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This entry was published on 2022-02-04
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SECTION 6802
Definitions
Education (EDN) CHAPTER 16, TITLE 8, ARTICLE 137
§ 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, 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.

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