2018 NJSBA Annual Meeting
Cannabis In New Jersey - Laws, Legislation, Legal Practice And Economics
Moderator/Speaker: Daniel T. McKillop, Esq. Scarinci Hollenbeck, LLC, Lyndhurst
Speakers: Assemblyman Raj Mukherji (33rd District), Majority Whip Mukherji Wolf, LLC, Jersey City Aaron Epstein, Esq., Executive Vice President Compassionate Care Research Institute d/b/a Garden State Dispensary, Woodbridge Paul P. Josephson, Esq. Duane Morris LLP, Cherry Hill Hugh O'Beirne President, NJ Cannabis Industry Association Amol Sinha Executive Director American Civil Liberties Union of New Jersey
MARIJUANA REFORM IN NEW JERSEY GET THE FACTS
Marijuana prohibition in New Jersey has failed. It’s time for common sense. Legalizing, taxing, and regulating marijuana for adults will put an end to the tremendous harms caused by our current laws, create jobs, increase public safety, and generate millions of dollars in revenue to fund projects that help all New Jerseyans.
From 2000-2010, police arrested New Jerseyans New Jersey police make more than nearly 210,000 times for an offense that Someone is arrested for 21,000 ARRESTS PER YEAR THE LAST 22 YEARS OF U.S. PRESIDENTS marijuana possession in New Jersey for marijuana possession. have admitted to doing. EVERY 22 MINUTES.
BLACK NEW JERSEYANS ARE NEARLY OVER THE PAST DECADE, NEW JERSEY 3X MORE LIKELY TO BE ARRESTED WASTED MORE THAN $1 BILLION for marijuana possession than whites, on police, courts, and jails enforcing despite similar usage rates. marijuana possession laws.
New Jersey’s Taxing and regulating marijuana will MEDICAL MARIJUANA SYSTEM FAILS GENERATE MORE THAN $100 MILLION to provide patients with the medicine they need. per year for New Jersey.
www.NJMarijuanaReform.org fb.me/NJU4MR @NJU4MR MARIJUANA ARRESTS HAVE SERIOUS CONSEQUENCES
An arrest for a single marijuana cigarette in New Jersey can create devastating consequences for someone’s life. With over 200,000 marijuana possession arrests in the past decade, our marijuana laws have done serious damage to our family members, neighbors, and friends. Consequences for one adult marijuana possession arrest could include:
UP TO 6 MONTHS IN JAIL LOSS OF EMPLOYMENT
DRIVER’S LICENSE SUSPENSION CRIMINAL RECORD FOR AT ARREST WARRANT FOR FAILURE FOR UP TO 2 YEARS LEAST 5 YEARS TO PAY FINES
UP TO $1,255 IN FEES AND FINES LOSS OF IMMIGRATION STATUS LOSS OF STUDENT FINANCIAL AID
3-YEAR BAN FROM PUBLIC HOUSING 5-YEAR BAN FROM ADOPTION
www.NJMarijuanaReform.org fb.me/NJU4MR @NJU4MR
RULE ADOPTIONS
VOLUME 43, ISSUE 23
ISSUE DATE:DECEMBER 5, 2011
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
BOARD OF MEDICAL EXAMINERS
Adopted New Rules: N.J.A.C. 13:35-7A
Compassionate Use Medical Marijuana
Proposed: November 15, 2010 at 42 N.J.R. 2728(a).
Adopted: October 12, 2011 by Paul Jordan, M.D., President, Board of Medical Examiners.
Filed: November 7, 2011 as R.2011 d.292, with substantial changes not requiring additional public notice and comment (see N.J.A.C. 1:30-6.3).
Authority: N.J.S.A. 24:6I-1 et seq. (P.L. 2009, c. 307).
Effective Date: December 5, 2011.
Expiration Date: May 3, 2018.
Summary of Public Comments and Agency Responses:
The Board of Medical Examiners (Board) received comments on the notice of proposal from the following:
1. Justin Escher Alpert;
2. Carolyn Torre, R.N., M.A., A.P.N., Director, Regulatory Affairs, New Jersey State Nurses Association; and
[page=3192] 3. Ken Wolski, R.M., M.P.A., Executive Director, Coalition for Medical Marijuana - New Jersey, Inc.
1. COMMENT: Ms. Torre, on behalf of the New Jersey State Nurses Association, and Mr. Alpert, expressed concerns regarding various aspects of proposed new rules N.J.A.C. 8:64, promulgated by the Department of Health and Senior Services to implement the Compassionate Use Medical Marijuana Act.
RESPONSE: The commenters' concerns are more appropriately directed to the Department of Health and Senior Services as they relate to the Department's proposed new rules N.J.A.C. 8:64. The Board notes that the commenters did not raise any objections to the Board's proposed new rules N.J.A.C. 13:35-7A.5.
2. COMMENT: Mr. Wolski, on behalf of the Coalition for Medical Marijuana - New Jersey, Inc., urged the Board to declare that the Compassionate Use Medical Marijuana Act effectively rescheduled marijuana in New Jersey; noting that passage of the Act is inconsistent with marijuana's continued inclusion in New Jersey's list of Schedule I drugs. In addition, the commenter objected to the requirement in proposed new rule N.J.A.C. 13:35-7A.3 that physicians possess an active controlled dangerous substances (CDS) registration in order to authorize the medical use of marijuana, noting that a CDS registration is irrelevant for participating in the distribution of a Schedule I drug. The commenter believes this requirement to be a "meaningless bureaucratic addition" to an overly restrictive set of regulations.
RESPONSE: In enacting the Compassionate Use Medical Marijuana Act, the New Jersey Legislature did not reschedule marijuana. In creating this limited exception for marijuana's lawful use in New Jersey, the Legislature did so, mindful of the drug's current status under the New Jersey Controlled Dangerous Substances Act. See N.J.S.A. 24:6I-2 (noting that marijuana shall have the same meaning under the Compassionate Use Medical Marijuana Act as under the New Jersey Controlled Dangerous Substances Act). Therefore, the Board believes that requiring physicians to possess an active CDS registration in order to participate in the distribution of marijuana for medical purposes, is reasonable and consistent with the classification of marijuana as a Schedule I medication under the New Jersey Controlled Dangerous Substances Act, N.J.S.A. 24:21-2. The Board, therefore, declines to amend N.J.A.C. 13:35-7A.3 to eliminate this requirement.
Summary of Agency-Initiated Changes:
Following the publication of the notice of proposal, the New Jersey Senate introduced a concurrent resolution (SCR 140), seeking, in part, to declare proposed new rule N.J.A.C. 13:35- 7A.5(c)3 inconsistent with the Compassionate Use Medical Marijuana Act. According to the concurrent resolution, the new rule would require physicians to "periodically attempt to stop a sick or dying patient's medical use of marijuana, decrease the quantity authorized, or try other drugs or treatment modalities" in contravention of the Act. In addition, following publication of the notice of proposal, numerous news media articles, referring to the Board's proposed new rules, reported that the rules would require physicians to "wean" dying patients off medical marijuana.
The Board believes that N.J.A.C. 13:35-7A.5(c), as proposed, does not require a physician to stop a patient's medical use of marijuana. Rather, the requirements set forth in N.J.A.C. 13:35- 7A.5(c) and (d), are intended to establish minimum standards of practice that a physician must adhere to as part of his or her ongoing obligations for treatment of the patient's underlying debilitating medical condition, and the assessment of the patient's response to the use of medical marijuana in connection with such treatment. The Board did not intend that a patient who is achieving desired treatment benefits associated with medical marijuana, and who is not experiencing any untoward or significant, negative side effects as a result of marijuana use, should have his or her medical marijuana treatment interrupted. The Board believes that this intent is clearly reflected in N.J.A.C. 13:35-7A.3(c)3 of the rule as originally proposed. The rule provides that a physician must make reasonable efforts to stop the medical use of marijuana, decrease the quantity authorized or try other drugs or treatment modalities "unless clinically contraindicated."
The Board, however, believes that additional clarification to N.J.A.C. 13:35-7A.3(c) and (d) is necessary in order to eliminate confusion that may exist among authorizing physicians, the patients who may choose to avail themselves of medical marijuana in the future, and members of the general public, about a patient's continued use of medical marijuana when treatment objectives are being met and the patient is not experiencing any untoward side effects.
As changed upon adoption, N.J.A.C. 13:35-7A.3(c) continues to require a physician to assess the patient's condition, at a minimum, once every three months, including the patient's progress toward treatment objectives. Subsection (c) continues to require a physician to assess the patient for physical or psychological problems associated with marijuana use. The changed language, however, expressly requires the physician's assessment to include whether the patient is achieving the therapeutic results intended and whether the patient has developed significant untoward side effects. As changed, the rule provides that if the physician determines that the patient is achieving treatment objectives, and is not experiencing untoward side effects or physical or psychological problems associated with marijuana use, the physician may continue the patient's treatment with medical marijuana without alteration. The Board has changed subsection (d) on adoption to clarify that if the patient is experiencing untoward side effects or physical or psychological problems associated with marijuana use, the physician must modify the patient's medical marijuana dosage or mode of delivery, undertake a trial of other drugs or treatment modalities, or discontinue the use of medical marijuana. Subsection (d) continues to require a physician to consider referring the patient for independent evaluation or treatment when treatment objectives are not being met.
The Division is also correcting the cross-references in N.J.A.C. 13:35-7A.6, which incorrectly referred to the Division's rules at N.J.A.C. 13:45A-32 rather than N.J.A.C. 13:45A-33, which are the Compassionate Use Medical Marijuana rules of the Division.
Federal Standards Statement
A Federal standards analysis is not required because the adopted new rules are being implemented pursuant to the New Jersey Compassionate Use Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq. Under existing Federal law, the manufacture, possession, sale or distribution of marijuana is prohibited. See 21 U.S.C. §§ 841 et seq. States, however, are not required to enforce Federal law. In enacting the New Jersey Compassionate Use Medical Marijuana Act, the New Jersey Legislature found that compliance with the Act does not put the State of New Jersey in violation of Federal law. See N.J.S.A. 24:6I-2.
Full text of the adoption follows (additions to proposal indicated in boldface with asterisks *thus*; deletions from proposal indicated in brackets with asterisks *[thus]*):
SUBCHAPTER 7A. COMPASSIONATE USE MEDICAL MARIJUANA
13:35-7A.1 Purpose and scope
(a) The rules in this subchapter implement certain provisions of the New Jersey Compassionate Use Medical Marijuana Act, P.L. 2009, c. 307.
(b) The rules in this subchapter shall apply to physicians who provide certifications and written instructions for patients seeking marijuana for medical use pursuant to rules adopted by the Board and by the Department of Health and Senior Services.
13:35-7A.2 Definitions
The following words and terms when used in this subchapter shall have the following meanings, unless the context indicates otherwise.
"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 N.J.A.C. 13:35-7A.5. For purposes of this definition, "ongoing responsibility" means:
1. The physician-patient relationship has existed for at least one year;
2. The physician has seen and/or assessed the patient for the debilitating medical condition on at least four visits; or
3. The physician assumes responsibility for providing management and care of the patient's debilitating medical condition after conducting a comprehensive medical history and physical examination, including a personal review of the patient's medical record maintained by other treating physicians reflecting the patient's reaction and response to conventional medical therapies.
[page=3193]"Certification" means a statement signed by a physician with whom a patient has a bona fide physician-patient relationship, which attests to the physician's authorization for the patient to be registered to use marijuana.
"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 its treatment: 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. Terminal illness, if the physician has determined a prognosis of less than 12 months of life; or
5. Any other medical condition or its treatment that is approved by the Department of Health and Senior Services by rule.
"Medical use of marijuana" means the acquisition, possession, transport or use of marijuana or paraphernalia by a qualified patient registered with the Department of Health and Senior Services under P.L. 2009, c. 307.
13:35-7A.3 Requirement for physician participation
(a) A physician shall provide a certification and written instructions for a patient for the medical use of marijuana only if:
1. The physician holds an active New Jersey license in good standing issued by the Board and possesses an active controlled dangerous substances registration issued by the Division of Consumer Affairs that is not subject to limitation; and
2. The physician has a bona fide physician-patient relationship with the patient.
13:35-7A.4 Certification requirements
(a) Prior to issuing a certification for the medical use of marijuana, the physician shall have conducted a comprehensive medical history and physical examination of the patient to determine whether the patient suffers from a debilitating medical condition that qualifies the patient to receive marijuana pursuant to N.J.S.A. 24:6I-3.
(b) The certification shall be signed and dated by the physician and shall attest to the physician's authorization for the patient to be registered with the Department of Health and Senior Services for the medical use of marijuana. If authorized by the Department of Health and Senior Services, the certification shall be electronically transmitted to the Department of Health and Senior Services. The certification shall include the following information:
1. Physician name, address and telephone number;
2. Physician license number and CDS registration number;
3. Patient name, address, telephone number and date of birth;
4. If applicable, caregiver name, address, telephone number and date of birth;
5. Diagnosis of debilitating medical condition; and
6. Any other information required by the Department of Health and Senior Services by rule.
(c) Prior to issuing a certification for the medical use of marijuana for a minor patient, a physician shall:
1. Obtain written confirmation from a physician trained in the care of pediatric patients and from a psychiatrist, establishing that, in their respective professional opinions, following review of the minor patient's medical record or examination of the minor patient, the minor patient is likely to receive therapeutic or palliative benefits from the medical use of marijuana to treat or alleviate symptoms associated with his or her debilitating medical condition. If the certifying physician is trained in the care of pediatric patients, he or she shall only be required to obtain written confirmation from a psychiatrist; and
2. Explain the potential risks and benefits of the medical use of marijuana to the minor patient and to a parent, guardian or person having legal custody of the minor patient. Such explanation shall be documented in the minor patient's medical record.
13:35-7A.5 Written instruction requirements; reassessment; records
(a) A physician may provide written instructions for the medical use of marijuana for a qualified patient registered with the Department of Health and Senior Services, provided the requirements in this section are satisfied. If authorized by the Department of Health and Senior Services, the physician may provide the written instruction by electronic or other means directly to an alternative treatment center on behalf of a registered qualifying patient.
(b) The physician's written instructions shall include the following information:
1. Physician name, address and telephone number;
2. Physician license number and CDS registration number;
3. Patient name, address, telephone number, date of birth and registry identification number;
4. If applicable, caregiver name, address, telephone number, date of birth and registry identification number;
5. Name of the permitted alternative treatment center;
6. Quantity of marijuana to be dispensed; and
7. Any other information required by the Department of Health and Senior Services by rule.
*[(c) A physician authorizing the medical use of marijuana shall:
1. Review, at a minimum of every three months, the course of treatment, any new information about the patient's debilitating medical condition and the patient's progress toward treatment objectives;
2. Remain alert to problems associated with physical and psychological dependence; and
3. Periodically make reasonable efforts, unless clinically contraindicated, to stop the medical use of marijuana, decrease the quantity authorized or try other drugs or treatment modalities in an effort to reduce the potential for abuse or the development of physical or psychological dependence.]*
*(c) A physician authorizing the medical use of marijuana shall review, at a minimum of every three months, the course of treatment for the patient's debilitating medical condition, and the patient's progress toward treatment objectives as a result of the use of medical marijuana, including whether the patient is achieving the therapeutic results intended, has developed significant untoward side effects, or is experiencing any physical or psychological problems associated with marijuana use. If the physician determines that the patient is achieving treatment objectives, and is not experiencing untoward side effects or physical or psychological problems associated with marijuana use, the physician may continue the patient's treatment with medical marijuana without alteration.*
*[(d) If treatment objectives are not being met, the physician shall:
1. Assess the appropriateness of continued treatment with marijuana or undertake a trial of other drugs or treatment modalities; and]*
*(d) If treatment objectives for the patient's debilitating medical condition are not being met as a result of the use of medical marijuana, or the patient is experiencing untoward side effects or physical or psychological problems associated with marijuana use, the physician shall:
1. Modify the dosage of medical marijuana or mode of delivery authorized, provided the authorized amount does not exceed two ounces in a 30-day period consistent with (g) below, undertake a trial of other drugs or treatment modalities, or discontinue the use of medical marijuana; and*
2. Consider referring the patient for independent evaluation or treatment in order to achieve treatment objectives.
(e) The physician shall remain alert to the possibility that marijuana may be misused or diverted. A physician issuing written instructions for a patient with a history of substance abuse shall exercise extra care by way of monitoring, documentation and possible consultation with addiction medicine specialists, and should consider the use of an agreement between the physician and the patient concerning the medical use of marijuana and consequences for misuse.
(f) The physician shall keep accurate and complete records that include:
1. The medical history and physical examination of the patient;
2. The diagnosis of the debilitating medical condition, including the patient's symptoms and their severity and the patient's reaction and [page=3194] response to conventional medical therapies, which qualify the patient for the medical use of marijuana;
3. Other evaluations and consultations;
4. Treatment plan objectives;
5. Evidence of informed consent. In obtaining informed consent, the physician shall advise the patient about the lack of scientific consensus for the medical use of marijuana, its sedative properties and the risks for addiction;
6. Treatments and other drugs prescribed or provided;
7. Any agreements with the patient; and
8. Periodic reviews conducted.
(g) A physician shall not issue written instructions authorizing a patient to receive more than two ounces of marijuana in a 30-day period.
(h) A physician may issue multiple written instructions at one time authorizing the patient to receive a total of up to a 90-day supply of marijuana, provided that the following conditions are met:
1. Each separate set of instructions is issued for the treatment of the patient's documented debilitating medical condition;
2. Each separate set of instructions indicates the earliest date on which the alternative treatment center may dispense the marijuana, except for the first dispensation if it is to be filled immediately; and
3. The physician has determined that providing the patient with multiple instructions in this manner does not create an undue risk of diversion or abuse.
(i) The physician shall keep a copy of the patient's, or if applicable, the caregiver's registry identification card, in the patient's medical record.
(j) If the physician determines that the patient's underlying debilitating medical condition no longer exists or that the patient's continued use of marijuana is no longer appropriate, the physician shall notify the Department of Health and Senior Services of his or her findings.
13:35-7A.6 Duty to report information to the Division
(a) A physician shall comply with all requests for information from the Division of Consumer Affairs concerning the issuance of certifications and written instructions for the medical use of marijuana as provided in N.J.A.C. 13:45A-*[32]**33*.
(b) Failure on the part of a physician to comply with the requirements of N.J.A.C. 13:45A- *[32]**33* may subject the physician to disciplinary action pursuant to N.J.S.A. 45:1-21 et seq. HEALTH AND SENIOR SERVICES
PUBLIC HEALTH SERVICES BRANCH
ENVIRONMENTAL AND OCCUPATIONAL HEALTH SERVICES DIVISION
MEDICINAL MARIJUANA PROGRAM
Medicinal Marijuana Program Rules
Adopted New Rules: N.J.A.C. 8:64
Proposed: February 22, 2011 at 43 N.J.R. 340(a).
Adopted: November 23, 2011 by Mary E. O’Dowd, MPH, Commissioner, Department of Health and Senior Services.
Filed: November 23, 2011 as R.2011 d.314, without change.
Authority: N.J.S.A. 24:6I-1 et seq., particularly 24:6I-7 and 16.
Effective Date: December 19, 2011.
Expiration Date: December 19, 2018.
Summary of Hearing Officer’s Recommendations and Agency’s Response:
Samuel T. Stewart, Regulatory Officer in the Department’s Office of Legal and Regulatory Compliance, served as the hearing officer at the March 7, 2011 public hearing held at the War Memorial Building, 1 Memorial Drive, Trenton, New Jersey. Terry Clancy, Ph.D., Executive Assistant in the Department’s Public Health Services Branch, served as a panelist with the hearing officer. The comment period for the notice of proposal closed on April 23, 2011. Thirty- one commenters presented comments at the public hearing. The hearing officer took no position on the rulemaking except to recommend that the agency review and respond to the comments in the context of reviewing and responding to the written comments submitted on the original notice of proposal dated November 15, 2010 at 42 N.J.R. 2668(a) and the notice of reproposal dated February 22, 2011 at 43 N.J.R. 340(a). The Department has accepted the hearing officer’s recommendation. A record of the public hearing is available for inspection in accordance with applicable law by contacting:
Department of Health and Senior Services
Office of Legal and Regulatory Compliance
John Fitch Plaza P.O. Box 360
Trenton, New Jersey 08625-0360
Summary of Public Comments and Agency Responses:
The Department received public comments on the original notice of proposal dated November 15, 2010, the notice of reproposal dated February 22, 2011, and at the public hearing on March 7, 2011. Accordingly, the comments and responses have been arranged in two sections. The first part provides a summary of the public comments and agency responses bearing on the notice of proposal dated November 15, 2010. The second part provides a summary of the public comments and agency responses bearing on the notice of reproposal dated February 22, 2011. Persons commenting at the public hearing testified exclusively with regard to the notice of reproposal dated February 22, 2011. Therefore, the Department identifies those commenters and responds to their comments in the second part of the summary of public comments and agency responses. The Department identifies twice those persons commenting on matters relevant to both parts.
Part One
1. Irvina Booker, Englewood, NJ
2. Association of Safe Access Providers (ASAP), Montclair, NJ by Marianne Bays, Ph.d
3. Marjaree Mayne, Pittstown, NJ
4. Coalition for Medical Marijuana - New Jersey, Inc., Trenton, NJ by Ken Wolski, RN MPA, Executive Director
5. New Jersey State Nurses Association, Trenton, NJ by Carolyn Torre, RN, MA, APN, Director, Regulatory Affairs
6. Charles Kwiatkowski (address not listed)
7. Bonnie L. Johnson, Absecon, NJ
8. Trish Buker, Riverside, NJ
9. New Jersey Hospice and Palliative Care Organization, Scotch Plains, NJ by Nora Giurici, BSN, CHPCA, Board of Trustees
10. Robert J. Schenk Jr., RPh, CCP, Colts Neck, NJ
11. Elaine Terranova, Little Egg Harbor, NJ
12. Elise Karen Segal, Winonah, NJ 13. Jim Mazzeo, Nutley, NJ
14. Barbara Rakoczy, Swedesboro, NJ
15. Robert James Kane, Bound Brook, NJ
16. American Civil liberties Union of New Jersey, Newark, NJ by Ed Barocas, Legal Director
17. National Organization for the Reform of Marijuana Laws – New Jersey, Brick, NJ by Anne M. Davis, Esq, Executive Director
18. Global Advisors Smokefree Policy, Summit, NJ by Karen Blumenfeld, Esq., Executive Director
19. Roger Tower, Lawrenceville, NJ
20. Edward Grimes, East Hanover, NJ
21. Edward R. Hannaman, Esq, Ewing, NJ
22. Drug Policy Alliance, Trenton, NJ by Roseanne Scotti
23. TA Davis, (address not listed)
24. Dennis J. Petro MD, Catasauqua, PA
25. Don & Gerry McGrath, Robbinsville, NJ
26. Anthony Kimmick, Toms River, NJ
27. Samuel A. Tait, Jr., Audubon, NJ
28. Marta Portuguez, Roselle Park, NJ
29. Medical Society of New Jersey, Lawrenceville, NJ by Lawrence Downs, Esq, General Counsel
30. New Jersey League for Nursing, Garwood, NJ by Eileen P. Williamson, RN, MSN, President
31. Louis Santiago, Freehold, NJ
32. New Jersey Hospice and Palliative Care Organization, Scotch Plains, NJ by Donald Pendley, M.A., CAE, APR, President
33. Justin Escher Alpert, Esq., Livingston, NJ 34. National Organization for the Reform of Marijuana Laws – Washington, DC by Paul Armentano, Deputy Director
35. Diane Riportella, Egg Harbor, NJ
36. Jeffrey S. Pollack, M.D., Mays Landing, NJ
37. Christiane Oliveri, Clifton, NJ
38. Michael Oliveri, Clifton, NJ
39. Lisa (Oliveri) Serafino, Clifton, NJ
The numbers in parenthesis after each comment below identify the respective commenters listed above.
General Comments
1. COMMENT: A number of commenters state that N.J.A.C. 8:64-10.6(c)5 and 10.7(c), which limit the percentage of delta-9-tetrahydrocannabinol (THC) in medicinal marijuana to no more than 10 percent, are inappropriate and overly restrictive rules. The commenters generally point out that other states do not limit THC content in their medicinal marijuana and that such provides patients with greater medicinal options for relief from pain and suffering. The commenters generally state that medicinal marijuana with a maximum of 10 percent THC will be less effective than marijuana with a higher THC content and that this will require higher dosages to achieve a palliative effect and may discourage some patients from participating in the Medicinal Marijuana Program (MMP) because they can obtain higher potency marijuana on the black market. (1, 2, 5, 6, 7, 9, 12, 16, 17, 21, 22, 24, 25, 28, 30, 32, 33, 35, 36, 37, and 38)
RESPONSE: By limiting medicinal marijuana to a maximum of 10 percent THC and mandating the sale of three strains of medicinal marijuana in a low, medium, and high potency, the Department is able to ensure that doctors and their patients have a reliable and standardized choice of potency options from which to choose. Relevant United States research studies, such as the study concluded in 2010 by the Medicinal Cannabis Research Center at the University of California San Diego, used medicinal marijuana that was no more than 10 percent THC, which was grown by the University of Mississippi. The Medicinal Cannabis Research Center study, conducted over a period of 10 years, demonstrated that medicinal marijuana from the University of Mississippi had a significant clinical effect. In October 2011, the Dutch Government announced that it would outlaw the sale of cannabis in coffee shops with a THC content greater than 15 percent, citing that marijuana with a greater THC concentration should be categorized with hard drugs such as cocaine and heroin. The 10 percent limit on THC content at the inception of the MMP will provide patients with effective medicine to start and allow the Department to collect data from patients and to evaluate whether the 10 percent limit on THC content should be revisited in future rulemaking. 2. COMMENT: A number of commenters state that N.J.A.C. 8:64-10.7(a), which limits the number of strains of medicinal marijuana that an Alternative Treatment Center (ATC) may cultivate to three, is an unreasonable limitation on each patient’s choice of medicine. The commenters generally state that patients should be free to try many strains of medicinal marijuana as certain strains relieve conditions such as nausea, while other strains relieve conditions such as spasticity, and still other strains relieve pain. (1, 5, 6, 7, 9, 12, 16, 17, 21, 22, 24, 25, 28, 30, 32, 33, 34, 36, 37, and 38)
RESPONSE: By mandating the sale of three strains of medicinal marijuana of a low, medium, and high dose, the Department is able to ensure patients have a reliable and standardized choice of potency options to choose from. Generally, marijuana is classified as a Schedule I drug under the Federal Controlled Dangerous Substances Act of 1970 and has not gone through a Food and Drug Administration testing process for safety or efficacy. The three strain mandate is a reasonable balancing of State action in developing the MMP to limit distribution to only registered qualifying patients, which is authorized under State law but still considered illegal under Federal law. In addition, the three-strain mandate will assist law enforcement authorities in identifying medicinal marijuana that originated from a permitted ATC, which will help prevent possible diversion and establish public trust in the program, a process that has proven challenging in other states. Inasmuch as this is a new program, data collected by the Department will help guide ATCs in choosing the best medicinal strains and help the Department determine through future rulemaking whether different or additional strains would prove beneficial to patients.
3. COMMENT: A number of commenters state that N.J.A.C. 8:64-5.1(a), which provides that the Commissioner shall not take action to approve additional debilitating medical conditions until the Department makes at least two annual reports to the Governor and the State Legislature concerning the MMP, is inappropriate and overly restrictive. The commenters generally point out that other states allow medicinal marijuana use for a wider array of debilitating medical conditions and that it is in the best interests of patient care to consider expanding the list of debilitating medical conditions without delay. (1, 3, 5, 6, 15, 16, 17, 21, 22, 30, 33, 35, 36, 37, and 38)
RESPONSE: The New Jersey Legislature held hearings prior to passage of the Act and made a determination as to the inclusion of specific debilitating medical conditions and, while considering the qualifying medical conditions under the medicinal marijuana laws in other states, defined its list of debilitating medical conditions as provided by N.J.S.A. 24:6I-3 to start the MMP. N.J.A.C. 8:64-4.3 requires ATCs to report patient survey information to the Department. Consistent with this approach, the Department disagrees that new qualifying conditions should be added before two years’ time. The Department will approve new qualifying conditions only after sufficient data is collected and analyzed to support any such addition. Two years’ time will provide the Department with the ability to collect the requisite data necessary to determine what new conditions, if any, should be added to the list of qualifying conditions. In addition, two years’ time will provide petitioners seeking to establish additional debilitating medical conditions under N.J.A.C. 8:64-5 with additional data to support a bona fide petition for the same. 4. COMMENT: A number of commenters state that two medicinal marijuana growers and four dispensers will not be sufficient to meet patient demand or to provide convenient access to patients and primary caregivers. These comments generally state that six ATCs will not be sufficient to meet patient demand or to provide convenient access to patients and primary caregivers. These commenters generally point out that traveling long distances to the closest ATC will be a hardship for those patients who are very ill and/or do not have a primary caregiver. (4, 5, 17, 19, 21, 34, 35, and 37)
RESPONSE: The Department agrees that two cultivators and four dispensers may not be sufficient to meet patient demand, accordingly, in the notice of reproposal dated February 22, 2011, the Department changed the definition of ATC at N.J.A.C. 8:64-1.2 to allow ATCs to both cultivate and dispense medicinal marijuana. As required by N.J.S.A. 24:6I-7a, which requires at least two ATCs in the northern, central, and southern regions of the State, the Department will follow the development of the MMP and seek to ensure the availability of a sufficient number of ATCs. Inasmuch as the MMP is a new program, the Department is without sufficient data upon which to formulate an opinion as to whether additional ATCs will be necessary at this time.
5. COMMENT: Three commenters state that two ounces per month is an insufficient amount of medicinal marijuana because it will only permit a patient to use marijuana once or twice per day. The commenters state that since the medicinal marijuana available under the proposed rules will be limited to 10 percent THC content, patients will be forced to consume higher dosages and will, therefore, run out of medicinal marijuana quickly if limited to no more than two ounces per month. (5, 36, and 37)
RESPONSE: The two ounces per month limitation is set by statute at N.J.S.A. 24:6I-10a, which provides that a physician may only authorize, and an ATC may only dispense, a maximum of two ounces of medicinal marijuana to a patient in a 30-day time period. Accordingly, the Department is required to comply with the statute and does not have the authority to exceed the two ounces per 30-day time period limit. The Department does not have sufficient data upon which to base a determination concerning the dosages and frequencies of dosages of medicinal marijuana for various debilitating medical conditions that physicians will determine, in consultation with their patients, to be effective.
6. COMMENT: A number of commenters stated that the requirement at N.J.A.C. 8:64-2.5(a)9i, which would require physicians to certify that a patient has not responded to conventional medical treatment prior to the physician’s recommendation that the patient may benefit from the medicinal use of marijuana, is inappropriate and inconsistent with the definition of “debilitating medical condition” in the enabling statute at N.J.S.A. 24:6I-3. (4, 5, 6, 9, 15, 22, 36, and 37)
RESPONSE: The Department agrees with the comments. N.J.S.A. 24:6I-3 of the enabling statute provides that only seizure disorders, including epilepsy, intractable skeletal muscular spasticity, and glaucoma must be resistant to conventional medical therapy before qualifying as debilitating medical conditions. In recognition of this, the Department removed this requirement from N.J.A.C. 8:64-2.5(a)9i, except for the conditions named in N.J.S.A. 24:6I-3, in the notice of reproposal dated February 22. 7. COMMENT: Three commenters object to the requirement at N.J.A.C. 8:64-2.5(a) that incorporates N.J.A.C. 13:35-7A by reference. Proposed N.J.A.C. 13:35-7A.5(c)3 would require physicians to “periodically make reasonable efforts, unless clinically contraindicated, to stop the medical use of marijuana, decrease the quantity authorized or try other drugs or treatment modalities in an effort to reduce the potential for abuse or the development of physical or psychological dependence.” The commenters generally state that medicinal marijuana patients are frequently terminally ill, and therefore, it makes no sense to attempt to wean these patients off of medicine that alleviates the patient’s suffering. (4, 15, and 24)
RESPONSE: The Department’s rule at N.J.A.C. 8:64-2.5(a) incorporates a Board of Medical Examiners (BME) rule at N.J.A.C. 13:35-7A by reference. The practice of medicine is regulated by the BME. The BME determined not to adopt the rule as proposed. Accordingly, the rule upon adoption will not require a physician to take steps periodically to stop or reduce the use of medicinal marijuana. The rule will provide, in relevant part at N.J.A.C. 13:35-7A.5(c), “[i]f the physician determines that the patient is achieving treatment objectives, and is not experiencing untoward side effects or physical or psychological problems associated with marijuana use, the physician may continue the patient’s treatment with medical marijuana without alteration.”
8. COMMENT: A number of commenters stated that proposed N.J.A.C. 8:64-12, Home delivery, is too restrictive. Generally, the comments stated that all patients should be eligible for home delivery automatically because most prospective qualifying patients are very ill and/or do not have a primary caregiver, making travel a hardship. (17, 19, 21, 22, 26, 32, 36, and 38) Two commenters stated that a one day wait for home delivery was cruel since it could cause a patient to suffer without his or her medicine. (21 and 32)
RESPONSE: A bi-partisan agreement between Governor Chris Christie and Assemblyman Reed Gusciora, one of the primary sponsors of the New Jersey Compassionate Use Medical Marijuana Act (the Act), that was announced on December 3, 2010, eliminated home delivery as part of an effort to reach a compromise to implement the MMP. In addition, the Department's concern for the security of patients, ATC employees, the potential for diversion, and the need to ensure the safety of the public weighed against home delivery in this rulemaking. Experience with the program will determine whether home delivery is needed in the future. The rules ensure that registered primary caregivers may purchase medicinal marijuana from ATCs for those patients who have difficulty traveling. Accordingly, the Department removed the option of home delivery by ATCs from N.J.A.C. 8:64-12 in the notice of reproposal dated February 22, 2011.
9. COMMENT: Several commenters stated that additional continuing medical education for doctors in subject areas relevant to the treatment of patients with medicinal marijuana is not necessary because physicians who possess an active controlled dangerous substances registration issued by the Division of Consumer Affairs regularly prescribe deadly and addictive drugs and medicinal marijuana is not deadly in any known dose and possesses only a mild risk of addiction, similar to caffeine. (6, 12, 25, and 36)
RESPONSE: Specific proposals for continuing medical education for doctors in subject areas relevant to the treatment of patients with medicinal marijuana are under consideration by the BME but have not been formally proposed. The Department will consult with the BME and aid in identifying specific subjects or particular courses as the BME continues to study this issue further.
10. COMMENT: A number of commenters stated that the fees to obtain registry identification cards for both qualifying patients and their primary caregivers are excessive. Generally, the commenters point out that the $200.00 fee proposed by the Department at N.J.A.C. 8:64-2.1(c) is the highest in the nation and constitutes an undue burden on very sick patients who are unable to work and have high medical expenses. (1, 2, 4, 9, 12, 15, 21, 22, 25, 26, 32, and 38)
RESPONSE: The Department disagrees with the commenters. Arizona, for example, charges $150.00 for a patient registry card that must be renewed annually. Colorado charges $90.00 for a patient registry card that must be renewed each year. Michigan charges $100.00 for a patient registry card that must be renewed each year. The Department charges $200.00 for a patient registry card that is valid for a two-year period, making the annual cost $100.00 per year. This is generally in accord with the fee schedule of the aforementioned states. In addition, N.J.S.A. 24:6I-11b provides that all fees collected shall be used to offset the cost of the MMP. In order to reduce the cost of registry identification cards for individuals with a limited income, the Department adopts N.J.A.C. 8:64-2.1(c)1, which provides that the fee for a registry identification card for an individual receiving Medicaid benefits, food stamp benefits (now known as the Supplemental Nutrition Assistance Program), New Jersey Temporary Disability Insurance benefits, Supplemental Security Income benefits, or Social Security Disability benefits will be $20.00. Because all registry identification cards will be valid for a period of two years, re- registration is only necessary once every two years.
11. COMMENT: One commenter states that there are many serious medical conditions not on the qualifying conditions list and specifically wants Diabetic Neuropathy added to this list of qualifying conditions. The commenter has diabetic neuropathy for which she is prescribed fentanyl, oxycodone, ultram, and xanax, and does not understand how she can be advised to take these powerful drugs, yet is prohibited from the opportunity to use medicinal marijuana which is far safer. (3)
RESPONSE: The initial list of debilitating medical conditions that qualify for treatment with medicinal marijuana was set by statute at N.J.S.A. 24:6I-3. After the Department has filed two annual reports on the MMP with the Governor and the State Legislature, the Department will accept petitions to establish additional debilitating medical conditions under N.J.A.C. 8:64-5. The Department will approve new debilitating medical conditions only after sufficient data is collected and analyzed to support any such addition.
12. COMMENT: One commenter states that limiting the THC content of medicinal marijuana guarantees that patients will continue to access the illegal underground market for more potent medicine. The commenter states that the physician registry is an unnecessary bureaucratic addition that is not called for in the statute and will have a chilling effect on physician registration. The commenter states that the patient registration requirements create a bureaucratic “Catch-22” because the application must be complete or it will be rejected, yet it is impossible to complete the application because completion requires the patient to provide the physician’s certification and the address of the ATC the patient intends to use – neither of which is available yet. (4)
RESPONSE: Federally approved studies conducted in the United States use medicinal marijuana that is no more than 10 percent THC, which is grown by the University of Mississippi. The Department refers the commenter to the Response to Comment 1. Since medicinal marijuana with a THC content of no more than 10 percent has a significant clinical effect, patients will have access to effective medicine through the MMP. The physician registry will enable the Department to verify that each registered, qualifying patient has been diagnosed with a debilitating medical condition, that the physician is in good standing, and that the physician has certified that the patient may benefit from using medicinal marijuana. The Department will make every effort to provide an efficient patient and primary caregiver registration process. N.J.A.C. 8:64-2.2(b) requires the Department to notify an applicant in writing, by electronic mail, or by telephone that an application is incomplete and to explain what information will be necessary in order to complete the application. The applicant will have 30 days to complete the application. The Department will only reject those applications that remain incomplete after 30 days.
13. COMMENT: One commenter asks if medicinal marijuana that contains only 10 percent THC will be adequate to meet the needs of patients and states that a review of the literature suggests that, as with other drugs, the efficacy of medicinal marijuana for symptom relief is both dose and frequency related. Most patients are described as using between .5 and one gram in a smoked form at one time. Since the New Jersey statute limits the quantity of marijuana to two ounces per month (about 57 grams), patients will already be restricted to using their supply no more than twice per day; if the strength of the THC is limited as well, symptom relief may not be achieved. Canada provides medicinal marijuana containing 15 percent THC to patients who have registered with Health Canada. (5)
RESPONSE: The Department does not have sufficient data upon which to base a determination concerning the dosages and frequencies of dosages of medicinal marijuana for various debilitating medical conditions that physicians will determine, in consultation with their patients, to be effective. The two ounces per month limitation is set by N.J.S.A. 24:6I-10a, which provides that a physician may only authorize, and an ATC may only dispense, a maximum of two ounces of medicinal marijuana to a patient in a 30-day time period. The Department is not authorized to increase the two ounces per month limitation. Relevant United States research studies use medicinal marijuana that is no more than 10 percent THC, which is grown by the University of Mississippi. Studies have shown that medicinal marijuana from the University of Mississippi has a significant clinical effect. In addition, the Department refers the commenter to the responses to Comments 1 and 5 as they related to the issue of THC concentration.
14. COMMENT: One commenter states that she has fibromyalgia and chronic fatigue and comments that she dislikes the addictive and harmful pills she is prescribed including oxycodone and does not understand how a distinction can be drawn between legally prescribed marijuana and legal narcotics or alcohol. Gambling and alcohol caused increased crime rates, so why don’t we make them both illegal if crime is such a big concern of these rules. (8) RESPONSE: The Department is bound by State and Federal Law and will comply with both to minimize crime in all forms.
15. COMMENT: One commenter, a licensed pharmacist, comments that only licensed New Jersey pharmacists should be allowed to dispense medicinal marijuana. (10)
RESPONSE: Unlike New Jersey, and the other states that have legalized marijuana for medicinal use, the Federal government classifies marijuana as a Schedule I Controlled Dangerous Substance, which represents the Federal government’s view that marijuana has no therapeutic value. As such, it is not approved by the U.S. Food and Drug Administration (FDA) and cannot be prescribed as medicine by doctors. Therefore, while the Department refers to the product as medicinal marijuana, technically, because of the supremacy of Federal law over State law in this regard, it is not an FDA-approved medicine and, therefore, cannot be dispensed as such by a pharmacist in New Jersey.
16. COMMENT: The commenter states that she suffers from fibromyalgia, chronic fatigue and Epstein-Barr syndrome and has been prescribed numerous drugs with no relief but has found marijuana has helped her. She feels the legal pills she is prescribed are harmful to her health and addictive, yet marijuana, which is not addictive and is safe is not available to her under the current rules. She doesn’t want to be a criminal, but wants to use marijuana to help with her conditions and pain. (11)
RESPONSE: The Department will approve new qualifying conditions only after sufficient data is collected and analyzed to support any such addition. Two years’ time provides the Department with the ability to collect the requisite data necessary to determine what new conditions, if any, should be added to the list of qualifying conditions. In addition, two years’ time will provide petitioners seeking to establish additional debilitating medical conditions under N.J.A.C. 8:64-5 with additional data to support a bona fide petition for the same.
17. COMMENT: The commenter states that the proposed rules set up a monopoly and place ATCs at an unnecessary risk of Federal prosecution. (12)
RESPONSE: N.J.S.A. 24:6I-7 requires that the Department issue permits to at least six ATCs and provides that the Department “shall seek to ensure the availability of a sufficient number of alternative treatment centers throughout the State, pursuant to need…” The Department believes that the initial selection of six ATCs is a reasonable number of ATCs, inasmuch as the MMP is a new program, and the Department is without sufficient data upon which to formulate an opinion as to whether additional ATCs will be necessary at this time. The Department disagrees that the proposed rules place ATCs at an unnecessary risk of Federal prosecution because most marijuana prosecutions arise from arrests made under state law. N.J.S.A. 24:6I-2b states that according to the U.S. Sentencing Commission and the Federal Bureau of Investigation, 99 out of every 100 marijuana arrests in the United States are made under state law, rather than under Federal law. N.J.S.A. 24:6I-2e provides that the purpose of the Act is to protect from arrest, prosecution, property forfeiture, and criminal and other penalties, patients, physicians, primary caregivers, and those who are authorized to produce marijuana for medical purposes. 18. COMMENT: The commenter states that he is a Crohn’s disease sufferer and credits marijuana for helping him cope with his disease for 40 years and strongly supports medicinal marijuana. (13)
RESPONSE: The Department thanks the commenter for his support of the program.
19. COMMENT: The commenter states that the Department has drafted appropriate rules to implement dispensing and advertising standards that will prevent the abuses seen in other states. The commenter supports standards that medicinal marijuana stores should not be able to advertise except in small dignified black and white advertising; that medicinal marijuana should not be visible to kids outside the store, that medicinal marijuana should not be sold in food form and should be dispensed in a plain container with a warning label that it is not approved by the FDA; that doctors who write orders for medicinal marijuana must perform a thorough and well- documented investigation of the patients medical condition; that organized crime should be prevented from running the medicinal marijuana stores; that medicinal marijuana stores should pay very high fees so taxpayers won’t have to support the program; that there should be tough controls on medicinal marijuana stores and medicinal marijuana doctors; that there should be tough security and anti-loitering rules at the medicinal marijuana stores; that medicinal marijuana stores should not be near schools; and that doctors should warn patients that marijuana is not FDA approved. (14)
RESPONSE: The Department has included a number of safeguards in the rules in Subchapter 12 to restrict exterior signage of ATCs to black text on a white background and to prevent medicinal marijuana from being visible from outside of the building. N.J.A.C. 8:64-10.8(e) will limit the distribution of medicinal marijuana to three forms: dried, oral lozenges, and topical formulations. N.J.A.C. 8:64-2.5 will require physicians to have an ongoing bona-fide physician-patient relationship, which will help prevent abuse of the MMP. The Department will not approve of any ATC locations that are within 1,000 feet of a school. The Department wishes to assure the commenter that it will make every effort to thoroughly vet ATC applicants and to enforce security measures so that the public will have confidence in the program.
