N.J. Admin. Code § 17:30A-7A.2

Current through Register Vol. 56, No. 23, December 2, 2024

Section 17:30A-7A.2 - Clinical registrant conduct; prohibitions; reporting; revocation

(a) A clinical registrant issued a permit pursuant to this chapter shall be authorized to engage in the cultivation, manufacturing, and dispensing of medical or personal use cannabis as is authorized for a non-clinical ATC holding a medical cannabis cultivator, medical cannabis manufacturer, or medical cannabis dispensary permit or an expanded ATC holding a cannabis cultivator, cannabis manufacturer, or cannabis dispensary license pursuant to the Act, this chapter, and N.J.A.C. 17:30, including dispensing medical cannabis or cannabis items to consumers 21 years of age or older, registered patients, and primary caregivers.

1. A clinical registrant may buy, sell, and transfer medical cannabis * or cannabis* items to and from another ATC or other New Jersey cannabis business that possesses a valid permit or license.

2. A clinical registrant may dispense usable cannabis, medical cannabis products, and cannabis products to a patient or caregiver with a registry identification card or a consumer 21 years of age or older, regardless of whether the individual is a participant in a research study.

(b) The clinical registrant shall additionally be authorized to engage in clinical research involving medical cannabis with the participation of registered patients who consent to being part of such research, subject to any restrictions established by the Commission.

1. A clinical registrant may dispense usable medical cannabis and medical cannabis products, in any form authorized by an institutional review board (IRB), directly to an academic medical center as part of a research study. An academic medical center that handles medical cannabis items shall do so in a manner consistent with the academic medical center's standards used for the handling, storage, and disposal of other patient medications.

i. Where an academic medical center is located outside of New Jersey, such dispensing shall be received by the academic medical center's partner state college or university and all cannabis items and medical cannabis items shall remain in New Jersey.

2. A clinical registrant applicant shall provide written documentation of an existing research contract with an academic medical center, which shall include a commitment by the academic medical center, or its affiliate, to engage in or oversee clinical research related to the use or adverse effects of cannabis in order to advise the clinical registrant concerning patient health and safety; medical applications; dispensing and management of controlled substances; and ways to mitigate adverse health or societal effects of adult, personal-use legalization, among other areas.

3. A clinical registrant shall have a written contractual relationship with no more than one academic medical center.

4. A research contract shall contain the responsibilities and duties of each party with respect to the research study.

5. A research contract shall include a description of the research study the clinical registrant and the academic medical center intend to conduct.

i. Research study topics may include, but are not limited to, the therapeutic or palliative efficacy of medical cannabis on the qualifying medical conditions established pursuant to the Act or on any other medical or psychological condition.

ii. The description of the research study shall include the research protocol, and a written procedure for conducting the research program, which shall include the following information:

(1) Each investigator's name, address, institutional affiliation, and qualifications, including a curriculum vitae and list of publications, if any;

(2) The title of the research study;

(3) The research study statement of the purpose;

(4) The types and amounts of medical cannabis items and the dosage and method of administration used in the research study;

(5) The duration of the research study; and

(6) The locations of the clinical registrant dispensaries that will be participating in the research study.

(c) A clinical registrant shall demonstrate to the Commission that an IRB has taken the following actions to review the research study and that the clinical registrant has met the requirements of this subsection:

1. An IRB shall review and approve each proposed research study in accordance with its established practices and procedures.

i. An IRB shall review the anticipated scope and research protocol of the proposed research study involving human subjects pursuant to the criteria at 45 CFR 46.111 (relating to criteria for IRB approval of research) and 21 CFR 56.111 (relating to criteria for IRB approval of research); and

2. Both an IRB and the clinical registrant shall ensure that the clinical registrant's research study addresses all of the following:

i. Protecting the rights and welfare of patients involved in research studies conducted pursuant to this section.

ii. Minimizing the risk of adverse outcomes for patients by using procedures that are consistent with sound research design and that do not expose patients to undue risk as a result of participating in the research study.

iii. Determining that the risks to patients involved in research programs are reasonable in relation to the anticipated benefits (if any) to the patients, and the importance of the knowledge that may be expected to result from the research program.

iv. Guaranteeing that informed consent will be obtained from each prospective participant or the participant's legally authorized representative and is properly documented.

v. Protecting the privacy of every patient and maintaining the confidentiality of patient data.

