24:5-10 - General drug or device adulterations - New Jersey Statutes

24:5-10.  General drug or device adulterations    For the purposes of this subtitle a drug or device shall be deemed adulterated:

    a.  (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance;  or (2) if it has been 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;  or (3) if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than one from a batch which has been certified under the Federal Act.

    b.  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 standard set forth in such compendium.  Such determination as to strength, quality, or purity shall be made in accordance with tests or methods of assay set forth in such compendium or in the absence of or inadequacy of such tests or methods of assay, those prescribed by the agency enforcing the Federal Act.  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.

    c.  If it is not subject to the provisions of paragraph (b) of this section  and its strength differs from, or its purity or quality falls below that which  it purports or is represented to possess.

    d.  If it is a drug and any substance has been (1) mixed or packed therewith  so as to reduce its strength, quality, or purity;  or (2) substituted wholly or  in part therefor.

    e.  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.

     Amended by L.1939, c. 320, p. 777, s. 21, eff. Jan. 1, 1940;  L.1966, c. 74,  s. 7.