New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle B - Division of Alcoholic Beverage Control › Chapter II - Rules of the Office of Cannabis Management › Part 113 - Medical Cannabis › Section 113.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
For the purposes of this Part, the following terms shall
					 have the following meanings:
(a)
Adverse event
means any untoward medical occurrence associated
				  with the use of a medical cannabis product in humans.
(b)
Advertising
means
				  disseminating communications in any manner or by any means, for the purpose of
				  causing, directly or indirectly, the purchase or use of a medical cannabis
				  product brand or medical cannabis product, including but not limited to
				  websites, social media, brochures, prints ads, TV, radio, streaming, out of
				  home, and digital advertisements.
(c)
Artificially derived
				  phytocannabinoid
means a phytocannabinoid that is created by a
				  chemical reaction that changes the molecular structure of any chemical
				  substance derived from cannabis sativa. Artificially derived phytocannabinoid
				  does not include: a naturally-occurring chemical substance that is separated
				  from cannabis sativa by a chemical or mechanical extraction process;
				  phytocannabinoids that are produced by decarboxylation of the
				  phytocannabinoid's respective naturally-occurring carboxylic acid form without
				  the use of a chemical catalyst; any other chemical substance identified by the
				  Board.
(d)
Board
means Cannabis Control Board.
(e)
Brand or Branding
means the name, entity name, or doing
				  business as name, registered trademark, logo, symbol, motto, selling message,
				  recognizable pattern of colors, or any other identifiable marker that
				  identifies one (1) medical cannabis registrant or medical cannabis registrant's
				  medical cannabis products as distinct from those cannabis products of other
				  medical cannabis registrants or adult-use cannabis licensees and is used in,
				  among other things, any packaging, labeling, advertising or
				  marketing.
(f)
Caring
				  for
means treating a patient, in the course of which the practitioner
				  has completed a full assessment of the patient's medical history and current
				  medical condition.
(g)
Certificate of analysis
means a certified report from a
				  cannabis laboratory meeting the testing requirements of section
				  113.15 of this Part.
(h)
Certified medical
use
				  means the acquisition, cultivation, manufacture, delivery, harvest, possession,
				  preparation, transfer, transportation, or use of medical cannabis for a
				  certified patient, or the acquisition, administration, cultivation,
				  manufacture, delivery, harvest, possession, preparation, transfer, or
				  transportation of medical cannabis by a designated caregiver or designated
				  caregiver facility, or paraphernalia relating to the administration of
				  cannabis, including whole cannabis flower, to treat or alleviate a certified
				  patient's medical condition or symptoms associated with the patient's medical
				  condition.
(i)
Certified
				  patient
means a patient who is a resident of New York or receiving
				  care and treatment in New York State and is certified in accordance with
				  section 113.3 of this Part.
(j)
Child-Resistant
means a
				  resealable package for dispensing any cannabis product intended for more than a
				  single use or containing multiple doses, that is designed or constructed to be
				  significantly difficult for children under five (5) years of age to open and
				  not difficult for adults to use properly as defined by
				  16 C.F.R. §
											1700.15 and
				  16 C.F.R. §
											1700.20.
(k)
Condition
means having
				  one of the following conditions: cancer, positive status for human
				  immunodeficiency virus or acquired immune deficiency syndrome, amyotrophic
				  lateral sclerosis, Parkinson's disease, multiple sclerosis, damage to the
				  nervous tissue of the spinal cord with objective neurological indication of
				  intractable spasticity, epilepsy, inflammatory bowel disease, neuropathies,
				  Huntington's disease, post-traumatic stress disorder, pain that degrades health
				  and functional capability (where the use of medical cannabis is an alternative
				  to opioid use), substance use disorder, Alzheimer's, muscular dystrophy,
				  dystonia, rheumatoid arthritis, autism or any other condition certified by the
				  practitioner.
(l)
Control
means the power, from a business organization and
				  ownership perspective, to order or direct the management, managers, or policies
				  of a person.
(m)
Date of
				  expiration or expiration date
means the date prior to which an
				  unopened medical cannabis product meets applicable standards of identity,
				  potency, and quality at the time of use, as determined by appropriate stability
				  testing, subject to any storage conditions stated on the labeling.
(n)
Designated caregiver
				  applicant
means a natural person who is applying to obtain, amend or
				  renew a registry identification number.
(o)
Designated caregiver
				  facility
means a facility that registers with the Office to assist one
				  (1) or more certified patients with the acquisition, possession, delivery,
				  transportation or administration of medical cannabis and is a: general hospital
				  or residential health care facility operating pursuant to Article 28 of the
				  Public Health Law; an adult care facility operating pursuant to Title 2 of
				  Article 7 of the Social Services Law; a community mental health residence
				  established pursuant to section 41.44  of the Mental Hygiene Law; a hospital
				  operating pursuant to section
				  7.17 of the Mental Hygiene Law; a
				  mental hygiene facility operating pursuant to Article 31 of the Mental Hygiene
				  Law; an inpatient or residential treatment program certified pursuant to
				  Article 32 of the Mental Hygiene Law; a residential facility for the care and
				  treatment of persons with developmental disabilities operating pursuant to
				  Article 16 of the Mental Hygiene Law; a residential treatment facility for
				  children and youth operating pursuant to Article 31 of the Mental Hygiene Law;
				  a private or public school; research institution with an internal review board;
				  or any other facility as determined by the Office.