(d) An academic medical center may not solicit or accept anything of value from an approved clinical registrant or its owner, passive investor, principal, MSC, financial source, or employee of an approved clinical registrant except for reasonable remuneration, specifically in a research contract for the services to be performed or costs to be incurred by the academic medical center.

(e) No permit holder issued a non-clinical medical cannabis cultivator, medical cannabis manufacturer, or medical cannabis dispensary permit may concurrently hold a clinical registrant permit, and no permit holder issued a clinical registrant permit may concurrently hold a non-clinical medical cannabis cultivator, medical cannabis manufacturer, or medical cannabis dispensary permit.

(f) No clinical registrant shall contract with an academic medical center that is part of a health care system that includes another academic medical center that has contracted with another clinical registrant permit applicant or permit holder.

(g) A clinical registrant shall have a written contractual relationship with no more than one academic medical center. An academic medical center may enter into a letter of intent with more than one clinical registrant ATC permit applicant but may only execute a research contract with one clinical registrant permit holder.

(h) A clinical registrant may not operate or be located on land that is valued, assessed, or taxed as an agricultural or horticultural use pursuant to the Farmland Assessment Act of 1964, P.L. 1964, c. 48 (N.J.S.A. 54:4-23.1 et seq.).

(i) Each clinical registrant shall submit a written report of the results and findings of its clinical research study to the Commission no later than one year following the conclusion of the research study or no later than 30 days following the acceptance of the research study * to be published* in a peer-reviewed medical journal, whichever is first.

1. The Commission may post such results and findings on its publicly accessible website and share them with other clinical registrant permit holders, academic medical centers, or any other person it determines would benefit from the findings.

2. Nothing in this subsection shall be deemed to require the disclosure of any clinical research that would infringe on the intellectual property of the clinical registrant or on the confidentiality of patient information.

(j) The Commission may suspend or revoke the permit of a clinical registrant where:

1. The academic medical center no longer meets the requirements to be an academic medical center pursuant to this chapter; or

2. The research contract between the clinical registrant and the academic medical center expires without being renewed or is terminated by either party.

(k) The Commission shall not revoke the permit on the grounds at (j) above, if, in the 90 days following receipt of the Commission's written notice of its intent to revoke the permit, the clinical registrant provides the Commission with documentation that:

1. It has established a contractual relationship with a qualifying academic medical center that is not already a party to a research contract with another clinical registrant permit holder; or

2. The clinical registrant's existing partner academic medical center meets the requirements to be an academic medical center established in this subchapter.

(l) If a permit is suspended or revoked, the Commission shall provide notice of the suspension or revocation to the applicant, in writing, which shall include:

1. The specific reason for the suspension or revocation; and

2. The opportunity to request an administrative hearing within 45 days after the date of the suspension or revocation.

(m) An administrative hearing pursuant to this section shall take place in the Office of Administrative Law in accordance with the Administrative Procedures Act, N.J.S.A. 52:14B-1 et seq., and 52:14F-1 et seq., and the Uniform Administrative Procedure Rules, N.J.A.C. 1:1.

(n) The final decision of a suspension or revocation after an administrative hearing shall be considered a final agency decision, subject to judicial review by, and of which jurisdiction and venue for such review are vested in, the Appellate Division of the Superior Court.

N.J. Admin. Code § 17:30A-7A.2

Adopted by 56 N.J.R. 1728(b), effective 8/19/2024