NY Educ L § 6815 (2021)
2021 New York Laws EDN - Education Title 8 - The Professions Article 137 - 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.