New Hampshire Revised Statutes 146:4 – Adulterated Drugs, Devices
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A drug or device shall be deemed to be adulterated in the following cases:
I. (1) If it consists in whole or in part of any filthy, putrid, or decomposed substances; or (2) 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; 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 (a) it is a drug and it bears or contains for purposes of coloring only, a color additive which is unsafe within the meaning of N.H. Rev. Stat. § 146:21; or (b) it is a color additive, the intended use of which in or on drugs is for the purpose of coloring only, and it is unsafe within the meaning of N.H. Rev. Stat. § 146:21.
II. 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 the 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 under authority of the federal act. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on the label.
III. If it is not subject to the provisions of paragraph II of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
IV. If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength; or (2) substituted wholly or in part therefor.
V. 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 good manufacturing practice to assure that such 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.
I. (1) If it consists in whole or in part of any filthy, putrid, or decomposed substances; or (2) 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; 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 (a) it is a drug and it bears or contains for purposes of coloring only, a color additive which is unsafe within the meaning of N.H. Rev. Stat. § 146:21; or (b) it is a color additive, the intended use of which in or on drugs is for the purpose of coloring only, and it is unsafe within the meaning of N.H. Rev. Stat. § 146:21.
Terms Used In New Hampshire Revised Statutes 146:4
- color: includes black, white and intermediate grays. See New Hampshire Revised Statutes 146:2
- color additive: means a material which-(a) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity from a vegetable, animal, mineral or other source, and (b) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto; except that such term does not include any material which has been or hereafter is exempted under the federal act. See New Hampshire Revised Statutes 146:2
- drug: means (1) articles recognized in the official United States Pharmacopoeia, or official National Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (4) articles intended for use as a component of any articles specified in clause (1), (2) or (3); but does not include devices or their components, parts, or accessories. See New Hampshire Revised Statutes 146:2
- federal act: means the Federal Food, Drug and Cosmetic Act (Title 21 U. See New Hampshire Revised Statutes 146:2
- following: when used by way of reference to any section of these laws, shall mean the section next preceding or following that in which such reference is made, unless some other is expressly designated. See New Hampshire Revised Statutes 21:13
- label: means a display of written, printed or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. See New Hampshire Revised Statutes 146:2
- official compendium: means the official United States Pharmacopoeia, official National Formulary, or any supplement of any of them. See New Hampshire Revised Statutes 146:2
II. 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 the 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 under authority of the federal act. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on the label.
III. If it is not subject to the provisions of paragraph II of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
IV. If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength; or (2) substituted wholly or in part therefor.
V. 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 good manufacturing practice to assure that such 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.