(p)
Exit package
means a
				  receptacle into which medical cannabis products are placed at the point of
				  sale. The exit package is optional.
(q)
Financial Interest
means
				  any actual or future right to ownership, investment or compensation arrangement
				  with another person, either directly or indirectly, through business,
				  investment, spouse, parent or child. Person with a financial interest does not
				  include a passive investor.
(r)
Form of medical cannabis or Form
means "form of medical
				  cannabis" as defined by Article 1 of the Cannabis Law.
(s)
Lot
means a quantity of
				  a medical cannabis product that has a homogenous and uniform phytocannabinoid
				  concentration and product quality, produced according to a stable processing
				  protocol specific to that product, during the same cycle of
				  manufacture.
(t)
Lot unique
				  identifier (Lot number or bar code)
means any distinctive combination
				  of letters, numbers, or symbols, or any combination of them, from which the
				  complete history of manufacturing, testing, holding, distribution or recall of
				  a lot of medical cannabis product can be determined.
(u) Manufacturing shall include, but not be
				  limited to cultivation, harvesting, extraction (or other processing), packaging
				  and labeling.
(v)
Medical
				  cannabis license
means a registration provided to a registered
				  organization. Medical cannabis license and registration as it pertains to a
				  registered organization shall be used interchangeably.
(w)
Medical cannabis product
is the final manufactured product of medical cannabis, as defined in section 3
				  of Article 1 of the Cannabis Law, delivered to the patient that represents a
				  specific phytocannabinoid concentration and form and active and inactive
				  ingredients, prepared in a specific dosage and form, to be administered as
				  recommended by the practitioner.
(x)
Office
means the Office
				  of Cannabis Management.
(y)
Person responsible for making health care decisions
means, in
				  association with certified patients under the age of eighteen (18) or otherwise
				  incapable of consent, a person legally authorized to make health care decisions
				  for the patient, including decisions on the use of medical cannabis and the
				  designation of caregivers.
(z)
Phytocannabinoids
refers to any of the chemical compounds,
				  excluding terpenes or any other compounds determined by the Office, that are
				  the active principles of the cannabis sativa, including but not limited to
				  tetrahydrocannabinol (THC) and CBD, and does not include synthetic cannabinoids
				  as that term is defined in subdivision (g) of schedule I of section 3306  of the
				  Public Health Law.
(aa)
Post-consumer recycled material
means new material produced
				  using material resulting from the recovery, separation, collection and
				  reprocessing of material that would otherwise be disposed of or processed as
				  waste and that was originally sold for consumption. It does not include
				  post-industrial material, or material generated by means of combustion,
				  incineration, pyrolysis, gasification, solvolysis, chemical recycling and any
				  high-heat or conversion process.
(ab)
Practitioner
means an
				  individual who is licensed, registered or certified by New York State to
				  prescribe controlled substances within the state. Nothing in this Part shall be
				  interpreted so as to give any such person authority to act outside their scope
				  of practice as defined by Title 8 of the Education Law. Additionally, nothing
				  in this Part shall be interpreted to allow any unlicensed, unregistered, or
				  uncertified person to act in a manner that would require a license,
				  registration, or certification pursuant to Title 8 of the Education
				  Law.
(ac)
Principal
				  packaging display panel
means the panel of the package or the
				  marketing layer that the registered organization intends to be displayed at the
				  dispensing site.
(ad)
Registered organization
means an organization registered as
				  defined under section 3  of the Cannabis Law.
(ae)
Registered organization
				  applicant
means an organization that has a significant presence in New
				  York State and is applying to be registered or to renew a registration as a
				  registered organization.
(af)
Registry application
means an application properly completed
				  and filed with the Office by a certified patient in accordance with Article 3
				  of the Cannabis Law and this Part.
(ag)
Registry identification
				  card
means a document that identifies a certified patient or
				  designated caregiver, as provided under Article 3 of the Cannabis
				  Law.
(ah)
Resealable
means a package that maintains its child-resistant
				  effectiveness, as well as preserving the integrity of cannabis products for
				  multiple doses.
(ai)
Serious adverse event
means one (1) or more of the following
				  outcomes: death, a life- threatening adverse event, inpatient hospitalization
				  or prolongation of existing hospitalization, a persistent or significant
				  incapacity or substantial disruption of the ability to conduct normal life
				  functions, or a congenital anomaly/birth defect.
(aj)
Significant presence
means significant presence as defined in Cannabis Law section 3(1).
(ak) Synthetic cannabis additives refer to
				  any chemical substances that do not naturally occur in cannabis
				  sativa.
(al) Synthetic terpenes
				  refer to any terpenes that do not naturally occur in cannabis sativa or that
				  are produced and created by chemical synthesis or biosynthesis that changes the
				  molecular structure of a chemical substance to create a terpene that is
				  naturally occurring in cannabis sativa.
(am)
Tamper-evident
means,
				  with respect to a device or process, bearing a seal, a label or a marking that
				  makes unauthorized access to or tampering with a package, product or container
				  easily detectable.
(an)
Use
				  by date
means the date prior to which an opened medical cannabis
				  product meets applicable standards of identity, potency, and quality at the
				  time of use, as determined by appropriate stability testing, subject to any
				  storage conditions stated on the labeling.