N.J. Admin. Code § 17:30A-1.2

Current through Register Vol. 56, No. 23, December 2, 2024
Section 17:30A-1.2 - Definitions

The following words and terms, as used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise, or another subchapter defines one of the following words or terms differently for the purposes of that subchapter:

"Academic medical center" means a health care practice, accredited medical training program, medical school, or school of osteopathic medicine, that has the ability to conduct research, which may include human clinical trials but in no case shall include animal testing, related to medical cannabis in partnership with clinical registrants as fully defined at N.J.A.C. 17:30A-7A.1.

"Act" means the Jake Honig Compassionate Use Medical Cannabis Act, N.J.S.A. 24:6I-1et seq.

"Adequate supply" means not more than is reasonably necessary to ensure the uninterrupted availability of marijuana, in all forms, to meet the needs of registered patients at a given ATC.

"Adulterated" or "adulteration" means made impure or inferior by adding extraneous ingredients.

"Aggregate ownership interest" means the total ownership interest held by an owner, including a passive investor, that is a person and by the spouse, domestic partner, civil union partner, child, sibling, or parent of the person.

"Alternative treatment center" or "ATC" means an entity that has been issued one or more permits to cultivate, manufacture, or dispense medicinal marijuana and related paraphernalia to registered qualifying patients in accordance with the provisions of the Act and this chapter. This term includes the ATC's officers, directors, board members, and employees and any clinical registrant. "Alternative treatment center" includes a "vertically integrated alternative treatment center" and both clinical registrant ATCs and non-clinical ATCs.

"ATC identification card" means a document issued by the Commission that identifies a person as a principal officer, director, board member, owner, or employee of an ATC.

"Bona fide physician-patient relationship" means a relationship in which the physician has ongoing responsibility for the assessment, care and treatment of a patient's debilitating medical condition consistent with the requirements of the Act and N.J.A.C. 13:35-7A.

"Business day" means any day other than Saturday, Sunday, or a State-recognized holiday.

"Cannabidiol" means a nonpsychoactive constituent of marijuana, C< >H< >O< >.

"Central region" means the counties of Hunterdon, Middlesex, Mercer, Monmouth, Ocean, Somerset, and Union.

"Certification" means a statement signed by a physician with whom a qualifying patient has a bona fide physician-patient relationship, which attests to the physician's authorization for the patient to apply for registration for the medical use of marijuana and meets the requirements of N.J.A.C. 13:35-7A.

"Clinical registrant" means a clinical research-focused alternative treatment center issued one or more ATC permits pursuant to N.J.S.A. 24:6I-7.3, as fully defined at N.J.A.C. 17:30A-7A.1.

"Commission" means the Cannabis Regulatory Commission, established pursuant to P.L. 2019, c. 153 and P.L. 2021, c. 16.

"Cultivation" includes the planting, propagating, cultivating, growing, harvesting, labeling, or storing of medicinal marijuana for the limited purpose of the Act and this chapter.

"Debilitating medical condition" means:

1. One of the following conditions, if resistant to, or if the patient is intolerant to, conventional medical therapy: seizure disorder, including epilepsy, intractable skeletal muscular spasticity, or glaucoma;
2. One of the following conditions, if severe or chronic pain, severe nausea or vomiting, cachexia, or wasting syndrome results from the condition, or treatment thereof: positive status for human immunodeficiency virus, acquired immune deficiency syndrome, or cancer;
3. Amyotrophic lateral sclerosis, multiple sclerosis, terminal cancer, muscular dystrophy, or inflammatory bowel disease, including Crohn's disease;
4. Anxiety, chronic pain associated with a musculoskeletal disorder, chronic pain of a visceral origin, migraines, Tourette syndrome, and post-traumatic stress disorder (PTSD);
5. Opioid use disorder, provided the qualifying patient is participating in, and compliant with, medication-assisted treatment for the opioid use disorder;
6. Terminal illness, if the physician has determined a prognosis of less than 12 months of life; or
7. Any other medical condition or its treatment that is approved by the Department pursuant to N.J.A.C. 17:30A-5.

"Disqualifying conviction" means a conviction of a crime involving any controlled dangerous substance or controlled substance analog as set forth in Chapter 35 of Title 2C of the New Jersey Statutes except paragraph (4) of subsection a. at N.J.S.A. 2C:35-10, or any similar law of the United States or of any other state.

"Electronic signature" or "signature" means either the name of one written by oneself or an electronic code, sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.

"Endorsement" means a designation set forth on the permit of an ATC that authorizes the ATC to cultivate, manufacture, or dispense medicinal marijuana for the benefit of qualifying patients.

"Executive Director" means the Executive Director of the Commission.

"Financial source" means a person or entity that lends any amount of capital to an ATC permit applicant or permit holder pursuant to a secured or unsecured financing agreement and who is not an owner, passive investor, or principal of such ATC permit applicant or permit holder.

