New Hampshire Revised Statutes 146:6 – Drugs, Devices, Misbranding
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A drug or device shall be deemed to be misbranded in the following cases:
I. If its labeling is false or misleading in any particular.
II. If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided, that under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the commissioner.
III. 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 thereon with such conspicuousness (as compared with other words, statements, designs or devices, 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.
IV. 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, 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 commissioner after investigation found to be, and by regulation 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.”
V. (1) If it is a drug, unless its label bears, to the exclusion of any other non-proprietary name, except the applicable systematic chemical name or the chemical formula, the established name (as defined in subparagraph (2)) of the drug, if such there be; and in case it is fabricated from 2 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 proportions of any bromide, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, hyposcine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein; provided that, the requirements for stating the quantity of the active ingredients, other than those specifically named in this paragraph, shall apply only to prescription drugs; provided further, that to the extent that compliance with this subparagraph is impracticable, exemption shall be allowed under regulations promulgated by the commissioner, or under the federal act. (2) As used in this paragraph the term “established name,” with respect to a drug or ingredient thereof, means the applicable official name designated pursuant to section 508 of the federal act, or if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium or then the common or usual name, if any, of such drug or of such ingredient.
VI. 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 commissioner shall promulgate regulations exempting such drug or device from such requirements.
VII. 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 commissioner.
VIII. If it has been found by the commissioner to be drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the commissioner shall by regulations require as necessary for the protection of public health. No such regulation shall be established for any drug recognized in an official compendium until the commissioner 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.
IX. If it is a drug and its container is so made, formed, or filled as to be misleading; or if it is an imitation of another drug; or if it is offered for sale under the name of another drug.
X. 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.
XI. (1) A drug intended for use by man which is a habit-forming drug to which paragraph IV applies; or because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or is limited by an approved application under section 505 of the federal act to use under the professional supervision of a practitioner licensed by law to administer such drug, shall be dispensed only upon a written prescription of a practitioner licensed by law to administer such drug, or upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in a drug being misbranded while held for sale. (2) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of paragraphs I, IX, XIII, and XIV of this section and the packaging requirements of paragraphs VII and VIII, if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber and, if stated in the prescription, the name of the patient, and the directions for use and the cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of business of dispensing of drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of subparagraph (1) of this paragraph.
XII. (1) A drug which is subject to paragraph XI(1) of this section shall be deemed to be misbranded if at any time prior to dispensing, its label fails to bear the statement “Caution: Federal Law Prohibits Dispensing Without Prescription”, or “Caution: State Law Prohibits Dispensing Without Prescription”. A drug to which paragraph XI(1) of this section does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence. (2) The commissioner may, by regulation, remove drugs subject to paragraph IV from the requirements of paragraph XI(1) of this section when such requirements are not necessary for the protection of the public health. Drugs removed from the prescription requirements of the federal act by regulations issued thereunder may also, by regulations issued by the commissioner, be removed from the requirements of paragraph XI(1). (3) Nothing in this section shall be construed to relieve any person from any requirements prescribed by or under authority of RSA 318-A.
XIII. If it is a color additive, the intended use of which in or on drugs 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 additives prescribed under the provisions of the federal act.
XIV. If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless it is a batch with respect to which a certificate or release has been issued pursuant to section 506 of the federal act, and such certificate or release is in effect with respect to such drug.
XV. If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any other antibiotic drug, or any derivative thereof, unless it is from a batch with respect to which a certificate or release has been issued pursuant to section 507 of the federal act, and such certificate or release is in effect with the respect to such drug: provided, that this paragraph shall not apply to any drug or class of drugs exempted by regulations promulgated under section 507(c) or (d) of the federal act. For the purpose of this paragraph the term “antibiotic drug” means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has the capacity to inhibit or destroy microorganism in dilute solution (including the chemically synthesized equivalent of any such substance).
