NY Educ L § 6802 (2021)
2021 New York Laws EDN - Education Title 8 - The Professions Article 137 - 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:   a. the direct application of an immunizing agent to adults, whether by injection,  ingestion,  inhalation  or  any  other  means, pursuant to a patient specific order or non-patient  specific  regimen  prescribed  or ordered  by  a  physician  or  certified  nurse  practitioner, who has a practice  site  in  the  county  or  adjoining  county  in   which   the immunization  is  administered,  for immunizations to prevent influenza, pneumococcal, acute herpes zoster, meningococcal,  tetanus,  diphtheria, COVID-19,  or  pertussis  disease and medications required for emergency treatment of anaphylaxis. If the commissioner of health determines  that there is an outbreak of disease, or that there is the imminent threat of an  outbreak  of  disease,  then  the commissioner of health may issue a non-patient specific regimen applicable statewide.   b. the direct application of an immunizing agent to  children  between the  ages  of  two  and  eighteen  years  of  age, whether by injection, ingestion, inhalation or any other means, pursuant to a patient specific order or  non-patient  specific  regimen  prescribed  or  ordered  by  a physician  or  certified  nurse practitioner, who has a practice site in the  county  or  adjoining  county  in   which   the   immunization   is administered,  for  immunization  to  prevent  influenza and medications required for emergency treatment  of  anaphylaxis  resulting  from  such immunization.  If the commissioner of health determines that there is an outbreak of influenza, or that  there  is  the  imminent  threat  of  an outbreak  of  influenza,  then  the  commissioner  of health may issue a non-patient specific regimen applicable statewide.   * NB Effective until January 31, 2022   * 22. "Administer", for the purpose of section sixty-eight hundred one of this article, means:   a. the direct application of an immunizing agent to adults, whether by injection, ingestion, inhalation or  any  other  means,  pursuant  to  a patient  specific  order  or  non-patient specific regimen prescribed or ordered  by  a  physician  or   certified   nurse   practitioner,   for: immunizations  to  prevent influenza, pneumococcal, acute herpes zoster, hepatitis A, hepatitis B, human papillomavirus, measles, mumps, rubella, varicella, COVID-19, meningococcal,  tetanus,  diphtheria  or  pertussis disease and medications required for emergency treatment of anaphylaxis; and  other  immunizations  recommended  by  the  advisory  committee  on immunization practices of the centers for disease control and prevention for patients eighteen years of age  or  older  if  the  commissioner  of health   in  consultation  with  the  commissioner  determines  that  an immunization: (i)(A) may be safely administered by a licensed pharmacist within their lawful scope of practice; and (B) is needed to prevent  the transmission  of  a reportable communicable disease that is prevalent in New York state; or (ii) is a recommended immunization for such  patients who:   (A)  meet  age  requirements,  (B)  lack  documentation  of  such immunization, (C) lack evidence  of  past  infection,  or  (D)  have  an additional  risk  factor  or  another  indication  as recommended by the advisory committee on immunization practices of the centers for  disease control  and  prevention.  If the commissioner of health determines that there is an outbreak of disease, or that there is the imminent threat of an outbreak of disease, then the commissioner  of  health  may  issue  a non-patient specific regimen applicable statewide.   b.  the  direct application of an immunizing agent to children between the ages of two  and  eighteen  years  of  age,  whether  by  injection, ingestion, inhalation or any other means, pursuant to a patient specific order  or  non-patient  specific  regimen  prescribed  or  ordered  by a physician or certified nurse practitioner, for immunization  to  prevent  influenza   and   medications   required   for  emergency  treatment  of anaphylaxis resulting from such immunization.  If  the  commissioner  of health  determines that there is an outbreak of influenza, or that there is   the   imminent  threat  of  an  outbreak  of  influenza,  then  the commissioner  of  health  may  issue  a  non-patient  specific   regimen applicable statewide.   * NB Effective January 31, 2022   23.  "Electronic prescription" means a prescription created, recorded, or stored by electronic means; issued with an electronic signature;  and transmitted  by  electronic means, in accordance with regulations of the commissioner and applicable regulations of the  commissioner  of  health and  federal  regulations; provided, however, that an original hard copy prescription  that  is  created  electronically  or  otherwise  may   be transmitted  from the prescriber to the pharmacist by facsimile and must be manually signed. "Electronic" means  of  or  relating  to  technology having     electrical,    digital,    magnetic,    wireless,    optical, electromagnetic, or similar capabilities. "Electronic  signature"  means an  electronic  sound,  symbol,  or  process,  attached  to or logically associated with an electronic prescription and executed or adopted by  a person  with  the  intent  to  sign the prescription, in accordance with regulations of  the  commissioner  and  applicable  regulations  of  the commissioner of health and federal regulations.   24.  "Compounding"  means  the  combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug  or  bulk  drug substance to create a drug with respect to an outsourcing facility under section  503B  of  the  Federal  Food, Drug and Cosmetic Act and further defined in this section.   25. "Outsourcing facility" means a facility that:  (a) is engaged in the compounding of sterile drugs;  (b) is currently  registered  as  an  outsourcing  facility  with  the Secretary of Health and Human Services; and  (c)  complies  with  all  applicable requirements of federal and state law, including the Federal Food, Drug and Cosmetic Act.   26. "Sterile drug" means  a  drug  that  is  intended  for  parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under federal or state law.   * 27.  "Biological  product"  means a biological product as defined in subsection (i) of section 351 of  the  Public  Health  Service  Act,  42 U.S.C. Section 262(i).   * NB Expires October 23, 2022   * 28.  "Interchangeable biological product" means a biological product licensed by the United States Food and Drug Administration  pursuant  to 42  U.S.C.  Section  262(k)(4)  as  set  forth  in the latest edition or supplement of the United States Food and Drug  Administration  Lists  of Licensed  Biological  Products  with  Reference  Product Exclusivity and Biosimilarity or Interchangeability Evaluations, sometimes  referred  to as  the  "Purple Book," or a biological product determined by the United States Food and Drug Administration to be therapeutically equivalent  as set  forth in the latest edition or supplement of the United States Food and  Drug  Administration  Approved  Drug  Products   with   Therapeutic Equivalence Evaluations, sometimes referred to as the "Orange Book."   * NB Expires October 23, 2022