20. COMMENT: The commenter states that the rules should permit primary caregivers to assist more than one registered qualifying patient. In addition, the Department should estimate the number of doctors that will register under the MMP and estimate the number of jobs that will be created by the MMP. (15)
RESPONSE: The Department is constrained by N.J.S.A. 24:6I-3, which defines a primary caregiver as a person who is only serving one registered qualifying patient. As indicated in the original notice of proposal dated November 15, 2010, the Department is without data sufficient to support an accurate estimate of the number of doctors that will register under the MMP and to estimate the number of jobs that will be created by the MMP as this will depend on patient demand for medicinal marijuana.
21. COMMENT: Two commenters state that N.J.A.C. 8:64-13.1(d) (codified as N.J.A.C. 8:64- 12.1(d) in the February 22, 2011 notice of reproposal), which will prohibit ATCs from advertising prices of medicinal marijuana except to registered qualifying patients and primary caregivers inside the ATC itself, violates the First Amendment to the United States Constitution. The commenters state that the rule serves to deny legal consumers of products from being provided with truthful, non-misleading information about those products, which is necessary for them to make informed decisions about those products, and that the State has no justifiable interest, that can override the First Amendment, in precluding or severely limiting the dissemination of non-misleading pricing information to legal consumers. (16 and 33)
RESPONSE: The Department respectfully disagrees with the commenters. The provision in question is a reasonable restriction upon advertising by alternative treatment centers that is intended to ensure that only those who are legally entitled to use medicinal marijuana receive pricing information. The requirement is necessary to protect the State’s substantial interest in ensuring that only those individuals who may legally purchase medicinal marijuana receive pricing information, thereby discouraging attempts by black market vendors to undercut lawful sales by alternative treatment centers. Unlike other forms of advertising, including advertising regarding alcohol and tobacco, it is significant that the use of marijuana remains illegal for most of the residents of the State. Since the use of marijuana is prohibited for most of the population, the need for its efficient allocation and distribution through commercial advertising is less compelling. Therefore, the advertising of medicinal marijuana must necessarily be limited and narrowly tailored to reach the small population of qualifying registered patients. Not only does the State have an interest in limiting advertising to legal users, the State has a substantial interest in discouraging commercial advertising of marijuana to the general public that would unavoidably encourage or trivialize the sale and use of an illegal drug. The rule directly advances the aforementioned substantial government interests and is not more extensive than necessary to serve those interests. The rule would not prevent alternative treatment centers from providing registered users with pricing information at the facility or when the qualifying registered patient otherwise contacts the facility, such as by phone. Although not defined in the proposed rules, the common meaning of the term, “advertise” is to make public announcement of, to make generally known or to call the attention of the public to a product or business. Therefore, the proposed rule is intended to prohibit ATCs from advertising prices to the public, but it is not intended to prohibit ATCs from providing pricing information to any qualifying registered patient or any registered primary caregiver. In addition, the advertising restriction is consistent with the Department’s longstanding public health policies against tobacco use and the advertising and sale of tobacco products to minors. Therefore, the Department makes no change on adoption.
22. COMMENT: A few commenters state ingesting medicinal marijuana is much healthier for patients than smoking. The rules should permit ATCs to produce and sell additional forms of edible medicinal marijuana because the effect of edibles can be more beneficial for pain and last longer. The commenters generally state that the art of producing edibles includes such marketable items as blueberry biscotti, truffles, chocolates, salad dressings, oils, and cannabis butter that can be used to make a variety of products. (17, 19, 22, and 23)
RESPONSE: The Department agrees that ingesting medicinal marijuana is healthier for patients than smoking. For this reason, the rules at N.J.A.C. 8:64-10.8(e) allow for the dispensing of lozenges and a topical formulation for those that do not want to utilize the dried form for smoking purposes. The Department disagrees that ATCs should be permitted to manufacture all forms of edibles; however, because such manufacture will make it more difficult for ATCs and registered qualifying patients to follow physician’s dosage instructions and to comply with N.J.S.A. 24:6I-10a, which limits the amount of medicinal marijuana that an ATC can dispense to a patient to two ounces in a 30-day period. The rules do not prohibit a registered qualifying patient or a primary caregiver from manufacturing edibles at home.
23. COMMENT: The commenter is concerned that, in the confines of a multi-unit dwelling, the smoke or vapor from a registered qualifying patient’s use of medicinal marijuana may escape into the atmosphere and be detected by others. The commenter requests that the Department adopt a rule that would operate to revoke the registration card of a patient in such circumstances. The commenter requests a rule that would require as a condition of registration that a patient be put on notice that their patient registration card would be revoked if the patient smoked anywhere in the presence of a minor, in the home during home healthcare visits, in the presence of anyone in the home who requires a smoke-free home environment, or outdoors within 25 feet of entrances/exits to public places. The commenter requests that the Department add a definition for the term, “smoking,” that mirrors the definition for the same in the Smoke Free Air Act. The commenter requests that N.J.A.C. 8:64-2.5(a)8 and 9 be amended to specifically state that physicians may only authorize the use of non-smoked forms of medicinal marijuana. The commenter requests that N.J.A.C. 8:64-5.3 be amended to “address the concerns of smoking secondhand smoke exposure to any smoked product, as an additional debilitating medical condition.” The commenter requests that N.J.A.C. 8:64-9.6(a) be amended to state, “[t]he ATC shall establish, implement and adhere to a written 100 percent alcohol, drug-free and tobacco (smoke)-free workplace policy.” The commenter requests that N.J.A.C. 8:64-11.1(a)4 be amended to require physicians and ATCs to provide smoking cessation materials and resources to patients. The commenter requests that N.J.A.C. 8:64-13.1(a) (codified as N.J.A.C. 8:64- 12.1(a) in the February 22, 2011 notice of reproposal) be amended to further restrict advertising by banning electronic communications; in addition, the rule should specify font size and type for signage. (18)
RESPONSE: N.J.S.A. 24:6I-8b contains a number of restrictions on smoking medicinal marijuana, including prohibitions against smoking the same in a school bus or other form of public transportation, in a private vehicle unless the vehicle is not in operation, on any school grounds, in any correctional facility, at any public park or beach, at any recreation center, or in any place where smoking is prohibited pursuant to N.J.S.A. 2C:33-13. The Department notes that smoking medicinal marijuana falls within the definition of “smoking” as set forth in the Smoke Free Air Act at N.J.S.A. 26:3D-57 and is, therefore, subject to the provisions of the Smoke Free Air Act. Since all of these prohibitions provide adequate protections for non-smokers, the Department declines to adopt the additional prohibitions suggested by the commenter. The Department declines to change N.J.A.C. 8:64-2.5(a)8 and 9 upon adoption as suggested by the commenter as such would be inconsistent with the definitions of “marijuana” and “usable marijuana” as set forth at N.J.S.A. 24:6I-3. The Department is not vested with the authority to add secondhand smoke exposure to the list of debilitating medical conditions and does not possess sufficient information upon which to conclude that secondhand smoke exposure is itself a diagnosis that may reasonably fall within the definition of debilitating medical condition as set forth in the Act. The commenter may file a petition to add secondhand smoke exposure as a debilitating medical condition under N.J.A.C. 8:64-5.3. The Department declines to change N.J.A.C. 8:64-9.6(a) upon adoption by adding the phrase “100 percent” because the language of the rule, which requires an ATC to have an alcohol, drug-free, and smoke-free workplace policy, is sufficiently clear to render the phrase “100 percent” superfluous. The Department declines to change N.J.A.C. 8:64-11.1(a)4 upon adoption to require physicians and ATCs to provide smoking cessation materials and resources to patients because smoking is a recognized method of using medicinal marijuana and N.J.A.C. 8:64-11.1(a)5, which requires ATCs to provide information to patients concerning alternate methods and forms of consumption or inhalation by which one can use medicinal marijuana, addresses the concerns raised by the commenter. The Department declines to change N.J.A.C. 8:64-12.1(a) to further restrict advertising by banning electronic communications because additional restrictions beyond those already in the rule may be inconsistent with First Amendment guarantees of free speech under the United States Constitution. The Department refers the commenter to the responses to Comments 21 and 56. The Department declines to change N.J.A.C. 8:64-12.1(a) to specify font size and type upon adoption because such specifications are within the ambit of local zoning ordinances.
24. COMMENT: The commenter states that patients should be allowed to grow their own marijuana at home. The proposed rules do not keep marijuana off of our streets and out of our children’s hands. Since the Legislature passed the Act, marijuana cannot legally remain a Schedule I drug as this classification is unconstitutional. (19)
RESPONSE: N.J.S.A. 24:6I-1 et seq. does not authorize patients to engage in home cultivation. Accordingly, the Department is without authority to permit home cultivation. The rules at N.J.A.C. 8:64 pertain only to the legal cultivation and dispensing of marijuana for medicinal purposes. The rules are designed to establish a safe, clean Medicinal Marijuana Program that is an alternative to the black market for registered, qualifying patients. Marijuana is classified as a Schedule I drug by the Federal government. Changing this classification would require a change in existing Federal law. State laws, such as N.J.S.A. 24:6I-1, are subordinate to Federal laws under the Supremacy Clause of the United States Constitution.
25. COMMENT: The commenter states that his physician recommended that he use medicinal marijuana last year, but the physician does not want to be part of any State registry as he is already registered with the State and the Federal Drug Enforcement Agency. The commenter states that he has been driven to the black market for relief and asks what the point is in having a MMP if the government makes it too difficult for patients to have access to medicinal marijuana. (20)
RESPONSE: Consistent with the requirements of a medical model, N.J.A.C. 8:64-2.4 requires physicians to register with the MMP. As with the majority of professional decisions, a physician is free to choose whether to register with the MMP. To date, more than 100 physicians have chosen to register with the MMP, providing most registered qualifying patients a number of doctors with whom they may consult concerning medicinal marijuana and who may be recommended by a treating physician within the ambit of a bona fide physician-patient relationship as defined at N.J.A.C. 8:64-1.2.
26. COMMENT: The commenter makes a number of comments concerning the rule, generally stating that the rules are contrary to the legislative intent expressed in the Act from beginning to end. The bona fide doctor/patient relationship defined at N.J.A.C. 8:64-1.2 should not be defined by treatment for a specific length of time, but rather on a reliance of the integrity of licensed physicians to determine whether they have a bona fide doctor/patient relationship. N.J.A.C. 8:64- 2.2 mandates that for a patient to register, the treating physician must register and obtain a certification number, in violation of the definition of “qualified patient” in the Act. N.J.A.C. 8:64-2.5(a)6 requires the physician to disclose the patient’s diagnosis, which violates patient confidentiality, and is not called for in the Act. N.J.A.C. 8:64-2.5(a)9, which requires physicians to inform patients that there exists a lack of scientific consensus for the use of medicinal marijuana, is in direct conflict with the Act, which states that modern medical research has discovered beneficial uses for marijuana. The commenter states there has never been a single fatality from the use of marijuana and that it is impossible to overdose on it. The commenter states that N.J.A.C. 8:64-2.2(f)1, which states that the custodial parent of a registered qualifying patient who is a minor shall be issued a primary caregiver registration card by the Department for no additional fee, is inconsistent with N.J.A.C. 8:64-2.3, which would appear to require the custodial parent of a registered qualifying patient who is a minor to submit to a background check, pay for the same, and also to pay a $200.00 fee for a registry identification card. The commenter states that N.J.A.C. 8:64-3.4(c), which requires registry cards to be surrendered to the Department when any information on the card changes or a new ATC is designated, will operate to deprive patients of medicinal marijuana between the time that the original registry certification card is surrendered and a new card is issued. N.J.A.C. 8:64-4.1(a) is inconsistent with the Act because the rule requires the qualifying patient, primary caregiver, parent, guardian, or other custodian of a qualifying patient who is a minor, to notify the Department of any change in the qualifying patient’s name, address, ATC, or physician within 10 days of the change, whereas the Act only places such notification requirements on qualifying patients. N.J.A.C. 8:64-4.3(a)2, which requires ATCs to report each patient’s diagnosis to the Department, encourages a violation of the Act, which provides that the patient’s application or receipt of a registry card does not constitute a waiver of the qualifying patient’s patient-physician privilege. The commenter states that N.J.A.C. 8:64-4.3(a)6 (codified as N.J.A.C. 8:64-4.3(a)5 in the February 22, 2011 notice of reproposal), which requires ATCs to provide a summary of patient surveys and evaluation of services to the Department, is an improper delegation to the ATCs of the Department’s responsibility to collect this information under the Act because the definition of ATC in the Act does not contain such obligations. N.J.A.C. 8:64-6.1(d), which states that the Department shall only accept and process ATC applications after making a formal request for applications (RFA), is in violation of the Act, which states that the Department “shall accept” ATC applications without such a constraint. N.J.A.C. 8:64-6.2 provides for a selection committee to review ATC applications, but the rule fails to include information as to the committee’s members or qualifications. N.J.A.C. 8:64-6.4 does not provide for a time frame within which the Department shall review and issue a decision on an ATC application. N.J.A.C. 8:64-7.1(b)2ii, which requires an ATC applicant to disclose the names, addresses, and other information concerning its employees, presumably before the ATC gets approval to operate, is not appropriate because it is inconsistent with how businesses operate. N.J.A.C. 8:64-9.3(a)9, which requires an ATC to disclose how it determines the prices it charges for medicinal marijuana, is of no legitimate concern to the Department. The requirements at N.J.A.C. 8:64-7.1(b) are unnecessary roadblocks to approval and are vague. N.J.A.C. 8:64-7.9(a)5 is not clear because it states an ATC-dispensary satellite location may not be within 1,000 feet of a school, yet the rules do not specify whether this restriction also applies to ATC-dispensaries themselves. The on-site prohibitions on food sales and consumption at N.J.A.C. 8:64-9.2, the on-site parking requirement at N.J.A.C. 8:64- 9.7(b), and the signage requirements at N.J.A.C. 8:64-13.1(c) (codified as N.J.A.C. 8:64-12.1(c) in the February 22, 2011 notice of reproposal) violate local land use laws, which are the province of local, not State, governments. The security requirements at N.J.A.C. 8:64-9.7(b) are overly burdensome and costly for the ATCs. N.J.A.C. 8:64-10.6(d)1 requires a statement on the medicinal marijuana package that states that the product is not intended to diagnose, treat, cure, or prevent any disease, which is inconsistent with the Act, which states that modern medical research has discovered beneficial uses for marijuana in treating or alleviating pain or other symptoms associated with certain debilitating medical conditions. N.J.A.C. 8:64-10.8(e) would allow oral lozenges to be dispensed by ATCs; however, oral lozenges are not used as a delivery method for medicinal marijuana according to most experienced people in the field. N.J.A.C. 8:64-10.11(e) provides that medicinal marijuana shall be transported in conformance with State and Federal laws, but since it is an illegal substance under Federal law, one is left to guess which Federal law applies. N.J.A.C. 8:64-11.1 requires the ATCs to provide educational materials to patients and primary caregivers, but this function should more properly be performed by the Department. N.J.A.C. 8:64-11.2(c), which requires ATCs to ask patients and primary caregivers for permission to contact them with information about peer review clinical studies concerning the use of medicinal marijuana, is a function that should be more properly performed by the Department. N.J.A.C. 8:64-11.3(b), which requires an ATC to maintain a copy of the registered qualifying patient’s (and, if applicable, primary caregiver’s) patient identification card and other form of government issued photo identification card, is violative of the Act, which only requires a patient to submit his or her patient identification card and physician’s recommendation to the ATC in order to obtain medicinal marijuana. N.J.A.C. 8:64-11.4, which requires ATCs to document patient self-assessment of pain, is not the proper function of the ATC, but rather, the Department. N.J.A.C. 8:64-11.5(a), which requires an ATC to stop dispensing medicinal marijuana to an individual that the ATC believes is abusing the substance or redistributing it, treats marijuana as illegal and patients as criminals. N.J.A.C. 8:64-13.1(f) (codified as N.J.A.C. 8:64-12.1(f) in the February 22, 2011 notice of reproposal), which prohibits an ATC from selling t-shirts or other promotional items displaying a reference to marijuana, is unconstitutional because the sale of medicinal marijuana by an ATC is a legitimate business. N.J.A.C. 8:64- 14.4(c) does not provide for testing of medicinal marijuana’s THC content. The commenter points out that the rules contain two sections on enforcement and penalties (N.J.A.C. 8:64-14.6 and 14.7) (codified as N.J.A.C. 8:64-13.6 and 13.7, respectively, in the February 22, 2011 notice of reproposal) and only one section (N.J.A.C. 8:64-14.11) (codified as N.J.A.C. 8:64-13.11 in the February 22, 2011 notice of reproposal) referencing the protections from prosecution that patients are guaranteed under the Act, stating that generally, the rules are misguided. (21)
RESPONSE: The definition of “bona fide physician-patient relationship” relies on the integrity of licensed physicians in that it allows for such a relationship to exist when a physician assumes responsibility for the management and care of a patient’s debilitating medical condition after conducting a comprehensive medical history and physical examination, including a personal review of the patient’s medical history. The Department disagrees that the definition of “qualifying patient” in the Act precludes a physician registry. The Department is required to verify that a qualifying patient has a certification signed by a physician, which certification establishes that a patient has a debilitating medical condition under N.J.S.A. 24:6I-3. Accordingly, N.J.A.C. 8:64-2.5(a)6 requires a physician to provide the Department with the qualifying patient’s diagnosis. The Department will not disclose patient identifiable health information to third parties and will maintain this information in a confidential manner. The Department disagrees that N.J.A.C. 8:64-2.5(a)9, which requires physicians to inform patients that there exists a lack of scientific consensus for the use of medicinal marijuana, is inconsistent with the legislative findings and declarations stated at N.J.S.A. 24:6I-2a, that modern medical research has discovered a beneficial use for marijuana. Medicinal marijuana provides benefits in treating or alleviating pain or other symptoms associated with certain debilitating medical conditions; however, there exists a lack of scientific consensus concerning, but not limited to, the following areas: dosages, frequency of dosages, delivery routes and methods, the most suitable strains for the treatment of specific conditions, and which cannabinoid compounds affect which areas of the body. The Department is without sufficient information upon which to form an opinion concerning the commenter’s statement that there has never been a single fatality from the use of marijuana and that it is impossible to overdose on it. The Department does not intend to require the parents of registered qualifying patients who are minors to submit to background checks or to pay a fee for a primary caregiver registration card as provided at N.J.A.C. 8:64- 2.2(f)1. The Department does not intend to apply N.J.A.C. 8:64-3.4(c) in a manner that will cause a registered qualifying patient to be deprived of medicinal marijuana while the patient awaits the Department’s issuance of a new registry identification card. N.J.A.C. 8:64-4.1(a) is consistent with the Act because the Act intends for the patient to notify the Department when certain material information changes and in some cases, where the patient is a minor or very ill, it is appropriate for the parent, guardian, or primary caregiver, who stands in the place of the patient, to provide such notification to the Department. The Department disagrees that N.J.A.C. 8:64-4.3(a)2 encourages a violation of patient confidentiality because the rule does not contain a requirement that the patient’s identity be linked to a record of the patient’s debilitating medical condition. The ATC reporting requirement at N.J.A.C. 8:64-4.3(a)6 is a means of collecting summaries of patient surveys by the Department, not a delegation of this responsibility to the ATCs. The Department disagrees that N.J.A.C. 8:64-6.1(d) is violative of the Act. The RFA process is a permitted exercise of the broad discretion granted to State agencies in determining how to fulfill their statutory obligations. The Department declines to specify selection committee members and qualifications at N.J.A.C. 8:64-6.2 upon adoption because this is not a requirement of the Act. In the event that the Department issues an RFA, the Commissioner will exercise discretion to appoint committee members who possess knowledge and expertise applicable to the committee’s role in evaluating and scoring each application. The Department declines to adopt a time for reviewing ATC applications at N.J.A.C. 8:64-6.4 because the timeframe of 60 days is set by statute at N.J.S.A. 24:6I-7e. The Department disagrees with the statement that N.J.A.C. 8:64-7.1(b)2ii is not an appropriate rule because it is inconsistent with how businesses operate. Businesses in the health care field, such as air medical services, are generally required to provide the names, addresses, and professional training and qualifications of their employees on their applications for licensure. The Department will look at this issue as it gathers more data and experience in the MMP. The Department disagrees that N.J.A.C. 8:64-9.3(a)9, which requires an ATC to disclose how it determines the prices it charges for medicinal marijuana, is of no legitimate concern of the Department. N.J.S.A. 24:6I-12c requires the Department to report to the Governor and the Legislature whether any ATC has charged excessive prices for medicinal marijuana that the ATC has dispensed. The Department disagrees that N.J.A.C. 8:64-7.1(b), which requires an ATC applicant to disclose the legal name of the corporation, a copy of the corporate by-laws, the names and addresses of the ATC’s owners, as well as other information, creates unnecessary and vague roadblocks to approval. The comment concerning N.J.A.C. 8:64- 7.9(a)5 is moot as the notice of reproposal dated February 22, 2011 does not provide for ATC satellite locations. The Department disagrees that the prohibitions on food sales and consumption at N.J.A.C. 8:64-9.2, the on-site parking requirement at N.J.A.C. 8:64-9.7(b), and the signage requirements at N.J.A.C. 8:64-13.1(c) (codified as N.J.A.C. 8:64-12.1(c) in the February 22, 2011 notice of reproposal) violate local land use laws, which are the sole province of local governments. It is well established that both the Department and local boards of health have joint authority to regulate in these areas for the benefit of public health and safety. The Department disagrees that the security requirements at N.J.A.C. 8:64-9.7(b) are overly burdensome to ATCs. The requirement that an ATC have a good alarm and security system is necessary to prevent diversion and cultivate public confidence in the MMP. The statement required by N.J.A.C. 8:64- 10.6(d)1 is not inconsistent with the Act because the Act does not state that medicinal marijuana is intended to diagnose, treat, cure, or prevent specific diseases. The rule at N.J.A.C. 8:64-10.8(e) is intended by the Department to permit an ATC to offer an edible form of medicinal marijuana to registering qualifying patients. The rule at N.J.A.C. 8:64-10.11 is intended by the Department to ensure that medicinal marijuana is transported in compliance with all State and Federal laws, including motor vehicle laws. The specific requirement that an ATC – cultivation transport marijuana in conformance with State and Federal law contained in N.J.A.C. 8:64-10.11(e) of the November 15, 2010 original notice of proposal was not contained in the February 22, 2011 notice of reproposal; therefore, this specific issue is moot. The rules at N.J.A.C. 8:64-11.1 and 11.2(c) are intended by the Department to ensure that ATCs, which have more physical contact with patients than Department employees, disseminate educational materials and make an effort to share information about peer review clinical studies to registered qualifying patients. N.J.A.C. 8:64-11.3(b), which requires an ATC to keep a copy of a registered qualifying patient’s photo identification card on file, is not violative of the Act. The rule is a valid exercise of the Department’s rulemaking authority under N.J.S.A. 24:6I-16 and necessary to verify the identity of a registered qualifying patient and, if applicable, a primary caregiver upon their first visit to the ATC. The Department intends N.J.A.C. 8:64-11.4 to provide information to the Department for use in determining the effectiveness of the MMP. N.J.A.C. 8:64-11.5(a) is intended to confer authority upon the ATC to stop dispensing medicinal marijuana to an individual that the ATC believes is using the medicine for an illegal purpose, not to treat the medicinal use of marijuana as illegal or to characterize patients as criminals. N.J.A.C. 8:64-12.1(f) is a limited restriction on the use of symbols or references to marijuana on t-shirts or novelty or promotional items that is constitutionally permitted. It is not a complete ban on the sale of t-shirts or promotional items, and it does not by its terms apply to paraphernalia, such as a vaporizer, which may understandably contain symbols or references to marijuana in an instructive label or pamphlet. The Department acknowledges that N.J.A.C. 8:64-13.4(c) does not specifically provide for testing of THC content. The rule does, however, provide that testing may include other things in addition to the listed items such as mold, heavy metals, pesticides, etc. Accordingly, the Department reserves the right to test for THC content. The Department intends N.J.A.C. 8:64- 13.6 and 13.7 to work together to provide a mechanism for the Department to enforce the provisions of the Act and the administrative rules. The Department intends N.J.A.C. 8:64-13.11 to reference the protections that patients are guaranteed under the Act and reserves the right to consider additional protections in future rulemaking.
27. COMMENT: The bona fide physician-patient relationship defined at N.J.A.C. 8:64-1.2 is inconsistent with the Act, which does not require that a physician treat a patient for a specific period of time in order for the bona fide physician-patient relationship to be created. The commenter is concerned that this provision could result in an unnecessary delay for a patient to obtain a physician’s certification to use medicinal marijuana. The word “certify” should be removed from the rules because Federal officials have the right to prosecute physicians for violations of Federal law, such as certifying or authorizing patients to use medicinal marijuana, and states should, therefore, avoid these words in order to protect physicians from Federal prosecution. N.J.A.C. 8:64-2.5(a)9, which requires physicians to inform patients that there exists a lack of scientific consensus for the use of medicinal marijuana, is more of a political statement than a medical statement and should be removed from the rules because it is an obtrusive interference with the physician-patient relationship. N.J.A.C. 8:64-3.4, which requires primary caregivers to execute a certification stating that they will comply with various conditions, including only purchasing medicinal marijuana from the designated ATC on his or her registry identification card, is not required by the Act and is unnecessarily and excessively intrusive. The requirement of approval of the local governing body where the ATC will be located is overly onerous and creates an unnecessary financial risk for ATCs. The restriction on consumption of food and beverages at ATCs is unique among medicinal marijuana states and is not justifiable. The complete ban on persons under the age of 18 in ATCs will present a hardship for patients and caregivers who need to pick up their medication but are unable to obtain child care. No such restriction applies to New Jersey pharmacies. The security requirements at N.J.A.C. 8:64-9, particularly the requirements to provide neighbors within 100 feet of the ATC with a phone number where they can reach an ATC employee after hours, the drug free school zone 1,000 foot location restriction, and the video monitoring requirements, are excessive. (22)
RESPONSE: N.J.S.A. 24:6I-3 defines “physician,” in relevant part, as a person 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 medical marijuana or consultation solely for that purpose.” The intent of the law is to prevent patients from simply consulting with a physician for the sole purpose of obtaining a patient registry identification card from the Department to use medicinal marijuana with no ongoing care or treatment from that physician. The definition of bona fide physician-patient relationship defined at N.J.A.C. 8:64-1.2 furthers the legislative intent through rulemaking, specifically by establishing what is meant by “ongoing” responsibility for the patient’s care. The Department notes that the Board of Medical Examiners (BME), which is the agency responsible for regulating physicians, proposed similar language to define “ongoing responsibility” at N.J.A.C. 13:35-7A.2. Accordingly, in the notice of reproposal dated February 22, 2011, the Department incorporates the BME rule by reference. The word “certification” is a defined term at N.J.S.A. 24:6I-3. The Department is bound by the language in the statute, which requires physicians to “certify” that they have a bona fide physician-patient relationship with a qualifying patient and on which certification the physician authorizes the patient to apply for registration to the MMP. The Department disagrees that N.J.A.C. 8:64-2.5(a)9 is in conflict with the Act because a lack of scientific consensus exists concerning such matters as which strains, dosages, and frequencies of dosages are the most effective for treating certain debilitating medical conditions. The Department intends N.J.A.C. 8:64-3.4 to be a valid exercise of rulemaking authority under N.J.S.A. 24:6I-16 that is consistent with the Act and that explains to primary caregivers, through reading and agreeing to the certification, that they are responsible to only purchase medicinal marijuana from an ATC, that they may not grow marijuana for their patient, that they are required to notify the Department if their patient wants to designate a new ATC, etc. The Department does not agree that requiring approval for the location of ATCs from local governments is overly restrictive. As a practical matter, ATCs and other businesses must generally locate in areas that local governments have zoned for their business activity. The restriction on the consumption of food and beverages at ATCs found at N.J.A.C. 8:64-9.2(b) is intended by the Department to foster a businesslike atmosphere at the ATC that is focused on providing the patient with medication. The general ban on persons under the age of 18 in ATCs at N.J.A.C. 8:64-9.2(d) does not apply to registered qualifying patients who are minors, as long as the minor is accompanied by his or her primary caregiver and is intended to limit the exposure of minors who are not registered qualifying patients to medicinal marijuana and paraphernalia. The Department believes that all of the security requirements are necessary in order to ensure a safe, adequate supply of medicinal marijuana to patients, to prevent diversion, and to instill public confidence in the integrity of the MMP.
28. COMMENT: The commenter states that he is a board-certified neurologist with over 25 years’ experience in neurology and clinical pharmacology, has performed and published clinical research on THC, and is accepted as an expert on medical cannabis by courts in the USA, Canada, and the UK. There are serious problems with the regulations. In medical research, one uses proven clinical trial methodology and exposes the results to scientific review. The proposed regulations ignore the past 30 years of cannabis research and return New Jersey to the 1970s’ model set by the Drug Enforcement Agency and the production of low quality marijuana at the University of Mississippi. Marijuana is recognized as safe and effective in patients who have not obtained symptom relief with conventional therapy in conditions such as neuropathic pain and spasticity. The regulations represent a missed opportunity for New Jersey to add to the medical development of cannabis. Additionally, seriously ill patients with cancer, MS, or ALS have very limited mobility. The logistics of access to medical marijuana as described in the regulations present an additional burden to caregivers. New Jersey has at least 1,800 pharmacies providing medication including Schedule II potent opiate drugs. The distribution of medicinal cannabis to seriously ill patients should minimize the bureaucratic excess demonstrated by the draft regulations. (24)
RESPONSE: The Department thanks the commenter for the comments concerning medical research. Although the Department relies upon the validity of the studies using marijuana grown by the University of Mississippi, the Department will collect data and continue its review of studies for use in future rulemaking. The rules ensure that registered primary caregivers may purchase medicinal marijuana from ATCs for those patients who have difficulty traveling.
29. COMMENT: The commenter states that he believes marijuana can be used as a treatment for some medical conditions. The commenter states that the rules should be focused and limited. The commenter does not think that anyone should be allowed to grow their own marijuana. The commenter does not want the general population to “go into a state of euphoria.” Generally, the commenter does not want the MMP to be abused and turn into something destructive to society. (27)
RESPONSE: The Department thanks the commenter for his support of the Act and the rules. 30. COMMENT: The commenter states that she suffers from fibromyalgia and gastro paresis, among other medical conditions. The commenter states that medicinal marijuana works in conjunction with her other medications to stimulate her appetite, reduce her nausea, muscle spasms, and body pain and allows her to feel normal. The commenter states that medicinal marijuana allows her to spend more quality time with her family. (28)
RESPONSE: The Department thanks the commenter for her statement in support of medicinal marijuana.
31. COMMENT: The commenter supports the rules on the grounds that the MMP should be limited to patients with bona fide physician-patient relationships who have been certified by those physicians as having a debilitating medical condition enumerated in the Act. (29)
RESPONSE: The Department thanks the commenter for its support of the rules.
32. COMMENT: Two commenters state that implementation of the Act has taken too long and states that the Act should be implemented without further delay. (30, 37)
RESPONSE: The Department is working to implement the Act through rulemaking as soon as possible. In addition, the Department is working closely with the ATCs to ensure that medicinal marijuana is available to registered qualifying patients as soon as practicable.
33. COMMENT: The program is overly restrictive and should have third-party oversight in the form of laboratory quality control of cannabinoid content. (31)
RESPONSE: The Department’s intent with regard to the rules is to ensure that the Act is implemented in a manner that provides access to medicinal marijuana by registered qualifying patients but also contains appropriate safeguards to prevent abuse and diversion, thus fostering public confidence in the integrity of the MMP. The Department’s intent regarding N.J.A.C. 8:64- 13.4(c) is to provide for testing of medicinal marijuana. The Department acknowledges that N.J.A.C. 8:64-13.4(c) does not specifically provide for testing of THC content. The rule does, however, provide that testing may include other things in addition to the listed items such as mold, heavy metals, pesticides, etc. Accordingly, the Department reserves the right to test for THC content.
34. COMMENT: The commenter states that N.J.A.C. 8:64-6.2(a), which requires documented involvement of an acute care hospital with an ATC, is unnecessary because medicinal marijuana is far more likely to be used in a home than in a hospital, and the administration of an ATC bears no relevance to that of a hospital. N.J.A.C. 8:64-11.4(b), which requires ATCs to assess a patient’s pain, is not the business of a dispensary and should be left to medical professionals. (32)
RESPONSE: The Department’s intent with regard to N.J.A.C. 8:64-6.2(a) is to accommodate a number of hospitals that have demonstrated a desire to share their expertise with ATCs in matters that are relevant to the functioning of ATCs. The Department does not intend N.J.A.C. 8:64-11.4(b) to direct the ATCs to assess the patient’s pain, the rule is intended to require the ATC to collect documentation of the patient’s self-assessment of pain and to transmit that data to the Department for review and analysis.
35. COMMENT: The commenter states that the Department’s rules are based on outright falsehoods and generally lack compassion; treat doctors, patients, and ATCs as criminals; and fail to carry out the spirit of the Act. The comment states that what is needed most is a change in attitude by the Department and the administration to recognize that we are not still fighting the abysmal war on drugs of the 1980s and to implement the Act in an honest and compassionate manner. (33)
RESPONSE: The Department intends the rules to strike a balance between the need to provide access to medicinal marijuana for registered qualifying patients and the need to establish adequate safeguards against abuse and diversion that will help foster public confidence in the integrity of the MMP.
36. COMMENT: The commenter states that he has been studying the medicinal use of marijuana since 1995 and has authored over 500 articles and white papers and a book on the subject. Chronic neuropathy should qualify as a debilitating medical condition under the rules. Neuropathic pain is treatable with medicinal marijuana and there is no legitimate reason to exclude this class of patients from relief under the MMP. (34)
RESPONSE: The Department is bound by the Act, which prescribes debilitating medical conditions at N.J.S.A. 24:6I-3. The law provides that the Commissioner may add additional debilitating medical conditions to the list. The Department has codified the process of accepting and processing petitions to add new debilitating medical conditions, which are found at N.J.A.C. 8:64-5.
37. COMMENT: The commenter is an internal medicine physician with an interest in the Act. The commenter states that there are a number of cannabinoids in addition to THC that the Department should consider in its regulatory decisions. One of these predominant cannabinoids is TetraHydroCannabiVarin (THCV), which is said to affect the pharmokinetics of THC including time of onset and offset. If a strain has a high concentration of CBD and a low potency of THC, such as the strain types that the Department’s rules will of necessity require ATCs to grow, that strain will produce in patients a strong, “dream-like head-stone.” The point here is that if the State wants to legislate against patients “getting high,” merely limiting the THC content will not suffice. The commenter does not favor such limits for medical reasons. Pharmokinetics teaches us that Dose=Potency x Quantity. Limiting THC content will result in patients using more, not less, marijuana. Since the chemical brew of marijuana smoke contains plant sterols and terpenes, patients may suffer undetermined deleterious effects. The THC restriction, therefore, will expose the patient to a greater concentration of carcinogens, not less. The euphoric effect cannot be separated from the therapeutic effect. Using medical marijuana, even strictly as medicine, will cause the user to get high. To some patients, this is an unacceptable side effect. To others, this effect is euphoric and desirable. This limbic central nervous system effect may at times be desirable medically. The commenter believes that most legitimate medicinal marijuana patients would not use two ounces per month if the THC content was unrestricted. If, however, the THC content is artificially low, a greater proportion of patients will need the full two ounces per month. Former Commissioner Alaigh quoted a recent study from McGill University in Canada as influencing her 10 percent THC limit decision. In that study, cannabis of 2.5 percent THC did not work at all, was minimally effective at six percent THC, and clinically, but modestly, effective at 9.4 percent. There was no available strain to test the hypothesis that THC content stronger than 9.4 percent would work even better, but the content is at the very least intuitive. For all of these reasons, there should not be a limit on THC content or the number of strains that can be cultivated. Until the FDA understands the true risk/safety/benefit profile of marijuana and puts science and logic ahead of politics, marijuana will remain a Schedule I substance; therefore, it is appropriate for the Department to institute a physician registry. Instead of requiring that an ATC have an affiliation with a hospital, which may fear loss of Federal funding, it may be more appropriate to require that registered physicians be on staff at a New Jersey acute care hospital. There is no need to have physicians on the ATC advisory board as this will severely limit the functionality of the advisory boards due to the scarcity of physicians willing to serve in an uncompensated manner. (36)
RESPONSE: The Department thanks the commenter for the comments, refers the commenter to the Responses to Comments 1, 12, and 13 in regard to THC content and the Response to Comment 34 regarding the hospital affiliation requirement. The Department thanks the commenter for the comment in favor of a physician registry. The Department has a number of advisory boards upon which physicians serve without compensation, has not been advised by any prospective ATCs that physicians are unwilling to serve on their medical advisory boards, and believes that physicians will be available in sufficient numbers to serve on ATC medical advisory boards. Accordingly, the Department adopts the rule as proposed.
38. COMMENT: The commenter is a patient with muscular dystrophy who states that medicinal marijuana has enabled him to stop taking a variety of prescription medications because it alleviates his painful symptoms. The commenter states that in order to escape criminal prosecution, he moved to California, where he can now access medicinal marijuana without fear of prosecution. Unfortunately, this also places him 3,000 miles from his family. The commenter requests that the Department revise its regulations to more closely follow the Act. (38)
RESPONSE: The Department thanks the commenter for his testimonial supporting the effectiveness of medicinal marijuana. N.J.S.A. 24:6I-2e provides that the purpose of the Act is to protect from arrest, prosecution, property forfeiture, and criminal and other penalties, patients, physicians, primary caregivers, and those who are authorized to produce marijuana for medical purposes. The Department intends the rules for the MMP to implement the provisions of the Act in a responsible fashion.
39. COMMENT: The commenter is the sister of a patient with muscular dystrophy. She states that her brother became dull and lifeless on prescription medications such as opiates. When he started using medicinal marijuana, the results were instantaneous and positive, and he was able to quit all the pills he was taking. To avoid prosecution, he moved to California, but the commenter lives in New Jersey and is unable to help her brother with his activities of daily living. The commenter states that if you had a sick loved one, you would want him to have the highest quality medicine and the right strains for his condition. This is what all patients deserve. (39) RESPONSE: The Department thanks the commenter for the comments in favor of medicinal marijuana.
Part Two
The Department received comments on the notice of reproposal dated February 22, 2011 via U.S. Mail and/or from the public hearing on March 7, 2011 from the following individuals:
1. New Jersey Prevention Network, Lakewood NJ by Diane Litterer, Executive Director
2. Steven Fenichel, M.D., Ocean City, NJ
3. Jeffrey S. Pollack, M.D., Mays Landing, NJ
4. New Jersey Hospice and Palliative Care Organization, Scotch Plains, NJ by Donald Pendley, M.A., CAE, APR, President
5. New Jersey Association of Mental Health and addiction agencies, Inc. (NJAMHAA) Mercerville, NJ by Debra L. Wentz, Ph.D., CEO
6. Russell W. Minor Sr., Barnegat, NJ
7. Charles Kwiatkowski (address not listed)
8. Lawrence M. Vargo, Jr., Trenton, NJ
9. Risa Sanders, Long Branch, NJ
10. Medical Marijuana Deliver Systems LLC, Seattle, WA by Jim Alekson, Managing Member
11. American Civil Liberties Union of New Jersey, Newark, NJ by Ed Barocas, Legal Director
12. New Jersey State Nurses Association, Trenton, NJ, by Carolyn Torre RN, MA, APN, Director, Regulatory Affairs
13. Drug Free Schools Coalition of New Jersey, Flemington, NJ by David G. Evans, Esq., Executive Director
14. Diane Riportella, Egg Harbor, NJ
15. Edward R. Hannaman, Esq, Ewing, NJ
16. Coalition for Medical Marijuana - New Jersey, Inc., Trenton, NJ by Ken Wolski, RN MPA, Executive Director
17. Justin Escher Alpert, Esq., Livingston, NJ 18. Nora Giuricci, Clark, NJ
19. Coalition for Medical Marijuana - New Jersey, Inc., Trenton, NJ by Ken Wolfenstein, RN
20. David Simms (address not listed)
21. A.J. Ballinger III (address not listed)
22. Don and Gerry McGrath, Robbinsville, NJ
23. Drug Policy Alliance, Trenton, NJ by Roseanne Scotti
24. Scott Hawkins, Kinnelon, NJ
25. Gold Leaf Organization, (address not listed) by Gregory Golden, Jr.
26. Jim Miller, Toms River, NJ
27. Association of Safe Access Providers (ASAP), Montclair, NJ by Marianne Bays, Ph.d
28. Coalition for Medical Marijuana - New Jersey, Inc., Trenton, NJ by Chris Goldstein
29. Jahan Marcu (address not listed)
30. Jack O’Brien, Laurel Lake, NJ
31. Jay Lassitier (address not listed)
32. NARC New Jersey, (address not listed) by Anne M. Davis, Esq.
33. Sandra Faiola (address not listed)
34. Jennifer Landi, Medford, NJ
35. Stephen Krisvillage (address not listed)
36. Flakewood Tucker, Marlton, NJ
37. Marta Portuguez (address not listed)
38. Rafael Portuguez (address not listed)
39. Luis Santiago, Freehold, NJ
40. David Barnes (address not listed) 41. North Jersey Professional Care (address not listed) and Veterans for Medical Cannabis Access (address not listed) by Darryl Milligan
42. Impact New Jersey (address not listed) and Compassionate Care Centers of America Foundation, Inc., (address not listed) by Raj Mukherji
43. Tom Ines (address not listed)
The numbers in parenthesis after each comment below identify the respective commenters listed above.
40. COMMENT: A number of commenters state that N.J.A.C. 8:64-10.6(c)5 and 10.7(c), which limit the percentage of THC in medicinal marijuana to no more than 10 percent, are inappropriate and overly restrictive rules. The commenters generally point out that other states do not limit THC content in their medicinal marijuana and that such provides patients with greater medicinal options for relief from pain and suffering. The commenters generally state that medicinal marijuana with a maximum of 10 percent THC will be less effective than marijuana with a higher THC content and that this will require higher dosages to achieve a palliative effect and may discourage some patients from participating in the Medicinal Marijuana Program because they can obtain higher potency marijuana on the black market. (2, 3, 4, 7, 9, 12, 14, 16, 18, 19, 23, 25, 27, 28, 29, 32, 34, 35, 36, and 37)
RESPONSE: By limiting medicinal marijuana to a maximum of 10 percent THC and mandating the sale of three strains of medicinal marijuana in a low, medium, and high potency, the Department is able to ensure that doctors and their patients have a reliable and standardized choice of potency options from which to choose. Relevant United States research studies, such as the study concluded in 2010 by the Medicinal Cannabis Research Center at the University of California San Diego, used medicinal marijuana that was no more than 10 percent THC, which was grown by the University of Mississippi. The Medicinal Cannabis Research Center study, conducted over a period of 10 years, demonstrated that medicinal marijuana from the University of Mississippi had a significant clinical effect. In October 2011, the Dutch Government announced that it would outlaw the sale of cannabis in coffee shops with a THC content greater than 15 percent, citing that marijuana with a greater THC concentration should be categorized with hard drugs, such as cocaine and heroin. The 10 percent limit on THC content at the inception of the MMP will provide patients with effective medicine to start and allow the Department to collect data from patients and to evaluate whether the 10 percent limit on THC content should be revisited in future rulemaking.
