New Jersey § 24:5-18

§ 24:5-18.

For the purposes of this subtitle a drug or device shall also be deemed to be misbranded: a. If its labeling is false or misleading in any particular. b. If in package form unless it bears a label containing the name and place of business

of the manufacturer, packer, or distributor. c. If any word, statement or other information required by or under authority of this

subtitle to appear on the label or labeling is not prominently placed thereon with

such conspicuousness (as compared with other words, statements or designs in the labeling)

and in such terms as to render it likely to be read and understood by the ordinary

individual under customary conditions of purchase and use. d. If it is for use by man and contains any quantity of the narcotic or hypnotic substance

alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis other than as defined in section 3 of P.L.2021, c. 16 ( C.24:6I-33 ) , carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium,

paraldehyde, peyote, or sulphonmethane; or any chemical derivative of such substance,

which derivative has been by the Department of Health of the State of New Jersey after

investigation found to be, and by regulations under this subtitle designated as, habit

forming; unless its label bears the name and quantity or proportion of such substance,

or derivative and in juxtaposition therewith, the statement “Warning--May be habit

forming.” e. If it is a drug and is not designated solely by a name recognized in an official

compendium, unless its label bears (1) the common or usual name of the drug, if such

there be; and (2) in case it is fabricated from 2 or more ingredients, the common

or usual name of each active ingredient, including the kind and quantity or proportion

of any alcohol, and also including, whether active or not, the name and quantity or

proportion of any bromides, ether, chloroform, acetanilid, acetphanetidin, amidopyrine,

antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides,

mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation

of any such substances, contained therein; provided, that to the extent that compliance

with the requirements of clause (2) of this paragraph is impracticable, exemptions

may be established by regulations promulgated by the State department. f. Unless its labeling bears (1) adequate directions for use; and (2) such 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 such manner and form, as are necessary for the protection of users;

provided, that where any requirement of clause (1) of this paragraph, as applied to

any drug or device, is not necessary for the protection of the public health, the

Department of Health of the State of New Jersey may promulgate regulations exempting

such drug or device from such requirement. g. If it purports to be a drug the name of which is recognized in an official compendium,

unless it is packaged and labeled as prescribed therein; provided, that the method

of packing may be modified with the consent of the State department. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic

Pharmacopoeia of the United States it shall be subject to the requirements of the

United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic

drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia

of the United States and not to those of the United States Pharmacopoeia. h. If it has been found by the Department of Health of the State of New Jersey to

be a drug liable to deterioration, unless it is packaged in such form and manner,

and its label bears a statement of such precautions, as the Department of Health of

the State of New Jersey may by regulations require as necessary for the protection

of the public health. No such regulation shall be established for any drug recognized in an official compendium

until the State department shall have informed the appropriate body charged with the

revision of such compendium of the need for such packaging or labeling requirements

and such body shall have failed within a reasonable time to prescribe such requirements. i. (1) If it is a drug and its container is so made, formed or filled as to be misleading;

or (2) if it is an imitation of another drug; or (3) if it is offered for sale under

the name of another drug. j. If it is dangerous to health when used in the dosage, or with the frequency or

duration prescribed, recommended, or suggested in the labeling thereof. k. If it is a depressant or stimulant drug as defined pursuant to law and not in the

possession or control of a person specified by law as entitled to possession or control

of such depressant or stimulant drug. Any depressant or stimulant drug misbranded under the preceding sentence shall be

deemed dangerous or fraudulent for purposes of marking and detaining under the provisions

of section 24:4-12 of this Title.