32-1967. Acts constituting misbranding of a
drug or device; exceptions; interpretation of misleading
label
A. A drug or device is misbranded:
1. If its labeling is false or misleading in any particular.
2. If in package form unless it bears a label containing both:
(a) The name and place of business of the manufacturer, packer or distributor.
(b) An accurate statement of the quantity of the contents in terms of weight,
measure or numerical count.
3. If any word, statement or other information required by or under authority of
this chapter to appear on the label or labeling is not prominently placed on the label or
labeling. Compliance with the federal act shall be deemed compliance with this chapter
except for compliance with paragraph 16 of this subsection.
4. If it is for use by humans and contains any quantity of the narcotic or hypnotic
substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal,
chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote
or sulfonmethane, or any chemical derivative of such substance, which derivative or other
substance has been found to be habit-forming, unless its label bears the name and
quantity or proportion of such substance or derivative.
5. If it is a drug unless its label bears, to the exclusion of any other
nonproprietary name, both:
(a) The established name of the drug, if there is an established name.
(b) In case it is fabricated from two or more ingredients, the established name and
quantity of each active ingredient, including the kind and quantity or proportion of any
alcohol, and also including, whether active or not, the established name and quantity or
proportion of any bromides, ether, chloroform, atropine, hyoscine, hyoscyamine, arsenic,
digitalis, digitalis glycosides, mercury, strychnine or thyroid, or derivative or
preparation of any such substances, provided that the requirements for stating the
quantity of the active ingredients, other than those specifically named in this
subdivision, apply only to prescription drugs.
6. Unless its labeling bears both:
(a) Adequate directions for use.
(b) Adequate warnings against use in those pathological conditions or by children
where its use may be dangerous to health, or against unsafe dosage or methods or duration
of administration or application, in a manner and form as are necessary for the
protection of users.
7. If it is recognized in an official compendium, unless it is packed and labeled
as prescribed in such compendium, provided that the method of packing may be modified
with the consent of the board.
8. If it has been found by the board to be a drug or device liable to
deterioration, unless it is packaged in that form and manner, and its label bears a
statement of such precautions, as the rules issued by the board require as necessary for
the protection of public health.
9. If its container is so made, formed or filled as to be misleading.
10. If it is an imitation of another drug or device.
11. If it is offered for sale under the name of another drug or device.
12. If it is dangerous to health when used in the dosage, manner or with the
frequency or duration prescribed, recommended or suggested in the labeling of the drug or
device.
13. If it is a color additive, the intended use of which in or on drugs or devices
is for the purpose of coloring only, unless its packaging and labeling are in conformity
with such packaging and labeling requirements applicable to such color additive in the
federal act or board rule.
14. In the case of any prescription-only drug or controlled substance distributed or
offered for sale in this state, unless the manufacturer, packer or distributor of such
drug or substance includes in all advertisements and other printed matter with respect to
that drug a true statement of:
(a) The established name.
(b) The formula showing quantitatively each ingredient.
(c) Other information in brief summary relating to side effects, contraindications
or effectiveness as required in board rules or the federal act.
15. If a trademark, trade name or other identifying mark, imprint or device of
another drug or device or any likeness of another drug or device has been placed on the
drug or device or on its container with intent to defraud.
16. In the case of any prescription-only drug or controlled substance if in final
dosage form unless it bears a label containing both:
(a) The name and place of business of the manufacturer, and if different, the
packer or distributor.
(b) An accurate statement of the quantity of the contents in terms of weight,
measure or numerical count.
B. Drugs and devices which are to be processed, labeled or repacked at
establishments other than those where originally processed or packed are exempt from any
labeling or packaging requirements of this chapter, provided that such drugs and devices
are being delivered, manufactured, processed, labeled, repacked or otherwise held in
compliance with board rules or under the federal act.
C. If an article is alleged to be misbranded because the labeling is misleading,
then in determining whether the labeling is misleading there shall be taken into account,
among other things, not only representations made or suggested by statement, word,
design, device or any combination of them, but also the extent to which the labeling
fails to reveal facts material in the light of such representations, or material with
respect to consequences which may result from the use of the article to which the
labeling relates under the conditions of use prescribed in the labeling or under such
conditions of use as are customary or usual.
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