41. COMMENT: A number of commenters state that N.J.A.C. 8:64-10.7(a), which limits the number of strains of medicinal marijuana that an ATC may cultivate to three, is an unreasonable limitation on each patient’s choice of medicine. The commenters generally state that patients should be free to try many strains of medicinal marijuana as certain strains relieve conditions such as nausea, other strains relieve conditions such as spasticity, and still other strains relieve pain. (2, 3, 4, 9, 12, 14, 16, 22, 23, 27, and 37) RESPONSE: By mandating the sale of three strains of medicinal marijuana of a low, medium, and high dose, the Department is able to ensure patients have a reliable and standardized choice of potency options to choose from. Generally, marijuana is classified as a Schedule I drug under the Federal Controlled Dangerous Substances Act of 1970 and has not gone through a Food and Drug Administration testing process for safety or efficacy. The three strain mandate is a reasonable balancing of State action in developing the MMP to limit distribution to only registered qualifying patients, which is authorized under State law but still considered illegal under Federal law. In addition, the three strain mandate will assist law enforcement authorities in identifying medicinal marijuana that originated from a permitted ATC, which will help prevent possible diversion and establish public trust in the program, a process that has proven challenging in other states. Inasmuch as this is a new program, data collected by the Department will help guide ATCs in choosing the best medicinal strains and help the Department determine through future rulemaking whether different or additional strains would prove beneficial to patients.
42. COMMENT: A number of commenters state that N.J.A.C. 8:64-5.1(a), which provides that the Commissioner shall not take action to approve additional debilitating medical conditions until the Department makes at least two annual reports to the Governor and the State Legislature concerning the MMP, is inappropriate and overly restrictive. The commenters generally point out that other states allow medicinal marijuana use for a wider array of debilitating medical conditions and that it is in the best interests of patient care to consider expanding the list of debilitating medical conditions without delay. Some commenters ask that specific conditions, such as nausea or vomiting, be included. (2, 3, 14, 16, 19, 23, 27, 32, and 34)
RESPONSE: The New Jersey Legislature held hearings prior to passage of the Act and made a determination as to the inclusion of specific debilitating medical conditions and, while considering the qualifying medical conditions under the medicinal marijuana laws in other states, defined its list of debilitating medical conditions as provided by N.J.S.A. 24:6I-3 to start the MMP. N.J.A.C. 8:64-4.3 will require ATCs to report patient survey information to the Department. Consistent with this approach, the Department disagrees that new qualifying conditions should be added before two years’ time. The Department will approve new qualifying conditions only after sufficient data is collected and analyzed to support any such addition. Two years’ time will provide the Department with the ability to collect the requisite data necessary to determine what new conditions, if any, should be added to the list of qualifying conditions. In addition, two years’ time will provide petitioners seeking to establish additional debilitating medical conditions under N.J.A.C. 8:64-5 with additional data to support a bona fide petition for the same.
43. COMMENT: A number of commenters state that six ATCs will not be sufficient to meet patient demand or to provide convenient access to patients and primary caregivers. These commenters generally point out that traveling long distances to the closest ATC will be a hardship for those patients who are very ill and/or do not have a primary caregiver. (3, 5, 14, and 16)
RESPONSE: N.J.S.A. 24:6I-7a requires at least two ATCs in the Northern, Central, and Southern regions of the State. The Department will follow the development of the Medicinal Marijuana Program and seek to ensure the availability of a sufficient number of ATCs. Inasmuch as the MMP is a new program, the Department is without sufficient data upon which to formulate an opinion as to whether additional ATCs will be necessary at this time.
44. COMMENT: Three commenters state that two ounces per month is an insufficient amount of medicinal marijuana because it will only permit a patient to use marijuana once or twice per day. The comments state that since the medicinal marijuana available under the proposed rules will be limited to 10 percent THC content, patients will be forced to consume higher dosages and will, therefore, run out of medicinal marijuana quickly if limited to no more than two ounces per month. (3 and 12)
RESPONSE: The two ounces per month limitation is set by statute at N.J.S.A. 24:6I-10a, which provides that a physician may only authorize, and an ATC may only dispense, a maximum of two ounces of medicinal marijuana to a patient in a 30-day time period. Accordingly, the Department is required to comply with the statute and does not have the authority to exceed the two ounces per 30-day time period limit. The Department does not have sufficient data upon which to base a determination concerning the dosages and frequencies of dosages of medicinal marijuana for various debilitating medical conditions that physicians will determine, in consultation with their patients, to be effective.
45. COMMENT: The commenter testified that the ATC application process, with its RFA requirement and deadline to accept applications, was onerous and designed to discourage applications. (36)
RESPONSE: The Department created the application process in an effort to implement the Act. The RFA process was a valid exercise of administrative authority conferred upon the Department by N.J.S.A. 24:6I-16.
46. COMMENT: A number of commenters object to the requirement at N.J.A.C. 8:64-2.5(a), which incorporates N.J.A.C. 13:35-7A by reference. Proposed N.J.A.C. 13:35-7A.5(c)3 would require physicians to “periodically make reasonable efforts, unless clinically contraindicated, to stop the medical use of marijuana, decrease the quantity authorized or try other drugs or treatment modalities in an effort to reduce the potential for abuse or the development of physical or psychological dependence.” The commenters generally state that medicinal marijuana patients are frequently terminally ill, and therefore, it makes no sense to attempt to wean these patients off of medicine that alleviates the patient’s suffering. (3)
RESPONSE: The Department’s rule at N.J.A.C. 8:64-2.5(a) incorporates a Board of Medical Examiners rule at N.J.A.C. 13:35-7A by reference. The practice of medicine is regulated by the BME. The BME determined not to adopt the rule as proposed. Accordingly, the rule upon adoption will not require a physician to take steps periodically to stop or reduce the use of medicinal marijuana. The rule will provide, in relevant part at N.J.A.C. 13:35-7A.5(c), “[i]f the physician determines that the patient is achieving treatment objectives, and is not experiencing untoward side effects or physical or psychological problems associated with marijuana use, the physician may continue the patient’s treatment with medical marijuana without alteration.” 47. COMMENT: A number of commenters stated that proposed N.J.A.C. 8:64-12, Home delivery, is too restrictive. Generally, the commenters stated that all patients should be eligible for home delivery automatically because most prospective qualifying patients are very ill and/or do not have a primary caregiver, making travel a hardship. (4, 14, 16, 23, 27, 33, and 34) One commenter stated that a one day wait for home delivery was cruel since it could cause a patient to suffer without his or her medicine. (4)
RESPONSE: A bi-partisan agreement between Governor Chris Christie and Assemblyman Reed Gusciora, one of the primary sponsors of the Act, that was announced on December 3, 2010, eliminated home delivery as part of an effort to reach a compromise to implement the MMP. In addition, the Department's concern for the security of patients, ATC employees, the potential for diversion, and the need to ensure the safety of the public weighed against home delivery in this rulemaking. Experience with the program will determine whether home delivery is needed in the future. The rules ensure that registered primary caregivers may purchase medicinal marijuana from ATCs for those patients who have difficulty traveling, thereby allowing those patients who are unable to travel to an ATC to receive medicinal marijuana. Accordingly, the Department removed home delivery from N.J.A.C. 8:64-12 in the notice of reproposal dated February 22, 2011.
48. COMMENT: The commenter represents a network of substance abuse agencies providing services in New Jersey. The commenter opposed passage of the Act and is concerned that the rules will send a mixed message to our youth. Nevertheless, the commenter supports the rules because they are restrictive. (1)
RESPONSE: The Department thanks the commenter for its support of the rules.
49. COMMENT: A number of commenters stated that the fees to obtain registry identification cards for both qualifying patients and their primary caregivers are excessive. Generally, the commenters point out that the $200.00 fee proposed by the Department at N.J.A.C. 8:64-2.1(c) is the highest in the nation and constitutes an undue burden on very sick patients that are unable to work and have high medical expenses. (2, 4, 14, 16, 18, 21, and 22)
RESPONSE: The Department disagrees with the comment. Arizona, for example, charges $150.00 for a patient registry card that must be renewed annually. Colorado charges $90.00 for a patient registry card that must be renewed each year. Michigan charges $100.00 for a patient registry card that must be renewed each year. The Department charges $200.00 for a patient registry card that is valid for a two-year period, making the annual cost $100.00 per year. This is generally in accord with the fee schedule of the aforementioned states. In addition, N.J.S.A. 24:6I-11b provides that all fees collected shall be used to offset the cost of the MMP. In order to reduce the cost of registry identification cards for individuals with a limited income, the Department adopts N.J.A.C. 8:64-2.1(c)1, which provides that the fee for a registry identification card for an individual receiving Medicaid benefits, food stamp benefits (now known as the Supplemental Nutrition Assistance Program), New Jersey Temporary Disability Insurance benefits, Supplemental Security Income benefits, or Social Security Disability benefits will be $20.00. Because all registry identification cards will be valid for a period of two years and re- registration is only necessary once every two years. 50. COMMENT: The commenter supports the positive innovation that the MMP should be limited to patients with bona fide physician-patient relationships as defined at N.J.A.C. 8:64-1.2. Marijuana is a Schedule I substance; therefore, it is appropriate for the Department to institute a physician registry, although the attestation is a major deterrent to physician participation because very few physicians have experience and training in pain management and addictive medicine. The Department does not yet understand that marijuana is not physically addictive. It is safe to immediately discontinue use, even in long-time users, and there are no physical withdrawal symptoms. The Department should remove the “experience and training in addictive medicine” attestation requirement. The physician certification statement at N.J.A.C. 8:64-2.5(a)9i should not have quotation marks, demonstrates the Department’s bias against medicinal marijuana, and is inappropriate because it must be stated exactly in all cases without regard for the individual circumstances of each patient. The list of qualifying debilitating medical conditions is a positive and clearly defines appropriate cannabis indications. (3)
RESPONSE: The Department thanks the commenter for the comments concerning the bona fide physician-patient relationship requirement, the physician registry, the safety of medicinal marijuana use, and the list of debilitating medical conditions. There is no requirement in the Department’s rules that a certifying physician must have or certify that he or she has “experience and training in addictive medicine.” The Department declines to remove the quotation marks from N.J.A.C. 8:64-2.5(a)9i because the Department intends this rule to memorialize that the certifying physician has explained the possible risks of medicinal marijuana use to the patient. The Department understands that marijuana may possess only mild physically addictive properties.
51. COMMENT: The commenter states that N.J.A.C. 8:64-6.2(a), which requires documented involvement of an acute care hospital with an ATC, is unnecessary because medicinal marijuana is far more likely to be used in a home than in a hospital and the administration of an ATC bears no relevance to that of a hospital. N.J.A.C. 8:64-11.4(b), which requires ATCs to assess patient’s pain, is not the business of a dispensary and should be left to medical professionals. (4)
RESPONSE: The Department’s intent with regard to N.J.A.C. 8:64-6.2(a) is to accommodate a number of hospitals that have demonstrated a desire to share their expertise with ATCs in matters that are relevant to the functioning of ATCs. The Department does not intend N.J.A.C. 8:64-11.4(b) to direct the ATCs to assess the patient’s pain, the rule is intended to require the ATC to collect documentation of the patient’s self-assessment of pain and to transmit that data to the Department for review and analysis.
52. COMMENT: The commenter supports the rules and would like to see the definition of “debilitating medical condition” at N.J.A.C. 8:64-1.2 modified to include a “time frame or a strong, general guideline provided for referring patients for marijuana therapy after resistance to conventional treatments becomes evident, in an effort to ease patients’ suffering.” (5)
RESPONSE: N.J.S.A. 24:6I-3 establishes the definition of the term, “debilitating medical condition.” The Department is bound by the definition in the statute. 53. COMMENT: A number of commenters state that marijuana helps relieve the pain that they have from a variety of ailments and injuries and that it helps them with nausea or stress. Some of these commenters testified that they have loved ones who benefit greatly from medicinal marijuana. Generally, these commenters state that they dislike being labeled as criminals because they have found that marijuana helps them to live more normal lives and they look forward to becoming registered qualifying patients. (6, 7, 20, 21, 26, 30, 31, 32, 33, 34, 35, 37, 38, 39, 40, and 41)
RESPONSE: The Department thanks the commenters for sharing their experiences in favor of medicinal marijuana.
54. COMMENT: The commenter states that the Department should include chronic pain and neuropathic pain as debilitating medical conditions. The commenter states that his physician estimates that he could reduce his dependency on serious pain medication, including daily regimens of morphine sulfate instant and extended relief and tramador, by one half by using medicinal marijuana, but the commenter does not qualify under the current list of debilitating medical conditions. (8)
RESPONSE: The list of debilitating medical conditions is prescribed by statute at N.J.S.A. 24:6I-3. The Department has adopted a process whereby individuals can petition to add additional debilitating medical conditions to the list at N.J.A.C. 8:64-5.
55. COMMENT: The commenter states that he represents a business entity that has developed a patch for the transcutaneous delivery of medicinal marijuana to humans and animals. The commenter states that the patch is a superior medicinal marijuana delivery system when compared to smoking and consistently offers dependable dosages. The Department should consider taking “the lead in demonstrating to the rest of the United States that marijuana can be effectively controlled for medicinal purposes.” (10)
RESPONSE: The Department does not have sufficient information upon which to base an opinion concerning the comment. The product described by the commenter has not been approved for use by the Federal Food and Drug Administration and therefore cannot be approved for use by the Department. The Department will continue to review literature, government approved studies, and journal publications concerning the transcutaneous delivery of medicinal marijuana and may consider additional delivery methods in future rulemaking.
56. COMMENT: One commenter states that N.J.A.C. 8:64-13.1(d), which will prohibit ATCs from advertising prices of medicinal marijuana except to registered qualifying patients and primary caregivers inside the ATC itself, violates the First Amendment to the United States Constitution. The commenter states that the rule serves to deny legal consumers of products from being provided with truthful, non-misleading information about those products, which is necessary for them to make informed decisions about those products, and that the State has no justifiable interest, that can override the First Amendment, in precluding or severely limiting the dissemination of non-misleading pricing information to legal consumers. (11) RESPONSE: The Department respectfully disagrees with the commenter. The provision in question is a reasonable restriction upon advertising by alternative treatment centers that is intended to ensure that only those who are legally entitled to use medicinal marijuana receive pricing information. The requirement is necessary to protect the State’s substantial interest in ensuring that only those individuals who may legally purchase medicinal marijuana receive pricing information, thereby discouraging attempts by black market vendors to undercut lawful sales by alternative treatment centers. Unlike other forms of advertising, including advertising regarding alcohol and tobacco, it is significant that the use of marijuana remains illegal for most of the residents of the State. Since the use of marijuana is prohibited for most of the population, the need for its efficient allocation and distribution through commercial advertising is less compelling. Therefore, the advertising of medicinal marijuana must necessarily be limited and narrowly tailored to reach the small population of qualifying registered patients. Not only does the State have an interest in limiting advertising to legal users, the State has a substantial interest in discouraging commercial advertising of marijuana to the general public that would unavoidably encourage or trivialize the sale and use of an illegal drug. The rule directly advances the aforementioned substantial government interests and is not more extensive than necessary to serve those interests. The rule would not prevent alternative treatment centers from providing registered users with pricing information at the facility or when the qualifying registered patient otherwise contacts the facility, such as by phone. Although not defined in the proposed rules, the common meaning of the term, “advertise” is to make public announcement of, to make generally known or to call the attention of the public to a product or business. Therefore, the proposed rule is intended to prohibit ATCs from advertising prices to the public, but it is not intended to prohibit ATCs from providing pricing information to any qualifying registered patient or any registered primary caregiver. In addition, the advertising restriction is consistent with the Department’s longstanding public health policies against tobacco use and the advertising and sale of tobacco products to minors. Therefore, the Department makes no change on adoption.
57. COMMENT: The commenter states that his organization opposed the Act. Marijuana has not been proven safe and effective. Marijuana is not medicine. The Act violates Federal law and is, therefore, illegal. The commenter is “not aware of any significant ‘clinical’ trials with smoked marijuana” and states that the 10 percent THC limit is too high. The commenter states that marijuana “is addictive at any level.” (13)
RESPONSE: The New Jersey Legislature found that modern medical research has discovered a beneficial use for marijuana in treating or alleviating the pain or other symptoms associated with certain debilitating conditions as found by the National Academy of Science’s Institute of Medicine in March 1999. This finding was declared at N.J.S.A. 24:6I-2.
58. COMMENT: The commenter makes a number of comments concerning the rule, generally stating that the rules are contrary to the legislative intent and effectively rewrite the Act from beginning to end. N.J.A.C. 8:64-2.2 mandates that for a patient to register, the treating physician must register and obtain a certification number, in violation of the definition of “qualified patient” in the Act. The commenter states that the Act purposely does not require a physician registry because marijuana is illegal under Federal law and it is unwise to create a registry of “marijuana doctors” who may then be in danger of Federal prosecution. N.J.A.C. 8:64-2.2 imposes conditions, such as requiring patients to provide a government photo identification card, that will be difficult for many patients to meet. N.J.A.C. 8:64-2.5(a)6 requires the physician to disclose the patient’s diagnosis, which violates patient confidentiality, and is not called for in the Act. N.J.A.C. 8:64-2.5(a)9, which requires physicians to inform patients that there exists a lack of scientific consensus for the use of medicinal marijuana, is in direct conflict with the Act, which states that modern medical research has discovered beneficial uses for marijuana. The commenter states there has never been a single fatality from the use of marijuana and that it is impossible to overdose on it. The commenter states that N.J.A.C. 8:64-2.2(f)1, which states that the custodial parent of a registered qualifying patient who is a minor shall be issued a primary caregiver registration card by the Department for no additional fee, is inconsistent with N.J.A.C. 8:64-2.3, which would appear to require the custodial parent of a registered qualifying patient who is a minor to submit to a background check, pay for the same, and also to pay a $200.00 fee for a registry identification card. The commenter states that N.J.A.C. 8:64-3.4(c), which requires registry cards to be surrendered to the Department when any information on the card changes or an new ATC is designated, will operate to deprive patients of medicinal marijuana between the time that the original registry certification card is surrendered and a new card is issued. N.J.A.C. 8:64-4.1(a) is inconsistent with the Act because the rule requires the qualifying patient, primary caregiver, parent, guardian, or other custodian of a qualifying patient who is a minor, to notify the Department of any change in the qualifying patient’s name, address, ATC, or physician within 10 days of the change, whereas the Act only places such notification requirements on qualifying patients. N.J.A.C. 8:64-4.3(a)2, which requires ATCs to report each patient’s diagnosis to the Department, encourages a violation of the Act, which provides that the patient’s application or receipt of a registry card does not constitute a waiver of the qualifying patient’s patient-physician privilege. The commenter states that N.J.A.C. 8:64-4.3(a)6 (codified as N.J.A.C. 8:64-4.3(a)5 in the February 22, 2011 notice of reproposal), which requires ATCs to provide a summary of patient surveys and evaluation of services to the Department, is an improper delegation to the ATCs of the Department’s responsibility to collect this information under the Act because the definition of ATC in the Act does not contain such obligations. N.J.A.C. 8:64-6.1(d), which states that the Department shall only accept and process ATC applications after making a formal request for applications (RFA), is in violation of the Act, which states that the Department “shall accept” ATC applications without such a constraint. N.J.A.C. 8:64-6.2 provides for a selection committee to review ATC applications, but the rule fails to include information as to the committee’s members or qualifications. N.J.A.C. 8:64-6.4 does not provide for a time frame within which the Department shall review and issue a decision on an ATC application. N.J.A.C. 8:64-7.1(b)2ii, which requires an ATC applicant to disclose the names, addresses, and other information concerning its employees, presumably before the ATC gets approval to operate, is not appropriate because it is inconsistent with how businesses operate. N.J.A.C. 8:64-9.3(a)9, which requires an ATC to disclose how it determines the prices it charges for medicinal marijuana, is of no legitimate concern to the Department. The requirements at N.J.A.C. 8:64-7.1(b) are unnecessary roadblocks to approval and are vague. The on-site prohibitions on food sales and consumption at N.J.A.C. 8:64-9.2, the on-site parking requirement at N.J.A.C. 8:64-9.7(b) and the signage requirements at N.J.A.C. 8:64-13.1(c) (codified as N.J.A.C. 8:64-12.1(c) in the February 22, 2011 notice of reproposal) violate local land use laws which are the province of local, not State, governments. The security requirements at N.J.A.C. 8:64-9.7(b) are overly burdensome and costly for the ATCs. N.J.A.C. 8:64-10.6(d)1 requires a statement on the medicinal marijuana package that states that the product is not intended to diagnose, treat, cure, or prevent any disease, which is inconsistent with the Act, which states that modern medical research has discovered beneficial uses for marijuana in treating or alleviating pain or other symptoms associated with certain debilitating medical conditions. N.J.A.C. 8:64-10.8(e) would allow oral lozenges to be dispensed by ATCs; however, oral lozenges are not used as a delivery method for medicinal marijuana according to most experienced people in the field. N.J.A.C. 8:64-10.11(e) (not codified in the February 22, 2011 notice of reproposal) provides that medicinal marijuana shall be transported in conformance with State and Federal laws, but since it is an illegal substance under Federal law, one is left to guess which Federal law applies. N.J.A.C. 8:64-11.1 requires the ATCs to provide educational materials to patients and primary caregivers, but this function should more properly be performed by the Department. N.J.A.C. 8:64-11.2(c), which requires ATCs to ask patients and primary caregivers for permission to contact them with information about peer review clinical studies concerning the use of medicinal marijuana, is a function that should be more properly performed by the Department. N.J.A.C. 8:64-11.3(b), which requires an ATC to maintain a copy of the registered qualifying patient’s (and, if applicable, primary caregiver’s) patient identification card and other form of government issued photo identification card, is violative of the Act, which only requires a patient to submit his or her patient identification card and physician’s recommendation to the ATC in order to obtain medicinal marijuana. N.J.A.C. 8:64- 11.4, which requires ATCs to document patient self-assessment of pain, is not the proper function of the ATC, but rather, the Department. N.J.A.C. 8:64-11.5(a), which requires an ATC to stop dispensing medicinal marijuana to an individual that the ATC believes is abusing the substance or redistributing it, treats marijuana as illegal and patients as criminals. N.J.A.C. 8:64- 12.1(f), which prohibits an ATC from selling t-shirts or other promotional items displaying a reference to marijuana, is unconstitutional because the sale of medicinal marijuana by an ATC is a legitimate business. N.J.A.C. 8:64-13.4(c) does not provide for testing of medicinal marijuana’s THC content. The commenter points out that N.J.A.C. 8:64-13.11, which references the protections from prosecution that patients are guaranteed under the Act, does not expand on the protections such as by providing that a patient shall not be fired from his job for using medicinal marijuana if there is no corresponding poor work performance. The commenter states that generally, the rules are not reasonable. (15)
RESPONSE: The Department disagrees that the definition of “qualifying patient” in the Act precludes a physician registry. The purpose of the physician registry is, consistent with a medical model of care, to place control for access to medicinal marijuana in the hands of qualified physicians. The requirement at N.J.A.C. 8:64-2.2 for a patient to provide a government photo identification card is intended to ensure proper patient identification. The Department is required to verify that a qualifying patient has a certification signed by a physician that establishes that a patient has a debilitating medical condition under N.J.S.A. 24:6I-3. Accordingly, N.J.A.C. 8:64- 2.5(a)6 requires a physician to provide the Department with the qualifying patient’s diagnosis. The Department will not disclose patient identifiable health information to third parties and will maintain this information in a confidential manner. The Department disagrees that N.J.A.C. 8:64-2.5(a)9, which requires physicians to inform patients that there exists a lack of scientific consensus for the use of medicinal marijuana, is inconsistent with the legislative findings and declarations stated at N.J.S.A. 24:6I-2a, that modern medical research has discovered a beneficial use for marijuana. Medicinal marijuana provides benefits in treating or alleviating pain or other symptoms associated with certain debilitating medical conditions; however, there exists a lack of scientific consensus concerning, but not limited to, the following areas: dosages, frequency of dosages, delivery routes and methods, the most suitable strains for the treatment of specific conditions, and which cannabinoid compounds affect which areas of the body. The Department is without sufficient information upon which to form an opinion concerning the commenter’s statement that there has never been a single fatality from the use of marijuana and that it is impossible to overdose on it. The Department does not intend to require the parents of registered qualifying patients who are minors to submit to background checks or to pay a fee for a primary caregiver registration card as provided at N.J.A.C. 8:64-2.2(f)1. The Department does not intend to apply N.J.A.C. 8:64-3.4(c) in a manner which will cause a registered qualifying patient to be deprived of medicinal marijuana while the patient awaits the Department issuance of a new registry identification card. N.J.A.C. 8:64-4.1(a) is consistent with the Act because the Act intends for the patient to notify the Department when certain material information changes and in some cases, where the patient is a minor or very ill, it is appropriate for the parent, guardian, or primary caregiver, who stands in the place of the patient, to provide such notification to the Department. The Department disagrees that N.J.A.C. 8:64-4.3(a)2 encourages a violation of patient confidentiality because the rule does not contain a requirement that the patient’s identity be linked to a record of the patient’s debilitating medical condition. The ATC reporting requirement at N.J.A.C. 8:64-4.3(a)6 is a means of collecting summaries of patient surveys by the Department, not a delegation of this responsibility to the ATCs. The Department disagrees that N.J.A.C. 8:64-6.1(d) is violative of the Act. The request for applications (RFA) process is a permitted exercise of the broad discretion granted to State agencies in determining how to fulfill their statutory obligations. In this case, N.J.A.C. 8:64-6.1(d) is reasonable and a permissible means of implementing the statutory requirements within the Department’s discretion, as provided by the Act, to determine whether ATC applicants meet the standards set forth in the Act and the rules, and this rule is in keeping with the Department’s discretion to issue additional permits “pursuant to need.” The Department declines to specify selection committee members and qualifications at N.J.A.C. 8:64-6.2 upon adoption because this is not a requirement of the Act. In the event that the Department issues an RFA, the Commissioner will exercise discretion to appoint committee members who possess knowledge and expertise applicable to the committee’s role in evaluating and scoring each application. The Department declines to adopt a time for reviewing ATC applications at N.J.A.C. 8:64-6.4 because the timeframe of 60 days is set by statute at N.J.S.A. 24:6I-7e. The Department disagrees with the statement that N.J.A.C. 8:64-7.1(b)2ii is not an appropriate rule because it is inconsistent with how businesses operate. Businesses in the health care field, such as air medical services, are generally required to provide the names, addresses, and professional training and qualifications of their employees on their applications for licensure. Accordingly, the rule is consistent with how businesses operate. The Department will look at this issue as it gathers more data and experience in the MMP. The Department disagrees that N.J.A.C. 8:64-9.3(a)9, which requires an ATC to disclose how it determines the prices it charges for medicinal marijuana, is of no legitimate concern of the Department. The rule at N.J.A.C. 8:64-10.8(e) is intended by the Department to permit an ATC to offer an edible form of medicinal marijuana to registering qualifying patients. Medicinal marijuana lozenges are available to patients in Colorado, Michigan, and other states that permit marijuana use for medicinal purposes.
N.J.S.A. 24:6I-12c requires the Department to report to the Governor and the Legislature whether any ATC has charged excessive prices for medicinal marijuana that the ATC has dispensed. The Department disagrees that N.J.A.C. 8:64-7.1(b), which requires an ATC applicant to disclose the legal name of the corporation, a copy of the corporate by-laws, the names and addresses of the ATC’s owners, as well as other information, creates unnecessary and vague roadblocks to approval. The Department disagrees that the prohibitions on food sales and consumption at N.J.A.C. 8:64-9.2, the on-site parking requirement at N.J.A.C. 8:64-9.7(b), and the signage requirements at N.J.A.C. 8:64-12.1(c) violate local land use laws, which are the sole province of local governments. It is well established that both the Department and local boards of health have joint authority to regulate in these areas for the benefit of public health and safety. The Department disagrees that the security requirements at N.J.A.C. 8:64-9.7(b) are overly burdensome to ATCs. The requirement that an ATC have a good alarm and security system is necessary to prevent diversion and cultivate public confidence in the MMP. The statement required by N.J.A.C. 8:64-10.6(d)1 is not inconsistent with the Act because the Act does not state that medicinal marijuana is intended to diagnose, treat, cure, or prevent specific diseases. The rule at N.J.A.C. 8:64-10.8(e) is intended by the Department to permit an ATC to offer an edible form of medicinal marijuana to registering qualifying patients. The rule at N.J.A.C. 8:64- 10.11 is intended by the Department to ensure that medicinal marijuana is transported in compliance with all State and Federal laws, including motor vehicle laws. The specific requirement that an ATC – cultivation transport marijuana in conformance with State and Federal law contained in N.J.A.C. 8:64-10.11(e) of the November 15, 2010 original notice of proposal was not contained in the February 22, 2011 notice of reproposal; therefore, this specific issue is moot. The rules at N.J.A.C. 8:64-11.1 and 11.2(c) are intended by the Department to ensure that ATCs, who have more physical contact with patients than Department employees, disseminate educational materials, and make an effort to share information about peer review clinical studies to registered qualifying patients. N.J.A.C. 8:64-11.3(b), which requires an ATC to keep a copy of a registered qualifying patient’s photo identification card on file, is not violative of the Act. The rule is a valid exercise of the Department’s rulemaking authority under N.J.S.A. 24:6I-16 and necessary to verify the identity of a registered qualifying patient and, if applicable, a primary caregiver upon their first visit to the ATC. The Department intends N.J.A.C. 8:64-11.4 to provide information to the Department for use in determining the effectiveness of the MMP. N.J.A.C. 8:64-11.5(a) is intended to confer authority upon the ATC to stop dispensing medicinal marijuana to an individual that the ATC believes is using the medicine for an illegal purpose, not to treat the medicinal use of marijuana as illegal or to characterize patients as criminals. N.J.A.C. 8:64-12.1(f) is a limited restriction on the use of symbols or references to marijuana on t-shirts or novelty or promotional items that is constitutionally permitted. It is not a complete ban on the sale of t-shirts or promotional items and it does not by its terms apply to paraphernalia, such as a vaporizer, which may understandably contain symbols or references to marijuana in an instructive label or pamphlet. The Department acknowledges that N.J.A.C. 8:64-13.4(c) does not specifically provide for testing of THC content. The rule does, however, provide that testing may include other things in addition to the listed items such as mold, heavy metals, pesticides, etc. Accordingly, the Department reserves the right to test for THC content. The Department intends N.J.A.C. 8:64-13.6 and 13.7 to work together to provide a mechanism for the Department to enforce the provisions of the Act and the administrative rules. The Department intends N.J.A.C. 8:64-13.11 to reference the protections that patients are guaranteed under the Act and reserves the right to consider additional protections in future rulemaking. 59. COMMENT: The commenter states that the entire physician registry should be removed. The physician certification statement on the “lack of scientific consensus for the use of medicinal marijuana” should be removed. The requirement that a physician must also possess an active controlled dangerous substances registration should be removed. The requirement that a physician shall refer a minor to a pediatrician and a psychiatrist before recommending medicinal marijuana should be removed. The ATCs should be allowed to makeup their own medical advisory boards, the ban on volume discounting should be removed, the ATCs should be allowed to carry an inventory equal to three month’s supply per patient, and home delivery should be permitted. The ATCs should not be permitted to collect patient identifiable health information or to survey patients. Patients should not be required to register with only one ATC at any given time and additional forms of proof of State residency should be permitted. The parent or guardian of a minor patient should not be required to qualify as a primary caregiver. (16)
RESPONSE: The Department disagrees that the physician registry should be removed. The purpose of the physician registry is, consistent with a medical model of care, to place control for access to medicinal marijuana in the hands of qualified physicians. The requirement at N.J.A.C. 8:64-2.2 for a patient to provide a government photo identification card is intended to ensure proper patient identification. The Department disagrees that N.J.A.C. 8:64-2.5(a)9, which requires physicians to inform patients that there exists a lack of scientific consensus for the use of medicinal marijuana, should be removed. Medicinal marijuana provides benefits in treating or alleviating pain or other symptoms associated with certain debilitating medical conditions; however, there exists a lack of scientific consensus concerning, but not limited to, the following areas: dosages, frequency of dosages, delivery routes and methods, the most suitable strains for the treatment of specific conditions, and which cannabinoid compounds affect which areas of the body. The requirement that a physician must possess an active controlled dangerous substances registration is appropriate and consistent with the current classification of marijuana as a Schedule I drug under Federal law. The requirements that a physician shall refer a minor to a pediatrician and a psychiatrist before recommending medicinal marijuana are intended by the Department to provide additional safeguards for the care of minors; therefore, the Department disagrees that they should be removed. N.J.A.C. 8:64-1.2 defines “medical advisory board” as a body that is appointed by the ATC. The Department’s intent with N.J.A.C. 8:64-10.1(a)2, which bans volume discounts on sales, is to discourage an ATC from becoming chiefly a cultivator that sells medicinal marijuana to other ATCs rather than a cultivator/dispenser that serves registered qualifying patients. The Department disagrees that three month’s supply per patient would be a reasonable inventory for an ATC to maintain. The Department intends N.J.A.C. 8:64-11.4, which requires an ATC to survey patients, to provide information to the Department for use in determining the effectiveness of the MMP. The Department intends N.J.A.C. 8:64-2.2(a)4i, which requires that a patient may register with only one ATC at any given time, to aid with control, monitoring, and inventory tracking at each ATC. The Department disagrees that additional forms of proof of State residency should be permitted because a driver’s license, government-issued identification card, or a utility bill is already acceptable as provided by N.J.A.C. 8:64-2.2(a)6. The Department disagrees that a parent or guardian of a minor registered qualifying patient should not be required to qualify as a primary caregiver. Accordingly, N.J.A.C. 8:64-2.2(f) requires such qualification; however, no application fee shall apply. 60. COMMENT: The commenter testified that the rules are arbitrary, capricious, and unconstitutional and that the Department needs to listen to patients and make significant changes. (17)
RESPONSE: The Department respectfully disagrees and considers the rules to be a valid exercise of the Department’s rulemaking authority under N.J.S.A. 24:6I-16. The rules are rationally related to the State’s objective of implementing a well-regulated medicinal marijuana program that will provide needed medicine to registered qualifying patients.
61. COMMENT: The bona fide physician-patient relationship defined at N.J.A.C. 8:64-1.2 is inconsistent with the Act, which does not require that a physician treat a patient for a specific period of time in order for the bona fide physician-patient relationship to be created. The commenter is concerned that this provision could result in an unnecessary delay for a patient to obtain a physician’s certification to use medicinal marijuana. The word “certify” should be removed from the rules because Federal officials have the right to prosecute physicians for violations of Federal law, such as certifying or authorizing patients to use medicinal marijuana and states should, therefore, avoid these words in order to protect physicians from Federal prosecution. N.J.A.C. 8:64-2.5(a)9, which requires physicians to inform patients that there exists a lack of scientific consensus for the use of medicinal marijuana, is more of a political statement than a medical statement and should be removed from the rules because it is an obtrusive interference with the physician-patient relationship. N.J.A.C. 8:64-3.4, which requires primary caregivers to execute a certification stating that they will comply with various conditions, including only purchasing medicinal marijuana from the designated ATC on his or her registry identification card, is not required by the Act and is unnecessarily and excessively intrusive. The requirement of approval of the local governing body where the ATC will be located is overly onerous and creates an unnecessary financial risk for ATCs. The restriction on consumption of food and beverages at ATCs is unique among medicinal marijuana states and is not justifiable. The complete ban on persons under the age of 18 in ATCs will present a hardship for patients and caregivers who need to pick up their medication but are unable to obtain child care. No such restriction applies to New Jersey pharmacies. The security requirements at N.J.A.C. 8:64-9, particularly the requirements to provide neighbors within 100 feet of the ATC with a phone number where they can reach an ATC employee after hours, the drug free school zone 1,000-foot location restriction, and the video monitoring requirements, are excessive. (23)
RESPONSE: N.J.S.A. 24:6I-3 defines “physician,” in relevant part, as a person 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 medical marijuana or consultation solely for that purpose.” The intent of the law is to prevent patients from simply consulting with a physician for the sole purpose of obtaining a patient registry identification card from the Department to use medicinal marijuana with no ongoing care or treatment from that physician. The definition of bona fide physician-patient relationship defined at N.J.A.C. 8:64-1.2 furthers the legislative intent through rulemaking, specifically by establishing what is meant by “ongoing” responsibility for the patient’s care. The Department notes that the Board of Medical Examiners, which is the agency responsible for regulating physicians, proposed similar language to define “ongoing responsibility” at N.J.A.C. 13:35-7A.2. Accordingly, in the notice of reproposal dated February 22, 2011, the Department incorporates the BME rule by reference. The word, “certification” is a defined term at N.J.S.A. 24:6I-3. The Department is bound by the language in the statute, which requires physicians to “certify” that they have a bona fide physician-patient relationship with a qualifying patient which attests to the physician’s authorization for the patient to apply for registration to the MMP. The Department disagrees that N.J.A.C. 8:64-2.5(a)9 is more of a political statement than a medical statement because the Department intends this rule to memorialize that the certifying physician has explained the possible risks of medicinal marijuana use to the patient. The Department intends N.J.A.C. 8:64-3.4 to be a valid exercise of rulemaking authority under N.J.S.A. 24:6I-16 that is consistent with the Act and that explains to primary caregivers, through reading and agreeing to the certification, that they are responsible to only purchase medicinal marijuana from an ATC, that they may not grow marijuana for their patient, that they are required to notify the Department if their patient wants to designate a new ATC, etc. The Department does not agree that requiring approval for the location of ATCs from local governments is overly restrictive. As a practical matter, ATCs and other businesses must generally locate in areas that local governments have zoned for their business activity. The restriction on the consumption of food and beverages at ATCs found at N.J.A.C. 8:64-9.2(b) is intended by the Department to foster a businesslike atmosphere at the ATC that is focused on providing the patient with medication. The general ban on persons under the age of 18 in ATCs at N.J.A.C. 8:64-9.2(d) does not apply to registered qualifying patients who are minors, as long as the minor is accompanied by his or her primary caregiver and is intended to limit the exposure of minors who are not registered qualifying patients to medicinal marijuana and paraphernalia. The Department believes that all of the security requirements are necessary in order to ensure a safe, adequate supply of medicinal marijuana to patients, to prevent diversion, and to instill public confidence in the integrity of the MMP.
62. COMMENT: The commenter states that he represents a business entity that sells medicinal marijuana patches, lozenges, etc. (24)
RESPONSE: The Department thanks the commenter for the comment.
63. COMMENT: The commenter represents an ATC applicant and testified that the rules are consistent with a medical model and are generally appropriate, especially for ATCs. (42)
RESPONSE: The Department thanks the commenter for his support of the rules.
64. COMMENT: The commenter states that the rule prohibiting a doctor who is on an ATC’s corporate board from serving on the medical advisory board and the rule that requires an ATC to affiliate with a hospital are restrictive. (43)
RESPONSE: The Department intends the definition of “medical advisory board” at N.J.A.C. 8:64-1.2 to establish an advisory body that can provide medical advice to an ATC without a conflict of interest that would be created if an owner or officer of the ATC were permitted to serve on the advisory board. The Department intends the rule requiring an ATC to affiliate with an acute care hospital to benefit the ATC by creating an association whereby the hospital would be in a position to provide the ATC with advice and consultation. Federal Standards Statement
Existing Federal law prohibits the manufacture, possession, sale, or distribution of marijuana for any reason. 21 U.S.C. §§ 841 et seq. The Act provides at N.J.S.A. 24:6I-2d, “States are not required to enforce federal law or prosecute people for engaging in activities prohibited by federal law; therefore, compliance with [the Act] does not put the State of New Jersey in violation of federal law.”
The new rules conflict with Federal law, which prohibits marijuana cultivation, possession, sale, and distribution. The Department has determined that the only way to fulfill its obligation to implement the Act pursuant to N.J.S.A. 24:6I-1 et seq., particularly 24:6I-7 and 16, is to promulgate the new rules to establish standards governing the cultivation, possession, manufacture, sale, and use of medicinal marijuana.
On October 19, 2009, United States Attorney General Eric Holder announced formal guidelines for the exercise of investigative and prosecutorial discretion by Federal prosecutors in states that have enacted laws authorizing the use of marijuana for medical purposes (enforcement guidelines). The accompanying press release describes the enforcement guidelines as establishing, “that the focus of federal resources should not be on individuals whose actions are in compliance with existing state laws, while underscoring that the [United States] Department [of Justice] will continue to prosecute people whose claims of compliance with state and local law conceal operations inconsistent with the terms, conditions, or purposes of those laws.” “Attorney General Announces Formal Medical Marijuana Guidelines,” Press Release, October 19, 2009, available at http://www.justice.gov/opa/pr/2009/October/09-ag-1119.html. In announcing the guidelines, Attorney General Holder stated, “It will not be a priority to use federal resources to prosecute patients with serious illnesses or their caregivers who are complying with state laws on medicinal marijuana, but we will not tolerate drug traffickers who hide behind claims of compliance with state law to mask activities that are clearly illegal.” The enforcement guidelines are available at http://www.justice.gov/opa/documents/medical- marijuana.pdf.
The new rules articulate standards that are achievable under current technology.
Full text of the new rules follows:
TEXTCHAPTER 64
MEDICINAL MARIJUANA PROGRAM RULES
SUBCHAPTER 1. GENERAL PROVISIONS
8:64-1.1 Purpose and scope
(a) This chapter implements the New Jersey Compassionate Use Medical Marijuana Act, P.L. 2009, c. 307 (approved January 18, 2010), codified at N.J.S.A. 24:6I-1 et seq. (Act). (b) This chapter is applicable to:
1. Persons seeking to register and/or who register with the Department of Health and Senior Services (Department) as qualifying patients and/or primary caregivers;
2. Physicians seeking to certify and/or who certify that a person has a debilitating medical condition;
3. Entities seeking to operate and/or operating alternative treatment centers, and their owners, directors, officers and employees; and
4. Persons seeking to petition the Department for identification of debilitating medical conditions not specified at N.J.S.A. 24:6I-3.
8:64-1.2 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.
“Act” shall mean the New Jersey Compassionate Use Medical Marijuana Act, P.L. 2009, c. 307 (approved January 18, 2010), codified at N.J.S.A. 24:6I-1 et seq.
“Adequate supply” shall mean not more than is reasonably necessary to assure the uninterrupted availability of marijuana to meet the needs of registered patients at a given ATC.
“Adulterated” or “adulteration” means made impure or inferior by adding extraneous ingredients.
“Alternative treatment center” or “ATC” means the permitted alternative treatment center authorized to grow and provide registered qualifying patients with usable marijuana and related paraphernalia in accordance with the provisions of the Act. This term shall include the organization’s officers, directors, board members and employees.
“ATC identification card” means a document issued by the Department 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.
“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.
“Commissioner” means the Commissioner of the Department of Health and Senior Services.
“Cultivation” includes the planting, propagating, cultivation, growing, harvesting, labeling or manufacturing, compounding and 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. Terminal illness, if the physician has determined a prognosis of less than 12 months of life; or
5. Any other medical condition or its treatment that is approved by the Department pursuant to N.J.A.C. 8:64-5.
“Department” means the Department of Health and Senior Services.
“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. of 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.
“Lozenge” means a solid oral dosage form that is designed to dissolve or disintegrate slowly in the mouth. They contain one or more active pharmaceutical ingredients that are slowly liberated from the flavored and sweetened base. Lozenges can be prepared by molding (gelatin and/or fused sucrose or sorbitol base) or by compression of sugar-based tablets.
“Marijuana” has the meaning given in 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 the ATC for the purpose of providing advise 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.
“Medicinal Marijuana Program” or “MMP” means the program within the Department of Health and Senior Services, which is responsible for the administration and implementation of activities related to the New Jersey Compassionate Use Medical Marijuana Act.
