2023 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.  (1)  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.
(2) 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.
b. The injection of medications for the treatment of mental health and
substance   use  disorder,  as  prescribed  or  ordered  by  a  licensed
prescriber, acting within the scope of their practice in this state  and
in  accordance  with  regulations  promulgated  by  the commissioner, in
consultation with the department of health and any other state  agencies
as necessary, provided that:
(1)   Such   administration   is   conducted   pursuant   to  a  valid
patient-specific prescription or patient-specific order that  authorizes
a  pharmacist  to  administer  medications approved by the U.S. Food and
Drug Administration for the treatment of mental health and substance use
disorder. The pharmacist shall notify the licensed prescriber  that  the
administration  is  complete  within  five  days  and  shall convey such
information to the prescriber by making an entry into  an  interoperable
electronic  medical records system, an electronic prescribing technology
or a pharmacy record, or by using facsimile, electronic transmission  or
other  electronic  means.  If  an  electronic  means  described  in this
subparagraph  is  not  available  to  the  pharmacist  at  the  time  of
communication,  the  pharmacist or pharmacist's designee may communicate
the information by telephone. Notification shall also be required  if  a
patient does not receive an administration or if the patient experiences
any side effects or adverse reactions to the medications. Administration

in  a  pharmacy  shall not commence until after the patient has received
the  initial  injection  and  is  considered  eligible  for  maintenance
treatment by the licensed prescriber.
(2)  Such  prescription  may be subject to reassessment at appropriate
intervals, as determined by the licensed prescriber.
(3)  Such  activity  is  conducted  in  accordance  with  regulations,
promulgated  or  adopted  by  the commissioner, in consultation with the
department of health and any other state agencies, as  necessary,  which
shall include requirements for the following:
(i)  Maintaining continued competency regarding the populations served
and medications administered.
(ii) Pre-administration patient consent and education regarding common
side effects, drug interactions,  injection  site  reactions  and  other
information routinely provided to patients upon dispensing. If a patient
is  unable to provide consent, the pharmacist must obtain consent from a
person  legally  responsible  when  the  recipient   is   incapable   of
consenting.
(iii)  When  administering  an injection in a pharmacy, the pharmacist
shall provide an area for the injection that provides for the  patient's
privacy.
(iv)  Ensuring  that  only  U.S. Food and Drug Administration approved
medications are administered.
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).
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."
29. "Self-administered hormonal contraceptives", for  the  purpose  of
section sixty-eight hundred one of this article, means self-administered
contraceptive  medications  or  devices approved by the federal Food and
Drug Administration to prevent pregnancy by using hormones  to  regulate
or   prevent  ovulation,  and  includes  oral  hormonal  contraceptives,
hormonal contraceptive vaginal rings and hormonal contraceptive patches.