I. If its labeling is false or misleading in any particular.
Terms Used In New Hampshire Revised Statutes 146:6
- color: includes black, white and intermediate grays. See New Hampshire Revised Statutes 146:2
- commissioner: means the commissioner of the department of health and human services. 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
- labeling: means all labels and other written, printed, or graphic matter (1) upon an article or any of its containers or wrappers, or (2) accompanying such article. 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
- person: may extend and be applied to bodies corporate and politic as well as to individuals. See New Hampshire Revised Statutes 21:9
- state: when applied to different parts of the United States, may extend to and include the District of Columbia and the several territories, so called; and the words "United States" shall include said district and territories. See New Hampshire Revised Statutes 21:4
II. If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided, that under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the commissioner.
III. 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 thereon with such conspicuousness (as compared with other words, statements, designs or devices, 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.
IV. 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, 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 commissioner after investigation found to be, and by regulation 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.”
V. (1) If it is a drug, unless its label bears, to the exclusion of any other non-proprietary name, except the applicable systematic chemical name or the chemical formula, the established name (as defined in subparagraph (2)) of the drug, if such there be; and in case it is fabricated from 2 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 proportions of any bromide, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, hyposcine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein; provided that, the requirements for stating the quantity of the active ingredients, other than those specifically named in this paragraph, shall apply only to prescription drugs; provided further, that to the extent that compliance with this subparagraph is impracticable, exemption shall be allowed under regulations promulgated by the commissioner, or under the federal act. (2) As used in this paragraph the term “established name,” with respect to a drug or ingredient thereof, means the applicable official name designated pursuant to section 508 of the federal act, or if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium or then the common or usual name, if any, of such drug or of such ingredient.
VI. 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 commissioner shall promulgate regulations exempting such drug or device from such requirements.
VII. 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 commissioner.
VIII. If it has been found by the commissioner to be drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the commissioner shall by regulations require as necessary for the protection of public health. No such regulation shall be established for any drug recognized in an official compendium until the commissioner 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.
IX. If it is a drug and its container is so made, formed, or filled as to be misleading; or if it is an imitation of another drug; or if it is offered for sale under the name of another drug.
X. 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.
XI. (1) A drug intended for use by man which is a habit-forming drug to which paragraph IV applies; or because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or is limited by an approved application under section 505 of the federal act to use under the professional supervision of a practitioner licensed by law to administer such drug, shall be dispensed only upon a written prescription of a practitioner licensed by law to administer such drug, or upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in a drug being misbranded while held for sale. (2) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of paragraphs I, IX, XIII, and XIV of this section and the packaging requirements of paragraphs VII and VIII, if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber and, if stated in the prescription, the name of the patient, and the directions for use and the cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of business of dispensing of drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of subparagraph (1) of this paragraph.
XII. (1) A drug which is subject to paragraph XI(1) of this section shall be deemed to be misbranded if at any time prior to dispensing, its label fails to bear the statement “Caution: Federal Law Prohibits Dispensing Without Prescription”, or “Caution: State Law Prohibits Dispensing Without Prescription”. A drug to which paragraph XI(1) of this section does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence. (2) The commissioner may, by regulation, remove drugs subject to paragraph IV from the requirements of paragraph XI(1) of this section when such requirements are not necessary for the protection of the public health. Drugs removed from the prescription requirements of the federal act by regulations issued thereunder may also, by regulations issued by the commissioner, be removed from the requirements of paragraph XI(1). (3) Nothing in this section shall be construed to relieve any person from any requirements prescribed by or under authority of RSA 318-A.
XIII. If it is a color additive, the intended use of which in or on drugs 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 additives prescribed under the provisions of the federal act.
XIV. If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless it is a batch with respect to which a certificate or release has been issued pursuant to section 506 of the federal act, and such certificate or release is in effect with respect to such drug.
XV. If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any other antibiotic drug, or any derivative thereof, unless it is from a batch with respect to which a certificate or release has been issued pursuant to section 507 of the federal act, and such certificate or release is in effect with the respect to such drug: provided, that this paragraph shall not apply to any drug or class of drugs exempted by regulations promulgated under section 507(c) or (d) of the federal act. For the purpose of this paragraph the term “antibiotic drug” means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has the capacity to inhibit or destroy microorganism in dilute solution (including the chemically synthesized equivalent of any such substance).