“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 in 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.
“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.
“Paraphernalia” has the meaning given in N.J.S.A. 2C:36-1.
“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. “Permitting authority” means the Medicinal Marijuana Program within the Department of which the mailing address is PO Box 360, Trenton, NJ 08625-0360.
“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-1 et 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. 8:64-2.3 and has satisfied the criminal history record background check requirement of N.J.A.C. 8:64-2.3(e); and
5. Has been designated as primary caregiver on the qualifying patient’s application or renewal for a registry identification card or in other written notification to the Department.
“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.
“Region” means either the northern region, central region or southern region as defined in this section.
“Registry identification card” means a document issued by the Department that identifies a person as a registered qualifying patient or primary caregiver. “Review panel” means a panel of health care professionals appointed by the Commissioner to review petitions and make recommendations for identification and approval of additional debilitating medical conditions.
“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.
“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.
SUBCHAPTER 2. REGISTRATION REQUIREMENTS FOR QUALIFYING PATIENTS AND PRIMARY CAREGIVERS
8:64-2.1 Fees for issuance and renewal of registration
(a) Registration and renewal fees are due upon filing of an application for issuance or renewal of registration as either a qualifying patient or a primary caregiver, and are non-refundable.
(b) An applicant for issuance of registration and registration renewal shall transmit to the Medicinal Marijuana Program a check or money order, or any other form of payment approved by the Medicinal Marijuana Program, that is made payable to the “Treasurer, State of New Jersey” in the amount of the required payment.
1. The Department shall place a 10-day hold on the issuance of a registry identification card for an application accompanied by a personal check.
(c) The fee to apply for issuance or renewal of a registry identification card is $200.00.
1. If an applicant can demonstrate eligibility to receive services under the New Jersey Medicaid program, receipt of current food stamp benefits, receipt of current New Jersey Temporary Disability Insurance benefits, Supplemental Security Income (SSI) benefits or Social Security Disability (SSD) benefits, then the fee to apply for a registry identification card is $20.00.
(d) The Department shall not grant an application fee refund if an applicant demonstrates eligibility for a reduced application fee as provided (c)1 above on or after the date of issuance of the applicant’s registry identification card.
(e) The Department shall notify an applicant who submits a reduced fee for which the applicant is not eligible and shall grant the applicant 30 days from the date of such notice to either:
1. Submit the correct fee to the Department; or
2. Demonstrate eligibility to receive services under the New Jersey Medicaid program, receipt of current food stamp benefits, New Jersey Temporary Disability Insurance benefits, Supplemental Security Income (SSI) benefits or Social Security Disability (SSD) benefits.
(f) The fee to apply for issuance or renewal of a primary caregiver identification card is $200.00.
8:64-2.2 Application for registration as a qualifying patient
(a) A person applying for issuance or renewal of registration as a qualifying patient shall provide the following to the Department:
1. The patient’s full name, address, date of birth, telephone number and signature;
2. The name, address and telephone number of the patient’s physician;
3. The physician certification identification number obtained from the patient’s physician;
4. The name, address and telephone number of the alternative treatment center with which the applicant would register. i. A qualifying patient shall be registered to purchase usable marijuana from only one ATC at any given time;
5. The correct application fee as specified at N.J.A.C. 8:64-2.1;
6. Proof that the applicant is a New Jersey resident, consisting of one or more of the following: i. A New Jersey driver’s license; ii. A government-issued identification card that shows the applicant’s name and address; or iii. A utility bill issued within the previous two months that shows the applicant’s name and address; and 7. One recent passport-size color photograph, two inches by two inches, taken against a white background or backdrop with the applicant‘s face being not less than three quarters of an inch in width. The applicant shall not wear a hat, glasses or any other item that may alter or disguise the overall features of the face in the photograph and the applicant shall legibly print his or her name on the back of the photograph submitted. The photo shall have been taken not more than 30 days prior to the date of the application.
(b) The Department shall notify the applicant in writing, by electronic mail or by telephone, if an application is incomplete and shall explain what documents or information is necessary for the Department to deem the application complete.
1. An applicant shall have 30 days from the date of a notification issued pursuant to (b) above to submit the materials required to complete the application.
2. The Department shall not process incomplete applications.
3. The Department shall not accept and shall return applications to applicants who fail to submit materials necessary to complete an application within the 30 days provided pursuant to (b)1 above.
4. Applicants whose applications are not accepted pursuant to (b)3 above who seek to reapply for registration would need to submit a new application and the applicable fee in accordance with (a) above.
(c) Prior to issuing or renewing a registry identification card, the Department shall verify the information submitted by the applicant.
(d) The Department shall approve or deny an application to issue or renew a registration within 30 days of receipt of the completed application or renewal and shall issue a registry identification card within five business days of approving the application or renewal.
(e) A qualifying patient may designate a primary caregiver either on the application for issuance or renewal of registry identification card or in another written notification to the Department.
1. The Department shall not acknowledge a qualifying patient’s designation of a primary caregiver unless and until the person designated as a primary caregiver successfully applies for primary caregiver registration in accordance with N.J.A.C. 8:64-2.3.
(f) As a condition of registration of a qualifying patient who is a minor, the minor’s custodial parent, guardian or other legal custodian of the minor shall consent in writing in the application for issuance or renewal of registration to the minor’s medical use of marijuana and shall acknowledge that the parent, guardian or custodian will control the acquisition and possession of the medicinal marijuana and any related paraphernalia dispensed by an alternative treatment center. 1. Upon the Department’s issuance of a registry identification card to a qualifying patient who is a minor, the Department shall issue a primary caregiver registry identification card to the minor’s custodial parent, guardian or other legal custodian of the minor, provided the custodial parent, guardian or other legal custodian has qualified as a primary caregiver pursuant to N.J.A.C. 8:64- 2.3; however, no application fee required pursuant to N.J.A.C. 8:64-2.3(a)3 shall apply.
8:64-2.3 Primary caregiver registration
(a) A person who a qualifying patient designates as a primary caregiver pursuant to N.J.A.C. 8:64-2.2(e) shall submit the following to the Department to apply for issuance or renewal of primary caregiver registration:
1. The applicant’s full name, address, date of birth, telephone number and signature;
2. Written consent to submit to a criminal history record background check pursuant to N.J.S.A. 24:6I-4. i. The applicant shall remit the fee for the criminal history record background check in compliance with the procedures established by the Division of State Police pursuant to N.J.A.C. 13:59;
3. The correct application fee as specified in N.J.A.C. 8:64-2.1;
4. A statement that the applicant agrees to assist the qualifying patient with the medical use of marijuana, is not currently serving as primary caregiver for another qualifying patient and is not the qualifying patient’s physician;
5. Proof that the applicant is a New Jersey resident, consisting of one or more of the following: i. A New Jersey driver’s license; ii. A government-issued identification card that shows the applicant’s name and address; or iii. A utility bill issued within the previous two months that shows the applicant’s name and address; and
6. One recent passport-size color photograph, two inches by two inches, taken against a white background or backdrop with the applicant’s face being not less than three quarters of an inch in width. The applicant shall not wear a hat, glasses or any other item that may alter or disguise the overall features of the face in the photograph and the applicant shall legibly print his or her name on the back of the photograph submitted. The photo shall have been taken not more than 30 days prior to the date of the application.
(b) The Department shall notify the applicant in writing, by electronic mail or by telephone, if an application is incomplete and shall explain what documents or information is necessary for the Department to deem the application to be complete. 1. An applicant shall have 30 days from the date of a notification issued pursuant to (b) above to submit the materials required to complete the application.
2. The Department shall not process incomplete applications.
3. The Department shall not accept and shall return applications to applicants who fail to submit materials necessary to complete an application within the 30 days provided pursuant to (b)1 above.
4. Applicants whose applications are not accepted for processing pursuant to (b)3 above who seek to reapply for registration shall submit a new application and the applicable fee in accordance with (a) above.
(c) Prior to issuing or renewing a registry identification card, the Department shall verify the information submitted by the applicant.
(d) The Department shall approve or deny an application or renewal within 30 days of receipt of the completed application or renewal and shall issue a registry identification card within five business days of approving the application or renewal.
(e) Each applicant for issuance or renewal of registration as a primary caregiver shall submit to a fingerprinting process as part of the criminal history record background check and shall comply with procedures established by the Division of State Police pursuant to N.J.A.C. 13:59 for obtaining readable fingerprint impressions.
(f) The Department shall deny registration of a primary caregiver who:
1. Refuses to consent to, or cooperate in, the securing of a criminal history record background check; or
2. Fails to provide any of the information required by (a) above.
(g) Subject to (h) below, the Department shall deny an application for issuance or renewal of registration as a primary caregiver if the criminal history record background check of the applicant reveals a disqualifying conviction.
1. If an applicant has a disqualifying conviction, the Department shall issue written notice to the applicant identifying the conviction that constitutes the basis for the denial of the application.
(h) The Department shall not deny an application for issuance or renewal of registration as a primary caregiver of an applicant who has a disqualifying conviction if the applicant affirmatively demonstrates to the Department by clear and convincing evidence that the applicant is rehabilitated.
1. In determining whether an applicant has demonstrated clear and convincing evidence of rehabilitation, the Department shall consider the following factors: i. The nature and responsibility of the position that the convicted individual would hold, has held or currently holds; ii. The nature and seriousness of the crime or offense; iii. The circumstances under which the crime or offense occurred; iv. The date of the crime or offense; v. The age of the individual when the crime or offense was committed; vi. Whether the crime or offense was an isolated or repeated incident; vii. Any social conditions that may have contributed to the commission of the crime or offense; and viii. Any evidence of rehabilitation, including good conduct in prison or in the community, counseling or psychiatric treatment received, acquisition of additional academic or vocational schooling, successful participation in correctional work-release programs or the recommendation of those who have had the individual under their supervision.
8:64-2.4 Physician registration
To be eligible to submit a certification pursuant to N.J.A.C. 8:64-2.5, a physician shall register using the secure Department web page at http://www.nj.gov/health/med_marijuana.shtml.
8:64-2.5 Physician certification
(a) A physician who is licensed and in good standing to practice medicine in this State and who is registered pursuant to N.J.A.C. 8:64-2.4 is eligible to authorize the medical use of marijuana by a qualifying patient pursuant to a certification the physician issues pursuant to N.J.A.C. 13:35-7A that contains:
1. The physician’s name, address and telephone number;
2. The physician’s license number as issued by the New Jersey Board of Medical Examiners;
3. A statement that the physician is licensed and in good standing to practice medicine in this State and possesses an active controlled dangerous substances registration issued by the Division of Consumer Affairs;
4. A statement that the physician has an ongoing responsibility for the assessment, care and treatment of the patient’s debilitating medical condition;
5. The patient’s name, address and telephone number; 6. The patient’s diagnosis;
7. A statement that the patient’s diagnosis qualifies as a debilitating medical condition that authorizes the patient to use medicinal marijuana pursuant to N.J.S.A. 24:6I-1 et seq.;
8. Written instructions to a registered qualifying patient and/or the patient’s primary caregiver concerning the total amount of usable marijuana that may be dispensed to the patient, in weight, in a 30-day period, which amount shall not exceed two ounces. i. If the physician does not specify an amount, the maximum amount that may be dispensed at one time is two ounces; and
9. The physician’s certification that the physician has explained the potential risks and benefits of the medical use of marijuana to the qualifying patient and has documented the explanation in the patient’s medical record. i. The certification shall include the following statement:
“I have completed a comprehensive history and physical on this patient and have documented an assessment and treatment plan. I have provided education to the patient on the lack of scientific consensus for the use of medicinal marijuana, its sedative properties and the risk of addiction. The patient has provided informed consent. I will continue to follow this patient at a minimum of every three months and reassess the patient’s debilitating medical condition and responses to treatment options.”
(b) Prior to complying with (a) above, a registered physician seeking to authorize the medicinal use of marijuana by a patient who is a minor shall:
1. Obtain written confirmation from a physician trained in the care of pediatric patients and from a psychiatrist establishing, in their professional opinions, following review of the minor patient’s medical record or examination of the minor patient, that the minor patient is likely to receive therapeutic or palliative benefits from the medical use of marijuana to treat or alleviate symptoms associated with his or her debilitating medical condition. i. If the certifying physician is trained in the care of pediatric patients, he or she shall only be required to obtain written confirmation from a psychiatrist; and
2. Explain the potential risks and benefits of the medical use of marijuana to the minor patient and to the minor patient’s parent, guardian or another person having legal custody of the minor patient. Such explanation shall be documented in the minor patient’s medical record.
(c) A physician may issue multiple written instructions at one time authorizing the patient to receive a total of up to a 90-day supply, provided that the following conditions are met:
1. Each separate set of instructions shall be issued for a legitimate medical purpose by the physician, as provided in the Act and this chapter; 2. Each separate set of instructions shall indicate the earliest date on which an ATC may dispense the marijuana, except for the first dispensation if it is to be filled immediately; and
3. The physician has determined that providing the patient with multiple instructions in this manner does not create an undue risk of diversion or abuse.
(d) A physician may provide written instructions for the medical use of marijuana by electronic or other means directly to an alternative treatment center on behalf of a registered qualifying patient.
8:64-2.6 Application denial and/or revocation of a registry identification card
(a) The Department shall deny an application for a registry identification card that:
1. Contains false information, including, but not limited to, a false name, address, physician certification, date of birth, signature or photo identification; or
2. Fails to provide any of the information required by N.J.A.C. 8:64-2.2(a).
(b) The Department shall revoke a registry identification card upon finding that a registered individual:
1. Submitted false information to the Department;
2. Has a disqualifying conviction; or
3. Ceases to have his or her debilitating condition.
SUBCHAPTER 3. REGISTRY IDENTIFICATION CARDS FOR QUALIFYING PATIENTS AND PRIMARY CAREGIVERS
8:64-3.1 Registry identification cards
(a) Subject to N.J.A.C. 8:64-3.2, each registry identification card shall be valid for two years from its effective date unless revoked or surrendered.
(b) Each person to whom the Department has issued a registry identification card shall possess the registry identification card whenever he or she is in possession of medicinal marijuana.
(c) Registry identification cards shall contain:
1. The name, address, date of birth and Department-issued registry identification number of the qualifying patient;
2. If the qualifying patient has designated a registered primary caregiver, the name, address, date of birth and Department-issued registry identification number of the primary caregiver; 3. If the qualifying patient is a minor, the name, address, date of birth and Department-issued registry identification number of the parent, guardian or person who has legal custody of a qualifying patient who is a minor;
4. An indication as to whether the cardholder is the qualifying patient, a primary caregiver, a minor who is a qualifying patient or the parent, guardian or person who has legal custody of a qualifying patient who is a minor;
5. A photograph of the cardholder;
6. The effective date and expiration date of the registry identification card; and
7. The telephone number and web address of the Medicinal Marijuana Program of the Department, so that the authenticity of the registry identification card can be validated.
(d) Each person to whom the Department issues a registry identification card shall produce it to Department staff for inspection upon demand or pursuant to N.J.A.C. 8:64-4.4(b).
(e) Registry identification cards shall not be transferable.
(f) Registry identification cards are the property of the Department and shall be surrendered to Department staff upon issuance of a new registry identification card or following the revocation or denial of renewal of registration of the registrant.
1. The temporary registry identification card may be surrendered by United States mail to the Medicinal Marijuana Program or in person.
(g) A person may voluntarily surrender a registry identification card with a written notice stating that the person wishes to voluntarily surrender the registry identification card pursuant to N.J.A.C. 8:64-3.1(f)1.
1. The Department shall deem a voluntarily surrendered registry identification card to be null and void on the date the Department receives it.
8:64-3.2 Provisional approval of primary caregiver and temporary registry identification card
(a) Notwithstanding N.J.A.C. 8:64-3.1(a) above, the Department shall issue a temporary registry identification card to an applicant for issuance or renewal of registration as a primary caregiver pending the results of the applicant’s criminal history record background check, provided the applicant otherwise satisfies the requirements for registration as a primary caregiver.
(b) A temporary registry identification card issued pursuant to this section shall be valid for no more than 30 days from its effective date. (c) The primary caregiver shall surrender the temporary registry identification card to the Department within 10 days following the date that the Department approves or denies the primary caregiver’s application. i. The temporary registry identification card may be surrendered by United States mail to the Medicinal Marijuana Program or in person pursuant to N.J.A.C. 8:64-3.1(f)1.
8:64-3.3 Registry identification card replacement
If a qualifying registered patient or registered primary caregiver becomes aware of the theft, loss or destruction of his or her registry identification card, he or she shall notify the MMP in writing or by telephone within 24 hours after the discovery of the occurrence of the theft, loss or destruction.
The Department shall deem the initial registry identification card null and void and issue a replacement registry identification card with a new random identification number within five business days of the request provided the applicant continues to satisfy the requirements for registration.
(c) An applicant for issuance of a registration replacement card shall transmit to the Medicinal Marijuana Program a check or money order, or any other form of payment approved by the Medicinal Marijuana Program, that is made payable to the “Treasurer, State of New Jersey” in the amount of the required payment.
1. The Department shall place a 10-day hold on the issuance of a registry identification card for an application accompanied by a personal check.
(d) The fee to apply for issuance of a registry identification card replacement is $10.00.
1. If an applicant can demonstrate eligibility to receive services under the New Jersey Medicaid program, receipt of current food stamp benefits, receipt of current New Jersey Temporary Disability Insurance benefits, Supplemental Security Income (SSI) benefits or Social Security Disability (SSD) benefits, then the fee to apply for a registry identification card replacement is $5.00.
8:64-3.4 Marijuana obtained from designated ATC
(a) As a condition of issuance of a primary caregiver registration card, a primary caregiver shall execute a certification in which the primary caregiver agrees to comply with (b) and (c) below.
(b) The registered primary caregiver shall only obtain medicinal marijuana for the qualifying patient from the alternative treatment center designated on his or her registry identification card and shall not:
1. Grow or cultivate medicinal marijuana for the qualifying patient; 2. Purchase medicinal marijuana through non-permitted alternative treatment centers or vendors; or
3. Obtain medicinal marijuana from or for other qualifying patients and/or primary caregivers.
(c) If the qualifying patient changes his or her designation of alternative treatment center, or makes a change to the information set forth on his or her registry identification card, both the qualifying patient and the primary caregiver shall surrender their registry identification cards to the Department and obtain new registry identification cards reflecting the change.
SUBCHAPTER 4. REPORTING REQUIREMENTS
8:64-4.1 Reporting requirements for qualifying patients, primary caregivers and physicians
(a) A qualifying patient or primary caregiver shall notify the Department of any change in the qualifying patient’s name, address, alternative treatment center or physician within 10 days of such change.
(b) Each primary caregiver to whom the Department issues a registry identification card shall notify the Department of any change in the primary caregiver’s name or address within 10 days of such change.
(c) A physician shall report a change in status of a qualifying patient’s debilitating medical condition that may affect the continued eligibility of that patient as a qualifying patient within 10 days of such change.
(d) A qualifying patient or primary caregiver shall notify the Department of the theft, loss or destruction of his or her registry identification card within 24 hours after the discovery of the occurrence of the theft, loss or destruction.
(e) Failure of a registrant to make a notification required pursuant to this section shall result in the Department deeming the registration of the registrant to be null and void.
(f) Such other information as may be required by the Department in the administration and enforcement of this chapter.
8:64-4.2 Reporting requirements of the Department
(a) The Commissioner shall report to the Governor, and to the Legislature pursuant to section 2 of P.L. 1991, c. 164 (N.J.S.A. 52:14-19.1):
1. No later than October 1, 2011, one year after the effective date of N.J.S.A. 24:6I-1 et seq., on the actions taken to implement the provisions of the New Jersey Compassionate Use Medical Marijuana Act; and 2. Annually thereafter on the number of applications for registry identification cards, the number of qualifying patients registered, the number of primary caregivers registered, the nature of the debilitating medical conditions of the patients, the number of registry identification cards revoked, the number of alternative treatment center permits issued and revoked and the number of physicians providing certifications for patients.
(b) The reports shall not contain any identifying information of patients, caregivers or physicians.
8:64-4.3 Alternative treatment center reporting requirements
(a) The ATC shall collect and submit to the Department for each calendar year at least the following statistical data:
1. The number of registered qualified patients and registered primary caregivers;
2. The debilitating medical conditions of qualified patients;
3. Patient demographic data;
4. Program costs;
5. A summary of the patient surveys and evaluation of services; and
6. Such other information as the Department may require in the administration and enforcement of this chapter.
8:64-4.4 Confidentiality
(a) The Department shall maintain a confidential list of the persons to whom it issues registry identification cards.
(b) Individual names and other identifying information on the list, and information contained in any application form, or accompanying or supporting document shall be confidential, and shall not be considered a public record under P.L. 1963, c. 73 (N.J.S.A. 47:1A-1 et seq.) or P.L. 2001, c. 404 (N.J.S.A. 47:1A-5 et seq.) and shall not be disclosed except to:
1. Authorized employees of the Department and the Division of Consumer Affairs in the Department of Law and Public Safety as necessary to perform official duties of the Department and the Division, as applicable; and
2. Authorized employees of State or law enforcement agencies, only as necessary to verify that a person who is engaged in the suspected or alleged medical use of marijuana is lawfully in possession of a registry identification card. SUBCHAPTER 5. ESTABLISHMENT OF ADDITIONAL DEBILITATING MEDICAL CONDITIONS
8:64-5.1 Review cycle for accepting petitions for additional qualifying debilitating medical condition
(a) The Commissioner shall take no action concerning the acceptance of petitions to approve other medical conditions or the treatment thereof as debilitating medical conditions pursuant to (b) below, before completing at least two annual reports required pursuant to N.J.A.C. 8:64-4.2.
1. The Department shall publish notice of an open period to accept petitions in the New Jersey Register.
(b) The process for review of petitions to approve other medical conditions or the treatment thereof as debilitating medical conditions pursuant to the definition at N.J.S.A. 24:6I-3 of “debilitating medical condition” at paragraph (5) shall include one review cycle each year, subject to (a) above.
(c) The beginning of each cycle shall be the first business day of the month.
(d) The Department shall accept petitions on the first business day of each cycle.
(e) The Department shall return to the petitioner a petition submitted in any month outside of the review cycle as not accepted for processing.
8:64-5.2 Panel to review petitions and make recommendations for identification and approval of additional debilitating medical conditions; membership; responsibilities
(a) The Commissioner shall appoint a review panel (panel) to make recommendations to the Commissioner regarding approval or denial of a petition submitted pursuant to this subchapter.
(b) The panel shall consist of not more than 15 health care professionals, among whom shall be:
1. The President of the Board of Medical Examiners or the President’s designee; and
2. Other physicians and non-physicians who are knowledgeable about the condition as to which the petition seeks approval; i. Each physician appointed to the review panel shall be nationally board-certified in his or her area of specialty; and
3. At least three physicians appointed to the review panel shall have expertise in pain and symptom management.
(c) The majority of the panel shall be physicians. (d) The Department shall convene the panel at least once per year to review petitions.
1. The panel may examine scientific and medical evidence and research pertaining to the petition, and may gather information, in person or in writing, from other parties knowledgeable about the addition of the debilitating medical conditions being considered.
2. The petitioner shall be given the opportunity to address the panel in person or by telephone.
3. The petitioner may request that his or her individual identifiable health information remain confidential.
4. The Department shall provide staff support to the panel and other administrative support.
5. The meetings will be considered open public meetings.
(e) The panel shall make a written recommendation to the Commissioner regarding approval or denial of the addition of a qualifying debilitating medical condition.
1. A quorum of the panel shall concur with the recommendation in order to be considered a final recommendation of the panel. i. For purposes of this subsection, a majority of the members appointed and serving on the panel constitute a quorum.
8:64-5.3 Addition of qualifying debilitating medical condition
(a) In order for the petition to be accepted for processing, the petitioner shall send a letter by certified mail to the Medicinal Marijuana Program that contains the following information:
1. The extent to which the condition is generally accepted by the medical community and other experts as a valid, existing medical condition;
2. If one or more treatments of the condition, rather than the condition itself, are alleged to be the cause of the patient’s suffering, the extent to which the treatments causing suffering are generally accepted by the medical community and other experts as valid treatments for the condition;
3. The extent to which the condition itself and/or the treatments thereof cause severe suffering, such as severe and/or chronic pain, severe nausea and/or vomiting or otherwise severely impair the patient’s ability to carry on activities of daily living;
4. The availability of conventional medical therapies other than those that cause suffering to alleviate suffering caused by the condition and/or the treatment thereof;
5. The extent to which evidence that is generally accepted among the medical community and other experts supports a finding that the use of marijuana alleviates suffering caused by the condition and/or the treatment thereof; and 6. Letters of support from physicians or other licensed health care professionals knowledgeable about the condition.
(b) Upon review of materials submitted pursuant to (a) above, the Commissioner shall make a final determination as to whether:
1. The petition is frivolous and, if so, to deny a petition without further review; or
2. The petition is bona fide and, if so, to accept the petition for further review.
(c) If the petition is accepted, the Department shall refer the written petition to the review panel established pursuant to N.J.A.C. 8:64-5.2.
(d) Within 60 days of the receipt of the petition, the review panel shall consider the petition in view of the factors identified in (a) above and shall issue an initial written recommendation to the Commissioner as to whether:
1. The medical condition and/or the treatment thereof is/are debilitating;
2. Marijuana is more likely than not to have the potential to be beneficial to treat or alleviate the debilitation associated with the medical condition and/or the treatment thereof; and
3. Other matters that the panel recommends that the Commissioner consider that are relevant to the approval or the denial of the petition.
(e) Upon receipt of the panel’s recommendation, the Department shall:
1. Post the review panel’s recommendations on the Department’s website for 60-day public comment period;
2. Post notice of a public meeting no fewer than 10 days prior to the public meeting; and
3. Hold a public hearing within the 60-day public comment period.
(f) After the public hearing, the Department shall forward the comments made during the public hearing to the review panel for its consideration.
1. If, based on a review of the comments, the panel determines substantive changes should be made to its initial recommendation, the Commissioner shall deny the petition and the Department shall provide the petitioner with a copy of the initial recommendation and an explanation of the substantive changes and the petitioner may resubmit the petition to the Department at any time.
2. If, based on a review of the comments, the panel determines to recommend no changes to its initial recommendation, the initial recommendation shall be deemed a final recommendation and the Commissioner will make a final determination on the petition within 180 days of receipt of the petition. 8:64-5.4 Denial of a petition considered final agency action subject to judicial review
(a) If a condition in a petition is the same as, or is, as determined by the Commissioner, substantially similar to a condition of which the Commissioner has issued a previous determination denying approval as a debilitating medical condition pursuant to N.J.A.C. 8:64- 5.3, the Commissioner may deny the new petition unless new scientific research supporting the request is brought forward.
(b) A decision of the Commissioner issued pursuant to N.J.A.C. 8:64-5.3 or this section is a final agency decision, of which jurisdiction and venue for judicial review are vested in the New Jersey Superior Court, Appellate Division.
SUBCHAPTER 6. ALTERNATIVE TREATMENT CENTER; PROCESS FOR DEPARTMENT REQUEST FOR APPLICATIONS
8:64-6.1 Notice of request for applications
(a) The Department may periodically request applications for the entities that seek authority to apply for a permit to operate an alternative treatment center.
(b) The Department shall announce a request for applications for entities that seek authority to apply for a permit to operate an alternative treatment center by publishing a notice of request for applications in the New Jersey Register, which notice shall:
1. Include eligibility criteria and a statement of the general criteria by which the Department shall evaluate applications; or
2. Identify such criteria by reference to the provisions of the Act and this chapter.
(c) A notice of request for applications shall establish weights for the criteria the Department shall use to evaluate applications and select successful applicants, and shall identify the process for obtaining application materials and the deadline for receipt of applications.
(d) The Department shall not consider an application that is submitted after the due date specified in, or that is not submitted in response to, a published notice of request for applications.
8:64-6.2 Criteria for identifying alternative treatment centers
(a) A selection committee shall evaluate applications on the following general criteria:
1. Submission of mandatory organizational information;
2. Documented involvement of a New Jersey acute care general hospital in the ATC’s organization;
3. Ability to meet overall health needs of qualified patients and safety of the public; 4. Community support and participation; and
5. Ability to provide appropriate research data.
(b) The applicant’s failure to address all applicable criteria and measures, to provide requested information or to present truthful information in the application process shall result in the application being considered non-responsive and shall be considered an unsuccessful application pursuant to N.J.A.C. 8:64-6.4.
8:64-6.3 Verification of applicant information
(a) The Department may verify information contained in each application and accompanying documentation by:
1. Contacting the applicant by telephone, mail or electronic mail;
2. Conducting an onsite visit; and
3. Requiring a face-to-face meeting and the production of additional identification materials if proof of identity is uncertain.
8:64-6.4 Award decisions
(a) The Department shall convene a selection committee to evaluate and score each application.
1. The selection committee shall evaluate and score each application based on the quality of the applicant’s submission, and its conformity to the notice of request for applications published in the New Jersey Register.
(b) The Department shall issue a written notice of its award decision to successful applicants.
1. A written notice of denial of an application (non-selection) is a final agency decision, of which jurisdiction and venue for judicial review are vested in the New Jersey Superior Court, Appellate Division.
(c) The record for review shall be the application and any attached supporting documents excluding information deemed exempt pursuant to N.J.S.A. 47:1A-1 et seq.
8:64-6.5 Request for application; fee
(a) As a condition of Department consideration of an application submitted in response to a request for applications issued pursuant to N.J.A.C. 8:64-6.1, applicants shall submit a fee of $20,000 for each application. 1. The applicant shall submit the fee with the application, in the form of two checks payable to the “Treasurer, State of New Jersey,” one of which is for $2,000 and the other of which is for $18,000.
2. If an application is unsuccessful, the Department shall retain the $2,000 fee and shall destroy the other check for $18,000.
3. Application fees of successful applicants are non-refundable.
(b) Applicants may submit an application for an ATC permit for one or more regions, but must submit a separate application for each region.
SUBCHAPTER 7. GENERAL PROCEDURES AND STANDARDS APPLICABLE TO ALTERNATIVE TREATMENT CENTERS
8:64 -7.1 Permit application procedures and requirements for alternative treatment centers
(a) An applicant for an ATC permit shall submit an application form and the fees required by N.J.A.C. 8:64-6.5, as well as all other required documentation on forms obtained from the permitting authority or on the Department’s website at www.state.nj.us/health.
(b) In addition to the application, the documentation shall include the following:
1. The legal name of the corporation, a copy of the articles of incorporation and by-laws, evidence that the corporation is in good standing with the New Jersey Secretary of State and a certificate certified under the seal of the New Jersey State Treasurer as to the legal status of the business entity; and
2. Each applicant, including the information for each subcontractor or affiliate to the entity named in the application shall submit: i. Documentation of a valid Business Registration Certificate on file with the New Jersey Department of the Treasury, Division of Revenue; ii. A list of the names, addresses and dates of birth of the proposed alternative treatment center’s employees, principal officers, directors, owners and board members, including service on any other ATC board; iii. A list of all persons or business entities having direct or indirect authority over the management or policies of the ATC;
A list of all persons or business entities having five percent or more ownership in the ATC, whether direct or indirect and whether the interest is in profits, land or building, including owners of any business entity that owns all or part of the land or building;
The identities of all creditors holding a security interest in the premises, if any; vi. The by-laws and a list of the members of the ATC’s medical advisory board; vii. Evidence of compliance with N.J.A.C. 8:21-3A.18 with regards to inspection and auditing of the ATC; viii. Evidence of the principals, directors, board members, owners and employees to cooperate with a criminal history record background check pursuant to N.J.A.C. 8:64-7.2, including payment of all applicable fees associated with the criminal history record background check, which shall be paid by the ATC or the individual; ix. The mailing and physical addresses of the proposed alternative treatment center; x. Written verification of the approval of the community or governing body of the municipality in which the alternative treatment center is or will be located; xi. Evidence of compliance with local codes and ordinances including, but not limited to, the distance to the closest school, church, temple or other places used exclusively for religious worship or a playground, park or child day care facility from the alternative treatment center; xii. A legible map or maps of the service areas by zip code to be served by the alternative treatment center showing the location of the alternative treatment center; and xiii. Text and graphic materials showing the exterior appearance of the ATC and its site compatibility with commercial structures already constructed or under construction within the immediate neighborhood.
(c) The applicant’s failure to provide requested information or to present truthful information in the application process shall result in a decision to not accept the application for processing. The Department shall notify the applicant of this decision and the filing fee shall be nonrefundable.
8:64-7.2 Criminal history record background checks for principals, directors, board members, owners and employees
(a) Each principal, director, board member, owner and employee shall provide written consent to submit to a criminal history record background check pursuant to N.J.S.A. 24:6I-4 and shall comply with procedures established by the Division of State Police pursuant to N.J.A.C. 13:59 for obtaining readable fingerprint impressions.
(b) The Department shall deny registration of a principal, director, board member, owner and employee who:
1. Refuses to consent to, or cooperate in, the securing of a criminal history record background check; or
2. Fails to provide any of the information required by (a) above. (c) Subject to N.J.A.C. 8:64-7.1, in considering any application for a permit for an ATC, the Department shall consider, at a minimum, the following factors in reviewing the qualifications of principals, directors, board members and owners applying for a permit as an alternative treatment center:
1. Any convictions of the applicant under any Federal, state or local laws relating to drug samples, wholesale or retail drug distribution or distribution of a controlled substance;
2. Any felony conviction under Federal laws, or the equivalent conviction under state or local laws;
3. The applicant’s past experience in the manufacturing or distribution of drugs or controlled substances;
4. The furnishing of false or fraudulent material in any application made in connection with drug or device manufacturing or distribution;
5. Suspension or revocation by Federal, state or local government of any registration currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances;
6. Compliance with license and/or registration requirements under any previously granted license or registration, if any;
7. Compliance with requirements to maintain and/or make available to the Department or Federal or law enforcement officials those records required by this subchapter; and
8. Any other factors or qualifications the Department considers relevant to and consistent with ensuring public health and safety.
(d) In considering any application for a permit for an ATC, the Department shall consider, at a minimum, the factors at (f) below in reviewing the qualifications of an employee who has a disqualifying conviction. The Department shall issue written notice to the employee identifying the conviction that constitutes the basis for the denial of the application.
(e) The Department shall not disqualify an applicant from serving as an officer, director, board member or employee of an alternative treatment center as a result of a disqualifying conviction if the applicant affirmatively demonstrates to the Department by clear and convincing evidence that the applicant is rehabilitated.
(f) In determining whether an applicant has demonstrated clear and convincing evidence of rehabilitation, the Department shall consider the following factors:
1. The nature and responsibility of the position that the convicted individual would hold, has held or currently holds; 2. The nature and seriousness of the crime or offense;
3. The circumstances under which the crime or offense occurred;
4. The date of the crime or offense;
5. The age of the individual when the crime or offense was committed;
6. Whether the crime or offense was an isolated or repeated incident;
7. Any social conditions that may have contributed to the commission of the crime or offense; and
8. Any evidence of rehabilitation, including good conduct in prison or in the community, counseling or psychiatric treatment received, acquisition of additional academic or vocational schooling, successful participation in correctional work-release programs or the recommendation of those who have had the individual under their supervision.
(g) In accordance with the provisions of the Administrative Procedures Act, N.J.S.A. 52:14B-1 et seq. and 52:14F-1 et seq., and the Uniform Administrative Procedures Rules, N.J.A.C. 1:1, any individual disqualified from owning or operating an alternative treatment center shall be given an opportunity to challenge the accuracy of the disqualifying criminal history record prior to being permanently disqualified from participation.
8:64-7.3 Verification of applicant information
(a) The Department may verify information contained in each selected application and accompanying documentation by:
1. Contacting the applicant by telephone, mail or electronic mail;
2. Conducting an onsite visit;
3. Requiring a face-to-face meeting and the production of additional identification materials if proof of identity is uncertain; and
4. Requiring additional relevant information as the Department deems necessary.
8:64-7.4 Submission to the jurisdiction of the State
(a) Prior to the issuance of any permit to an ATC, every principal officer, owner, director and board member of the ATC must execute a certification stating that he or she submits to the jurisdiction of the courts of the State of New Jersey and agrees to comply with all the requirements of the laws of the State of New Jersey pertaining to the Medicinal Marijuana Program. Copies of such certifications shall be maintained by the ATC at the ATC's principal office, which shall be located within the State of New Jersey. (b) Failure to establish or maintain compliance with the requirements of this section shall constitute sufficient cause for the denial, suspension or revocation of any permit issued to an ATC.
8:64-7.5 Permit issuance; nontransferability of permit
(a) Upon approval of the application for an ATC permit and payment of the required fee, the permitting authority may conduct an onsite assessment of the alternative treatment center to determine if the facility adheres to the Act and this chapter.
(b) An ATC permit is not assignable or transferable without Department approval, and it shall be immediately null and void if the alternative treatment center ceases to operate, if the alternative treatment center’s ownership changes or if the alternative treatment center relocates.
(c) This chapter does not prohibit a political subdivision of this State from limiting the number of alternative treatment centers that may operate in the political subdivision or from enacting reasonable local ordinances applicable to alternative treatment centers.
8:64-7.6 Permit required; term; posting
(a) No person shall operate an alternative treatment center without a Department-issued permit.
(b) The permit holder shall have responsibility for the management, operation and financial viability of the alternative treatment center.
(c) A permit shall be in effect for a period of one year and shall be renewable thereafter subject to N.J.A.C. 8:64-7.7.
(d) The permit holder shall post the permit in a conspicuous location on the premises of each permitted alternative treatment center.
8:64-7.7 Renewal of alternative treatment center permit
(a) 60 days prior to the expiration of an ATC permit, an ATC that seeks to renew the permit shall submit to the permitting authority an application for renewal of the permit with all required documentation and the required fees pursuant to N.J.A.C. 8:64-7.10.
1. An ATC shall update and ensure the correctness of all information submitted in previous applications for a permit or otherwise on file with the Department.
2. Failure to provide correct and current up-to-date information is grounds for denial of application for renewal of the permit.
(b) The permit period for an alternative treatment center shall be from January 1st (or the date of approval of the application, if later) through December 31st of a given year. (c) The Department may deny the application for renewal of the permit if the applicant is noncompliant with applicable local rules, ordinances and/or zoning requirements, or if the Department determines that the facility is in violation of the Act or this chapter.
(d) The Department may issue and/or renew a permit subject to conditions set forth in this chapter.
8:64-7.8 Amendments to alternative treatment center permit
(a) An ATC shall submit to the Department an application for an amended permit, together with fees, if applicable, pursuant to N.J.A.C. 8:64-7.10, prior to any:
1. Change of the alternative treatment center’s location;
2. Change of the alternative treatment center’s ownership;
3. Change of the alternative treatment center’s name;
4. Change in the alternative treatment center’s capacity; or
5. Modification of or addition to the alternative treatment center’s physical plant.
(b) The alternative treatment center shall submit the application to the permitting authority no later than 30 business days prior to the change.
8:64-7.9 ATC location; satellite sites prohibited
(a) An ATC shall conduct all operations authorized by the Act at the address(es) identified on the permit issued by the Department. The Department shall not authorize or permit dispensing operations at any satellite locations. However, an ATC, as approved by the Department, may cultivate marijuana at a location separate from the location where the ATC shall dispense the marijuana, but both locations shall be within the same region.
1. The ATC permit shall identify the physical address(es) of the ATC site(s).
2. The Department shall conduct an onsite assessment of each proposed ATC site prior to permit issuance.
(b) This chapter does not prohibit a political subdivision of this State from limiting the number of ATCs that may operate in the political subdivision or from enacting reasonable local ordinances applicable to ATCs.
8:64-7.10 Fees
(a) The following fees apply: 1. The annual fee for the review of a permit renewal application for an alternative treatment center is $20,000;
2. The fee for a change of location of the alternative treatment center is $10,000;
3. The fee for a change of capacity or any physical modification or addition to the facility is $2,000; and
4. The fee for the transfer of ownership of a permit is $20,000.
(b) Fees shall be paid by certified check, money order or any other form of payment approved by the Medicinal Marijuana Program, and made payable to the “Treasurer, State of New Jersey.”
8:64- 7.11 Waiver
The Commissioner, or the Commissioner's designee, in accordance with the general purposes and intent of N.J.S.A. 24:6I-1 et seq. and this chapter, may waive a requirement regarding the operations of the ATC, if in the Commissioner's, or the Commissioner's designee's, determination, such a waiver is necessary to achieve the purpose of the Act and provide access to patients who would otherwise qualify for the use of medicinal marijuana to alleviate suffering from debilitating medical conditions, and does not create a danger to the public health, safety or welfare.
SUBCHAPTER 8. ALTERNATIVE TREATMENT CENTER IDENTIFICATION CARDS
8:64-8.1 Department issuance of identification cards; expiration
(a) The Department shall issue each qualified principal officer, director, owner, board member and employee of an alternative treatment center an ATC identification card within 10 business days of the date the Department receives a completed Department-approved application form with required documents including a copy of a New Jersey driver’s license or other State-issued photo identification.
(b) Principal officers, directors, owners, board members and employees shall not begin working at the registered ATC before the Department issues an ATC identification card and the card is in the registrant’s physical possession.
(c) ATC identification cards issued to principal officers, directors, owners, board members and employees of an alternative treatment center expire one year after the date of issuance.
(d) ATC identification cards shall contain:
1. The name of the individual;
2. The name of the ATC; 3. The date of issuance and expiration; and
4. A photograph of the cardholder.
8:64-8.2 Notice to Department when employment or affiliation ceases; expiration of an ATC identification card
(a) The alternative treatment center shall notify the permitting authority within 10 business days of the date that a principal officer, director, board member or employee ceases to work at or be affiliated with the alternative treatment center.
1. The alternative treatment center identification card of a principal officer, director, board member or employee expires immediately when a person ceases to work at or be affiliated with the alternative treatment center.
8:64-8.3 Surrender of ATC identification cards
(a) The alternative treatment center shall surrender to the permitting authority the ATC identification card of any principal officer, director, board member or employee who is no longer eligible to validly use or possess the card for any reason.
(b) The alternative treatment center shall document the reason the person is no long eligible to validly use or possess the card in the alternative treatment center’s personnel files and shall submit a copy of the documentation to the permitting authority.
SUBCHAPTER 9. ALTERNATIVE TREATMENT CENTER GENERAL ADMINISTRATIVE REQUIREMENTS FOR ORGANIZATION AND RECORDKEEPING
8:64-9.1 Alternative treatment centers policies, procedures and records
(a) Each alternative treatment center shall develop, implement and maintain on the premises an operations manual that addresses, at a minimum, the following:
1. Procedures for the oversight of the alternative treatment center;
2. Procedures for safely growing and dispensing medicinal marijuana;
3. Procedures to ensure accurate recordkeeping, including inventory protocols to ensure that quantities cultivated do not suggest redistribution;
4. Employee security policies;
5. Safety and security procedures, including a disaster plan with procedures to be followed in case of fire or other emergencies; 6. Personal safety and crime prevention techniques;
7. The alternative treatment center’s alcohol, smoke and drug-free workplace policies; and
8. A description of the ATCs: i. Hours of operation and after hour contact information; ii. Fee schedule and availability of sliding fee scales based on income; iii. Expectations of onsite personnel in maintaining confidentiality and privacy of the operations and clients of the ATC; iv. Criteria for involuntary disenrollment from the ATC’s list of qualifying patients pursuant to unacceptable behavior and appeal process; and v. Registered qualifying patient’s assumption of risk in complying with ATC registration policies.
(b) The permit holder shall ensure that the operating manual of the alternative treatment center is available for inspection by the Department, upon request.
8:64-9.2 Prohibitions applicable to alternative treatment centers
(a) Consumption of marijuana and/or alcohol on, or public areas in the vicinity of, the premises of an ATC is prohibited.
