2010 New York Code
EDN - Education
Title 8 - THE PROFESSIONS
Article 137 - (6800 - 6828) PHARMACY
6815 - Adulterating, misbranding and substituting.

§ 6815. Adulterating,  misbranding  and substituting.   1.   Adultered
  drugs.  A drug or device shall be deemed to be 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 that has been certified in accordance with regulations provided in
  this article.
    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 the tests or methods of assay set forth
  in such compendium, or, in the absence or inadequacy of  such  tests  or
  methods  of  assay,  then  in  accordance with tests or methods of assay
  prescribed by regulations of the board of pharmacy as promulgated  under
  this  article.  Deviations  from  the official assays may be made in the
  quantities of samples  and  reagents  employed,  provided  they  are  in
  proportion  to the quantities stated in the official compendium. No drug
  defined in an official compendium shall  be  deemed  to  be  adulterated
  under  this  paragraph  because  (1) it exceeds the standard of strength
  therefor set forth in such compendium, if  such  difference  is  plainly
  stated  on  its  label;  or (2) it falls below the standard of strength,
  quality, or purity  therefor  set  forth  in  such  compendium  if  such
  difference is plainly stated on its label, except that this clause shall
  apply only to such drugs, or classes of drugs, as are specified in regu-
  lations  which  the board shall promulgate when, as applied to any drug,
  or class of drugs, the prohibition of such difference is  not  necessary
  for  the  protection of the public health. 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
  subdivision 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 quality or  strength  or  (2)  substituted
  wholly or in part therefor.
    e.  If it is sold under or by a name not recognized in or according to
  a formula not given in the United States pharmacopoeia or  the  national
  formulary  but that is found in some other standard work on pharmacology
  recognized by the board, and it differs in strength, quality  or  purity
  from the strength, quality or purity required, or the formula prescribed
  in, the standard work.
    2.  Misbranded  and  substituted  drugs  and devices. A drug or device
  shall 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 (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 the board  may  establish  reasonable  variations  as  to
  quantity and exemptions as to small packages.
    c.  If  any word, statement, or other information required by or under
  authority of this article 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.
    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, 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  secretary,  after  investigation,  found  to be, and by regulations
  under  this  article,  or  by  regulations  promulgated  by  the  board,
  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  two  or  more ingredients, the common or usual name of each active
  ingredient, including the kind and quantity by percentage or  amount  of
  any  alcohol,  and  also  including, whether active or not, the name and
  quantity or proportion of any bromides, ether,  chloroform,  acetanilid,
  acetphenetidin,    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   shall   be   established   by   regulations
  promulgated by the board.
    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 board shall 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 secretary in accordance with regulations  promulgated  by
  the  board.  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
  with  respect to packaging and labeling 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.  (1) If it is a drug and its container is so made, formed or filled
  as to be misleading; (2) if it is an imitation of another drug;  (3)  if
  it  is  offered  for  sale  under the name of another drug; or (4) if it
  bears a copy, counterfeit, or  colorable  imitation  of  the  trademark,
  label, container or identifying name or design of another drug.

i.  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.
    j.  Except  as  required  by article thirty-three of the public health
  law, the labeling provisions of this article  shall  not  apply  to  the
  compounding  and  dispensing  of  drugs on the written prescription of a
  physician, a dentist, a podiatrist or a veterinarian, which prescription
  when filled shall be kept on  file  for  at  least  five  years  by  the
  pharmacist or druggist. Such drug shall bear a label containing the name
  and  place  of  business of the dispenser, the serial number and date of
  the  prescription,  directions  for  use  as  may  be  stated   in   the
  prescription,  name  and  address  of  the  patient  and the name of the
  physician  or  other  practitioner  authorized  by  law  to  issue   the
  prescription.   In addition, such label shall contain the proprietary or
  brand name of the drug and, if applicable, the strength of the contents,
  unless the person issuing the  prescription  explicitly  states  on  the
  prescription,  in his own handwriting, that the name of the drug and the
  strength thereof should not appear on the label.