New York Laws
Article 137 - Pharmacy
6802 - Definitions.

(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 into the deltoid muscle 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 prescription
or 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 and the pharmacist notifies the
licensed prescriber that the administration is complete. Administration
in a pharmacy may 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) Training accredited by the accreditation council for pharmacy
education, that may include educational experiences obtained through
pharmacy school curricula, or a similar health authority or professional
body appropriate for the medications being administered and their
respective patient populations. Such training must be satisfactory to
the commissioner and the department of health, in consultation with the
board of pharmacy and any other state agencies, as necessary, which
shall include, but not be limited to learning modules on techniques for
administration by injections, indications, precautions, and
contraindications in the use of agent or agents; record keeping and
information; and handling emergencies, including anaphylaxis,
needle-sticks and cardiopulmonary resuscitation.
(ii) Maintaining continued competency regarding the populations served
and medications administered.
(iii) 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.
(iv) When administering an injection in a pharmacy, the pharmacist
shall provide an area for the injection that provides for the patient's
privacy.
(v) Record keeping and reporting of such administration by electronic
transmission or facsimile to the patient's licensed prescriber, and, to
the extent practicable, make himself or herself available to discuss the
outcome of such injection, including any adverse reactions, with the
licensed prescriber acting within their scope of practice.
(vi) Ensuring that only U.S. Food and Drug Administration approved
medications are administered.
* NB Effective December 28, 2023
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.
* NB Effective November 2, 2024