(b) Consumption of food and/or beverages by qualifying patients and primary caregivers on the premises of an ATC is prohibited.
(c) Sales of food, beverages, alcohol or tobacco on the premises of an ATC is prohibited.
(d) Entry onto the premises of an ATC by a person who is under the age of 18 is prohibited unless he or she is a registered, qualifying patient accompanied by his or her primary caregiver and both are in possession of a registry identification card.
8:64-9.3 Organization and recordkeeping requirements applicable to alternative treatment centers
(a) The ATC shall maintain the following administrative records, as applicable:
1. Organization charts consistent with the job descriptions in N.J.A.C. 8:64-9.4(a)6;
2. A general description of any facilities to be used as an ATC and a floor plan identifying the square footage available and descriptions of the functional areas of the ATC; 3. If applicable, a projection of the number of qualified patients to be served by the ATC;
4. Projections by the ATC for a two-year period of the ratio of registered qualifying patients-to- demand for usable marijuana and procedures by which the ATC shall periodically review these ratios for consistency with actual patient demand ratios;
5. Procedures by which the ATC shall ensure the availability of medicinal marijuana in accordance with projected and actual demand ratios;
6. The name, medical license number, résumé and contact address of the medical director of the ATC, if applicable;
7. The name, résumé and address of the chief administrative officer of the ATC; and
8. The standards and procedures by which the ATC determines the price it charges for usable marijuana and a record of the prices charged.
(b) ATCs shall maintain business records including, manual or computerized records of assets and liabilities, monetary transactions, various journals, ledgers and supporting documents, including agreements, checks, invoices and vouchers that the ATC keeps as its books of accounts.
(c) Business records include sales records that indicate the name of the qualifying patient or primary caregiver to whom marijuana is distributed, the quantity, strength and form and the cost of the product.
(d) The bylaws of the ATC and its affiliates or sub-contractors shall contain provisions relative to the disposition of revenues and receipts as may be necessary and appropriate to establish and maintain its nonprofit status, as applicable.
8:64-9.4 Personnel records
(a) Each alternative treatment center shall maintain a personnel record for each employee, principal officer, director, board member, agent or volunteer that includes, at a minimum, the following:
1. An application for employment or to volunteer;
2. A copy of his or her current ATC identification card and a copy of his or her driver’s license or other State-issued photo identification card;
3. Documentation of the certification of each principal officer, director or board member stating that he or she submits to the jurisdiction of the courts of the State of New Jersey and agrees to comply with all the requirements of the laws of the State of New Jersey pertaining to the Medicinal Marijuana Program; 4. Documentation of verification of references;
5. Documentation of background checks;
6. The job description or employment contract that include duties, authority, responsibilities, qualifications and supervision;
7. Documentation of all required training, including training regarding privacy and confidentiality requirements, and the signed statement of the individual indicating the date, time and place he or she received said training and the topics discussed, including the name and title of presenters;
8. Documentation of periodic performance evaluations;
9. A record of any disciplinary action taken; and
10. Documentation of the results of drug tests authorized pursuant to this chapter.
(b) The permit holder shall maintain personnel records for at least 12 months after termination of the individual’s affiliation with the alternative treatment center, for the purposes of this rule.
1. Permit holders are responsible for maintaining personnel records for all other business purposes in accordance with their business practice.
8:64–9.5 Alternative treatment center employee training
(a) Each alternative treatment center shall either:
1. Develop, implement and maintain on the premises an onsite training curriculum; or
2. Enter into contractual relationships with outside resources capable of meeting employee, agent and volunteer training needs.
(b) Each employee, agent or volunteer, at the time of his or her initial appointment, shall receive, as a minimum, training in the following:
1. Professional conduct, ethics and State and Federal laws regarding patient confidentiality;
2. Informational developments in the field of medical use of marijuana;
3. The proper use of security measures and controls that have been adopted; and
4. Specific procedural instructions for responding to an emergency, including a robbery or workplace violence. 8:64-9.6 Alcohol and drug-free workplace policy and smoke free workplace policy; employee assistance program
(a) The ATC shall establish, implement and adhere to a written alcohol, drug-free and smoke- free workplace policy.
(b) The permit holder shall ensure that the policy is available to the Department upon request.
(c) The policy shall address the following:
1. The policy’s inapplicability if an employee, who is also a qualifying patient, fails the drug test solely because of the presence of marijuana in a confirmed positive test result;
2. The ATC’s policy providing for probable cause substance abuse testing consistent with applicable State and Federal law; and
3. Opportunities for assistance of an employee with a substance abuse problem.
(d) The ATC shall maintain a contract with an approved New Jersey employee assistance program.
8:64-9.7 Security
(a) Each alternative treatment center shall provide effective controls and procedures to guard against theft and diversion of marijuana including, when appropriate, systems to protect against electronic records tampering.
(b) At minimum, each alternative treatment center shall:
1. Install, maintain in good working order and operate a safety and security alarm system at its authorized physical address(es) that will provide suitable protection 24 hours a day, seven days a week against theft and diversion and that provides, at a minimum: i. Immediate automatic or electronic notification to alert State or local police agencies to an unauthorized breach of security at the alternative treatment center; and ii. A backup system that activates immediately and automatically upon a loss of electrical support and that immediately issues either automatically or electronic notification to State or local police agencies of the loss of electrical support;
2. Implement appropriate security and safety measures to deter and prevent the unauthorized entrance into areas containing marijuana and the theft of marijuana;
3. Implement security measures that protect the premises, registered qualifying patients, registered primary caregivers and principal officers, directors, board members and employees of the alternative treatment center; 4. Establish a protocol for testing and maintenance of the security alarm system;
5. Conduct maintenance inspections and tests of the security alarm system at the ATC’s authorized location at intervals not to exceed 30 days from the previous inspection and test and promptly implement all necessary repairs to ensure the proper operation of the alarm system;
6. In the event of a failure of the security alarm system due to a loss of electrical support or mechanical malfunction that is expected to last longer than eight hours: i. Notify the Department pursuant to N.J.A.C. 8:64-9.8; and ii. Provide alternative security measures approved by the Department or close the authorized physical addresses impacted by the failure or malfunction until the security alarm system is restored to full operation;
7. Keep access from outside the premises to a minimum and ensure that access is well controlled;
8. Keep the outside areas of the premises and its perimeter well lighted. i. Exterior lighting must be sufficient to deter nuisance and criminal activity and facilitate surveillance and must not disturb surrounding businesses or neighbors;
9. Provide law enforcement and neighbors within 100 feet of the ATC with the name and phone number of a staff person to notify during and after operating hours to whom they can report problems with the establishment;
10. Equip interior and exterior premises with electronic monitoring, video cameras and panic buttons. i. A video surveillance system shall be installed and operated to clearly monitor all critical control activities of the ATC and shall be in working order and operating at all times. The ATC shall provide two monitors for remote viewing via telephone lines in State offices. This system shall be approved by the MMP prior to permit issuance. ii. The original tapes or digital pictures produced by this system shall be stored in a safe place with a 30-day archive;
11. Limit entry into areas where marijuana is held to authorized personnel;
12. Consistently and systematically prevent loitering, that is, the presence of persons who are not on-duty personnel of the ATC and who are not ATC registrants engaging in authorized ATC- dispensary activity; and
13. Provide onsite parking.
8:64-9.8 Reportable events (a) An ATC, upon becoming aware of a reportable loss, discrepancies identified during inventory, diversion or theft, whether or not the medicinal marijuana, funds or other lost or stolen property is subsequently recovered and/or the responsible parties are identified and action taken against them, shall:
1. Immediately notify appropriate law enforcement authorities by telephone; and
2. Notify the permitting authority immediately but no later than three hours after discovery of the event.
(b) The ATC shall notify the permitting authority within 24 hours by telephone at (609) 826- 4935, followed by written notification within 10 business days, of any of the following:
1. An alarm activation or other event that requires response by public safety personnel;
2. A breach of security;
3. The failure of the security alarm system due to a loss of electrical support or mechanical malfunction that is expected to last longer than eight hours; and
4. Corrective measures taken, if any.
(c) An ATC shall maintain documentation in an auditable form for a period of at least two years after the reporting of an occurrence that is reportable pursuant to this section.
8:64-9.9 Inventory
(a) Each alternative treatment center, at a minimum, shall:
1. Conduct an initial comprehensive inventory of all medicinal marijuana, including marijuana available for cultivation and usable marijuana available for dispensing, seedling to mature marijuana plants and unusable marijuana, at the authorized location on the date the alternative treatment center first engages in the production or dispensing of medicinal marijuana; i. If an alternative treatment center commences business with no medicinal marijuana on hand, the ATC shall record this fact as the initial inventory; ii. Marijuana is deemed to be “on hand” if it is in the possession of or under the control of an ATC; iii. An inventory shall include damaged, defective, expired or adulterated marijuana awaiting disposal, including the name, the quantity and the reasons for which the ATC is maintaining the marijuana;
2. Establish inventory controls and procedures for the conduct of inventory reviews and comprehensive inventories of cultivating, stored, usable and unusable marijuana; 3. Conduct a monthly inventory of cultivating, stored, usable and unusable marijuana;
4. Conduct a comprehensive annual inventory at least once every year from the date of the previous comprehensive inventory;
5. Promptly transcribe inventories taken by use of an oral recording device; and
6. If marijuana is disposed of, maintain a written record of the date, the quantity disposed of, the manner of disposal and the persons present during the disposal, with their signatures; i. ATCs shall keep disposal records for at least two years.
(b) The record of an inventory conducted pursuant to this section shall include, at a minimum, the date of the inventory, a summary of the inventory findings and the name, signature and title of the individuals who conducted the inventory.
8:64–9.10 Destruction of marijuana; recordkeeping
(a) If a permit to operate an alternative treatment center expires without being renewed or is revoked, the permit holder shall:
1. Destroy or dispose of all unused marijuana or surplus inventory in its possession by providing it to the New Jersey State Police for destruction;
2. Create and maintain a written record of the disposal of marijuana that is identified for disposal by the alternative treatment center and weigh and inventory prior to destruction; and
3. Discontinue production of marijuana.
(b) Within 10 business days after destroying the marijuana, the holder of the permit shall notify the Department, in writing, of the amount of marijuana destroyed.
(c) A qualifying patient or a primary caregiver in possession of unused, unadulterated marijuana that is no longer needed for the qualifying patient’s medical use shall dispose of the marijuana by:
1. Returning it to an alternative treatment center; or
2. Transporting it or arranging for pickup by State or local police; i. The person or entity submitting marijuana for disposal pursuant to this section shall present a valid registry identification card and a New Jersey driver’s license or other State-issued photographic identification to the ATC or the police, as applicable.
SUBCHAPTER 10. PLANT CULTIVATION AUTHORIZED CONDUCT 8:64-10.1 Indoor cultivation site; limitation of inventory
(a) An alternative treatment center shall:
1. Produce marijuana only at the indoor cultivation site and area authorized in the permit;
2. Sell marijuana with a consistent unit price and label and without volume discounts;
3. Limit its inventory of usable marijuana and seeds to reflect current patient needs as identified by the number of patients registered with the alternative treatment center;
4. Comply with applicable laws and rules of the New Jersey Department of Agriculture and attendant inspection and enforcement activities; and
5. Comply with N.J.A.C. 8:21-3A.8 and 9.
8:64-10.2 Accessibility of marijuana storage areas
(a) An ATC shall limit access to medicinal marijuana storage areas to the absolute minimum number of specifically authorized employees.
1. When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests or visitors to be present in or pass through medicinal marijuana storage areas, the ATC shall provide for adequate observation of the area by an employee whom the permit holder specifically authorized by policy or job description to supervise the activity.
(b) Each alternative treatment center shall ensure that the storage of usable marijuana prepared for dispensing to patients is in a locked area with adequate security.
1. For purposes of this section, “adequate security,” at a minimum, shall be assessed, established and maintained based on: i. The quantity of usable marijuana kept on hand; ii. The alternative treatment center’s inventory system for tracking and dispensing usable marijuana; iii. The number of principal officers, directors, board members, agents, volunteers or employees who have or could have access to the usable marijuana; iv. The geographic location of the alternative treatment center and its associated environmental characteristics, such as the remoteness of the facility from local populations and the relative level of crime associated with the area; v. The scope and sustainability of the security alarm system; and vi. The findings of root cause analyses of any breaches of security and/or inventory discrepancies for usable marijuana at that location.
8:64-10.3 Recordkeeping
(a) An ATC shall maintain records identifying the source of each ingredient used in the manufacture or processing of marijuana.
1. Records identifying the source of each ingredient shall include the date of receipt of the ingredient, vendor’s name and address, the name of the ingredient and the vendor’s batch number, lot number and control number or other identifying symbol, if any, used by the vendor to identify the ingredient, as well as the grade and quantity of said ingredient;
(b) An alternative treatment center shall meet good manufacturing practices at N.J.A.C. 8:21 for the production of marijuana lozenges or topical formulations;
(c) An alternative treatment center shall maintain a system of recordkeeping that will permit the identification for purposes of recall of any lot or batch of medicinal marijuana from registered qualifying patients when such is found to be unsafe for use.
1. As part of this system, the alternative treatment center shall ensure that the container of any drug at any stage in the process of manufacture and distribution bears an identifying name and number, commonly known as a “lot” or “control” number, to make it possible to determine the complete manufacturing history of the package of the marijuana.
8:64-10.4 Physical plant
(a) All cultivation of marijuana shall take place in an enclosed, locked facility.
(b) Access to the enclosed, locked facility is limited to a cardholder who is a principal officer, director, board member or employee of an ATC when acting in his or her official capacity.
8:64-10.5 Storage of marijuana
Medicinal marijuana that is prepared for distribution shall be stored securely in compliance with 21 CFR 1301.72.
8:64-10.6 Informational policies; labeling
(a) An ATC shall establish and implement policies that require the ATC to maintain information about the different potencies, effects and forms for each usable marijuana package that the ATC prepares to dispense to registered qualifying patients and their caregivers.
(b) The ATC shall place a legible, firmly affixed label containing the information specified in (c) below on each package of medicinal marijuana it prepares to dispense and shall not dispense medicinal marijuana if the package does not bear the label. (c) The label required pursuant to (b) above shall contain the following:
1. The name and address of the alternative treatment center that produced the medicinal marijuana;
2. The quantity of the medicinal marijuana contained within the package;
3. The date that the ATC packaged the content;
4. A sequential serial number, lot number and bar code to identify lot associated with manufacturing and processing;
5. The cannabinoid profile of the medicinal marijuana contained within the package, including THC level not to exceed 10 percent;
6. Whether the medicinal marijuana is of the low, medium or high strength strain;
7. A statement that the product is for medical use by a qualifying patient and not for resale;
8. A list of any other ingredients besides medicinal marijuana contained within the package;
9. The date of dispensing to the qualifying patient or primary caregiver; and
10. The qualifying patient’s name and registry identification card number.
(d) Labeling shall be clear and truthful in all respects and shall not be false or misleading.
1. A label containing any statements about the product other than those specified in this chapter shall contain the following statement prominently displayed, and in boldface type: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
(e) The ATC shall file the form of label with the permitting program.
8:64-10.7 Strains of marijuana
(a) An ATC shall cultivate no more than three strains of medicinal marijuana.
(b) Strains of marijuana authorized for cultivation shall be labeled as one of the following strengths: low, medium or high.
(c) The maximum THC content of any sold product shall not exceed 10 percent.
8:64-10.8 Processing and packaging of marijuana (a) An ATC shall process marijuana in a safe and sanitary manner to protect registered qualifying patients from adulterated marijuana and shall process the dried leaves and flowers of the female marijuana plant only, which shall be:
1. Well cured and free of seeds and stems;
2. Free of dirt, sand, debris or other foreign matter; and
3. Free of mold, rot or other fungus or bacterial diseases.
(b) Medicinal marijuana shall be packaged in a secure area connected to the production area.
1. The dried product shall be handled on food grade stainless steel benches (tables).
2. Proper sanitation shall be maintained.
3. Proper rodent/bird exclusion practices shall be employed at all times.
(c) Each package of usable marijuana, at a minimum, shall:
1. Contain no more than ¼ ounce of marijuana or equivalent dose dependent on form;
2. Bear a label that complies with N.J.A.C. 8:64-10.7; and
3. Be in a closed container that holds no more than ¼ ounce and sealed, so that the package cannot be opened, and the contents consumed, without the seal being broken.
(d) Once a package is sealed, the ATC shall not open the package except for quality control. Once the seal is broken at an ATC, the marijuana is deemed unusable.
(e) An ATC shall package or dispense medicinal marijuana only in:
Dried form for direct dispensing to qualifying patients;
Oral lozenges for direct dispensing to qualifying patients; or
Topical formulations for direct dispensing to qualifying patients.
(f) The ATC shall submit the label to the MMP for approval and record. The MMP shall provide a copy of the label to authorized employees of State or law enforcement agencies, as necessary to perform official duties of that department and that division.
8:64-10.9 Pesticide use prohibited Inasmuch as there are no pesticides authorized for use on marijuana, and the unauthorized application of pesticides is unlawful, an ATC shall not apply pesticides in the cultivation of marijuana.
8:64-10.10 Organic certification
Marijuana for medical use may be labeled “organic” if the registered dispensary is certified as being in compliance with the United States Department of Agriculture certification requirements applying to organic products.
8:64-10.11 Secure transport
(a) An ATC that is authorized by permit to cultivate medicinal marijuana at one location and to dispense it at a second location shall transport only usable marijuana from the cultivation site to the dispensing site according to a delivery plan submitted to the Department.
(b) An ATC shall staff each transport vehicle with a delivery team consisting of at least two registered ATC employees.
1. At least one delivery team member shall remain with the vehicle at all times that the vehicle contains medicinal marijuana.
2. Each delivery team member shall have access to a secure form of communication with the ATC, such as a cellular telephone, at all times that the vehicle contains medicinal marijuana.
3. Each delivery team member shall possess his or her ATC employee identification card at all times and shall produce it to Department staff or law enforcement officials upon demand.
(c) Each transport vehicle shall be equipped with a secure lockbox or locking cargo area, which shall be used for the sanitary and secure transport of medicinal marijuana.
(d) Each ATC shall maintain current commercial automobile liability insurance on each vehicle used for transport of medicinal marijuana in the amount of one million dollars per incident.
(e) Each ATC shall ensure that vehicles used to transport medicinal marijuana bear no markings that would either identify or indicate that the vehicle is used to transport medicinal marijuana.
(f) Each ATC shall ensure that transports are completed in a timely and efficient manner. A transport vehicle shall proceed from the departure point where the medicinal marijuana is loaded directly to the destination point where the medicinal marijuana is unloaded without intervening stops or delays.
(g) Each ATC shall maintain a record of each transport of medicinal marijuana in a transport logbook. For each transport, the logbook shall record:
1. The date and time that the transport began and ended; 2. The names of the ATC employees comprising the delivery team;
3. The weight of the medicinal marijuana transported;
4. The lot number of the medicinal marijuana, the name of the strain and whether it is high, medium or low potency; and
5. The signatures of the ATC employees comprising the delivery team.
(h) An ATC shall report any vehicle accidents, diversions, losses, or other reportable events that occur during transport to the permitting authority in accordance with N.J.A.C. 8:64-9.8.
8:64-10.12 Home delivery prohibited
An alternative treatment center shall not deliver marijuana to the home or residence of a registered qualifying patient or primary caregiver.
SUBCHAPTER 11. DISPENSING AUTHORIZED CONDUCT
8:64-11.1 Education policies
(a) Each ATC shall establish and implement policies describing its plans for providing information to registered qualifying patients and primary caregivers as to:
1. Limitations of the right to possess and use marijuana pursuant to the Act and this chapter;
2. Potential side effects of marijuana use and how this shall be communicated to registered qualifying patients and primary caregivers;
3. The differing strengths of products dispensed;
4. Safe techniques for use of medicinal marijuana and paraphernalia;
5. Alternative methods and forms of consumption or inhalation by which one can use medicinal marijuana;
6. Signs and symptoms of substance abuse;
7. Opportunities to participate in substance abuse programs; and
8. Information on tolerance, dependence and withdrawal.
8:64-11.2 Patient informational materials (a) Each ATC shall maintain, and make available for distribution to registered qualifying patients and their primary caregivers, an adequate supply of up-to-date informational materials addressing the matters identified in the policies developed pursuant to N.J.A.C. 8:64-11.1.
(b) Informational materials must be available for inspection by the Department upon request.
(c) Each ATC shall provide registered qualifying patients and their primary caregivers with a notice requesting approval for the ATC to contact registered qualifying patients and their primary caregivers with information concerning ongoing peer reviewed clinical studies related to the use of marijuana.
8:64-11.3 Notice of and adherence to ATC designation
(a) The Department shall maintain a list of the qualified patients who have designated each ATC to provide medicinal marijuana for the patient’s medical use.
(b) An alternative treatment center shall maintain, and make available for Department inspection upon request, a copy of the registry identification card and New Jersey driver’s license or other State-issued photographic identification of each current qualifying patient and his or her primary caregiver, if any.
(c) The Department shall issue written notice to each affected ATC each time a registered qualifying patient and/or his or her primary caregiver designates or ceases his or her designation of the ATC.
1. Upon receipt of a notice issued pursuant to (c) above, the ATC shall update its records to reflect the content of the notice.
(d) An ATC shall not provide dispensary services to qualifying patients and/or their primary caregivers who have not previously designated the ATC as their registered ATC, as reflected on the registry identification card of the qualifying patient and/or his or her primary caregiver.
8:64-11.4 Pain and/or primary qualifying symptom assessment records
(a) An alternative treatment center shall formulate a system for documenting a patient’s self- assessment of pain and/or primary qualifying symptom using a pain rating scale.
1. An alternative treatment center serving different patient populations shall make more than one pain scale available for patient use, as appropriate.
(b) An alternative treatment center shall document a patient’s self-assessment of pain or primary qualifying symptom upon commencement of the dispensing of medicinal marijuana to the patient and thereafter at three-month intervals. 1. The ATC shall maintain the record for the patient’s use and information in consulting with his or her physician as to the use of medicinal marijuana to address the patient’s qualifying debilitating condition.
(c) ATCs shall provide “log books” to registered qualifying patients and registered primary caregivers who request them to keep track of the strains used and their effects.
8:64-11.5 Prohibitions
(a) An ATC shall not furnish usable marijuana to a registered patient or primary caregiver if the ATC suspects or has reason to believe that the person is abusing marijuana or other substances or unlawfully redistributing usable marijuana.
(b) An ATC shall dispense medicinal marijuana only in the forms authorized pursuant to N.J.A.C. 8:64-10.8(e) directly to registered qualifying patients and their registered primary caregivers.
8:64-11.6 Inventory
(a) An alternative treatment center is authorized to possess two ounces of usable marijuana per registered qualifying patient plus an additional supply, not to exceed the amount needed to enable the alternative treatment center to meet the demand of newly registered qualifying patients, consistent with actual demand ratios calculated pursuant to N.J.A.C. 8:64-9.3(a)3, 4 and 5.
(b) During the first 60 days after commencement of operations, an alternative treatment center is authorized to possess a reasonable supply of usable marijuana to build initial inventory, without the ATC having been designated for use by any registered qualifying patients or primary caregivers.
(c) When there is a decrease in the number of registered qualifying patients and primary caregivers who have designated the alternative treatment center as their dispensary, the alternative treatment center shall have 10 business days to adjust the inventory.
(d) Two alternative treatment center employees shall weigh, log-in and sign-out quantities of packaged usable marijuana to perform dispensing.
SUBCHAPTER 12. MARKETING AND ADVERTISING
8:64–12.1 Marketing and advertising
(a) Alternative treatment centers shall restrict signage to black text on a white background on external signage, labeling and brochures for the alternative treatment center.
(b) Alternative treatment center signage shall not be illuminated at any time. (c) Alternative treatment centers shall not display on the exterior of the facility advertisements for medicinal marijuana or a brand name except for purposes of identifying the building by the permitted name.
(d) Alternative treatment centers shall not advertise the price of marijuana, except that:
1. An ATC can provide a catalogue or a printed list of the prices and strains of medicinal marijuana available at the alternative treatment center to registered qualifying patients and primary caregivers.
(e) Marijuana and paraphernalia shall not be displayed or clearly visible to a person from the exterior of an alternative treatment center.
(f) Alternative treatment centers shall not produce any items for sale or promotional gifts, such as T-shirts or novelty items, bearing a symbol or references to marijuana. This prohibition shall not pertain to paraphernalia sold to registered qualifying patients or their primary caregivers.
SUBCHAPTER 13. MONITORING, ENFORCEMENT ACTIONS, APPEAL RIGHTS AND EXEMPTION FROM STATE CRIMINAL AND CIVIL PENALTIES FOR THE MEDICAL USE OF MARIJUANA
8:64-13.1 Monitoring
The Department may request information from physicians, ATCs, registered qualifying patients, primary caregivers, the parents, guardians or custodians of registered qualifying patients who are minors in order to assess the impact and effectiveness of the New Jersey Compassionate Use Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq.
8:64-13.2 Inspections
When a permit application is approved and an ATC is ready for operation, representatives of the Department or any other State agency, as applicable, shall conduct an inspection to determine if the facility complies with applicable laws and rules.
8:64-13.3 Onsite assessment
(a) An ATC is subject to onsite assessment by the Department at any time.
(b) The Department may enter an ATC without notice to carry out an onsite assessment in accordance with the Act and this chapter.
1. All ATCs shall provide the Department or the Department’s designee immediate access to any material and information.
(c) Submission of an application for an ATC permit constitutes permission for entry and onsite assessment of an ATC. (d) Failure to cooperate with an onsite assessment and or to provide the Department access to the premises or information may be grounds to revoke the permit of the ATC and to refer the matter to State law enforcement agencies.
(e) An onsite assessment may include, but not be limited to:
1. The review of all ATC documents and records and conferences with qualifying patients and primary caregivers and other persons with information, and the making and retaining of copies and/or extracts;
2. The use of any computer system at the ATC to examine electronic data;
3. The reproduction and retention of any document and/or electronic data in the form of a printout or other output;
4. The examination and collection of samples of any marijuana found at the ATC; and
5. The seizure and detention of any marijuana or thing believed to contain marijuana found at the ATC. i. If the Department makes a seizure, it shall take such measures as are reasonable in the circumstances to give to the owner or other person in charge of the place where the seizure occurs notice of the seizure. ii. If the Department determines that the detention of the substance or thing seized is no longer necessary to ensure compliance with applicable law and the ATC permit, the Department shall notify in writing the ATC permit holder of that determination and shall return the substance or thing to the permit holder, upon the permit holder issuing a receipt to the Department for the return of the substance or thing. iii. The Department shall maintain documentation of the chain of custody of seized substances or things, in accordance with N.J.A.C. 8:64-13.4.
(f) During an onsite assessment, if the Department identifies violations of the Act or this chapter, the Department shall provide written notice of the nature of the violations to the ATC.
1. The ATC shall notify the Department in writing, with a postmark date that is within 20 business days of the date of the notice of violations, of the corrective actions the ATC has taken to correct the violations and the date of implementation of the corrective action.
8:64-13.4 Quality control; sample collection; chain of custody
(a) To ensure the safety of registered qualifying patients, an ATC shall provide samples to the Department during announced and unannounced inspections for product quality control.
(b) To implement the requirement in (a) above, the Department shall: 1. Collect soil and plant samples and samples of products containing marijuana cultivated and/or dispensed, as applicable, by the ATC;
2. Place the permit number of the ATC on each sample container;
3. Label the sample containers with a description and the quantity of its content;
4. Seal the sample containers; and
5. Have ATC and Department staff initial each sample container.
(c) The Department shall maintain documentation of the chain of custody of samples taken.
1. The Department shall provide a receipt for the collected samples to the ATC’s authorized representative.
2. The Department shall maintain an accounting of all collected sample containers for control purposes.
3. The Department shall test samples. i. Sample testing may include tests for, among other things, the presence of pests, mold, mildew, heavy metals and pesticides and the accuracy of labeling.
4. The Department shall issue written reports of the results of its testing to the ATC.
5. The ATC shall pay the expenses for the testing.
8:64-13.5 Notice of violations and enforcement actions
The Department shall issue a written notice to an ATC permit holder of a proposed assessment of civil monetary penalties, suspension or revocation of a permit, setting forth the specific violations, charges or reasons for the action, by transmitting the notice by certified mail to the ATC.
8:64-13.6 Prohibitions, restrictions and limitations on the cultivation or dispensing of medicinal marijuana and criminal penalties
(a) Participation in the Medicinal Marijuana Program by an ATC, or the employees of an ATC, does not relieve the ATC or its employees from criminal prosecution or civil penalties for activities not authorized by the Act, this chapter or the ATC permit.
(b) Distribution of medicinal marijuana to qualified patients or their primary caregivers shall take place at the Department approved location identified on the ATC’s permit.
1. ATCs shall not be located within a drug-free school zone. (c) Any person who makes a fraudulent representation to a law enforcement officer about the person’s participation in the Medicinal Marijuana Program to avoid arrest or prosecution for a marijuana-related offense is guilty of a petty disorderly persons offense and shall be sentenced in accordance with applicable law.
(d) A person who knowingly sells, offers or exposes for sale or otherwise transfers or possesses with the intent to sell, offer or expose for sale or transfer a document that falsely purports to be a registry identification card or an ATC identification card issued pursuant to the Act, or a registry identification card or an ATC identification card issued pursuant to the Act that has been altered, is guilty of a crime of the third degree. A person who knowingly presents to a law enforcement officer a document that falsely purports to be a registry identification card or an ATC identification card issued pursuant to the Act, or a registry identification card or an ATC identification card that has been issued pursuant to the Act that has been altered, is guilty of a crime of the fourth degree. The provisions of this section are intended to supplement current law and shall not limit prosecution or conviction for any other offense.
(e) If an ATC or employee of an ATC sells, distributes, dispenses or transfers marijuana to a person not approved by the Department pursuant to the Act and this chapter, or obtains or transports marijuana outside New Jersey in violation of Federal law, the ATC or employee of the ATC shall be subject to arrest, prosecution and civil or criminal penalties pursuant to State law.
8:64-13.7 Revocation of registry identification card, ATC identification card, ATC permit
Violation of any provision of this chapter may result in the immediate revocation of any privilege granted under the Act and this chapter.
8:64-13.8 Onsite inspection and corrective actions
(a) Any failure to adhere to the Act and this chapter documented by the Department during monitoring may result in sanctions, including suspension, revocation, non-renewal or denial of permit and referral to State or law enforcement.
1. The Department shall refer complaints involving alleged criminal activity made against an ATC to the appropriate New Jersey State or local authorities.
(b) An ATC shall maintain detailed confidential sales records in a manner and format approved by the Department pursuant to N.J.A.C. 8:64-9.
1. The Department or its agents shall have complete access to the sales and other financial records of an ATC and shall be granted immediate access to those records upon request.
2. The Department may, within its sole discretion, periodically require the audit of an ATC’s financial records by an independent certified public accountant approved by the Department. i. An ATC that is required to be audited shall bear all costs related to such audit. A requested audit shall be concluded within a reasonable period, as determined by the Department. Results of a required audit shall be forwarded to the Medicinal Marijuana Program coordinator or designee.
3. An ATC shall submit reports on at least a quarterly basis, or as otherwise requested, by the Department.
(c) If violations of requirements of the Act or this chapter are cited as a result of inspection or review of financial records, the ATC shall be provided with an official written report of the findings within seven business days following the inspection.
1. Unless otherwise specified by the Department, the ATC shall correct the violation within 20 calendar days of receipt of the official written report citing the violation(s).
2. The violation shall not be deemed corrected until the Department verifies in writing within seven calendar days of receiving notice of the corrective action that the corrective action is satisfactory.
3. If the violation has not been corrected, the Department may issue a notice of contemplated action to revoke the ATC permit.
(d) Pursuant to N.J.S.A. 24:6I-7, the Commissioner may order the summary suspension of a ATC permit upon a finding that violations pose an immediate threat to the health, safety and welfare of the public, qualified patients or primary caregivers including, but not limited to:
1. Failure to comply with or satisfy any provision of this chapter;
2. Failure to allow a monitoring visit by authorized representatives of the Department;
3. Falsification of any material or information submitted to the Department;
4. Diversion of marijuana, as determined by the Department;
5. Threatening or harming a patient, a medical practitioner or an employee of the Department.
(e) Upon a finding described in (d) above, the Commissioner or the Commissioner’s authorized representative shall serve notice by certified mail to the ATC or its registered agent of the nature of the findings and violations and the proposed order of suspension.
1. Except in the case of a life-threatening emergency, the notice shall provide the ATC with 72 hours from receipt to correct the violations and provide proof to the Department of such correction.
(f) If the Department determines the violations have not been corrected, and the facility has not filed notice requesting a hearing to contest the notice of suspension within 48 hours of receipt of the Commissioner’s notice pursuant to (g) below, then the ATC permit shall be deemed suspended.
1. Upon the effective date of the suspension, the ATC shall cease and desist the operations and cooperate with the Department as necessary in the orderly transfer of registrations of qualifying patients and primary caregivers to another ATC.
(g) If the facility requests a hearing within 48 hours of receipt of a notice of proposed suspension of permit, the Department shall arrange for an immediate hearing to be conducted by the Commissioner and a final agency decision shall be issued within 48 hours by the Commissioner. If the Commissioner affirms the proposed suspension of the permit, the order shall become final. The ATC may apply for injunctive relief against the Commissioner’s order in the New Jersey Superior Court, Appellate Division.
(h) Notwithstanding the issuance of an order for proposed suspension of a permit, the Department may concurrently or subsequently impose other enforcement actions pursuant to the Act and this chapter.
(i) The Department may rescind the order for suspension upon a finding that the ATC has corrected the conditions that were the basis for the action.
8:64-13.9 Revocation of a permit
(a) The Department may issue a notice of the proposed revocation of an ATC permit in the following circumstances:
1. The ATC has failed to comply with administrative requirements related to an ATC permit, posing an immediate and serious risk of harm or actual harm to the health, safety and welfare of qualifying patients, primary residents or employees and the ATC has not corrected such violations in accordance with an approved plan of correction or subsequent to imposition of other enforcement remedies issued pursuant to these rules;
2. The ATC has exhibited a pattern and practice of violating permit requirements posing a serious risk of harm to the health, safety and welfare of qualifying patients, primary residents or employees. A pattern and practice may be demonstrated by the repeated violation of identical or substantially-related permit standards during three consecutive inspections or the issuance of civil monetary penalties pursuant to the Act or other enforcement actions for unrelated violations on three or more consecutive onsite assessments;
3. Failure of an ATC to correct identified violations that led to the issuance of an order for suspension of a permit; or
4. Continuance of an ATC on conditional permit status for a period of 12 months or more.
(b) The notice shall be served in accordance with this subchapter. (c) The ATC has a right to request a hearing pursuant to this subchapter.
8:64-13.10 Appeal rights
(a) Denial of an application or revocation of a registry identification card shall constitute a final agency decision subject to review by the Superior Court, Appellate Division.
1. An individual has the right to appeal a final agency decision within 45 days to the New Jersey Superior Court, Appellate Division, Richard J. Hughes Justice Complex, PO Box 006, Trenton, NJ 08625-0006.
8:64-13.11 Exemption from State criminal and civil penalties for the medical use of marijuana
(a) The provisions of N.J.S.A. 2C:35-18 shall apply to any qualifying patient, primary caregiver, alternative treatment center, physician or any other person acting in accordance with the provisions of the Act and this chapter.
(b) A qualifying patient, primary caregiver, alternative treatment center, physician or any other person acting in accordance with the provisions of the Act shall not be subject to any civil or administrative penalty or denied any right or privilege, including, but not limited to, civil penalty or disciplinary action by a professional licensing board, related to the medical use of marijuana as authorized under the Act and this chapter.
(c) Possession of, or application for, a registry identification card shall not alone constitute probable cause to search the person or the property of the person possessing or applying for the registry identification card or otherwise subject the person or his or her property to inspection by any governmental agency.
(d) The provisions of section 2 of P.L.1939, c. 248 (N.J.S.A. 26:2-82), relating to destruction of marijuana determined to exist by the Department, shall not apply if a qualifying patient or primary caregiver has in his or her possession a registry identification card and no more than the maximum amount of usable marijuana that may be obtained in accordance with N.J.S.A. 24:6I- 10 and this chapter.
(e) No person shall be subject to arrest or prosecution for constructive possession, conspiracy or any other offense for simply being in the presence or vicinity of the medical use of marijuana as authorized under the Act and this chapter.
(f) No custodial parent, guardian or person who has legal custody of a qualifying patient who is a minor shall be subject to arrest or prosecution for constructive possession, conspiracy or any other offense for assisting the minor in the medical use of marijuana as authorized under the Act and this chapter.
43 N.J.R. 3335(a) December 19, 2011 Filed December 1, 2011
New Jersey information is provided by and printed with permission of the New Jersey Office of Administrative Law, Division of Administrative Rules.
The Department of Health Medicinal Marijuana Program
2015 Annual Report and 2015 Biennial Report
March 2016
The Department of Health Medicinal Marijuana Program
Table of Contents
2015 Annual Report…………………………….2
2015 Biennial Report………………………….14
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The Department of Health Medicinal Marijuana Program
2015 Annual Report
This document reports the current status of the New Jersey Department of Health (DOH) Medicinal Marijuana Program’s (MMP) progress in the implementation of the New Jersey Compassionate Use Medical Marijuana Act (the Act), N.J.S.A. 24:6I-1 et seq. This report provides an update of program developments in calendar year 2015 on the status of the Alternative Treatment Centers (ATCs); medicinal marijuana cultivation; ATC examinations; the patient, caregiver, and physician registries; outreach and communication; education; marijuana testing; the regulatory process; and concludes with calendar year 2015 statistics.
Alternative Treatment Centers (ATCs)
Greenleaf Compassion Center (GCC) in Montclair, Essex County, was issued a permit to cultivate on April 16, 2012, and issued a final permit on October 15, 2012. GCC began dispensing medicinal marijuana to patients on December 6, 2012. Since its initial permitting, 1,493 patients have been served, 6,755 transactions completed, and 221.7 pounds of product dispensed. From January 1, 2015 through December 31, 2015, 1,031 patients were served, 4,529 transactions completed, and 141.7 pounds of product dispensed. GCC dispensed product on 246 days in 2015. The Department maintains 24/7 video surveillance of the ATC operation and access to its internal inventory management system. GCC was re- permitted on January 1, 2015.
Compassionate Care Foundation (CCF) in Egg Harbor, Atlantic County, was issued a permit to cultivate on June 6, 2013, and issued a final permit on October 3, 2013. CCF began dispensing medicinal marijuana to patients on October 28, 2013. Since its initial permitting, 2,275 patients have been served, 12,884 transactions completed, and 514.7 pounds of product dispensed. From January 1, 2015 through December 31, 2015, 1,292 patients were served, 7,916 transactions completed, and 302.7 pounds of product dispensed. CCF dispensed product on 285 days in 2015. The Department maintains 24/7 video surveillance of the ATC operation and access to its internal inventory management system.
Garden State Dispensary (GSD) in Woodbridge, Middlesex County, was issued a permit to cultivate on August 7, 2013, and issued a final permit on November 20, 2013. GSD began dispensing medicinal marijuana to patients on November 22, 2013. Since its initial permitting, 4,785 patients have been served, 32,962 transactions completed, and 1,149.9 pounds of product dispensed. From January 1, 2015 through December 31, 2015, 2,620 patients were served, 19,942 transactions completed, and 634.9 pounds of product dispensed. GSD dispensed
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The Department of Health Medicinal Marijuana Program
product on 326 days in 2015. The Department maintains 24/7 video surveillance of the ATC operation and access to its internal inventory management system.
Breakwater ATC (Breakwater) in Cranbury, Middlesex County, was issued a temporary permit to cultivate on November 20, 2014 and issued a final permit on October 14, 2015. Breakwater began dispensing medicinal marijuana to patients on October 15, 2015. From October 15, 2015 through December 31, 2015, 413 patients were served, 783 transactions completed, and 45 pounds of product dispensed. Breakwater dispensed product on 67 days in 2015. The Department maintains 24/7 video surveillance of the ATC operation and access to its internal inventory management system.
Compassionate Science ATC (CS) in Bellmawr, Camden County was issued a temporary permit to cultivate on June 29, 2015 and issued a final permit on September 21, 2015. CS began dispensing medicinal marijuana to patients on September 30, 2015. From September 30, 2015 through December 31, 2015, 778 patients were served, 1,279 transactions completed, and 105 pounds of product dispensed. CS dispensed product on 93 days in 2015. The Department maintains 24/7 video surveillance of the ATC operation and access to its internal inventory management system.
Foundation Harmony (Harmony) has secured a host community in Secaucus, Hudson County. The examination of Harmony principals, corporate structure, and funding source was initiated on December 2, 2014, and is ongoing. The Department is working with Harmony to achieve regulatory compliance during the examination process.
Medicinal Marijuana Cultivation
As a result of amendments to P.L.2009, c.307, ATCs are not limited in the number of strains of medicinal marijuana cultivated. The chart below outlines the number of medicinal marijuana strains cultivated by permitted ATCs since the inception of the program. The laboratory results of strains available are contained in the MMP Strain Library which is available to physicians and patients.
GCC CCF GSD BW CS Total Total Strains Initiated 13 26 31 8 26 104 Strains Discontinued 4 10 4 3 0 21 Strains in Cultivation 9 16 27 5 26 83 Strains Tested 13 15 25 5 15 73 *CBD Strains Available 2 2 3 1 2 10 Total Strains Available 10 14 24 5 15 68 *CBD strains are, at a minimum, a 1 to 1 ratio of CBD to THC
March 2016 Page 3
The Department of Health Medicinal Marijuana Program
ATC Examinations
The Department executed a Memorandum of Agreement with the Department of Law and Public Safety (LPS) on January 12, 2012. LPS agreed to assist DOH with obtaining credible and relevant criminal, financial, and other information; as well as provide legal expertise in the examination of the ATCs’ principals and business structure to assist the Department in making informed decisions regarding ATC permitting.
Greenleaf Compassion Center (GCC) – Examination of GCC principals and business structure was initiated on December 15, 2011. Examination was completed on April 16, 2012. GCC was issued an ATC permit upon review and approval of the examination and attaining full regulatory compliance.
Compassionate Care Foundation (CCF) – Examination of CCF principals was initiated on February 13, 2012. Examination was completed on March 18, 2013. CCF was issued an ATC permit upon review and approval of the examination and attaining full regulatory compliance.
Garden State Dispensary (GSD) – Examination of GSD principals was initiated on September 4, 2012. Examination was completed on April 24, 2013. GSD was issued an ATC permit upon review and approval of the examination and attaining full regulatory compliance.
Breakwater ATC (Breakwater) – Examination of Breakwater principals was initiated on August 24, 2012. Examination was completed on December 13, 2013. Breakwater was issued an ATC permit upon review and approval of the examination and attaining full regulatory compliance.
Compassionate Science ATC (CSATC) – The examination of CSATC principals, corporate structure, and funding source was initiated on February 12, 2013. Examination was completed on June 3, 2015. CSATC was issued an ATC permit upon review and approval of the examination and attaining full regulatory compliance.
Foundation Harmony (Harmony) –The examination of Harmony principals, corporate structure, and funding source was initiated on December 2, 2014 and is ongoing.
Examination timeframes are impacted by a number of factors including the complexity of the ATC business structure, their contractual agreements and their responsiveness to requests for information.
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The Department of Health Medicinal Marijuana Program
Patients/Caregiver Registry
The MMP developed an electronic patient and caregiver registration and payment process (the registry). The registry is an encrypted, public web application that provides end-to-end security of personal, medical and financial information of the applicant. This registry opened on August 9, 2012. Since the registry opened, 6,960 qualifying patients and 631 caregivers have been registered with the program. From January 1, 2015 through December 31, 2015, 2,557 qualifying patients and 79 caregivers registered with the program. The MMP has issued identification cards to 6,527 qualifying applicants completing the registration process. Additionally, all authorized debilitating illnesses are represented in the present patient population.