"Financial source agreement" means any agreement, contract, arrangement, or other type of formal understanding between a financial source and an ATC permit applicant or permit holder where the financial source lends capital to the ATC permit applicant or permit holder pursuant to a secured or unsecured financing agreement and does not receive ownership interest.

"Institutional Review Board" or "IRB" means a board, committee, research approval committee, or group created or designated by an academic medical center, as applicable, that reviews and approves the proposed* scope and research protocols of a clinical registrant's proposed research study.

"Lozenge" means a solid oral dosage form that is designed to dissolve or disintegrate slowly in the mouth.

"Management services agreement" means any agreement, contract, arrangement, or other type of formal understanding between a management services contractor and an ATC permit applicant or permit holder where the management services contractor provides professional staffing, administrative, operational, advisory, or management services to the ATC permit applicant or permit holder in exchange for remuneration, but not an ownership interest.

"Management services contractor" or "MSC" means a third-party vendor-contractor person or entity supervised by the principals and owners of the ATC permit applicant or permit holder, that provides professional staffing, administrative, operational, advisory, or management services to the ATC permit applicant or permit holder in exchange for remuneration pursuant to a management services agreement.

"Manufacturing" means compounding, making, and processing medicinal marijuana in all forms.

"Marijuana" has the meaning given at section 2 of the "New Jersey Controlled Dangerous Substances Act," P.L. 1970, c. 226 (N.J.S.A. 24:21-2).

"Mature plant" means a harvestable female marijuana plant that is flowering and either greater than 12 inches in height or greater than 12 inches in diameter.

"Medical advisory board" means a five-member panel appointed by an ATC to provide advice to the ATC on all aspects of its business. The medical advisory board shall:

1. Be comprised of three New Jersey licensed health care professionals, at least one of whom shall be a physician; one patient registered with the ATC; and one business owner from the same region as the ATC.
i. No ATC owners, employees, officers, or board members shall serve on the medical advisory board; and
2. Meet at least two times per calendar year.

"Medical use of marijuana" means the acquisition, possession, transport, or use of marijuana or paraphernalia by a registered qualifying patient as authorized by the Act.

"Medication-assisted treatment" means "Medication-Assisted Treatment (MAT)" as 42 CFR Part 8--Medication Assisted Treatment of Opioid Use Disorders, defines that term, particularly at ? 8.2.

"Military veteran" means a person who served in any branch of the active or reserve component of the United State military and/or the National Guard of any state military service and who was discharged or released under conditions other than dishonorable.

"Minor" means a person who is under 18 years of age and who has not been married or previously declared by a court or an administrative agency to be emancipated.

"Misbranded" means the term "misbranded" as defined at N.J.S.A. 24:5-16 and 17.

"Nonprofit entity" means corporations, associations or organizations not conducted for pecuniary profit of any private shareholder or individual, and established, organized, or chartered without capital stock under the provisions of Titles 15, 15A, 16 or 17 of the Revised Statutes; or a special charter; or any similar general or special law of this or any other state, that are exempt from the tax imposed by the Corporation Business Tax Act, as set forth at N.J.S.A. 54:10A-3(e). A nonprofit entity is not required to be a tax-exempt organization under 26 U.S.C. 501.(c)(3).

"Northern region" means the counties of Bergen, Essex, Hudson, Morris, Passaic, Sussex, and Warren.

"Oil" means a viscous liquid substance containing cannabinoids, such as THC and cannabidiol, which are extracted from the marijuana plant.

1. An ATC may manufacture oil for use in preloaded cartridges, or in topical or oral formulations.

"Onsite assessment" means a visit by an employee of the Department to ensure compliance with the Act and this chapter to any site that has received a permit as an alternative treatment center.

"Organic" means the organic program standards as defined at N.J.A.C. 2:78.

"Owner" means:

1. Any person or entity that holds at least a five percent aggregate ownership interest in an ATC permit applicant or permit holder;
2. Where an entity, including a parent company, holds at least a five percent ownership interest in an ATC permit applicant or permit holder, any person or entity that holds at least a 10 percent aggregate ownership interest in or is a member of the executive team of such entity, except that, where such entity holding at least a five percent ownership interest in an ATC permit applicant or permit holder:
i. Is a nonprofit entity, any person or entity that is an officer of that nonprofit entity in accordance with the articles of incorporation, or the bylaws, or is a member of the governing board of such entity;
ii. Is a qualified institutional investor, any person or entity that holds at least a 30 percent aggregate ownership interest in or is a member of the executive team of such entity; or
iii. Is a trust, any trustee of such entity; or
3. A significantly involved person of a cannabis business license applicant or license holder, as that term is defined pursuant to N.J.S.A. 24:6I-3.

"Paraphernalia" has the meaning given at N.J.S.A. 2C:36-1.

"Passive investor" means a person or entity that:

1. Holds an aggregate ownership interest that is greater than zero percent but less than five percent in an ATC permit applicant or permit holder; and
2. Does not have control or decision-making authority over the management, operations, or policies of such permit applicant's or permit holder's ATC.

"Permit" means the document issued by the Department pursuant to this chapter granting the legal right to operate as an alternative treatment center for a specified time.

