N.Y. Comp. Codes R. & Regs. tit. 9 § 113.1

Current through Register Vol. 46, No. 36, September 4, 2024

Section 113.1 - Definitions

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.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 113.1

Adopted New York State Register February 22, 2023/Volume XLV, Issue 08, eff. 2/22/2023