On August 18, 2014, the MMP initiated the patient and caregiver registration renewal process. From January 1, 2015 through December 31, 2015, 530 qualifying patients and 28 caregivers completed the renewal process. A prorated registration fee is provided to patients who paid an initial registration fee but did not receive medicinal marijuana for a period of time after receiving their initial MMP ID card. The prorated fee is applied at the time of registration renewal and deducts for the time period a patient did not receive medicinal marijuana from an Alternative Treatment Center.
The patient and caregiver registration fee is $200.00 for two years. Patients and caregivers that receive New Jersey Medicaid, Supplemental Nutrition Assistance Program (SNAP) benefits, New Jersey Temporary Disability Insurance benefits, Supplemental Security Income (SSI) benefits or Social Security Disability (SSD) benefits, receive a reduced registration fee of $20.00. Approximately 48 percent of registered patients and caregivers receive the reduced application fee of $20.00.
Physician Registry
Since the inception of the program, 452 physicians have registered with the program; of those physicians registered, 362 are active, 83 requested to be inactivated, and 7 were disapproved. From January 1, 2015 through December 31, 2015, 37 new physicians registered with the program. Of active physicians, 74 percent are currently authorizing patients for the program. All registered physicians are listed on the MMP website. Patients may ask their primary physician to register with the MMP or they may locate a participating physician on the website by county and/or medical specialty.
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The Department of Health Medicinal Marijuana Program
Participating physicians must hold an active New Jersey medical license in good standing issued by the NJ Board of Medical Examiners, possess an active controlled dangerous substances registration issued by the NJ Division of Consumer Affairs that is not subject to limitation, and practice within the State of New Jersey.
Outreach & Communication
The MMP developed a Customer Service Unit (CSU) for physicians, patients, caregivers, ATCs and the public. The CSU has responded to 32,493 public inquiries via telephone and e-mail. The CSU has also assisted patients and caregivers through the registration process.
The MMP communicates with ATCs in the examination process to facilitate the review of submissions. Additionally, the MMP communicates daily with operational ATCs to monitor activity, obtain status reports, and resolve any programmatic issues to ensure compliance with the Act and applicable regulations.
Education
The MMP has partnered with the New Jersey Board of Medical Examiners, the Medical Society of New Jersey, and the Drug Policy Alliance to provide an electronic library of scholarly articles and research materials, which are available on the MMP website.
The MMP has developed a Medicinal Marijuana Strain Library available to registered physicians and patients through the MMP registry. The library contains laboratory testing results of available strains of medicinal marijuana cultivated by the ATCs. As of December 31, 2015, there were 68 distinct strains available and posted on the library site. The library is designed to assist physicians and patients in making informed decisions regarding medicinal marijuana use.
Marijuana Testing
The MMP worked with several State agencies to develop marijuana sampling and testing protocols that ensure compliance with labeling standards and the quality of the product. Furthermore, the Department’s Public Health Environmental Laboratory (PHEL) established additional, scientific protocols for product sampling and testing.
The PHEL worked with the Department of Agriculture to develop protocols related to testing for molds and pesticides. The MMP sampling and testing process
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The Department of Health Medicinal Marijuana Program
was developed after researching marijuana testing protocols in the United States, Canada, and Europe. Product testing is necessary to establish cannabinoid profiles and screen the product for mold and other contaminants that can be dangerous for patients with compromised immune systems. The PHEL has developed a testing protocol for the detection of pesticides. Additionally, ATCs have provided the MMP with certification that no chemical pesticides are used in the cultivation of medicinal marijuana.
As of December 31, 2015, the MMP has conducted laboratory testing on 72 distinct strains (68 available, 4 discontinued) of medicinal marijuana cultivated by operating ATCs.
Medical Review Panel
The Department received recommendations for volunteers who may be interested in serving on the medical review panel. The Department conducted outreach to prospective panel members. The table below lists the confirmed members, their specialty area, and requirements as per the rules.
Panel Member Specialty Rule Requirement Stewart A. Berkowitz, MD President, New Jersey State President, New Jersey State Board of Medical Examiners Board of Medical Examiners Alex Bekker, MD, PhD Anesthesiology Pain& symptom management expertise/Physician Petros Levounis, MD, MA Psychiatry Pain& symptom management Addiction Medicine expertise/Physician Cheryl Kennedy, MD Psychiatrist Pain& symptom management Addiction Medicine expertise/Physician Jessica Ann Scerbo, MD Pediatric, Hematology & Physician Oncology Mary L. Johansen, PhD Nursing Non-physician Mary M. Bridgeman, Pharm D. Pharmacist Non-physician Stephanie Zarus, Pharm D. Pain Management Non-physician
The process as set forth in the rules will continue to move forward through 2016. The process of allowing for petitions to consider additional illnesses is subject to public notice.
March 2016 Page 7
The Department of Health Medicinal Marijuana Program
Regulatory Process
Manufacturing Standards
In March of 2015 the Department provided standards for manufacturing lozenge, topical formulations and edible form products. To date one ATC (Compassionate Sciences) has provided a manufacturing proposal to the Department and has started the development of a manufacturing process room within their facility.
Permitting Process
The Department and New Jersey Department of Law and Public Safety established a permitting process to thoroughly review the financial and personal backgrounds of the principals associated with the ATCs. The permitting process is modeled after protocols and procedures for reviewing the background and finances of casino operators undertaken by the Division of Gaming Enforcement, within LPS. Additionally, the MMP has developed an:
Online registration process for patients, caregivers and ATC employees. Successful applicants are issued an identification card specific to their role within the program;
Identification card system with various security features that mitigate counterfeiting and which can be validated by law enforcement through an online search; and
ATC Monitoring Unit that conducts on-site inspections, monitors the ATCs by video in real time, and remotely accesses the ATC internal inventory management systems.
The DOH has collaborated with several State and private entities to implement the Act, including, but not limited to, LPS, including the Office of the Attorney General, the Boards of Medical Examiners and Pharmacy, and the Division of Gaming Enforcement; the Departments of Agriculture, Environmental Protection, Labor and Workforce Development, and Treasury; the Motor Vehicle Commission; Rutgers University; the University of Mississippi; the Drug Policy Alliance; the Medical Society of New Jersey; and the Coalition for Medical Marijuana New Jersey. Each has lent expertise to program implementation and operation.
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Budget
The FY16 MMP budget consists of an appropriation of $1,607,000 and a carry forward from FY15 of $439,730 for a total overall budget of $2,046,730. Revenue generated from July 1, 2015 to December 31, 2015 from the issuance of patient and caregiver identification cards and ATC permitting is $243,093. This revenue is used to help offset the operation cost of the program.
Program Statistics
Patient Registry Applications Current New in 2015 Patients Active 6,126 2,557 Patients Inactive 188 115 Patients Deceased 646 561 Patients Disapproved 339 136 Total Patient Applications 7,299 3,369
Qualifying Patients Registered* 6,960 3,233
Caregiver Registry Applications Current New in 2015 Caregivers Active 360 79 Caregivers Inactive 271 51 Caregivers Disapproved 0 0 Total Caregiver Applications 631 130
Primary Caregivers Registered* 631 130
Registry Identification Cards Revoked 0
*Approximately 48% of registered patients and caregivers qualified for and received the reduced application fee of $20.00.
Alternative Treatment Center Examinations
Initiated 6 Completed 5 Ongoing 1
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Alternative Treatment Center Permits
Issued 5 Full 5 Limited 0 Revoked 0
Physician Registry Current New in 2015 Physicians Active* 362 37 Physicians Inactivated 83 41 Physicians Disapproved 7 3 Total Physician Activity 452 81 *Of the 362 active registered physicians, 270 or 75% are executing certifications for registered patients.
Nature of the Patients’ Qualifying Illness Since Program Inception
Debilitating Condition Count of Patient Percentage of Conditions Population Glaucoma 220 6.07% Inflammatory Bowel Disease 1,090 11.11% Intractable Skeletal Spasticity 3,339 34.02% Lateral Sclerosis 65 0.66% Multiple Sclerosis 985 10.04% Muscular Dystrophy 129 1.31% Seizure Disorder 596 6.07% Severe or Chronic Pain 2,507 25.54% Terminal Cancer 695 7.08% Terminal Illness 189 1.93% Total *9,815 100.00% *Condition count is greater than patient total as some patients suffer from multiple qualifying illnesses.
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Frequency of Condition 4000
3500 3,339
3000
2,507 2500
2000
1500
1,090 985 1000 695 596 500 220 189 65 129 0
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Active Registered Physicians by Specialty 100
89 90
80 71 70
60
50 46
40 37 31 30 26 26
20 14 13 9 10
0
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Caregiver Frequency by Patient Condition 250
204 200
174 165
150 130
100
74
47 50 26 16 18 9
0
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2015 Biennial Report
This document shall serve as the biennial report to the Governor and Legislature on the New Jersey Department of Health Medicinal Marijuana Program. This report addresses the statutory reporting requirements found at N.J.S.A. 24:6I-12(c). Unless otherwise specified, data within this report covers the time period of January 1, 2014 through February 15, 2016. The purpose of this report is to document the evaluations conducted in the following areas: whether there are sufficient numbers of alternative treatment centers to meet the needs of registered qualifying patients throughout the State; whether the maximum amount of medicinal marijuana allowed pursuant to law is sufficient to meet the medical needs of qualifying patients; and whether any alternative treatment center has charged excessive prices for marijuana that the center dispensed.
Summary
On January 18, 2010, Governor Jon Corzine signed the New Jersey Compassionate Use Medical Marijuana Act (Act), N.J.S.A 24:6I-1 et seq., into law. The Act placed the responsibility of implementation with the New Jersey Department of Health (Department). Since the passage of the Act, the Department has built a Medicinal Marijuana Program (MMP) with the following goals: to implement a program that allows patients with qualifying debilitating medical conditions to obtain medicinal marijuana in a timely, safe and responsible manner; to ensure the integrity of the program by conducting appropriate background examinations of those entities and individuals involved with the program, specifically Alternate Treatment Centers; to protect the public from the risks associated with the cultivation and distribution of medicinal marijuana, including safety risks posed by product diversion; and to create and administer a medicinal marijuana program with the highest standards, that will serve as a model for other states that have enacted legislation to legalize marijuana for medicinal purposes.
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Evaluation 1
Purpose Evaluate whether there are sufficient numbers of Alternative Treatment Centers (ATCs) to meet the needs of registered qualifying patients throughout the State.
Background Information Alternative Treatment Centers Examination A background examination process for qualifying Alternative Treatment Centers was developed by the Department in cooperation with the Department of Law and Public Safety (LPS). The purpose of the examination is to ensure the long-term integrity of the MMP by thoroughly reviewing all aspects of the ATC’s business, financial, and personnel structures. The background examination materials were disseminated to the six selected ATCs on November 18, 2011. ATCs were instructed to complete the background examination materials and submit them to the Department for processing. Timeline • December 15, 2011 - Preliminary examination materials received from Greenleaf Compassion Center (GCC). The GCC examination was completed on April 16, 2012. • February 13, 2012 - Preliminary examination materials received from Compassionate Care Foundation (CCF). The CCF examination was completed on March 18, 2013. • August 24, 2012 - Preliminary examination materials received from Breakwater ATC (BW). Breakwater examination was completed on December 13, 2013. • September 4, 2012 - Preliminary examination materials received from Compassionate Care Center of America, conducting business as Garden State Dispensary (GSD). GSD examination was completed on April 24, 2013. • February 21, 2013 – Preliminary examination materials received from Compassionate Science ATC (CS). CS examination was completed on June 3, 2015. • August 30, 2013 - Preliminary examination materials received from Foundation Harmony (FH). FH examination is ongoing. All ATCs have and continue to augment their initial submissions with additional information as necessary. Five of the six selected ATCs have completed the background examination process. The average timeframe of examinations is 14 months. The process is
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comprehensive. Timeframes are impacted by a number of factors including the complexity of the ATC business structure, their contractual agreements, and their timeliness and responsiveness to Department requests. Five of the six selected ATCs have been permitted by the Department and are operational. GCC is located in the north, GSD and Breakwater in the central, CCF and CS in the south region of the State. All five ATC locations are easily accessible by major roadways.
Patient Access
Patient and caregiver registration was initiated on August 9, 2012. As of February 15, 2016, there are 6,466 patients assigned to the 5 operational ATCs. GCC started dispensing to patients on December 6, 2012. From January 1, 2014 through February 15, 2016, GCC has been open for business 390 days and has dispensed 201.7 pounds of medicinal marijuana product. Currently, GCC is open Monday through Friday, 10:00am to 5:00pm. GCC’s current number of assigned patients is 1,253. CCF became operational on October 28, 2013. From January 1, 2014 through February 15, 2016, CCF has been open for business 574 days and has dispensed 529.6 pounds of medicinal marijuana product. Currently, CCF is open Monday, Tuesday and Friday, 10:00am to 5:00pm, Wednesday, 10:00am to 7:00pm., and Saturday and Sunday, 9:00am to 1:00pm. CCF’s current number of assigned patients is 1,144. GSD became operational on November 22, 2013. From January 1, 2014 through February 15, 2016, GSD has been open for business 768 days and has dispensed 1,155.3 pounds of medicinal marijuana product. Currently, GSD is open Sunday through Saturday, 10:00am to 6:00pm. GSD’s current number of assigned patients is 2,616. CS became operational on September 24, 2015. As of February 15, 2016, CS has been open for business 128 days, dispensing 159.9 pounds of medicinal marijuana product. Currently, CS is open Sunday through Saturday, 11:00am to 7:00pm. CS’ current number of assigned patients is 913. BW became operational on October 15, 2015. As of February 15, 2016, BW has been open for business 97 days and has dispensed 70.3 pounds of medicinal marijuana product. Currently, BW is open Monday through Wednesday, 10:30am to 6:30pm, Thursday and Friday, 10:30am to 8:30pm and Saturday, 12:00pm to 4:00pm. BW’s current number of assigned patients is 540.
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To date the registered qualifying patient population of 6,466 is divided among the five operational ATCs as follows:
ATC Patient Population (% of Total) Greenleaf Compassion Center 1,253 (19.38%) Compassionate Care Foundation 1,144 (17.69%) Garden State Dispensary 2,616 (40.46% Compassionate Sciences 913 (14.12%) Breakwater 540 (8.35%) Total 6,466 (100%) .
ATC Cultivation From January 1, 2014 through February 15, 2016 GCC has initiated 4,375 marijuana plants and harvested 2,541 marijuana plants. Their cultivation rate is 58 percent. GCC currently has 659 plants in active cultivation. From January 1, 2014 through February 15, CCF has initiated 21,565 marijuana plants and harvested 12,056 marijuana plants. Their cultivation rate is 55 percent. CCF currently has 772 plants in active cultivation. From January 1, 2014 through February 15, GSD has initiated 19,632 marijuana plants and harvested 9,276 marijuana plants. Their cultivation rate is 47 percent. GSD currently has 3,167 plants in active cultivation. From September 24, 2015 through February 15, 2016, CS has initiated 5,669 marijuana plants and harvested 2,560 marijuana plants. Their cultivation rate is 45 percent. CS currently has 2,834 plants in active cultivation. From October 15, 2015 through February 15, 2016 BW has initiated 2,090 marijuana plants and harvested 974 marijuana plants. Their cultivation rate is 46 percent. BW currently has 498 plants in active cultivation.
ATC Harvest Yield GCC has harvested 2,541 marijuana plants and dispensed 2,973 ounces to patients. GCC produced 1.17 ounces per plant harvested and dispensed 1.17 ounces per plant. CCF has harvested 12,056 marijuana plants and dispensed 7,855 ounces to patients. CCF produced .75 ounces per plant harvested and dispensed .65 ounces per plant.
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GSD has harvested 9,276 marijuana plants and dispensed 19,432.76 ounces to patients. GSD produces 2.09 ounces per plant harvested and dispensed 2.09 ounces per plant. CS has harvested 2,560 marijuana plants and dispensed 2559.2 ounces to patients. CS produces 2.27 ounces per plant harvested and dispensed .99 ounces per plant. BW has harvested 974 marijuana plants and dispensed 1125.92 ounces to patients. BW produces 2.28 ounces per plant harvested and dispensed 1.15 ounces per plant.
ATC Initiated Harvested Cultivation Yield per Yield Product Rate plant Dispensed Dispensed GCC 4,375 2,541 58% 1.17 ounces 1.17 ounces 2,973 ounces CCF 21,565 12,056 55% .75 ounces .65 ounces 7,855 ounces GSD 19,632 9,276 47% 2.09 ounces 2.09 ounces 19,432.76 ounces CS 5,669 2,560 45% 2.27 ounces .99 ounces 2559.2 ounces BW 2,090 974 46% 2.28 ounces 1.15 ounces 1125.92 ounces
MMP Customer Service Outreach Since the MMP’s inception, the MMP Customer Service Unit (CSU) has provided electronic and telephonic guidance to the MMP patient and caregiver population. The CSU maintains a web-site at http://nj.gov/health/medicalmarijuana/. The web-site routinely provides updates and information for patients, physicians and caregivers. The web-site also maintains a section on frequently asked questions. As each subsequent ATC is permitted to operate, the CSU initiates email and personal contact with the patient base to provide updates on MMP’s status, including but not limited to new ATC availability.
Evaluation Study & Design MMP compiled internal (MMP Registry) and external (ATC Internal Inventory Management System) statistics from patient registry; ATC permitting dates; and ATC cultivation, harvest, and dispensing logs to conduct an evaluation of the five permitted ATCs’ ability to serve the patient population at specific time periods during the program. Consideration is given to individual ATC’s cultivation and harvest success as obtained from the ATC internal inventory management systems.
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Results Three significant factors in measuring an ATC’s ability to meet patient needs have emerged in this evaluation. The first is the cultivation success rate of plants initiated to plants surviving to harvest. The second is the yield rate per ounce of useable product per harvested plant. The third factor is continuity in cultivation schedules. A high rate of success in these three areas equates to a greater number of patients being served.
Greenleaf Compassion Center - Montclair GCC has a success rate of 58 percent in cultivation, a yield per plant of 1.17 oz. and presently has 59 plants in cultivation. From January 1, 2014 through February 15, 2016 the GCC has been operating 390 days. GCC has 19.38 percent (1253) of the total registered patient population and has served 100 percent of that population and is meeting its patients’ needs.
Compassionate Care Center - Egg Harbor CCF has a success rate of 55 percent in cultivation, a yield per plant of .75 oz. and presently has 772 plants in cultivation. From January 1, 2014 through February 15, 2016 CCF has been operating 574 days. CCF has 17.69 percent (1,144) of the total registered patient population and has served 100 percent of that population.
Garden State Dispensary - Woodbridge GSD has had success rate of 47 percent in cultivation, a yield per plant of 2.09 oz. and presently has 3,167 plants in cultivation. From January 1, 2014 through February 15, 2016 GSD has been operating 768 days. GSD has 40.46 percent (2,616) of the total registered patient population and has served 100 percent of that population.
Compassionate Sciences - Bellmawr CS has had success rate of 45 percent in cultivation, a yield per plant of 2.27 oz. and presently has 2,834 plants in cultivation. With the opening of CS on September 30, 2015, there were four ATCs operational in the state. CS has acquired 14.12 percent (913) of the total registered patient population and has served 100 percent of that population. CS began operations with an initial inventory of 1,792 ounces of product.
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Breakwater - Cranbury BW has had a success rate of 46 percent in cultivation, a yield per plant of 2.28 oz. and presently has 498 plants in cultivation. With the opening of BW on October 15, 2015, there were five ATCs operational in the state. BW has acquired 8.35 percent (540) of the total registered patient population and has served 100 percent of that population. BW began operations with an initial inventory of 1,296 ounces of product.
Conclusions & Recommendations: The MMP Customer Service Unit contacts, via email and telephone, each patient registered with the program to advise them of the opening of additional ATCs. As of February 15, 2015, GSD supplies 40.46 percent of the total patients registered with MMP, GCC supplies 19.38 percent, CCF supplies 17.69 percent, CS supplies 14.12 percent and BW supplies 8.35 percent. The success of the five ATC’s in the areas of cultivation, yield per plant, and continuity in cultivation adequately serve their respective patient bases - with the ability to serve new patients beyond their current assigned patients. Each geographic region of the State is represented by an operational ATC and all ATC locations are easily accessible by major roadways. As of February 15, 2016, 6,466 patients are active with MMP since the registry opened on August 9, 2012. The average registry growth has been 247 patients per month. The anticipated growth by July 1, 2016 is 1,112 patients, bringing the patient total to 7,578. The current combined capacity of the operating ATC’s exceeds the current patient base. The program concludes that the present number of ATCs is capable of meeting the current registered qualifying patient needs. MMP does not at this time recommend additional ATCs beyond the six identified in the initial selection process.
Evaluation 2
Purpose Evaluate whether the maximum amount of medicinal marijuana allowed pursuant to the Act is sufficient to meet the medical needs of registered qualifying patients.
Background Information The patient registry opened on August, 2012. On that date, physicians were able to initiate patient certifications for the use of medicinal marijuana. By statute,
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a physician is permitted to certify no more than two ounces of medicinal marijuana in a 30-day time-period and may certify up to 90 days before patient reevaluation. Medicinal marijuana is certified and dispensed in increments of one-eighth and one-quarter of an ounce. If a physician does not enumerate a specific 30-day amount, the program defaults the patient to the two-ounce maximum.
Evaluation Study & Design The MMP derived statistical information from the program registry to compile trends in physician-certification amounts and patient-purchase amounts.
Results As of February 15, 2016, 363 of active physicians registered with MMP have been certifying medicinal marijuana use. Those physicians have provided certifications to 6,466 patients. A review of the certifications revealed that 61 percent certified more than one ounce and 39 percent certified one ounce or less. A review of patient purchases from the five permitted ATCs for the calendar month of December 2015 revealed that of 2,483 total transactions, 8 percent were for more than an ounce and 92 percent were for one ounce or less.
Conclusions & Recommendations The MMP is a physician-driven medical model. Physicians are responsible for establishing bona fide relationships with their patients, conducting a comprehensive evaluation of the patient and, if in their determination the patient is eligible for the program, certifying the use of medicinal marijuana and the amount to be obtained in a given certification period. Purchasing trends reveal that the vast majority of patients purchase one ounce or less, regardless of the physician’s certified amount. As medicinal marijuana is not covered by insurance, patient purchasing is on a need-only basis and utilization is largely conducted by the patient’s self-monitoring of medicating need. The program concludes that based on this evidence the patients’ medical needs are being met by the two-ounce limit.
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Evaluation 3
Purpose Determine whether any ATC has charged excessive prices for marijuana that the center dispensed.
Background Information A background examination process for qualifying ATCs was developed by the Department in cooperation with the New Jersey Department of Law and Public Safety. The purpose of the examination is to ensure the long-term integrity of MMP by thoroughly reviewing all aspects of the ATC’s business, financial and personnel structures. The first six ATCs’ are required to be nonprofit organizations. By definition, a nonprofit organization uses its surplus revenues to achieve its goals rather than distributing that revenue as profit or dividends. Nonprofit organizations are permitted to generate surplus revenue but they must be retained by the organization for its self-preservation, expansion, or plans in furtherance of the nonprofit’s stated mission. One of the more challenging aspects of the ATC examinations has been the review of the ATC business plans and service agreements with contractors. Several ATC examinations resulted in multiple reiterations of funding contract and service agreements before the Department was satisfied with the ATC’s adherence to nonprofit standards. The Act requires the first two ATCs issued permits in each region of the State to be nonprofit entities. However, federal law does not allow ATCs to register as a nonprofit organization due to the nature of their business in cultivating and distributing marijuana, which is not allowed under federal law. The Department’s vision of the ATCs as nonprofit organizations is that they are formed to benefit the participants of the medicinal marijuana program in a tangible way. One such way is providing product at a reasonable price. The price of one ounce of medicinal marijuana dispensed by New Jersey ATCs ranges from $425.00 to $520.00 with an average price of $489.00. The MMP researched programs similar to New Jersey’s about medicinal marijuana prices with the results listed below. The cost of living index was obtained from the United States Census Bureau 2015 statistical abstract. Adjusting for cost of living, New Jersey’s average price per ounce is not excessive.
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State Average price per ounce Cost of living index New Jersey $489 125.6 Arizona $300 98.8 New Mexico $284 104.2 Vermont $358 123.8 Maine $300 114.7 Rhode Island $311 123.3 Average $311 (about 37% less) 112.4 (10% less)
According to 2015 data from the Drug Enforcement Agency (DEA), the price of hydroponic black market marijuana in the State of New Jersey is $400 to $450 per ounce. The average price of ATC marijuana is $489, or between 5 and 16 percent above the DEA reported black market price.
Patients are permitted to choose any operational ATC from which to purchase medicinal marijuana. A patient may switch their ATC affiliation at any time without incurring additional costs.
Evaluation Study & Design MMP obtained information from the following sources: five other state medical marijuana programs with similar regulatory requirements to New Jersey; national cost of living variations, DEA reported prices of black market marijuana in New Jersey; and internal program experience while conducting ATC examinations.
Results Six of the 23 states that have legalized marijuana for medicinal purposes, permit cultivation and dispensary operations. The five states reported have an average price per ounce of 33% less than New Jersey. The average cost of living in the states with similar regulatory requirements is on average 10% less than New Jersey. The DEA-reported price of hydroponic black market marijuana in New Jersey is between $400 and $450 dollars per ounce. ATC marijuana is cultivated, packaged and dispensed in secure, sanitary environments. ATCs are not permitted to utilize pesticides and the Department tests for cannabinoid profiles as well as toxic metals and mycotoxins. Patients are provided with a laboratory tested product with known ingredients. Registration in MMP affords patients protection under the Act in securing medicinal marijuana from an ATC. Registered patients are able to switch ATC at any time and at no cost.
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The United States federal tax code 280E requires ATCs pay a federal corporate tax rate of 34 percent. This equates to $166.26 for each ounce sold at the average ATC price of $489.
Conclusions & Recommendations Based upon cost of living variations, the price of New Jersey medicinal marijuana is comparable with the price in states with similar regulatory models. The price of New Jersey medicinal marijuana is within five and sixteen percent of New Jersey black market marijuana. New Jersey medicinal marijuana is regulated and tested, patients are afforded protection under the Act and are able to change ATC affiliation at any time at no cost. ATCs are required to pay federal corporate tax at a rate of 34 percent. Given those considerations, as well as the regulatory oversight and patient protections built into the program, the Department determines that no ATCs are charging excessive prices for medicinal marijuana.
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2016 Annual Report
The Department of Health Medicinal Marijuana Program
This document reports the current status of the New Jersey Department of Health (Department) Medicinal Marijuana Program’s (MMP) progress in the implementation of the New Jersey Compassionate Use Medical Marijuana Act (the Act), N.J.S.A. 24:6I-1 et seq. This report provides an update of program developments in calendar year 2016 on the status of the Alternative Treatment Centers (ATCs); medicinal marijuana cultivation; ATC examinations; the patient, caregiver, and physician registries; outreach and communication; education; marijuana testing; the regulatory process; and concludes with calendar year 2016 statistics (i.e., through December 31, 2016).
Alternative Treatment Centers (ATCs)
Greenleaf Compassion Center (GCC) in Montclair, Essex County, was issued a permit to cultivate on April 16, 2012, and issued a final permit on October 15, 2012. GCC began dispensing medicinal marijuana to patients on December 6, 2012. Since its initial permitting, 2,192 patients have been served, 12,083 transactions completed, and 395.45 pounds of product dispensed. From January 1, 2016 through December 31, 2016, 1,288 patients were served, 5,330 transactions completed, and 172.5 pounds of product dispensed. GCC dispensed product on 276 days in 2016. The Department maintains 24/7 video surveillance of the ATC operation and access to its internal inventory management system. GCC was re- permitted on January 1, 2016.
Compassionate Care Foundation (CCF) in Egg Harbor, Atlantic County, was issued a permit to cultivate on June 6, 2013, and issued a final permit on October 3, 2013. CCF began dispensing medicinal marijuana to patients on October 28, 2013. Since its initial permitting, 2,661 patients have been served, 26,683 transactions completed, and 967.41 pounds of product dispensed. From January 1, 2016 through December 31, 2016, 1,527 patients were served, 13,799 transactions completed, and 450.9 pounds of product dispensed. CCF dispensed product on 359 days in 2016. The Department maintains 24/7 video surveillance of the ATC operation and access to its internal inventory management system. CCF was re-permitted on January 1, 2016.
Garden State Dispensary (GSD) in Woodbridge, Middlesex County, was issued a permit to cultivate on August 7, 2013, and issued a final permit on November 20, 2013. GSD began dispensing medicinal marijuana to patients on November 22, 2013. Since its initial permitting, 4,902 patients have been served, 53,132 transactions completed, and 1843.37 pounds of product dispensed. From January 1, 2016 through December 31, 2016, 2,687 patients were served, 20,170 transactions completed, and 691.3 pounds of product dispensed. GSD dispensed product on 361 days in 2016. The Department maintains 24/7 video surveillance
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of the ATC operation and access to its internal inventory management system. GSD was re-permitted on January 1, 2016.
Breakwater ATC (BW) in Cranbury, Middlesex County, was issued a temporary permit to cultivate on November 20, 2014 and issued a final permit on October 14, 2015. Breakwater began dispensing medicinal marijuana to patients on October 15, 2015. Since its initial permitting, 2,203 patients have been served, 14,726 transactions completed, and 540.28 pounds of product dispensed. From January 1, 2016 through December 31, 2016, 2068 patients were served, 13,943 transactions completed, and 494.2 pounds of product dispensed. Breakwater dispensed product on 308 days in 2016. The Department maintains 24/7 video surveillance of the ATC operation and access to its internal inventory management system. BW was re-permitted on January 1, 2016.
Compassionate Science ATC (CS) in Bellmawr, Camden County was issued a temporary permit to cultivate on June 29, 2015 and issued a final permit on September 21, 2015. CS began dispensing medicinal marijuana to patients on September 30, 2015. Since its initial permitting, 2,870 patients have been served, 32,702 transactions completed, and 991.82 pounds of product dispensed. From January 1, 2016 through December 31, 2016, 2,762 patients were served, 31,423 transactions completed, and 884.9 pounds of product dispensed. CS dispensed product on 359 days in 2016. The Department maintains 24/7 video surveillance of the ATC operation and access to its internal inventory management system. CS was re-permitted on January 1, 2016.
Foundation Harmony (Harmony) has secured a host community in Secaucus, Hudson County. The examination of Harmony principals, corporate structure, and funding source was initiated on December 2, 2014, and is ongoing.
Medicinal Marijuana Cultivation
As a result of amendments to P.L.2009, c.307, ATCs are not limited in the number of strains of medicinal marijuana cultivated. The chart below outlines the number of medicinal marijuana strains cultivated by permitted ATCs since the inception of the program through December 31, 2016. The laboratory results of strains available are contained in the MMP Strain Library which is available to physicians and patients.
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Table 1: Medicinal Marijuana Strains by ATC
GCC CCF GSD BW CS Total Total Strains Initiated 21 47 58 26 48 200 Strains Discontinued 5 10 34 6 2 57 Strains in Cultivation 16 26 20 20 46 128 Strains Tested 9 22 26 13 27 97 *CBD Strains Available 2 2 4 1 2 11 Total Strains Available 8 12 17 10 23 70 *CBD strains are, at a minimum, a 1 to 1 ratio of CBD to THC CBD = Cannabidiol THC= Tetrahydrocannabinol
ATC Examinations
The Department executed a Memorandum of Agreement with the Department of Law and Public Safety (LPS) on January 12, 2012. LPS agreed to assist DOH with obtaining credible and relevant criminal, financial, and other information; as well as provide legal expertise in the examination of the ATCs’ principals and business structure to assist the Department in making informed decisions regarding ATC permitting.
Greenleaf Compassion Center (GCC) - Examination of GCC principals and business structure was initiated on December 15, 2011. Examination was completed on April 16, 2012. GCC was issued an ATC permit upon review and approval of the examination and attaining full regulatory compliance.
Compassionate Care Foundation (CCF) - Examination of CCF principals was initiated on February 13, 2012. Examination was completed on March 18, 2013. CCF was issued an ATC permit upon review and approval of the examination and attaining full regulatory compliance.
Garden State Dispensary (GSD) - Examination of GSD principals was initiated on September 4, 2012. Examination was completed on April 24, 2013. GSD was issued an ATC permit upon review and approval of the examination and attaining full regulatory compliance.
Breakwater ATC (Breakwater) - Examination of Breakwater principals was initiated on August 24, 2012. Examination was completed on December 13, 2013. Breakwater was issued an ATC permit upon review and approval of the examination and attaining full regulatory compliance.
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Compassionate Science ATC (CSATC) - The examination of CSATC principals, corporate structure, and funding source was initiated on February 12, 2013. Examination was completed on June 3, 2015. CSATC was issued an ATC permit upon review and approval of the examination and attaining full regulatory compliance.
Foundation Harmony (Harmony) - The examination of Harmony principals, corporate structure, and funding source was initiated on December 2, 2014 and is ongoing.
Examination timeframes are impacted by a number of factors including the complexity of the ATC business structure, their contractual agreements and their responsiveness to requests for information.
Patients/Caregiver Registry
The MMP developed an electronic patient and caregiver registration and payment process (the registry). The registry is an encrypted, public web application that provides end-to-end security of personal, medical and financial information of the applicant. This registry opened on August 9, 2012. Since the registry opened, 12,514 qualifying patients and 1,030 caregivers have been registered with the program. From January 1, 2016 through December 31, 2016, 5,060 qualifying patients and 315 caregivers registered with the program. The MMP has issued identification cards to 11,617 qualifying applicants completing the registration process. Additionally, all authorized debilitating illnesses are represented in the present patient population.
The patient and caregiver registration fee is $200.00 for two years. Patients and caregivers that receive New Jersey Medicaid, Supplemental Nutrition Assistance Program (SNAP) benefits, New Jersey Temporary Disability Insurance benefits, Supplemental Security Income (SSI) benefits or Social Security Disability (SSD) benefits, receive a reduced registration fee of $20.00. Approximately 45 percent of registered patients and caregivers receive the reduced application fee of $20.00.
Physician Registry
Since the inception of the program, 529 physicians have registered with the program; of those physicians registered, 426 are active, 91 requested to be inactivated, and 12 were disapproved. From January 1, 2016 through December 31, 2016, 77 physicians registered with the program, 64 are active, 8 are inactivated, and 5 were disapproved. Of active physicians, 73 percent are currently
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authorizing patients for the program. All registered physicians are listed on the MMP website. Patients may ask their primary physician to register with the MMP or they may locate a participating physician on the website by county and/or medical specialty.
Participating physicians must hold an active New Jersey medical license in good standing issued by the NJ Board of Medical Examiners, possess an active controlled dangerous substances registration issued by the NJ Division of Consumer Affairs that is not subject to limitation, and practice within the State of New Jersey.
Outreach & Communication
The MMP developed a Customer Service Unit (CSU) to provide program information for physicians, patients, caregivers, ATCs and the public. Through December 31, 2016, CSU had responded to 47,463 public inquiries via telephone and e-mail. The CSU also assists patients and caregivers through the registration process.
The MMP communicates with ATCs in the examination process to facilitate the review of submissions. Additionally, the MMP communicates daily with operational ATCs to monitor activity, obtain status reports, and resolve any programmatic issues to ensure compliance with the Act and applicable regulations.
Education
The MMP has partnered with the New Jersey Board of Medical Examiners, the Medical Society of New Jersey, and the Drug Policy Alliance to provide an electronic library of scholarly articles and research materials, which are available on the MMP website.
The MMP has developed a Medicinal Marijuana Strain Library available to registered physicians and patients through the MMP registry. The library contains laboratory testing results of available strains of medicinal marijuana cultivated by the ATCs. As of December 31, 2016, there were 97 distinct strains tested which are posted on the library site. The library is designed to assist physicians and patients in making informed decisions regarding medicinal marijuana use.
Marijuana Testing
The MMP worked with several State agencies to develop marijuana sampling and testing protocols that ensure compliance with labeling standards and the quality of the product. Furthermore, the Department’s Public Health Environmental
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Laboratory (PHEL) established additional, scientific protocols for product sampling and testing.
The PHEL worked with the Department of Agriculture to develop protocols related to testing for molds and pesticides. The MMP sampling and testing process was developed after researching marijuana testing protocols in the United States, Canada, and Europe. Product testing is necessary to establish cannabinoid profiles and screen the product for mold and other contaminants that can be dangerous for patients with compromised immune systems. The PHEL has developed a testing protocol for the detection of pesticides. Additionally, ATCs have provided the MMP with certification that no chemical pesticides are used in the cultivation of medicinal marijuana.
As of December 31, 2016, the MMP has conducted laboratory testing on 97 distinct strains of medicinal marijuana cultivated by operating ATCs.
Medical Review Panel
The table below lists the confirmed Medical Review Panel members, their specialty area, and requirements as per the rules.
Table 2: Medical Review Panel
Panel Member Specialty Rule Requirement Stewart A. Berkowitz, MD President, New Jersey State President, New Jersey State Board of Medical Examiners Board of Medical Examiners Alex Bekker, MD, PhD Anesthesiology Pain & symptom Chairperson management expertise/Physician Petros Levounis, MD, MA Psychiatry Pain & symptom Addiction Medicine management expertise/Physician Cheryl Kennedy, MD Psychiatrist Pain & symptom Vice Chairperson Addiction Medicine management expertise/Physician Jessica Ann Scerbo, MD Pediatric, Hematology & Physician Oncology Mary L. Johansen, PhD Nursing Non-physician Mary M. Bridgeman, Pharm D. Pharmacist Non-physician Stephanie Zarus, Pharm D. Pain Management Non-physician
Additional Debilitating Medical Conditions Process
The first Medical Review Panel meeting was held on May 25, 2016. During this meeting the Medical Review Panel Chairperson and Vice Chairperson were
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elected, the Medical Review Panel bylaws were approved and the panel received public comment from attendees.
From August 1, 2016 to August 31, 2016 the Department accepted petitions for additional debilitating medical conditions. At the close of this period the Department received sixty-eight (68) petitions.
A DOH review of the received petitions determined that forty-five (45) met the qualifications of the MMP Rules and Regulations and would be forwarded to the Medical Review Panel for review. Eighteen (18) did not meet the requirements and were returned to the petitioners. Five (5) petitions that were submitted for Post-Traumatic Stress Disorder (PTSD) were returned to the petitioners because on September 14, 2016, Governor Chris Christie signed N.J. Assembly Bill A-457 into law, allowing PTSD to be included as a debilitating medical condition under the “New Jersey Compassionate Use Medical Marijuana Act”.
In December 2016, the qualifying petitions were posted on the Department’s website and provided to the Medical Review Panel. The Panel will be holding public meetings in 2017 to consider each of those petitions and to make recommendations to the Commissioner of Health.
Regulatory Process
Manufacturing Standards
In March 2015, the Department provided standards to the ATCs for manufacturing lozenge, topical formulations and edible form products. To date, one ATC (Compassionate Science) has implemented the manufacturing standards and is currently dispensing a lozenge and a topical formulation.
Permitting Process
The Department and New Jersey Department of Law and Public Safety (LPS) established a permitting process to thoroughly review the financial and personal backgrounds of the principals associated with the ATCs. The permitting process is modeled after protocols and procedures for reviewing the background and finances of casino operators undertaken by the Division of Gaming Enforcement, within LPS. Additionally, the MMP has developed an:
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Online registration process for patients, caregivers and ATC employees. Successful applicants are issued an identification card specific to their role within the program;
Identification card system with various security features that mitigate counterfeiting and which can be validated by law enforcement through an online search; and
ATC Monitoring Unit that conducts on-site inspections, monitors the ATCs by video in real time, and remotely accesses the ATC internal inventory management systems.
The DOH has collaborated with several State and private entities to implement the Act, including, but not limited to, LPS, including the Office of the Attorney General, the Boards of Medical Examiners and Pharmacy, and the Division of Gaming Enforcement; the Departments of Agriculture, Environmental Protection, Labor and Workforce Development, and Treasury; the Motor Vehicle Commission; Rutgers University; the University of Mississippi; the Drug Policy Alliance; the Medical Society of New Jersey; and the Coalition for Medical Marijuana New Jersey. Each has lent expertise to program implementation and operation.
Budget
The State Fiscal year 2017 (SFY17) MMP budget consists of an appropriation of $1,607,000 and a carry forward from SFY16 of $98,386 for a total overall budget of $1,705,386. Revenue generated from January 1, 2016 to December 31, 2016 from the issuance of patient and caregiver identification cards and ATC permitting is $881,358. This revenue is used to help offset the operating cost of the program.
Program Statistics
Patient Registry Applications New in 2016 Total from Program Inception Patients Active 4,735 10,799 Patients Inactive 22 245 Patients Deceased 303 1,470 Patients Disapproved 215 613 Total Patient Applications 5,275 13,127
Qualifying Patients Registered* 5,060 12,514
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Caregiver Registry Applications New in 2016 Total from Program Inception Caregivers Active 180 543 Caregivers Inactive 135 487 Caregivers Disapproved 0 0 Total Caregiver Applications 315 1,030
Primary Caregivers Registered* 315 1,030
Registry Identification Cards Revoked 0
*Approximately 45% of registered patients and caregivers qualified for and received the reduced application fee of $20.00.
Physician Registry New in 2016 Total from Program Inception Physicians Active* 64 426 Physicians Inactivated 8 91 Physicians Disapproved 5 12 Total Physician Activity 77 529 *Of the 426 active registered physicians, 309 or 73% are executing certifications for registered patients.
Alternative Treatment Center Examinations (Through December 31, 2016)
Initiated 6 Completed 5 Ongoing 1
Alternative Treatment Center Permits (Through December 31, 2016)
Issued 5 Full 5 Limited 0 Revoked 0
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Table 3:
Nature of the Patients’ Qualifying Illness
(August 9, 2012 through December 31, 2016)
Debilitating Condition Count of Patient Percentage of Conditions Population Glaucoma 309 1.77% Inflammatory Bowel Disease 1,792 10.25% Intractable Skeletal Spasticity 6,748 38.61% Lateral Sclerosis 101 0.58% Multiple Sclerosis 1,356 7.76% Muscular Dystrophy 163 0.93% *Post-Traumatic Stress Disorder 466 2.67% (PTSD) Seizure Disorder 913 5.23% Severe or Chronic Pain 4,177 23.90% Terminal Cancer 1,152 6.59% Terminal Illness 299 1.71% Grand Total **17,476 100.00%
* On September 14, 2016, N.J. Assembly Bill was signed into law by Governor Chris Christie, allowing PTSD to be included as a debilitating medical condition under the “New Jersey Compassionate Use Medical Marijuana Act”.
**Condition count is greater than patient total as some patients suffer from multiple qualifying illnesses.
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Figure 1:
Frequency of Condition
(August 9, 2012 through December 31, 2016)
8000
7000 6,748
6000
5000
4,177 4000
3000
2000 1,792
1,356 1,152 913 1000 466 309 299 101 163 0
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Figure 2:
Active Registered Physicians by Specialty
(August 9, 2012 through December 31, 2016)
100
90 88 82 80
70
59 60
50 43 41 39 40 36
30
20 17 15
10 6
0
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Figure 1:
Caregiver Frequency by Patient Condition
(August 9, 2012 through December 31, 2016)
400
354 350
305 300
262
250
200
160
150 131
100 74
50 41 25 23 19 11
0
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CHAPTER 307
AN ACT concerning the medical use of marijuana and revising parts of statutory law.
BE IT ENACTED by the Senate and General Assembly of the State of New Jersey:
C.24:6I-1 Short title. 1. This act shall be known and may be cited as the "New Jersey Compassionate Use Medical Marijuana Act."
