methods used in, or the facilities
or controls used for its manufacture, processing, packing, or holding
do not conform to or are not operated or administered in conformity
with current good manufacturing practice to assure that the drug
meets the requirements of this chapter as to safety and has the
identity and strength, and meets the quality and purity
characteristics, which it purports or is represented to possess.
d. If its container is composed, in whole or part, of any
poisonous or deleterious substance which may render the contents
injurious to health.
2. If it purports to be or is represented as a drug, the name of
which is recognized in an official compendium, and its strength
differs from, or its quality or purity falls below, the standards set
forth in the official compendium. A determination as to strength,
quality, or purity shall be made in accordance with the tests or
methods of assay set forth in the official compendium, or in the
absence of or inadequacy of such tests or methods of assay, those
prescribed under authority of the federal Act. A drug defined in an
official compendium is not adulterated under this subsection because
it differs from the standard of strength, quality, or purity set
forth in the official compendium, if its difference in strength,
quality, or purity from such standards is plainly stated on its
label. If a drug is recognized in both the United States
Pharmacopoeia National Formulary and the Homeopathic Pharmacopoeia of
the United States it is subject to the United States Pharmacopoeia
National Formulary unless it is labeled and offered for sale as a
homeopathic drug, in which case it is subject to the Homeopathic
Pharmacopoeia of the United States and not to the United States
Pharmacopoeia National Formulary.
3. If it is not subject to subsection 2 and its strength differs
from, or its purity or quality falls below, that which it purports or
is represented to possess.
4. If it is a drug and any substance has been mixed or packed
with it so as to reduce its quality or strength, or any substance has
been substituted for it wholly or in part.
5. If it is, or purports to be or is represented as, a device
which is subject to a performance standard established under section
514 of the federal Act, unless the device is in all respects in
conformity with such standard.
6. If it is a device banned by the board or by the United States
food and drug administration.
7. If it is a device and the methods used in, or the facilities
or controls used for its manufacture, packing, storage, or
installation are not in conformity with applicable requirements under
section 520(f)(1) of the federal Act or an applicable condition as
prescribed by an order under section 520(f)(2) of the federal Act.
8. If it is a device for which an exemption has been granted
under section 520(g) of the federal Act for investigational use and
the person who was granted the exemption or any investigator who uses
the device under the exemption fails to comply with a requirement
prescribed by or under that section. Section History: Recent Form
89 Acts, ch 197, § 9
CS89, § 203B.9
C93, § 126.9