"Permit applicant" means a person or entity that is applying for, or has a pending application for, an alternative treatment center permit.

"Permit holder" or "permittee" means a person or entity registered to do business in New Jersey that holds an alternative treatment center permit.

"Permitting authority" means the Commission, whose mailing address is PO Box 216, Trenton, NJ 08625-0216.

"Petition" means a written request made by an individual submitted pursuant to this chapter to approve other medical conditions or the treatment thereof as a debilitating medical condition.

"Physician" means a person licensed to practice medicine and surgery pursuant to Title 45 of the Revised Statutes with whom the patient has a bona fide physician-patient relationship and who is the primary care physician, hospice physician or physician responsible for the ongoing treatment of a patient's debilitating medical condition; provided, however, that such ongoing treatment shall not be limited to the provision of authorization for a patient to use medicinal marijuana or consultation solely for that purpose.

"Primary caregiver" or "caregiver" means a resident of the State who:

1. Is at least 18 years old;
2. Has agreed to assist with a registered qualifying patient's medical use of marijuana, is not currently serving as primary caregiver for another qualifying patient, and is not the qualifying patient's physician;
3. Has never been convicted of possession or sale of a controlled dangerous substance, unless such conviction occurred after October 1, 2010, the effective date of the Act, N.J.S.A. 24:6I-1et seq., and was for a violation of Federal law related to possession or sale of marijuana that is authorized under the Act;
4. Has registered with the Department pursuant to N.J.A.C. 17:30A-2.3 and has satisfied the criminal history record background check requirement of N.J.A.C. 17:30A-2.3(e); and
5. Has been designated as one of the primary caregivers on the qualifying patient's application or renewal for a registry identification card or in other written notification to the Department.

"Proof of New Jersey residency" means one or more of the following:

1. A New Jersey driver's license that is in effect and good standing;
2. A Federal, State, or local government-issued identification card that shows the applicant's name and New Jersey address;
3. A utility bill issued within the 90 days preceding the application date that shows the applicant's name and New Jersey address;
4. Correspondence from the Internal Revenue Service or the New Jersey Division of Taxation issued within the year preceding the application date that shows the applicant's name and New Jersey address;
5. A non-driver identification card issued by the New Jersey Motor Vehicle Commission that is in effect and good standing;
6. Federal, State, or local government correspondence issued to the applicant within the 90 days preceding the application date that shows the applicant's name and New Jersey address; or
7. Bank statements issued within each of the three months preceding the application date that show the applicant's name and New Jersey address.

"Qualifying patient" or "patient" means a resident of the State who has been provided with a certification by a physician pursuant to a bona fide physician-patient relationship.

"Reduced-fee eligible" means a person is:

1. A senior citizen or a military veteran; or
2. A beneficiary or recipient of:
i. New Jersey Medicaid;
ii. NJ FamilyCare;
iii. Supplemental Nutrition Assistance Program (SNAP);
iv. New Jersey Temporary Disability Insurance (TDI);
v. Supplemental Security Income (SSI); or
vi. Social Security Disability (SSD).

"Region" means either the northern region, central region, or southern region.

"Registry identification card" means a document issued by the Commission that identifies a person as a registered qualifying patient or primary caregiver.

"Review panel" means a panel of health care professionals appointed by the Commission to review petitions and make recommendations about the medicinal use of marijuana.

"Security alarm system" means any device or series of devices, including, but not limited to, a signal system interconnected with a radio frequency method, such as cellular, private radio signals or other mechanical or electronic device, used to detect an unauthorized intrusion.

"Seedling" means a cannabis plant that has no flowers and that is less than 12 inches in height and less than 12 inches in diameter.

"Senior citizen" means a person age 65 and older.

"Southern region" means the counties of Atlantic, Burlington, Camden, Cape May, Cumberland, Gloucester, and Salem.

"THC" means delta-9-tetrahydrocannabinol.

"Topical formulation" means a transcutaneous therapeutic marijuana extract formulation comprising of water, short carbon chains, alcohol, dimethysulfoxide, polyethylene glycol, polypropylene glycol, glycerin, mineral, and mixtures thereof.

"Unusable marijuana" means marijuana seedlings, seeds, stems, stalks, or roots.

"Usable marijuana" means the dried leaves and flowers of the female marijuana plant, and any mixture or preparation thereof, and does not include the seedlings, seeds, stems, stalks, or roots of the plant.

"Utility bill" means a bill for one or more of the following services: gas, electric, water, sewer, cellular or landline telephone, internet, or cable or satellite television.

"Vertical integration" means the co-location or combination of two or more of the following activities related to the production of usable marijuana for qualifying patients in one location: cultivation, manufacturing, and dispensing.

N.J. Admin. Code § 17:30A-1.2

Amended by R.2019 d.049, effective 5/20/2019.
See: 50 N.J.R. 1398(a), 51 N.J.R. 732(a).
Rewrote the section.
Amended by 56 N.J.R. 1728(b), effective 8/19/2024