C.24:6I-2 Findings, declarations relative to the medical use of marijuana. 2. The Legislature finds and declares that: a. Modern medical research has discovered a beneficial use for marijuana in treating or alleviating the pain or other symptoms associated with certain debilitating medical conditions, as found by the National Academy of Sciences' Institute of Medicine in March 1999; b. According to the U.S. Sentencing Commission and the Federal Bureau of Investigation, 99 out of every 100 marijuana arrests in the country are made under state law, rather than under federal law. Consequently, changing state law will have the practical effect of protecting from arrest the vast majority of seriously ill people who have a medical need to use marijuana; c. Although federal law currently prohibits the use of marijuana, the laws of Alaska, California, Colorado, Hawaii, Maine, Michigan, Montana, Nevada, New Mexico, Oregon, Rhode Island, Vermont, and Washington permit the use of marijuana for medical purposes, and in Arizona doctors are permitted to prescribe marijuana. New Jersey joins this effort for the health and welfare of its citizens; d. States are not required to enforce federal law or prosecute people for engaging in activities prohibited by federal law; therefore, compliance with this act does not put the State of New Jersey in violation of federal law; and e. Compassion dictates that a distinction be made between medical and non-medical uses of marijuana. Hence, the purpose of this act is to protect from arrest, prosecution, property forfeiture, and criminal and other penalties, those patients who use marijuana to alleviate suffering from debilitating medical conditions, as well as their physicians, primary caregivers, and those who are authorized to produce marijuana for medical purposes.
C.24:6I-3 Definitions relative to the medical use of marijuana. 3. As used in this act: “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. “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. “Commissioner” means the Commissioner of Health and Senior Services. “Debilitating medical condition” means: (1) one of the following conditions, if resistant 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) terminal illness, if the physician has determined a prognosis of less than 12 months of life; or (5) any other medical condition or its treatment that is approved by the department by regulation. “Department” means the Department of Health and Senior Services. “Marijuana” has the meaning given in section 2 of the “New Jersey Controlled Dangerous Substances Act,” P.L.1970, c.226 (C.24:21-2). “Medical marijuana alternative treatment center” or “alternative treatment center” means an organization approved by the department to perform activities necessary to provide registered qualifying patients with usable marijuana and related paraphernalia in accordance with the provisions of this act. This term shall include the organization’s officers, directors, board members, and employees. “Medical use of marijuana” means the acquisition, possession, transport, or use of marijuana or paraphernalia by a registered qualifying patient as authorized by this act. “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. “Paraphernalia” has the meaning given in N.J.S.2C:36-1. “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 medical marijuana or consultation solely for that purpose. “Primary caregiver” or “caregiver” means a resident of the State who: a. is at least 18 years old; b. 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; c. has never been convicted of possession or sale of a controlled dangerous substance, unless such conviction occurred after the effective date of this act and was for a violation of federal law related to possession or sale of marijuana that is authorized under this act; d. has registered with the department pursuant to section 4 of this act, and has satisfied the criminal history record background check requirement of section 4 of this act; and e. has been designated as primary caregiver on the qualifying patient's application or renewal for a registry identification card or in other written notification to the department. “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. “Registry identification card” means a document issued by the department that identifies a person as a registered qualifying patient or primary caregiver. “Usable marijuana” means the dried leaves and flowers of marijuana, and any mixture or preparation thereof, and does not include the seeds, stems, stalks or roots of the plant.
C.24:6I-4 Registry of qualifying patients, primary caregivers. 4. a. The department shall establish a registry of qualifying patients and their primary caregivers, and shall issue a registry identification card, which shall be valid for two years, to a qualifying patient and primary caregiver, if applicable, who submits the following, in accordance with regulations adopted by the department: (1) a certification that meets the requirements of section 5 of this act; (2) an application or renewal fee, which may be based on a sliding scale as determined by the commissioner; (3) the name, address and date of birth of the patient and caregiver, as applicable; and (4) the name, address and telephone number of the patient’s physician. b. Before issuing a registry identification card, the department shall verify the information contained in the application or renewal form submitted pursuant to this section. In the case of a primary caregiver, the department shall provisionally approve an application pending the results of a criminal history record background check, if the caregiver otherwise meets the requirements of this act. The department shall approve or deny an application or renewal within 30 days of receipt of the completed application or renewal, and shall issue a registry identification card within five days of approving the application or renewal. The department may deny an application or renewal only if the applicant fails to provide the information required pursuant to this section, or if the department determines that the information was incorrect or falsified or does not meet the requirements of this act. Denial of an application shall be a final agency decision, subject to review by the Superior Court, Appellate Division. c. (1) The commissioner shall require each applicant seeking to serve as a primary caregiver to undergo a criminal history record background check. The commissioner is authorized to exchange fingerprint data with and receive criminal history record background information from the Division of State Police and the Federal Bureau of Investigation consistent with the provisions of applicable federal and State laws, rules, and regulations. The Division of State Police shall forward criminal history record background information to the commissioner in a timely manner when requested pursuant to the provisions of this section. An applicant seeking to serve as a primary caregiver shall submit to being fingerprinted in accordance with applicable State and federal laws, rules, and regulations. No check of criminal history record background information shall be performed pursuant to this section unless the applicant has furnished his written consent to that check. An applicant who refuses to consent to, or cooperate in, the securing of a check of criminal history record background information shall not be considered for inclusion in the registry as a primary caregiver or issuance of an identification card. An applicant shall bear the cost for the criminal history record background check, including all costs of administering and processing the check. (2) The commissioner shall not approve an applicant seeking to serve as a primary caregiver if the criminal history record background information of the applicant reveals a disqualifying conviction. For the purposes of this section, a disqualifying conviction shall mean 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. of N.J.S.2C:35-10, or any similar law of the United States or of any other state. (3) Upon receipt of the criminal history record background information from the Division of State Police and the Federal Bureau of Investigation, the commissioner shall provide written notification to the applicant of his qualification or disqualification for serving as a primary caregiver. If the applicant is disqualified because of a disqualifying conviction pursuant to the provisions of this section, the conviction that constitutes the basis for the disqualification shall be identified in the written notice. (4) The Division of State Police shall promptly notify the commissioner in the event that an individual who was the subject of a criminal history record background check conducted pursuant to this section is convicted of a crime or offense in this State after the date the background check was performed. Upon receipt of that notification, the commissioner shall make a determination regarding the continued eligibility of the applicant to serve as a primary caregiver. (5) Notwithstanding the provisions of subsection b. of this section to the contrary, no applicant shall be disqualified from serving as a registered primary caregiver on the basis of any conviction disclosed by a criminal history record background check conducted pursuant to this section if the individual has affirmatively demonstrated to the commissioner clear and convincing evidence of rehabilitation. In determining whether clear and convincing evidence of rehabilitation has been demonstrated, the following factors shall be considered: (a) the nature and responsibility of the position which the convicted individual would hold, has held, or currently holds; (b) the nature and seriousness of the crime or offense; (c) the circumstances under which the crime or offense occurred; (d) the date of the crime or offense; (e) the age of the individual when the crime or offense was committed; (f) whether the crime or offense was an isolated or repeated incident; (g) any social conditions which may have contributed to the commission of the crime or offense; and (h) any evidence of rehabilitation, including good conduct in prison or in the community, counseling or psychiatric treatment received, acquisition of additional academic or vocational schooling, successful participation in correctional work-release programs, or the recommendation of those who have had the individual under their supervision. d. A registry identification card shall contain the following information: (1) the name, address and date of birth of the patient and primary caregiver, if applicable; (2) the expiration date of the registry identification card; (3) photo identification of the cardholder; and (4) such other information that the department may specify by regulation. e. (1) A patient who has been issued a registry identification card shall notify the department of any change in the patient’s name, address, or physician or change in status of the patient’s debilitating medical condition, within 10 days of such change, or the registry identification card shall be deemed null and void. (2) A primary caregiver who has been issued a registry identification card shall notify the department of any change in the caregiver’s name or address within 10 days of such change, or the registry identification card shall be deemed null and void. f. The department shall maintain a confidential list of the persons to whom it has issued registry identification cards. Individual names and other identifying information on the list, and information contained in any application form, or accompanying or supporting document shall be confidential, and shall not be considered a public record under P.L.1963, c.73 (C.47:1A-1 et seq.) or P.L.2001, c.404 (C.47:1A-5 et al.), and shall not be disclosed except to: (1) authorized employees of the department and the Division of Consumer Affairs in the Department of Law and Public Safety as necessary to perform official duties of the department and the division, as applicable; and (2) authorized employees of State or local law enforcement agencies, only as necessary to verify that a person who is engaged in the suspected or alleged medical use of marijuana is lawfully in possession of a registry identification card. g. Applying for or receiving a registry card does not constitute a waiver of the qualifying patient’s patient-physician privilege.2 C.24:6I-5 Certification authorizing medical use of marijuana. 5. a. Medical use of marijuana by a qualifying patient may be authorized pursuant to a certification which meets the requirements of this act. In order to provide such certification, a physician shall be licensed and in good standing to practice in the State. The certification shall attest that the above criteria have been met. b. The provisions of subsection a. of this section shall not apply to a qualifying patient who is a minor unless the custodial parent, guardian, or person who has legal custody of the minor, consents in writing that the minor patient has that person’s permission for the medical use of marijuana and that the person will control the acquisition and possession of the medical marijuana and any related paraphernalia from the alternative treatment center.
C.24:6I-6 Applicability of N.J.S.2C:35-18. 6. a. The provisions of N.J.S.2C:35-18 shall apply to any qualifying patient, primary caregiver, alternative treatment center, physician, or any other person acting in accordance with the provisions of this act. b. A qualifying patient, primary caregiver, alternative treatment center, physician, or any other person acting in accordance with the provisions of this act shall not be subject to any civil or administrative penalty, or denied any right or privilege, including, but not limited to, civil penalty or disciplinary action by a professional licensing board, related to the medical use of marijuana as authorized under this act. c. Possession of, or application for, a registry identification card shall not alone constitute probable cause to search the person or the property of the person possessing or applying for the registry identification card, or otherwise subject the person or his property to inspection by any governmental agency. d. The provisions of section 2 of P.L.1939, c.248 (C.26:2-82), relating to destruction of marijuana determined to exist by the department, shall not apply if a qualifying patient or primary caregiver has in his possession a registry identification card and no more than the maximum amount of usable marijuana that may be obtained in accordance with section 10 of this act. e. No person shall be subject to arrest or prosecution for constructive possession, conspiracy or any other offense for simply being in the presence or vicinity of the medical use of marijuana as authorized under this act. f. No custodial parent, guardian, or person who has legal custody of a qualifying patient who is a minor shall be subject to arrest or prosecution for constructive possession, conspiracy or any other offense for assisting the minor in the medical use of marijuana as authorized under this act.
C.24:6I-7 Applications for permits to operate as alternative treatment center; regulations. 7. a. The department shall accept applications from entities for permits to operate as alternative treatment centers, and may charge a reasonable fee for the issuance of a permit under this section. The department shall seek to ensure the availability of a sufficient number of alternative treatment centers throughout the State, pursuant to need, including at least two each in the northern, central, and southern regions of the State. The first two centers issued a permit in each region shall be nonprofit entities, and centers subsequently issued permits may be nonprofit or for-profit entities. An alternative treatment center shall be authorized to acquire a reasonable initial and ongoing inventory, as determined by the department, of marijuana seeds or seedlings and paraphernalia, possess, cultivate, plant, grow, harvest, process, display, manufacture, deliver, transfer, transport, distribute, supply, sell, or dispense marijuana, or related supplies to qualifying patients or their primary caregivers who are registered with the department pursuant to section 4 of this act. Applicants for authorization as nonprofit alternative treatment centers shall be subject to all applicable State laws governing nonprofit entities, but need not be recognized as a 501(c)(3) organization by the federal Internal Revenue Service. b. The department shall require that an applicant provide such information as the department determines to be necessary pursuant to regulations adopted pursuant to this act. c. A person who has been convicted 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. of N.J.S.2C:35-10, or any similar law of the United States or any other state shall not be issued a permit to operate as an alternative treatment center or be a director, officer, or employee of an alternative treatment center, unless such conviction occurred after the effective date of this act and was for a violation of federal law relating to possession or sale of marijuana for conduct that is authorized under this act. d. (1) The commissioner shall require each applicant seeking a permit to operate as an alternative treatment center to undergo a criminal history record background check. For purposes of this section, the term “applicant” shall include any owner, director, officer, or employee of an alternative treatment center. The commissioner is authorized to exchange fingerprint data with and receive criminal history record background information from the Division of State Police and the Federal Bureau of Investigation consistent with the provisions of applicable federal and State laws, rules, and regulations. The Division of State Police shall forward criminal history record background information to the commissioner in a timely manner when requested pursuant to the provisions of this section. An applicant shall submit to being fingerprinted in accordance with applicable State and federal laws, rules, and regulations. No check of criminal history record background information shall be performed pursuant to this section unless the applicant has furnished his written consent to that check. An applicant who refuses to consent to, or cooperate in, the securing of a check of criminal history record background information shall not be considered for a permit to operate, or authorization to be employed at, an alternative treatment center. An applicant shall bear the cost for the criminal history record background check, including all costs of administering and processing the check. (2) The commissioner shall not approve an applicant for a permit to operate, or authorization to be employed at, an alternative treatment center if the criminal history record background information of the applicant reveals a disqualifying conviction as set forth in subsection c. of this section. (3) Upon receipt of the criminal history record background information from the Division of State Police and the Federal Bureau of Investigation, the commissioner shall provide written notification to the applicant of his qualification for or disqualification for a permit to operate or be a director, officer, or employee of an alternative treatment center. If the applicant is disqualified because of a disqualifying conviction pursuant to the provisions of this section, the conviction that constitutes the basis for the disqualification shall be identified in the written notice. (4) The Division of State Police shall promptly notify the commissioner in the event that an individual who was the subject of a criminal history record background check conducted pursuant to this section is convicted of a crime or offense in this State after the date the background check was performed. Upon receipt of that notification, the commissioner shall make a determination regarding the continued eligibility to operate or be a director, officer, or employee of an alternative treatment center. (5) Notwithstanding the provisions of subsection b. of this section to the contrary, the commissioner may offer provisional authority for an applicant to be an employee of an alternative treatment center for a period not to exceed three months if the applicant submits to the commissioner a sworn statement attesting that the person has not been convicted of any disqualifying conviction pursuant to this section. (6) Notwithstanding the provisions of subsection b. of this section to the contrary, no employee of an alternative treatment center shall be disqualified on the basis of any conviction disclosed by a criminal history record background check conducted pursuant to this section if the individual has affirmatively demonstrated to the commissioner clear and convincing evidence of rehabilitation. In determining whether clear and convincing evidence of rehabilitation has been demonstrated, the following factors shall be considered: (a) the nature and responsibility of the position which the convicted individual would hold, has held or currently holds; (b) the nature and seriousness of the crime or offense; (c) the circumstances under which the crime or offense occurred; (d) the date of the crime or offense; (e) the age of the individual when the crime or offense was committed; (f) whether the crime or offense was an isolated or repeated incident; (g) any social conditions which may have contributed to the commission of the crime or offense; and (h) any evidence of rehabilitation, including good conduct in prison or in the community, counseling or psychiatric treatment received, acquisition of additional academic or vocational schooling, successful participation in correctional work-release programs, or the recommendation of those who have had the individual under their supervision. e. The department shall issue a permit to a person to operate as an alternative treatment center if the department finds that issuing such a permit would be consistent with the purposes of this act and the requirements of this section are met and the department has verified the information contained in the application. The department shall approve or deny an application within 60 days after receipt of a completed application. The denial of an application shall be considered a final agency decision, subject to review by the Appellate Division of the Superior Court. The department may suspend or revoke a permit to operate as an alternative treatment center for cause, which shall be subject to review by the Appellate Division of the Superior Court. f. A person who has been issued a permit pursuant to this section shall display the permit at the premises of the alternative treatment center at all times when marijuana is being produced, or dispensed to a registered qualifying patient or the patient’s primary caregiver. g. An alternative treatment center shall report any change in information to the department not later than 10 days after such change, or the permit shall be deemed null and void. h. An alternative treatment center may charge a registered qualifying patient or primary caregiver for the reasonable costs associated with the production and distribution of marijuana for the cardholder. i. The commissioner shall adopt regulations to: (1) require such written documentation of each delivery of marijuana to, and pickup of marijuana for, a registered qualifying patient, including the date and amount dispensed, to be maintained in the records of the alternative treatment center, as the commissioner determines necessary to ensure effective documentation of the operations of each alternative treatment center; (2) monitor, oversee, and investigate all activities performed by an alternative treatment center; and (3) ensure adequate security of all facilities 24 hours per day, including production and retail locations, and security of all delivery methods to registered qualifying patients.
C.24:6I-8 Inapplicability of act. 8. The provisions of this act shall not be construed to permit a person to: a. operate, navigate, or be in actual physical control of any vehicle, aircraft, railroad train, stationary heavy equipment or vessel while under the influence of marijuana; or b. smoke marijuana in a school bus or other form of public transportation, in a private vehicle unless the vehicle is not in operation, on any school grounds, in any correctional facility, at any public park or beach, at any recreation center, or in any place where smoking is prohibited pursuant to N.J.S.2C:33-13. A person who commits an act as provided in this section shall be subject to such penalties as are provided by law.
C.24:6I-9 Falsification of registration card, degree of crime. 9. A person who knowingly sells, offers, or exposes for sale, or otherwise transfers, or possesses with the intent to sell, offer or expose for sale or transfer a document that falsely purports to be a registration card issued pursuant to this act, or a registration card issued pursuant to this act that has been altered, is guilty of a crime of the third degree. A person who knowingly presents to a law enforcement officer a document that falsely purports to be a registration card issued pursuant to this act, or a registration card that has been issued pursuant to this act that has been altered, is guilty of a crime of the fourth degree. The provisions of this section are intended to supplement current law and shall not limit prosecution or conviction for any other offense.
C.24:6I-10 Written instructions to patient, caregiver. 10. a. A physician shall provide written instructions for a registered qualifying patient or his caregiver to present to an alternative treatment center concerning the total amount of usable marijuana that a patient may be dispensed, in weight, in a 30-day period, which amount shall not exceed two ounces. If no amount is noted, the maximum amount that may be dispensed at one time is two ounces. b. A physician may issue multiple written instructions at one time authorizing the patient to receive a total of up to a 90-day supply, provided that the following conditions are met: (1) Each separate set of instructions shall be issued for a legitimate medical purpose by the physician, as provided in this act; (2) Each separate set of instructions shall indicate the earliest date on which a center may dispense the marijuana, except for the first dispensation if it is to be filled immediately; and (3) The physician has determined that providing the patient with multiple instructions in this manner does not create an undue risk of diversion or abuse. c. A registered qualifying patient or his primary caregiver shall present the patient’s or caregiver’s registry identification card, as applicable, and these written instructions to the alternative treatment center, which shall verify and log the documentation presented. A physician may provide a copy of a written instruction by electronic or other means, as determined by the commissioner, directly to an alternative treatment center on behalf of a registered qualifying patient. The dispensation of marijuana pursuant to any written instructions shall occur within one month of the date that the instructions were written or the instructions are void. d. A patient may be registered at only one alternative treatment center at any time.
C.45:1-45.1 Information required for monitoring; rules, regulations. 11. a. A physician who provides a certification or written instruction for the medical use of marijuana to a qualifying patient pursuant to P.L.2009, c.307 (C.24:6I-1 et al.) and any alternative treatment center shall furnish to the Director of the Division of Consumer Affairs in the Department of Law and Public Safety such information, in such a format and at such intervals, as the director shall prescribe by regulation, for inclusion in a system established to monitor the dispensation of marijuana in this State for medical use as authorized by the provisions of P.L.2009, c.307 (C.24:6I-1 et al.), which system shall serve the same purpose as, and be cross- referenced with, the electronic system for monitoring controlled dangerous substances established pursuant to section 25 of P.L.2007, c.244 (C.45:1-45). b. The Director of the Division of Consumer Affairs, pursuant to the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.), and in consultation with the Commissioner of Health and Senior Services, shall adopt rules and regulations to effectuate the purposes of subsection a. of this section. c. Notwithstanding any provision of P.L.1968, c.410 to the contrary, the Director of the Division of Consumer Affairs shall adopt, immediately upon filing with the Office of Administrative Law and no later than the 90th day after the effective date of P.L.2009, c.307 (C.24:6I-1 et al.), such regulations as the director deems necessary to implement the provisions of subsection a. of this section. Regulations adopted pursuant to this subsection shall be effective until the adoption of rules and regulations pursuant to subsection b. of this section and may be amended, adopted, or readopted by the director in accordance with the requirements of P.L.1968, c.410.
12. N.J.S.2C:35-18 is amended to read as follows:
Exemption, burden of proof. 2C:35-18. Exemption; Burden of Proof. a. If conduct is authorized by the provisions of P.L.1970, c.226 (C.24:21-1 et seq.) or P.L.2009, c.307 (C.24:6I-1 et al.), that authorization shall, subject to the provisions of this section, constitute an exemption from criminal liability under this chapter or chapter 36, and the absence of such authorization shall not be construed to be an element of any offense in this chapter or chapter 36. It is an affirmative defense to any criminal action arising under this chapter or chapter 36 that the defendant is the authorized holder of an appropriate registration, permit or order form or is otherwise exempted or excepted from criminal liability by virtue of any provision of P.L.1970, c.226 (C.24:21-1 et seq.) or P.L.2009, c.307 (C.24:6I-1 et al.). The affirmative defense established herein shall be proved by the defendant by a preponderance of the evidence. It shall not be necessary for the State to negate any exemption set forth in this act or in any provision of Title 24 of the Revised Statutes in any complaint, information, indictment or other pleading or in any trial, hearing or other proceeding under this act. b. No liability shall be imposed by virtue of this chapter or chapter 36 upon any duly authorized State officer, engaged in the enforcement of any law or municipal ordinance relating to controlled dangerous substances or controlled substance analogs.
C.24:6I-11 Grants, contributions, use of fees. 13. a. The commissioner may accept from any governmental department or agency, public or private body or any other source grants or contributions to be used in carrying out the purposes of this act. b. All fees collected pursuant to this act, including those from qualifying patients and alternative treatment centers’ initial, modification and renewal applications, shall be used to offset the cost of the department’s administration of the provisions of this act.
C.24:6I-12 Report to Governor, Legislature. 14. a. The commissioner shall report to the Governor, and to the Legislature pursuant to section 2 of P.L.1991, c.164 (C.52:14-19.1): (1) no later than one year after the effective date of this act, on the actions taken to implement the provisions of this act; and (2) annually thereafter on the number of applications for registry identification cards, the number of qualifying patients registered, the number of primary caregivers registered, the nature of the debilitating medical conditions of the patients, the number of registry identification cards revoked, the number of alternative treatment center permits issued and revoked, and the number of physicians providing certifications for patients. b. The reports shall not contain any identifying information of patients, caregivers, or physicians. c. Within two years after the effective date of this act and every two years thereafter, the commissioner shall: evaluate whether there are sufficient numbers of alternative treatment centers to meet the needs of registered qualifying patients throughout the State; evaluate whether the maximum amount of medical marijuana allowed pursuant to this act is sufficient to meet the medical needs of qualifying patients; and determine whether any alternative treatment center has charged excessive prices for marijuana that the center dispensed. The commissioner shall report his findings no later than two years after the effective date of this act, and every two years thereafter, to the Governor, and to the Legislature pursuant to section 2 of P.L.1991, c.164 (C.52:14-19.1).
C.24:6I-13 Exchange of data, information. 15. a. The Department of Health and Senior Services is authorized to exchange fingerprint data with, and receive information from, the Division of State Police in the Department of Law and Public Safety and the Federal Bureau of Investigation for use in reviewing applications for individuals seeking to serve as primary caregivers pursuant to section 4 of P.L.2009, c.307 (C.24:6I-4), and for permits to operate as, or to be a director, officer, or employee of, alternative treatment centers pursuant to section 7 of P.L.2009, c.307 (C.24:6I-7). b. The Division of State Police shall promptly notify the Department of Health and Senior Services in the event an applicant seeking to serve as a primary caregiver or an applicant for a permit to operate as, or to be a director, officer, or employee of, an alternative treatment center, who was the subject of a criminal history record background check conducted pursuant to subsection a. of this section, is convicted of a crime involving possession or sale of a controlled dangerous substance.
C.24:6I-14 Construction of act. 16. Nothing in this act shall be construed to require a government medical assistance program or private health insurer to reimburse a person for costs associated with the medical use of marijuana, or an employer to accommodate the medical use of marijuana in any workplace.
C.24:6I-15 Additional immunity. 17. In addition to any immunity or defense provided by law, the State and any employee or agent of the State shall not be held liable for any actions taken in accordance with this act or for any deleterious outcomes from the medical use of marijuana by any registered qualifying patient.
C.24:6I-16 Rules, regulations. 18. a. Pursuant to the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.), the commissioner shall promulgate rules and regulations to effectuate the purposes of this act, in consultation with the Department of Law and Public Safety. b. Notwithstanding any provision of P.L.1968, c.410 to the contrary, the commissioner shall adopt, immediately upon filing with the Office of Administrative Law and no later than the 90th day after the effective date of this act, such regulations as the commissioner deems necessary to implement the provisions of this act. Regulations adopted pursuant to this subsection shall be effective until the adoption of rules and regulations pursuant to subsection a. of this section and may be amended, adopted, or readopted by the commissioner in accordance with the requirements of P.L.1968, c.410.
19. This act shall take effect on the first day of the sixth month after enactment, but the commissioner and the Director of the Division of Consumer Affairs may take such anticipatory administrative action in advance thereof as may be necessary to effectuate the provisions of this act.
Approved January 18, 2010.
CHAPTER 160
AN ACT concerning medical marijuana and amending P.L.2009, c.307.
BE IT ENACTED by the Senate and General Assembly of the State of New Jersey:
1. Section 5 of P.L.2009, c.307 (C.24:6I-5) is amended to read as follows:
C.24:6I-5 Certification authorizing medical use of marijuana. 5. a. Medical use of marijuana by a qualifying patient may be authorized pursuant to a certification which meets the requirements of this act. In order to provide such certification, a physician shall be licensed and in good standing to practice in the State. The certification shall attest that the above criteria have been met. b. The provisions of subsection a. of this section shall not apply to a qualifying patient who is a minor unless the custodial parent, guardian, or person who has legal custody of the minor receives from the physician an explanation of the potential risks and benefits of the medical use of marijuana and consents in writing that the minor patient has that person's permission for the medical use of marijuana and that the person will control the acquisition and possession of the medical marijuana and any related paraphernalia from the alternative treatment center. The physician shall document the explanation of the potential risks and benefits in the minor patient’s medical record.
2. Section 7 of P.L.2009, c.307 (C.24:6I-7) is amended to read as follows:
C.24:6I-7 Applications for permits to operate as alternative treatment center; regulations. 7. a. The department shall accept applications from entities for permits to operate as alternative treatment centers, and may charge a reasonable fee for the issuance of a permit under this section. The department shall seek to ensure the availability of a sufficient number of alternative treatment centers throughout the State, pursuant to need, including at least two each in the northern, central, and southern regions of the State. The first two centers issued a permit in each region shall be nonprofit entities, and centers subsequently issued permits may be nonprofit or for-profit entities. An alternative treatment center shall be authorized to acquire a reasonable initial and ongoing inventory, as determined by the department, of marijuana seeds or seedlings and paraphernalia, possess, cultivate, plant, grow, harvest, process, display, manufacture, deliver, transfer, transport, distribute, supply, sell, or dispense marijuana, or related supplies to qualifying patients or their primary caregivers who are registered with the department pursuant to section 4 of this act. An alternative treatment center shall not be limited in the number of strains of medical marijuana cultivated, and may package and directly dispense marijuana to qualifying patients in dried form, oral lozenges, topical formulations, or edible form, or any other form as authorized by the commissioner. Edible form shall include tablets, capsules, drops or syrups and any other form as authorized by the commissioner. Edible forms shall be available only to qualifying patients who are minors. Applicants for authorization as nonprofit alternative treatment centers shall be subject to all applicable State laws governing nonprofit entities, but need not be recognized as a 501(c)(3) organization by the federal Internal Revenue Service. b. The department shall require that an applicant provide such information as the department determines to be necessary pursuant to regulations adopted pursuant to this act. c. A person who has been convicted of a crime involving any controlled dangerous substance or controlled substance analog as set forth in chapter 35 of Title 2C of the New
P.L.2013, CHAPTER 160 2
Jersey Statutes except paragraph (4) of subsection a. of N.J.S.2C:35-10, or any similar law of the United States or any other state shall not be issued a permit to operate as an alternative treatment center or be a director, officer, or employee of an alternative treatment center, unless such conviction occurred after the effective date of this act and was for a violation of federal law relating to possession or sale of marijuana for conduct that is authorized under this act. d. (1) The commissioner shall require each applicant seeking a permit to operate as an alternative treatment center to undergo a criminal history record background check. For purposes of this section, the term "applicant" shall include any owner, director, officer, or employee of an alternative treatment center. The commissioner is authorized to exchange fingerprint data with and receive criminal history record background information from the Division of State Police and the Federal Bureau of Investigation consistent with the provisions of applicable federal and State laws, rules, and regulations. The Division of State Police shall forward criminal history record background information to the commissioner in a timely manner when requested pursuant to the provisions of this section. An applicant shall submit to being fingerprinted in accordance with applicable State and federal laws, rules, and regulations. No check of criminal history record background information shall be performed pursuant to this section unless the applicant has furnished his written consent to that check. An applicant who refuses to consent to, or cooperate in, the securing of a check of criminal history record background information shall not be considered for a permit to operate, or authorization to be employed at, an alternative treatment center. An applicant shall bear the cost for the criminal history record background check, including all costs of administering and processing the check. (2) The commissioner shall not approve an applicant for a permit to operate, or authorization to be employed at, an alternative treatment center if the criminal history record background information of the applicant reveals a disqualifying conviction as set forth in subsection c. of this section. (3) Upon receipt of the criminal history record background information from the Division of State Police and the Federal Bureau of Investigation, the commissioner shall provide written notification to the applicant of his qualification for or disqualification for a permit to operate or be a director, officer, or employee of an alternative treatment center. If the applicant is disqualified because of a disqualifying conviction pursuant to the provisions of this section, the conviction that constitutes the basis for the disqualification shall be identified in the written notice. (4) The Division of State Police shall promptly notify the commissioner in the event that an individual who was the subject of a criminal history record background check conducted pursuant to this section is convicted of a crime or offense in this State after the date the background check was performed. Upon receipt of that notification, the commissioner shall make a determination regarding the continued eligibility to operate or be a director, officer, or employee of an alternative treatment center. (5) Notwithstanding the provisions of subsection b. of this section to the contrary, the commissioner may offer provisional authority for an applicant to be an employee of an alternative treatment center for a period not to exceed three months if the applicant submits to the commissioner a sworn statement attesting that the person has not been convicted of any disqualifying conviction pursuant to this section. (6) Notwithstanding the provisions of subsection b. of this section to the contrary, no employee of an alternative treatment center shall be disqualified on the basis of any conviction disclosed by a criminal history record background check conducted pursuant to
P.L.2013, CHAPTER 160 3 this section if the individual has affirmatively demonstrated to the commissioner clear and convincing evidence of rehabilitation. In determining whether clear and convincing evidence of rehabilitation has been demonstrated, the following factors shall be considered: (a) the nature and responsibility of the position which the convicted individual would hold, has held or currently holds; (b) the nature and seriousness of the crime or offense; (c) the circumstances under which the crime or offense occurred; (d) the date of the crime or offense; (e) the age of the individual when the crime or offense was committed; (f) whether the crime or offense was an isolated or repeated incident; (g) any social conditions which may have contributed to the commission of the crime or offense; and (h) any evidence of rehabilitation, including good conduct in prison or in the community, counseling or psychiatric treatment received, acquisition of additional academic or vocational schooling, successful participation in correctional work-release programs, or the recommendation of those who have had the individual under their supervision. e. The department shall issue a permit to a person to operate as an alternative treatment center if the department finds that issuing such a permit would be consistent with the purposes of this act and the requirements of this section are met and the department has verified the information contained in the application. The department shall approve or deny an application within 60 days after receipt of a completed application. The denial of an application shall be considered a final agency decision, subject to review by the Appellate Division of the Superior Court. The department may suspend or revoke a permit to operate as an alternative treatment center for cause, which shall be subject to review by the Appellate Division of the Superior Court. f. A person who has been issued a permit pursuant to this section shall display the permit at the premises of the alternative treatment center at all times when marijuana is being produced, or dispensed to a registered qualifying patient or the patient's primary caregiver. g. An alternative treatment center shall report any change in information to the department not later than 10 days after such change, or the permit shall be deemed null and void. h. An alternative treatment center may charge a registered qualifying patient or primary caregiver for the reasonable costs associated with the production and distribution of marijuana for the cardholder. i. The commissioner shall adopt regulations to: (1) require such written documentation of each delivery of marijuana to, and pickup of marijuana for, a registered qualifying patient, including the date and amount dispensed, to be maintained in the records of the alternative treatment center, as the commissioner determines necessary to ensure effective documentation of the operations of each alternative treatment center; (2) monitor, oversee, and investigate all activities performed by an alternative treatment center; and (3) ensure adequate security of all facilities 24 hours per day, including production and retail locations, and security of all delivery methods to registered qualifying patients.
3. This act shall take effect immediately.
Approved September 10, 2013.
ASSEMBLY COMMITTEE SUBSTITUTE FOR ASSEMBLY, Nos. 3740 and 3437
STATE OF NEW JERSEY 218th LEGISLATURE
ADOPTED MARCH 22, 2018
Sponsored by: Assemblyman HERB CONAWAY, JR. District 7 (Burlington) Assemblyman REED GUSCIORA District 15 (Hunterdon and Mercer) Assemblyman TIM EUSTACE District 38 (Bergen and Passaic) Assemblywoman CAROL A. MURPHY District 7 (Burlington)
SYNOPSIS Authorizes medical marijuana for treatment of any diagnosed condition; revises requirements for physicians to authorize qualifying patients; and revises requirements for alternative treatment center operations and permitting.
CURRENT VERSION OF TEXT Substitute as adopted by the Assembly Health and Senior Services Committee.
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1 AN ACT concerning medical marijuana and revising and 2 supplementing P.L.2009, c.307. 3 4 BE IT ENACTED by the Senate and General Assembly of the State 5 of New Jersey: 6 7 1. Section 2 of P.L.2009, c.307 (C.24:6I-2) is amended to read 8 as follows: 9 2. The Legislature finds and declares that: 10 a. Modern medical research has discovered a beneficial use for 11 marijuana in treating or alleviating the pain or other symptoms 12 associated with certain [debilitating] qualifying medical 13 conditions, as found by the National Academy of Sciences' Institute 14 of Medicine in March 1999; 15 b. According to the U.S. Sentencing Commission and the 16 Federal Bureau of Investigation, 99 out of every 100 marijuana 17 arrests in the country are made under state law, rather than under 18 federal law. Consequently, changing state law will have the 19 practical effect of protecting from arrest the vast majority of 20 seriously ill people who have a medical need to use marijuana; 21 c. Although federal law currently prohibits the use of 22 marijuana, the laws of Alaska, California, Colorado, Hawaii, Maine, 23 Michigan, Montana, Nevada, New Mexico, Oregon, Rhode Island, 24 Vermont, and Washington permit the use of marijuana for medical 25 purposes, and in Arizona doctors are permitted to prescribe 26 marijuana. New Jersey joins this effort for the health and welfare 27 of its citizens; 28 d. States are not required to enforce federal law or prosecute 29 people for engaging in activities prohibited by federal law; 30 therefore, compliance with this act does not put the State of New 31 Jersey in violation of federal law; and 32 e. Compassion dictates that a distinction be made between 33 medical and non-medical uses of marijuana. Hence, the purpose of 34 this act is to protect from arrest, prosecution, property forfeiture, 35 and criminal and other penalties, those patients who use marijuana 36 to alleviate suffering from [debilitating] certain qualifying medical 37 conditions, as well as their physicians, primary caregivers, and 38 those who are authorized to produce marijuana for medical 39 purposes. 40 (cf: P.L.2009, c.307, s.2) 41 42 2. Section 3 of P.L.2009, c.307 (C.24:6I-3) is amended to read 43 as follows:
EXPLANATION – Matter enclosed in bold-faced brackets [thus] in the above bill is not enacted and is intended to be omitted in the law.
Matter underlined thus is new matter.
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1 3. As used in [this act] P.L.2009, c.307 (C.24:6I-1 et al.), 2 P.L.2015, c.158 (C.18A:40-12.22), and P.L. , c. (C. ) 3 (pending before the Legislature as this bill): 4 “ATC identification card” means a document issued by the 5 department that identifies a person as an owner, director, board 6 member, principal officer, or employee of an ATC. 7 "Bona fide physician-patient relationship" means a relationship 8 in which the physician has ongoing responsibility for the 9 assessment, care, and treatment of a patient's [debilitating] 10 qualifying medical condition. 11 ["Certification" means a statement signed by a physician with 12 whom a qualifying patient has a bona fide physician-patient 13 relationship, which attests to the physician's authorization for the 14 patient to apply for registration for the medical use of marijuana.] 15 “Central region” means the counties of Hunterdon, Middlesex, 16 Mercer, Monmouth, Ocean, Somerset, and Union. 17 "Commissioner" means the Commissioner of Health. 18 “Common ownership or control” means: 19 (1) between two for-profit entities, the same individuals or 20 entities own and control more than 50 percent of both entities; 21 (2) between a nonprofit entity and a for-profit entity, a majority 22 of the directors, trustees, or members of the governing body of the 23 nonprofit entity directly or indirectly own and control more than 50 24 percent of the for-profit entity; and 25 (3) between two nonprofit entities, the same directors, trustees, 26 or governing body members comprise a majority of the voting 27 directors, trustees, or governing body members of both nonprofits. 28 “Cultivate” means possessing, planting, propagating, cultivating, 29 growing, harvesting, processing, labeling, manufacturing, 30 compounding, and storing medical marijuana consistent with 31 P.L.2009, c.307 (C.24:6I-1 et al.). 32 ["Debilitating medical condition" means: 33 (1) one of the following conditions, if resistant to conventional 34 medical therapy: seizure disorder, including epilepsy; intractable 35 skeletal muscular spasticity; post-traumatic stress disorder; or 36 glaucoma; 37 (2) one of the following conditions, if severe or chronic pain, 38 severe nausea or vomiting, cachexia, or wasting syndrome results 39 from the condition or treatment thereof: positive status for human 40 immunodeficiency virus; acquired immune deficiency syndrome; or 41 cancer; 42 (3) amyotrophic lateral sclerosis, multiple sclerosis, terminal 43 cancer, muscular dystrophy, or inflammatory bowel disease, 44 including Crohn's disease; 45 (4) terminal illness, if the physician has determined a prognosis 46 of less than 12 months of life; or 47 (5) any other medical condition or its treatment that is approved 48 by the department by regulation.]
