2010 New York Code
EDN - Education
Title 8 - THE PROFESSIONS
Article 137 - (6800 - 6828) PHARMACY
6802 - Definitions.

§ 6802. Definitions.  1.  "Pharmacy"  means  any place in which drugs,
  prescriptions or poisons are possessed for the purpose  of  compounding,
  preserving, dispensing or retailing, or in which drugs, prescriptions or
  poisons  are  compounded,  preserved, dispensed or retailed, or in which
  such drugs, prescriptions or poisons are  by  advertising  or  otherwise
  offered for sale at retail.
    3.  "Formulary"  means  the  latest  edition  of the official national
  formulary, and its supplement.
    4. "Pharmacopeia",  when  not  otherwise  limited,  means  the  latest
  edition of the official United States pharmacopeia, and its supplement.
    5.   "Homeopathic   pharmacopeia"   means   the  official  homeopathic
  pharmacopeia of the United States, and its supplement.
    6.  "Official   compendium"   means   the   official   United   States
  pharmacopeia,  official  homeopathic  pharmacopeia of the United States,
  official national formulary, or their supplements.
    7. "Drugs" means:
    a. Articles recognized in the  official  United  States  pharmacopeia,
  official  homeopathic  pharmacopeia  of  the  United States, or official
  national formulary.
    b. Articles intended for  use  in  the  diagnosis,  cure,  mitigation,
  treatment or prevention of disease in man or animals.
    c.  Articles (other than food) intended to affect the structure or any
  function of the body of man or animals.
    d. Articles intended for use as a component of any  article  specified
  in  paragraphs  a,  b,  or  c;  but  does  not  include devices or their
  components, parts or accessories.
    8. "Cosmetics" means:
    a. Articles intended to be rubbed, poured, sprinkled  or  sprayed  on,
  introduced  into  or  otherwise applied to the human body for cleansing,
  beautifying, promoting attractiveness, or altering the appearance.
    b. Articles intended for use as a  component  of  any  such  articles;
  except that the term shall not include soap.
    9.  "Poison", where not otherwise limited, means any drug, chemical or
  preparation likely to be destructive to adult human life in quantity  of
  sixty grains or less.
    10.  "Label"  means  a display of written, printed or pictorial matter
  upon the immediate container  of  any  drug,  device  or  cosmetic.  Any
  requirement  made  by or under authority of this article, 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  there
  be  any,  of  the  retail package of such drug, device or cosmetic or is
  easily legible through the outside container or wrapper.
    11. "Immediate container" does not include package liners.
    12.  "Labeling"  means  all  labels  and  other  written,  printed  or
  pictorial matter:
    a.  Upon  any  drug,  device  or  cosmetic or any of its containers or
  wrappers, or
    b. Accompanying such drug, device or cosmetic.
    13. "Misbranding". If a drug, device or  cosmetic  is  alleged  to  be
  misbranded because the labeling is misleading, or if an advertisement is
  alleged to be false because it is misleading then in determining whether
  the  labeling  or  advertisement is misleading there shall be taken into
  account (among other things) not only representations made or  suggested
  by  statement,  word,  design, device, sound or any combination thereof,
  but also the extent to which the labeling fails to reveal facts material
  in the light  of  such  representations  or  material  with  respect  to
  consequences  which  may  result  from  the  use of the drug, device, or

cosmetic  to  which  the  labeling  or  advertising  relates  under  the
  conditions  of  use prescribed in the labeling or advertising thereof or
  under such conditions of use as are customary or usual. No drug,  device
  or   cosmetic  which  is  subject  to,  and  complies  with  regulations
  promulgated under the provisions of the federal food, drug, and cosmetic
  act, relating to adulteration and misbranding  shall  be  deemed  to  be
  adulterated or misbranded in violation of the provisions of this article
  because  of  its  failure to comply with the board's regulations, or the
  rules of the state board of pharmacy, insofar as the regulations are  in
  conflict with regulations relating to adulteration and misbranding under
  the federal food, drug and cosmetic act.
    14.  "Antiseptic". The representation of a drug, device or cosmetic in
  its  labeling,  as  an  antiseptic,  shall  be  considered   to   be   a
  representation  that  it  is  a  germicide, except in the case of a drug
  purporting to be, or represented as, an antiseptic for inhibitory use as
  a wet dressing, ointment, dusting powder, or such other use as  involves
  prolonged contact with the body.
    15. "New drug" means:
    a.  Any  drug  not  generally  recognized,  among experts qualified by
  scientific  training  and  experience  to  evaluate   the   safety   and
  effectiveness  of  drugs,  as  safe  and  effective  for  use  under the
  conditions prescribed, recommended or suggested by the drug's  labeling,
  except  that  such  a drug not so recognized shall not be deemed to be a
  "new drug" if at any time prior to  September  first,  nineteen  hundred
  thirty-nine  it  was  subject to the former federal food and drug act of
  June thirtieth, nineteen hundred six, as amended, and if  at  such  time
  its   labeling   contained   the  same  representations  concerning  the
  conditions of its use;
    b. Any drug, the composition of which is such  that  the  drug,  as  a
  result  of  investigations to determine its safety and effectiveness for
  use under such conditions, has become  recognized,  but  which  has  not
  otherwise  than in such investigations been used to a material extent or
  for a material time under such conditions.
    16. "Device" means instruments, apparatus, and contrivances, including
  their components, parts and accessories, intended:
    a.  For  use  in  the  diagnosis,  cure,  mitigation,  treatment,   or
  prevention of disease in man or animals; or
    b.  To  affect  the  structure  or  any function of the body of man or
  animals.
    17. The term "Federal Food, Drug and Cosmetic Act" means  the  Federal
  Food,  Drug,  and Cosmetic Act of the United States of America, approved
  June twenty-fifth, nineteen hundred thirty-eight,  officially  cited  as
  public  document  number  seven hundred seventeen-seventy-fifth congress
  (chapter  six  hundred  seventy-five--third  session),   and   all   its
  amendments now or hereafter enacted.
    18. "Wholesaler" means a person who bottles, packs or purchases drugs,
  devices  or  cosmetics  for  the  purpose  of  selling  or  reselling to
  pharmacies or to other channels as provided in this article.
    19. "Advertisement" means  all  representations  disseminated  in  any
  manner  or  by  any  means,  other  than by labeling, for the purpose of
  inducing, or which are likely to induce,  directly  or  indirectly,  the
  purchase of drugs, devices or cosmetics.
    20.  "Controlled  substance"  means  any  drug defined as a controlled
  substance by article thirty-three of the public health law.
    21. "Manufacturer" means a  person  who  compounds,  mixes,  prepares,
  produces,  and  bottles  or  packs  drugs,  cosmetics or devices for the
  purpose of distributing or selling to pharmacies or to other channels of
  distribution.

* 22. "Administer", for the purpose of section sixty-eight hundred one
  of this article, means the direct application of an immunizing agent  to
  adults,  whether by injection, ingestion or any other means, pursuant to
  a patient specific order or non-patient specific regimen  prescribed  or
  ordered  issued by a physician or certified nurse practitioner who has a
  practice site in the county in which the immunization  is  administered.
  However if the county where the immunization is to be administered has a
  population of seventy-five thousand or less, then the licensed physician
  or  certified  nurse  practitioner  may  be in an adjoining county. Such
  administration  shall  be  limited  to  immunizing  agents  to   prevent
  influenza or pneumococcal disease and medications required for emergency
  treatment of anaphylaxis.
    * NB Repealed March 31, 2012

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