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1 "Department" means the Department of Health. 2 “Immediate family” means the spouse, child, sibling, or parent of 3 an individual, and shall include the siblings and parents of the 4 individual’s spouse and the spouse of the individual’s child. 5 “Interest holder” means a direct or indirect owner, part owner, 6 investor, lender, stockholder, officer, director, partner, or member 7 of any corporation, partnership, limited liability company, limited 8 liability partnership, employee cooperative, association, nonprofit 9 corporation, business entity, or any other person with a direct 10 ownership interest or indirect interest through intermediary business 11 entities or other structures in an alternative treatment center. 12 "Marijuana" has the meaning given in section 2 of the "New 13 Jersey Controlled Dangerous Substances Act," P.L.1970, c.226 14 (C.24:21-2). 15 "Medical marijuana alternative treatment center" or "alternative 16 treatment center" or “ATC” means an organization [approved] 17 issued a permit by the department to [perform activities necessary 18 to provide registered qualifying patients with usable marijuana and 19 related paraphernalia in accordance with the provisions of this act] 20 operate as a medical marijuana cultivator-processor or as a medical 21 marijuana dispensary. This term shall include the organization's 22 officers, directors, board members, and employees. 23 “Medical marijuana cultivator-processor” means an organization 24 holding a permit issued by the department that authorizes the 25 organization to: possess and cultivate marijuana; produce, 26 manufacture, or otherwise create marijuana-infused and marijuana- 27 derived products; and deliver, transfer, transport, distribute, supply, 28 and sell medical marijuana, marijuana-infused products, marijuana- 29 derived products, and related supplies to medical marijuana 30 dispensaries. A medical marijuana cultivator-processor permit shall 31 not authorize the permit holder to deliver, transfer, transport, 32 distribute, supply, sell, or dispense medical marijuana, marijuana- 33 infused products, marijuana-derived products, or related supplies to 34 qualifying patients or their primary caregivers. 35 “Medical marijuana dispensary” means an organization issued a 36 permit by the department that authorizes the organization to obtain 37 medical marijuana, marijuana-infused products, and marijuana 38 derived products from a medical marijuana cultivator-processor, 39 and to possess, display, deliver, transfer, transport, distribute, 40 supply, sell, and dispense medical marijuana, marijuana-infused 41 products, marijuana-derived products, and related supplies to 42 qualifying patients and their primary caregivers. A medical 43 marijuana dispensary permit shall not authorize the permit holder to 44 cultivate marijuana or to manufacture or process marijuana-infused 45 or marijuana-derived products. 46 "Medical use of marijuana" means the acquisition, possession, 47 transport, or use of marijuana or paraphernalia by a registered 48 qualifying patient as authorized by [this act] P.L.2009, c.307
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1 (C.24:6I-1 et al.), P.L.2015, c.158 (C.18A:40-12.22), and P.L. , c. 2 (C. ) (pending before the Legislature as this bill). 3 "Minor" means a person who is under 18 years of age and who 4 has not been married or previously declared by a court or an 5 administrative agency to be emancipated. 6 “Northern region” means the counties of Bergen, Essex, Hudson, 7 Morris, Passaic, Sussex, and Warren. 8 "Paraphernalia" has the meaning given in N.J.S.2C:36-1. 9 "Physician" means a person licensed to practice medicine and 10 surgery pursuant to Title 45 of the Revised Statutes with whom the 11 patient has a bona fide physician-patient relationship and who is the 12 primary care physician, hospice physician, or physician responsible 13 for the ongoing treatment of a patient's [debilitating] qualifying 14 medical condition, provided, however, that the ongoing treatment 15 shall not be limited to the provision of authorization for a patient to 16 use medical marijuana or consultation solely for that purpose. 17 "Primary caregiver" or "caregiver" means a resident of the State 18 who: 19 a. is at least 18 years old; 20 b. has agreed to assist with a registered qualifying patient's 21 medical use of marijuana, is not currently serving as primary 22 caregiver for [another] more than one other qualifying patient, and 23 is not the qualifying patient's physician; 24 c. subject to the provisions of paragraph (2) of section 4 of 25 P.L.2009, c.307 (C.24:6I-4), has never been convicted of possession 26 or sale of a controlled dangerous substance, unless such conviction 27 occurred after the effective date of [this act] P.L.2009, c.307 28 (C.24:6I-1 et al.) and was for a violation of federal law related to 29 possession or sale of marijuana that is authorized under [this act] 30 P.L.2009, c.307 (C.24:6I-1 et al.), P.L.2015, c.158 (C.18A:40- 31 12.22), or P.L. , c. (C. ) (pending before the Legislature as 32 this bill); 33 d. has registered with the department pursuant to section 4 of 34 [this act] P.L.2009, c.307 (C.24:6I-4), and, if the individual is not 35 an immediate family member of the patient, has satisfied the 36 criminal history record background check requirement of section 4 37 of [this act] P.L.2009, c.307 (C.24:6I-4); and 38 e. has been designated as primary caregiver on the qualifying 39 patient's application or renewal for a registry identification card or 40 in other written notification to the department. 41 “Qualifying medical condition” means any medical condition 42 diagnosed by a physician, including the symptoms of the condition 43 and any symptoms resulting from any treatment for the condition, 44 which the physician determines may be treated using medical 45 marijuana. 46 "Qualifying patient" or "patient" means a resident of the State 47 who has been [provided with a certification] authorized for the
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1 medical use of marijuana by a physician pursuant to a bona fide 2 physician-patient relationship. 3 “Region” means the northern region, the central region, or the 4 southern region, as defined in this section. 5 "Registry identification card" means a document issued by the 6 department that identifies a person as a registered qualifying patient 7 or primary caregiver. 8 “Southern region” means the counties of Atlantic, Burlington, 9 Camden, Cape May, Cumberland, Gloucester, and Salem. 10 "Usable marijuana" means the dried leaves and flowers of 11 marijuana, and any mixture or preparation thereof, and does not 12 include the seeds, stems, stalks, or roots of the plant. 13 (cf: P.L.2016, c.53, s.1) 14 15 3. Section 4 of P.L.2009, c.307 (C.24:6I-4) is amended to read 16 as follows: 17 4. a. The department shall establish a registry of qualifying 18 patients and their primary caregivers, and shall issue a registry 19 identification card, which shall be valid for two years, to a 20 qualifying patient and primary caregiver, if applicable, who submits 21 the following, in accordance with regulations adopted by the 22 department: 23 (1) a [certification that meets the requirements of section 5 of 24 this act] documentation of a physician’s authorization for the 25 medical use of marijuana; 26 (2) an application or renewal fee, which may be based on a 27 sliding scale as determined by the commissioner; except that no 28 application or renewal fee shall apply to a qualifying patient, or in 29 the case of an immediate family member of the patient who serves 30 as primary caregiver to the patient. In all other cases, the 31 application and renewal fee shall not exceed $10 for patients who 32 are indigent and $50 for all other cardholders; 33 (3) the name, address, and date of birth of the patient and 34 caregiver, as applicable; and 35 (4) the name, address, and telephone number of the patient's 36 physician. 37 b. Before issuing a registry identification card, the department 38 shall verify the information contained in the application or renewal 39 form submitted pursuant to this section. In the case of a primary 40 caregiver who is not an immediate family member of the patient, 41 the department shall provisionally approve an application pending 42 the results of a criminal history record background check, if the 43 caregiver otherwise meets the requirements of [this act] P.L.2009, 44 c.307 (C.24:6I-1 et al.). The department shall approve or deny an 45 application or renewal within 30 days of receipt of the completed 46 application or renewal, and shall issue a registry identification card 47 within five days of approving the application or renewal. The 48 department may deny an application or renewal only if the applicant
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1 fails to provide the information required pursuant to this section, or 2 if the department determines that the information was incorrect or 3 falsified or does not meet the requirements of [this act] P.L.2009, 4 c.307 (C.24:6I-1 et al.). Denial of an application shall be a final 5 agency decision, subject to review by the Superior Court, Appellate 6 Division. 7 c. (1) The commissioner shall require each applicant seeking 8 to serve as a primary caregiver who is not an immediate family 9 member of the patient to undergo a criminal history record 10 background check. The commissioner is authorized to exchange 11 fingerprint data with and receive criminal history record 12 background information from the Division of State Police and the 13 Federal Bureau of Investigation consistent with the provisions of 14 applicable federal and State laws, rules, and regulations. The 15 Division of State Police shall forward criminal history record 16 background information to the commissioner in a timely manner 17 when requested pursuant to the provisions of this section. 18 An applicant seeking to serve as a primary caregiver who is not 19 an immediate family member of the patient shall submit to being 20 fingerprinted in accordance with applicable State and federal laws, 21 rules, and regulations. No check of criminal history record 22 background information shall be performed pursuant to this section 23 unless the applicant has furnished [his] the applicant’s written 24 consent to that check. An applicant who is not an immediate family 25 member of the patient who refuses to consent to, or cooperate in, 26 the securing of a check of criminal history record background 27 information shall not be considered for inclusion in the registry as a 28 primary caregiver or issuance of an identification card. An 29 applicant shall bear the cost for the criminal history record 30 background check, including all costs of administering and 31 processing the check. No criminal history record background check 32 shall be required of an applicant to be a primary caregiver if the 33 applicant is an immediate family member of the patient. 34 (2) The commissioner shall not approve an applicant seeking to 35 serve as a primary caregiver who is not an immediate family 36 member of the patient if the criminal history record background 37 information of the applicant reveals a disqualifying conviction. For 38 the purposes of this section, a disqualifying conviction shall mean a 39 conviction of a crime involving any controlled dangerous substance 40 or controlled substance analog as set forth in chapter 35 of Title 2C 41 of the New Jersey Statutes except paragraph (4) of subsection a. of 42 N.J.S.2C:35-10, or any similar law of the United States or of any 43 other state. 44 (3) Upon receipt of the criminal history record background 45 information from the Division of State Police and the Federal 46 Bureau of Investigation, the commissioner shall provide written 47 notification to the applicant of [his] the applicant’s qualification or 48 disqualification for serving as a primary caregiver.
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1 If the applicant is disqualified because of a disqualifying 2 conviction pursuant to the provisions of this section, the conviction 3 that constitutes the basis for the disqualification shall be identified 4 in the written notice. 5 (4) The Division of State Police shall promptly notify the 6 commissioner in the event that an individual who was the subject of 7 a criminal history record background check conducted pursuant to 8 this section is convicted of a crime or offense in this State after the 9 date the background check was performed. Upon receipt of that 10 notification, the commissioner shall make a determination regarding 11 the continued eligibility of the applicant to serve as a primary 12 caregiver. 13 (5) Notwithstanding the provisions of subsection b. of this 14 section to the contrary, no applicant shall be disqualified from 15 serving as a registered primary caregiver on the basis of any 16 conviction disclosed by a criminal history record background check 17 conducted pursuant to this section if the individual has affirmatively 18 demonstrated to the commissioner clear and convincing evidence of 19 rehabilitation. In determining whether clear and convincing 20 evidence of rehabilitation has been demonstrated, the following 21 factors shall be considered: 22 (a) the nature and responsibility of the position which the 23 convicted individual would hold, has held, or currently holds; 24 (b) the nature and seriousness of the crime or offense; 25 (c) the circumstances under which the crime or offense 26 occurred; 27 (d) the date of the crime or offense; 28 (e) the age of the individual when the crime or offense was 29 committed; 30 (f) whether the crime or offense was an isolated or repeated 31 incident; 32 (g) any social conditions which may have contributed to the 33 commission of the crime or offense; and 34 (h) any evidence of rehabilitation, including good conduct in 35 prison or in the community, counseling or psychiatric treatment 36 received, acquisition of additional academic or vocational 37 schooling, successful participation in correctional work-release 38 programs, or the recommendation of those who have had the 39 individual under their supervision. 40 d. A registry identification card shall contain the following 41 information: 42 (1) the name, address, and date of birth of the patient and 43 primary caregiver, if applicable; 44 (2) the expiration date of the registry identification card; 45 (3) photo identification of the cardholder; and 46 (4) such other information that the department may specify by 47 regulation. 48 e. (1) A patient who has been issued a registry identification 49 card shall notify the department of any change in the patient's name,
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1 address, or physician or change in status of the patient's 2 [debilitating] qualifying medical condition, within 10 days of such 3 change, or the registry identification card shall be deemed null and 4 void. 5 (2) A primary caregiver who has been issued a registry 6 identification card shall notify the department of any change in the 7 caregiver's name or address within 10 days of such change, or the 8 registry identification card shall be deemed null and void. 9 f. The department shall maintain a confidential list of the 10 persons to whom it has issued registry identification cards. 11 Individual names and other identifying information on the list, and 12 information contained in any application form, or accompanying or 13 supporting document shall be confidential, and shall not be 14 considered a public record under P.L.1963, c.73 (C.47:1A-1 et seq.) 15 or P.L.2001, c.404 (C.47:1A-5 et al.), and shall not be disclosed 16 except to: 17 (1) authorized employees of the department and the Division of 18 Consumer Affairs in the Department of Law and Public Safety as 19 necessary to perform official duties of the department and the 20 division, as applicable; and 21 (2) authorized employees of State or local law enforcement 22 agencies, only as necessary to verify that a person who is engaged 23 in the suspected or alleged medical use of marijuana is lawfully in 24 possession of a registry identification card. 25 g. Applying for or receiving a registry card does not constitute 26 a waiver of the qualifying patient's patient-physician privilege. 27 (cf: P.L.2009, c.307, s.4) 28 29 4. (New section) a. A physician shall not be required to enroll 30 in any medical marijuana physician registry or undergo any 31 additional registration process as a condition of authorizing patients 32 for the medical use of marijuana. 33 b. When authorizing a qualifying patient who is a minor for the 34 medical use of marijuana, if the treating physician is not trained in 35 the care of pediatric patients, the treating physician shall, prior to 36 authorizing the patient for the medical use of marijuana, obtain 37 written confirmation from a physician trained in the care of 38 pediatric patients establishing, in the physician’s professional 39 opinion, and following an examination of the minor patient or 40 review of the minor patient’s medical record, that the minor patient 41 is likely to receive therapeutic or palliative benefits from the 42 medical use of marijuana to treat or alleviate symptoms associated 43 with the patient’s qualifying medical condition. If the treating 44 physician is trained in the care of pediatric patients, no additional 45 written confirmation from any other physician shall be required as a 46 condition of authorizing the patient for the medical use of 47 marijuana.
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1 5. (New section) a. Except as provided in subsection b. of this 2 section, no physician who has authorized a patient for the medical 3 use of marijuana pursuant to P.L.2009, c.307 (C.24:6I-1 et al.) 4 within the past 90 days, and no member of such physician’s 5 immediate family, shall be an interest holder in, or receive any form 6 of direct or indirect compensation from, any alternative treatment 7 center. 8 b. Nothing in subsection a. of this section shall be construed to 9 prevent a physician from serving on the medical advisory board of 10 an alternative treatment center established pursuant to section 9 of 11 P.L. , c. (C. ) (pending before the Legislature as this bill) 12 and receiving a reasonable stipend for such service, provided that: 13 (1) the stipend does not exceed the stipend paid to any other 14 member of the medical advisory board for serving on the board; and 15 (2) the amount of the stipend is not based on patient volumes at 16 the alternative treatment center or on the number of authorizations 17 for the medical use of marijuana the physician issues pursuant to 18 P.L.2009, c.307 (C.24:6I-1 et al.). 19 c. A physician, or an immediate family member of a physician, 20 who applies for an ATC identification card shall certify that the 21 physician has not authorized a patient for the medical use of 22 marijuana pursuant to P.L.2009, c.307 (C.24:6I-1 et al.) within the 23 90 days immediately preceding the date of the application. 24 d. A person who violates subsection a. of this section shall be 25 guilty of a crime of the fourth degree. 26 27 6. Section 7 of P.L.2009, c.307 (C.24:6I-7) is amended to read 28 as follows: 29 7. a. The department shall accept applications from entities 30 for permits to operate as alternative treatment centers [, and may 31 charge a reasonable fee for the issuance of a permit under this 32 section]. [The department shall seek to ensure the availability of a 33 sufficient number of] To ensure adequate access to alternative 34 treatment centers throughout the State, [pursuant to need, including 35 at least two each in] the department shall grant permits authorizing 36 a total of 12 medical marijuana cultivator-processors and 40 37 medical marijuana dispensaries in the State, which to the extent 38 possible in light of patient need, shall be evenly distributed among 39 the northern, central, and southern regions of the State; this total 40 number of permits shall include the six alternative treatment center 41 permits issued prior to the effective date of P.L. , c. (C. ) 42 (pending before the Legislature as this bill), which shall constitute 43 six of the medical marijuana cultivator-processor permits and six of 44 the medical marijuana dispensary permits, plus the six medical 45 marijuana cultivator-processor permits and the 34 medical 46 marijuana dispensary permits issued pursuant to section 6 of P.L. , 47 c. (C. ) (pending before the Legislature as this bill).
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1 An initial application for a medical marijuana cultivator- 2 processor permit or a medical marijuana dispensary permit shall 3 meet the application requirements set forth in section 8 of P.L. , c. 4 (C. ) (pending before the Legislature as this bill). 5 An alternative treatment center holding a permit that was issued 6 prior to the effective date of P.L. , c. (C. ) (pending before 7 the Legislature as this bill) shall be deemed to hold both a medical 8 marijuana cultivator-processor permit and a medical marijuana 9 dispensary permit, and shall be authorized to hold both permits 10 concurrently. [The first two centers issued a permit in each region 11 shall be nonprofit entities, and centers subsequently issued permits 12 may be nonprofit or for-profit entities] 13 No interest holder, or natural person with a direct or indirect 14 interest through intermediary business entities or other structures, in 15 any medical marijuana cultivator-processor, shall own, either in 16 whole or in part, or be directly or indirectly interested in, a medical 17 marijuana dispensary. The foregoing shall not apply to interest 18 holders of a medical marijuana alternative treatment center issued a 19 permit by the department prior to the effective date of P.L. , c. 20 (C. ) (pending before the Legislature as this bill). 21 No interest holder, or natural person with a direct or indirect 22 interest through intermediary business entities or other structures, in 23 any medical marijuana dispensary, shall own, either in whole or in 24 part, or be directly or indirectly interested in, a medical marijuana 25 cultivator-processor. The foregoing shall not apply to interest 26 holders of a medical marijuana alternative treatment center issued a 27 permit by the department prior to the effective date of P.L. , c. 28 (C. ) (pending before the Legislature as this bill). 29 No natural person or entity shall hold an interest in more than 30 one medical marijuana cultivator-processor or more than one 31 medical marijuana dispensary at any time, except that an interest 32 holder in a medical marijuana alternative treatment center that was 33 issued a permit by the department prior to the effective date of P.L., 34 c. (C. ) (pending before the Legislature as this bill) may 35 concurrently hold up to a 15 percent ownership interest in up to one 36 additional medical marijuana alternative treatment center that was 37 issued a permit by the department prior to the effective date of P.L., 38 c. (C. ) (pending before the Legislature as this bill), up to one 39 medical marijuana cultivator-processor, or up to one medical 40 marijuana dispensary; a medical marijuana cultivator-processor may 41 concurrently hold up to a 15 percent ownership interest in up to one 42 additional medical marijuana cultivator-processor or up to one 43 medical marijuana alternative treatment center that was issued a 44 permit by the department prior to the effective date of P.L. , c. 45 (C. ) (pending before the Legislature as this bill); and a medical 46 marijuana dispensary may concurrently hold up to a 15 percent 47 ownership interest in up to one additional medical marijuana 48 dispensary or up to one medical marijuana alternative treatment
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1 center that was issued a permit by the department prior to the 2 effective date of P.L. , c. (C. ) (pending before the 3 Legislature as this bill). 4 None of the ownership restrictions set forth in this subsection 5 shall be construed to be implicated solely by any person’s 6 ownership of less than one percent of the total capitalization of a 7 publicly traded company, provided that the stockholder is not also 8 an employee, officer, or director of the publicly traded company. 9 [An alternative treatment center] A medical marijuana 10 cultivator-processor shall be authorized to acquire a reasonable 11 initial and ongoing inventory, as determined by the department, of 12 marijuana seeds or seedlings and paraphernalia, possess, cultivate, 13 plant, grow, harvest, process, [display,] and manufacture medical 14 marijuana and marijuana-infused and marijuana-derived products, 15 and deliver, transfer, transport, distribute, supply, sell, or dispense 16 medical marijuana, [or] marijuana-infused products, marijuana- 17 derived products, and related supplies to any medical marijuana 18 dispensary in the State. If approved by the department, a medical 19 marijuana cultivator-processor may operate, within the scope of its 20 permit, from more than one physical location. Medical marijuana 21 dispensaries may purchase or acquire medical marijuana, 22 marijuana-infused and marijuana-derived products, paraphernalia, 23 and related supplies from any medical marijuana cultivator- 24 processor in the State, and distribute, supply, sell, or dispense 25 marijuana, marijuana-infused products, marijuana-derived products, 26 and related supplies to qualifying patients or their primary 27 caregivers who are registered with the department pursuant to 28 section 4 of [this act] P.L.2009, c.307 (C.24:6I-4). [An alternative 29 treatment center] A medical marijuana cultivator-producer shall not 30 be limited in the number of strains of medical marijuana cultivated 31 [, and] or the number of products manufactured. A medical 32 marijuana cultivator-producer may package, and a medical 33 marijuana dispensary may directly dispense [marijuana] to 34 qualifying patients and their primary caregivers, medical marijuana 35 in dried form, oral lozenges, topical formulations, transdermal form, 36 sublingual form, tincture form, or edible form, or any other form as 37 authorized by the commissioner. Edible form shall include tablets, 38 capsules, drops or syrups, and any other form as authorized by the 39 commissioner. [Edible forms shall be available only to qualifying 40 patients who are minors.] 41 Applicants that choose to apply for authorization as [nonprofit] 42 alternative treatment centers with nonprofit status shall be subject to 43 all applicable State laws governing nonprofit entities, but need not 44 be recognized as a 501(c)(3) organization by the federal Internal 45 Revenue Service. 46 b. The department shall require that an applicant provide such 47 information as the department determines to be necessary pursuant
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1 to regulations adopted pursuant to [this act] P.L.2009, c.307 2 (C.24:6I-1 et al.) and may, in its discretion, require any applicant to 3 submit a personal history disclosure and conduct financial due 4 diligence on any person or entity providing $100,000 or more in 5 financial backing to an applicant. 6 c. A person who has been convicted of a crime involving any 7 controlled dangerous substance or controlled substance analog as 8 set forth in chapter 35 of Title 2C of the New Jersey Statutes except 9 paragraph (4) of subsection a. of N.J.S.2C:35-10, or any similar law 10 of the United States or any other state shall not be issued a permit to 11 operate as an alternative treatment center or be [a director, officer, 12 or employee of an alternative treatment center] issued an ATC 13 identification card, unless such conviction occurred after the 14 effective date of [this act] P.L.2009, c.307 (C.24:6I-1 et al.) and 15 was for a violation of federal law relating to possession or sale of 16 marijuana for conduct that is authorized under [this act] P.L.2009, 17 c.307 (C.24:6I-1 et al.), P.L.2015, c.158 (C.18A:40-12.22), or P.L. , 18 c. (C. ) (pending before the Legislature as this bill). 19 d. (1) The commissioner shall require each applicant seeking 20 a permit to operate as an alternative treatment center to undergo a 21 criminal history record background check. For purposes of this 22 section, the term "applicant" shall include any applicant for an ATC 23 identification card authorizing the individual to be an owner, 24 director, board member, principal officer, or employee of an 25 alternative treatment center. The commissioner is authorized to 26 exchange fingerprint data with and receive criminal history record 27 background information from the Division of State Police and the 28 Federal Bureau of Investigation consistent with the provisions of 29 applicable federal and State laws, rules, and regulations. The 30 Division of State Police shall forward criminal history record 31 background information to the commissioner in a timely manner 32 when requested pursuant to the provisions of this section. 33 An applicant shall submit to being fingerprinted in accordance 34 with applicable State and federal laws, rules, and regulations. No 35 check of criminal history record background information shall be 36 performed pursuant to this section unless the applicant has 37 furnished [his] written consent to that check. An applicant who 38 refuses to consent to, or cooperate in, the securing of a check of 39 criminal history record background information shall not be 40 considered for [a permit to operate, or authorization to be employed 41 at, an alternative treatment center] issuance of an ATC 42 identification card. An applicant shall bear the cost for the criminal 43 history record background check, including all costs of 44 administering and processing the check. 45 (2) The commissioner shall not approve an applicant for [a 46 permit to operate, or authorization to be employed at, an alternative 47 treatment center] issuance of an ATC identification card if the 48 criminal history record background information of the applicant
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1 reveals a disqualifying conviction as set forth in subsection c. of 2 this section. 3 (3) Upon receipt of the criminal history record background 4 information from the Division of State Police and the Federal 5 Bureau of Investigation, the commissioner shall provide written 6 notification to the applicant of [his] the applicant’s qualification 7 for or disqualification for [a permit to operate or] issuance of an 8 ATC identification card authorizing the individual to be [a] an 9 owner, director, board member, principal officer, or employee of an 10 alternative treatment center, as appropriate. 11 If the applicant is disqualified because of a disqualifying 12 conviction pursuant to the provisions of this section, the conviction 13 that constitutes the basis for the disqualification shall be identified 14 in the written notice. 15 (4) The Division of State Police shall promptly notify the 16 commissioner in the event that an individual who was the subject of 17 a criminal history record background check conducted pursuant to 18 this section is convicted of a crime or offense in this State after the 19 date the background check was performed. Upon receipt of that 20 notification, the commissioner shall make a determination regarding 21 the continued eligibility to operate or be [a] an owner, director, 22 board member, principal officer, or employee of an alternative 23 treatment center. 24 (5) Notwithstanding the provisions of subsection b. of this 25 section to the contrary, the commissioner may offer [provisional 26 authority for] an applicant to be an employee of an alternative 27 treatment center a provisional ATC identification card, which shall 28 be valid for a period not to exceed three months, if the applicant 29 submits to the commissioner a sworn statement attesting that the 30 [person] applicant has not been convicted of any disqualifying 31 conviction pursuant to this section. 32 (6) Notwithstanding the provisions of subsection b. of this 33 section to the contrary, no employee of an alternative treatment 34 center shall be disqualified from issuance of an ATC identification 35 card on the basis of any conviction disclosed by a criminal history 36 record background check conducted pursuant to this section if the 37 individual has affirmatively demonstrated to the commissioner clear 38 and convincing evidence of rehabilitation. In determining whether 39 clear and convincing evidence of rehabilitation has been 40 demonstrated, the following factors shall be considered: 41 (a) the nature and responsibility of the position which the 42 convicted individual would hold, has held, or currently holds; 43 (b) the nature and seriousness of the crime or offense; 44 (c) the circumstances under which the crime or offense 45 occurred; 46 (d) the date of the crime or offense; 47 (e) the age of the individual when the crime or offense was 48 committed;
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1 (f) whether the crime or offense was an isolated or repeated 2 incident; 3 (g) any social conditions which may have contributed to the 4 commission of the crime or offense; and 5 (h) any evidence of rehabilitation, including good conduct in 6 prison or in the community, counseling or psychiatric treatment 7 received, acquisition of additional academic or vocational 8 schooling, successful participation in correctional work-release 9 programs, or the recommendation of those who have had the 10 individual under their supervision. 11 e. The department shall issue [a permit to a person to operate 12 as] an alternative treatment center permit to an applicant if the 13 department finds that issuing such a permit would be consistent 14 with the purposes of [this act] P.L.2009, c.307 (C.24:6I-1 et al.) 15 and the requirements of this section are met and the department has 16 verified the information contained in the application. An initial 17 permit to operate an alternative treatment center issued pursuant to 18 this subsection shall be valid for three years, and thereafter shall be 19 renewable biennially. The department shall approve or deny an 20 application within 60 days after receipt of a completed application. 21 The denial of an application shall be considered a final agency 22 decision, subject to review by the Appellate Division of the 23 Superior Court. The department may suspend or revoke a permit to 24 operate as an alternative treatment center for cause, which shall be 25 subject to review by the Appellate Division of the Superior Court. 26 f. A person [who has been] or entity issued a medical 27 marijuana cultivator-processor permit pursuant to this section shall 28 display the permit at the premises of the [alternative treatment 29 center] medical marijuana cultivator-processor facility at all times 30 when marijuana is being produced, [or] , cultivated, processed, or 31 manufactured, and a person or entity issued a medical marijuana 32 dispensary permit pursuant to this section shall display the permit 33 on the premises of the medical marijuana dispensary at all times 34 when medical marijuana is being dispensed to a registered 35 qualifying patient or the patient's primary caregiver. An individual 36 who has been issued an ATC identification card shall have the card 37 on the cardholder’s person at all times that the individual is on the 38 premises of an alternative treatment center. 39 g. An alternative treatment center shall report any change in 40 information to the department not later than 10 days after such 41 change, or the permit shall be deemed null and void. 42 h. [An alternative treatment center] A medical marijuana 43 cultivator-processor may charge a medical marijuana dispensary for 44 the reasonable costs associated with the production, cultivation, 45 processing, and manufacture of medical marijuana and marijuana- 46 infused and marijuana-derived products, and a medical marijuana 47 dispensary may charge a registered qualifying patient or primary
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1 caregiver for the reasonable costs associated with the [production 2 and] distribution of medical marijuana [for] to the cardholder. 3 i. The commissioner shall adopt regulations to: 4 (1) require such written documentation of each delivery of 5 marijuana to, and pickup of marijuana for, a registered qualifying 6 patient, including the date and amount dispensed, to be maintained 7 in the records of the [alternative treatment center] medical 8 marijuana dispensary, as the commissioner determines necessary to 9 ensure effective documentation of the operations of each 10 [alternative treatment center] medical marijuana dispensary; 11 (2) monitor, oversee, and investigate all activities performed by 12 an alternative treatment center; and 13 (3) ensure adequate security of all facilities 24 hours per day, 14 including production and retail locations, and security of all 15 delivery methods to registered qualifying patients. 16 j. A medical marijuana cultivator-processor may apply to the 17 department for approval to relocate to another location within the 18 same region, and a medical marijuana dispensary may apply to the 19 department for approval to relocate the medical marijuana 20 dispensary to another location within the same county. The 21 department may approve an application for relocation if the 22 department finds the relocation would be consistent with the 23 purposes of P.L.2009, c.307 (C.24:6I-1 et al.). The denial of an 24 application to relocate a medical marijuana cultivator-processor or 25 medical marijuana dispensary shall be considered a final agency 26 decision, subject to review by the Appellate Division of the 27 Superior Court. 28 k. (1) A medical marijuana cultivator-processor or medical 29 marijuana dispensary may apply to the department for approval to 30 sell or transfer its permit to another entity. The department shall 31 not approve the sale or transfer of a medical marijuana cultivator 32 processor or medical marijuana dispensary permit until each 33 applicant at the entity applying to purchase or receive the transfer of 34 the permit undergoes a criminal history record background check 35 pursuant to subsection d. of this section, the department finds that 36 the sale or transfer of the permit would be consistent with the 37 purposes of P.L.2009, c.307 (C.24:6I-1 et al.), the requirements of 38 this section are met, and the department has verified the information 39 contained in the application. The department shall approve or deny 40 an application within 90 days after receipt of a completed 41 application. The denial of an application to sell or transfer a 42 medical marijuana cultivator processor or medical marijuana 43 dispensary permit shall be considered a final agency decision, 44 subject to review by the Appellate Division of the Superior Court. 45 The sale or transfer of a permit pursuant to this subsection shall not 46 constitute authorization to relocate the permitted facility unless the 47 entity purchasing or receiving transfer of the permit additionally
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1 receives approval for the relocation from the department pursuant to 2 subsection j. of this section. 3 (2) If a nonprofit medical marijuana cultivator processor or 4 medical marijuana dispensary proposes to sell or transfer its permit 5 to a for-profit entity, its board of directors may proceed with the 6 sale or transfer upon receiving approval for the sale or transfer from 7 the department pursuant to paragraph (1) of this subsection, and, 8 except as provided in paragraph (3) of this subsection, after 9 obtaining an independent appraisal for the fair market value of the 10 permit. The sale or transfer of the permit shall be consistent with 11 the requirements of the “New Jersey Nonprofit Corporation Act,” 12 N.J.S.15A:1-1 et seq. The proceeds of the sale or transfer, 13 following satisfaction of the obligations of the medical marijuana 14 cultivator-processor or medical marijuana dispensary, shall be 15 retained or expended in a manner consistent with the requirements 16 of the “New Jersey Nonprofit Corporation Act,” N.J.S.15A:1-1 et 17 seq., or until the organization is lawfully wound down or dissolved. 18 If a nonprofit medical marijuana cultivator processor or medical 19 marijuana dispensary seeks to sell or transfer its permit to a for- 20 profit entity with which it shares common ownership or control, the 21 sale or transfer shall not proceed unless at least one disinterested 22 director or trustee approves the sale or transfer in accordance with 23 the requirements of the “New Jersey Nonprofit Corporation Act,” 24 N.J.S.15A:1-1 et seq. 25 (3) In the case of a nonprofit alternative treatment center that 26 was issued a permit prior to the effective date of P.L. , c. (C. ) 27 (pending before the Legislature as this bill), in lieu of obtaining an 28 independent appraisal of the fair market value of the alternative 29 treatment center’s medical marijuana cultivator-processor or 30 medical marijuana dispensary permit as required under paragraph 31 (2) of this subsection, upon receiving approval for the sale from the 32 department pursuant to paragraph (1) of this subsection, a nonprofit 33 alternative treatment center that was issued a permit prior to the 34 effective date of P.L. , c. (C. ) (pending before the 35 Legislature as this bill) may, on a single occasion and no later than 36 one year after the effective date of P.L. , c. (C. ) (pending 37 before the Legislature as this bill), elect to pay the department a fee 38 of $300,000 and sell or transfer its medical marijuana cultivator 39 processor permit or medical marijuana dispensary permit for a sum 40 that satisfies its outstanding obligations. 41 l. The maximum fees that may be charged in connection with 42 an alternative treatment center permit shall be as follows: 43 (1) for issuance of an initial three-year permit or biennial 44 renewal of an existing permit, $40,000; 45 (2) for authorization to relocate a medical marijuana cultivator- 46 processor to a new location within the same region, or for 47 authorization to relocate a medical marijuana dispensary to another 48 location within the same county, $20,000;
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1 (3) except as otherwise provided in paragraph (3) of subsection 2 k. of this section, to sell or transfer an alternative treatment center 3 permit, $150,000; 4 (cf: P.L.2013, c.160, s.2) 5 6 7. (New section) The department shall begin accepting and 7 processing applications for six additional cultivator-processors and 8 34 additional medical marijuana dispensaries no later than 90 days 9 after the effective date of P.L. , c. (C. ) (pending before the 10 Legislature as this bill). 11 The department shall make a determination as to a permit 12 application within 90 days after receiving the application, and shall 13 issue an initial permit to an approved applicant immediately upon 14 collection of the permit fee, unless the department finds the 15 applicant is not implementing the plans, procedures, protocols, 16 actions, or other measures set forth in the applicant’s permit 17 application submitted pursuant to section 7 of P.L. , c. (C. ) 18 (pending before the Legislature as this bill), or is otherwise not in 19 compliance with the requirements of P.L.2009, c.307 (C.24:6I-1 et 20 al.), in which case the department shall issue the permit to the next 21 highest scoring applicant in the same region that is in compliance 22 with the applicant’s permit application and the requirements of 23 P.L.2009, c.307 (C.24:6I-1 et al.). 24 25 8. (New section) a. Each application for an initial three year 26 permit to operate a medical marijuana cultivator processor or 27 medical marijuana dispensary, and for biennial renewal of such 28 permit, shall be submitted to the department. A separate application 29 shall be required for each location at which an applicant seeks to 30 operate. Renewal applications shall be submitted to the department 31 no later than 90 days before the date the current permit will expire. 32 b. An initial medical marijuana cultivator-processor or medical 33 marijuana dispensary permit application shall be evaluated and 34 scored on a 100 point scale, consistent with the requirements of 35 subsections c. and d. of this section, plus any bonus points awarded 36 pursuant to subsection e. of this section. 37 c. In addition to any points awarded for an initial application 38 for a medical marijuana cultivator-processor permit or a medical 39 marijuana dispensary permit pursuant to subsection d. of this 40 section and any bonus points awarded pursuant to subsection e. of 41 this section, up to 21 points may be awarded for the summary of the 42 applicant’s operating plan, excluding safety and security criteria: 43 (1) In the case of an applicant for a medical marijuana 44 cultivator-processor permit, the operating plan summary shall 45 include a written description, of up to 1,000 words per topic, 46 concerning the applicant’s qualifications for, experience in, and 47 knowledge of each of the following topics:
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1 (a) State-licensed cultivation of medical marijuana and 2 manufacture of marijuana products using appropriate extraction 3 methods; 4 (b) conventional horticulture or agriculture, familiarity with 5 good agricultural practices, and any relevant certifications or 6 degrees; 7 (c) pharmaceutical manufacturing, good manufacturing 8 practices, quality control, and quality assurance; 9 (d) recall plans; 10 (e) packaging and labeling; 11 (f) inventory control and tracking software or systems for the 12 production of medical marijuana; 13 (g) analytical chemistry and testing of marijuana and marijuana- 14 infused or marijuana-derived products and formulations; 15 (h) water management practices; 16 (i) odor mitigation practices; 17 (j) onsite and offsite recordkeeping; 18 (k) strain variety and plant genetics; 19 (l) pest control and disease management practices, including 20 plans for the use of pesticides, nutrients, and additives; 21 (m) waste disposal plans; and 22 (n) compliance with applicable laws and regulations. 23 (2) In the case of an applicant for a medical marijuana 24 dispensary permit, the operating plan summary shall include a 25 written description, of up 1,000 words per topic, concerning the 26 applicant’s qualifications for, experience in, and knowledge of each 27 of the following topics: 28 (a) State-licensed dispensation of medical marijuana to 29 qualifying patients; 30 (b) healthcare, medicine, and treatment of patients with 31 debilitating medical conditions; 32 (c) marijuana product evaluation procedures; 33 (d) recall plans; 34 (e) packaging and labeling; 35 (f) inventory control and point-of-sale software or systems for 36 the sale of medical marijuana; 37 (g) patient counseling procedures; 38 (h) the routes of administration, strains, varieties, and 39 cannabinoid profiles of medical marijuana products; 40 (i) odor mitigation practices; 41 (j) onsite and offsite recordkeeping; 42 (k) the composition of the applicant’s medical advisory board, if 43 any; 44 (l) compliance with State and federal patient privacy rules; 45 (m) waste disposal plans; and 46 (n) compliance with applicable laws and regulations. 47 d. In addition to any points awarded for an operating plan 48 summary submitted pursuant to subsection c. of this section and any 49 bonus points awarded pursuant to subsection e. of this section, up
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1 79 points may be awarded for an initial application for a medical 2 marijuana cultivator-processor permit or a medical marijuana 3 dispensary permit, as follows: 4 (1) Up to four points may be awarded for the applicant’s 5 environmental impact plan, which shall not exceed five pages. 6 (2) Up to 7.5 points may be awarded for the summary of the 7 applicant’s safety and security plans and procedures, which shall 8 include descriptions of the following: 9 (a) plans for the use of security personnel; 10 (b) the experience or qualifications of existing security 11 personnel; 12 (c) security and surveillance features, including descriptions of 13 any alarm systems, video surveillance systems, and access and 14 visitor management systems, along with drawings identifying the 15 proposed locations for surveillance cameras and other security 16 features; 17 (d) plans for the storage of medical marijuana and medical 18 marijuana products, including any safes, vaults, and climate control 19 systems that will be utilized for this purpose; 20 (e) a diversion prevention plan; 21 (f) an emergency management plan; 22 (g) procedures for screening, monitoring, and performing 23 criminal history record background checks of employees; 24 (h) cybersecurity procedures, including, in the case of an 25 applicant for a medical marijuana dispensary permit, procedures for 26 collecting, processing, and storing patient data, and the applicant’s 27 familiarity with State and federal privacy laws; 28 (i) workplace safety plans and the applicant’s familiarity with 29 federal Occupational Safety and Health Administration regulations; 30 (j) the applicant’s history of workers’ compensation claims and 31 safety assessments; 32 (k) procedures for reporting adverse events; and 33 (l) a sanitation practices plan. 34 (3) Up to 15 total points may be awarded for the summary of the 35 applicant’s business experience, subject to the following 36 requirements: 37 (a) up to six points may be awarded for the description of the 38 applicant’s experience operating businesses in highly-regulated 39 industries; 40 (b) up to six points may be awarded for a description of the 41 applicant’s experience in operating alternative treatment centers and 42 related medical marijuana production and dispensation entities 43 under the laws of New Jersey or any other state; 44 (c) up to three points may be awarded for the applicant’s plan, 45 which shall not exceed three pages, to comply with and mitigate the 46 effects of 26 U.S.C. s.280E on marijuana businesses, and for 47 evidence that the applicant is not in arrears with respect to any tax 48 obligation to the State.
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1 In evaluating the experience described under subparagraphs (a) 2 and (b) of this paragraph, the department shall afford the greatest 3 weight to the experience of the applicant itself, controlling owners, 4 and entities with common ownership or control with the applicant; 5 followed by the experience of those with a 15 percent or greater 6 ownership interest in the applicant’s organization; followed by 7 interest holders in the applicant’s organization; followed by other 8 officers, directors, and bona fide full-time employees of the 9 applicant as of the submission date of the application. 10 (4) Up to 15 points may be awarded based on a description of 11 the proposed location for the applicant’s alternative treatment center 12 site, which shall be awarded as follows: 13 (a) up to seven points may be awarded for a description of the 14 proposed location, the surrounding area, and the suitability or 15 advantages of the proposed location, along with a floor plan and 16 optional renderings or architectural or engineering plans; 17 (b) four points may be awarded for submitting zoning approvals 18 for the proposed location, which shall consist of a letter or affidavit 19 from appropriate municipal officials that the location will conform 20 to municipal zoning requirements allowing for the cultivation, 21 processing, or dispensing of medical marijuana, marijuana-infused 22 and marijuana-derived products, and related supplies, as 23 appropriate; and 24 (c) four points may be awarded for submitting proof of local 25 support for the suitability of the location, which may be 26 demonstrated by a letter from the municipality’s highest-ranking 27 official or by a resolution adopted by the municipality’s governing 28 body indicating that the intended location is appropriately located 29 or otherwise suitable for the cultivation, processing, or dispensing 30 of medical marijuana, marijuana-infused and marijuana-derived 31 products, and related supplies, as appropriate. 32 Notwithstanding any other provision of this subsection, an 33 application shall be disqualified from consideration unless it 34 includes documentation demonstrating that the applicant will have 35 final control of the premises upon approval of the application, 36 including, but not limited to, a lease agreement, contract for sale, 37 title, deed, or similar documentation. In addition, if the applicant 38 will lease the premises, the application will be disqualified from 39 consideration unless it includes certification from the landlord that 40 the landlord is aware that the tenant’s use of the premises will 41 involve cultivation, processing, or dispensing of medical marijuana 42 and medical marijuana products, as appropriate. An application 43 shall not be disqualified from consideration if the application does 44 not include the materials described in subparagraphs (b) or (c) of 45 this paragraph. 46 (5) Up to 15 total points may be awarded in the community 47 impact and social responsibility section of the application, subject 48 to the following requirements:
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1 (a) up to four points may be awarded for a community impact 2 plan, not to exceed five pages, summarizing how the applicant 3 intends to have a positive impact on the community in which the 4 proposed medical marijuana cultivator-processor or medical 5 marijuana dispensary is to be located, which shall include an 6 economic impact plan, a description of outreach activities, and any 7 financial assistance or discount plans the applicant will provide to 8 qualifying patients and primary caregivers; 9 (b) up to three points may be awarded for a written description 10 of the applicant’s record of social responsibility, philanthropy, and 11 ties to the proposed host community, which shall not exceed five 12 pages; and 13 (c) up to four points may be awarded for a written description of 14 any research the applicant has conducted on the medical efficacy or 15 adverse effects of marijuana use and the applicant’s participation in 16 or support of marijuana-related research and educational activities, 17 which shall not exceed three pages; and 18 (d) up to four points may be awarded for a written plan, which 19 shall not exceed three pages, describing any research and 20 development regarding the medical efficacy or adverse effects of 21 marijuana, and any marijuana-related educational and outreach 22 activities, the applicant intends to conduct if issued a permit by the 23 department. 24 In evaluating the information submitted pursuant to 25 subparagraphs (b) and (c) of this paragraph, the department shall 26 afford the greatest weight to the experience of the applicant itself, 27 controlling owners, and entities with common ownership or control 28 with the applicant; followed by the experience of those with a 15 29 percent or greater ownership interest in the applicant’s organization; 30 followed by interest holders in the applicant’s organization; 31 followed by other officers, directors, and bona fide full-time 32 employees of the applicant as of the submission date of the 33 application. 34 (6) Up to 7.5 total points may be awarded for the applicant’s 35 workforce development and job creation plan, which may be 36 awarded based on the following criteria: 37 (a) up to four points may be awarded for a description of the 38 applicant’s workforce development and job creation plan, which 39 may include information on the applicant or its owners’ history of 40 job creation and planned job creation at its proposed medical 41 marijuana cultivator-processor or medical marijuana dispensary; 42 education, training, and resources to be made available for 43 employees; any relevant certifications; and an optional diversity 44 plan; and 45 (b) 3.5 points shall be awarded to any applicant that has 46 executed a labor peace agreement or card check and neutrality 47 agreement with a collective bargaining unit for the proposed 48 medical marijuana cultivator-processor or medical marijuana 49 dispensary. An applicant that does not submit the information
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1 described in this subparagraph shall not be disqualified from 2 consideration. 3 (7) Up to 15 total points may be awarded for the description of 4 applicant’s business and financial plan: 5 (a) up to five points may be awarded for an executive summary 6 of the applicant’s business plan, which shall not exceed 1,500 7 words; 8 (b) up to five points may be awarded for a demonstration of the 9 applicant’s financial ability to implement its business plan, which 10 shall not exceed 10 pages including attachments, and which may 11 include, but shall not be limited to, bank statements, business and 12 individual financial statements, net worth statements, and debt and 13 equity financing statements. An applicant who demonstrates the 14 availability of at least $500,000 in a bank account in the applicant’s 15 name at the time the application is submitted shall be awarded full 16 points under this subparagraph; 17 (c) up to five points may be awarded for a description of the 18 applicant’s experience complying with guidance pertaining to 19 marijuana issued by the Financial Crimes Enforcement Network 20 under 31 U.S.C. s.5311 et seq., the federal Bank Secrecy Act, which 21 may be demonstrated by submitting letters regarding its banking 22 history from banks or credit unions that certify they are aware of the 23 business activities of the applicant, or entities with common 24 ownership or control of the applicant’s organization, in any state 25 where the applicant has operated a business related to medical 26 marijuana. For the purposes of this subparagraph, the department 27 shall consider only bank references involving accounts in the name 28 of the applicant or of an entity with common ownership or control 29 of the applicant’s organization. An applicant who does not submit 30 the information described in this subparagraph shall not be 31 disqualified from consideration. 32 e. Up to a total of 40 bonus points may be added to the 33 applicant’s total score based on the following: 34 (1) If any of the applicant’s majority or controlling owners were 35 previously approved by the department to serve as an officer, 36 director, principal, or key employee of an alternative treatment 37 center, and the individual served in such capacity at the alternative 38 treatment center for two or more years, the department shall award 39 10 bonus points, which shall be added to the applicant’s total score. 40 No points shall be deducted from the applicant’s total score if none 41 of the majority or controlling owners meet the requirements of this 42 paragraph. 43 (2) If an applicant can demonstrate that its governance structure 44 includes the involvement of a licensed and accredited school of 45 medicine or osteopathic medicine, a general acute care hospital or 46 ambulatory care facility licensed in New Jersey, or a pharmacy, the 47 department shall award 15 bonus points, which shall be added to the 48 applicant’s total score, provided the following conditions are met:
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1 (a) the school, hospital, facility, or pharmacy has conducted or 2 participated in institutional review board-approved research related 3 to marijuana involving the use of human subjects; 4 (b) the school, hospital, facility, or pharmacy holds a profit 5 share or ownership interest in the applicant’s organization of 10 6 percent or more; and 7 (c) the school, hospital, facility, or pharmacy participates in 8 major decision-making activities within the applicant’s 9 organization, which may be demonstrated by representation on the 10 board of directors of the applicant’s organization. 11 No points shall be deducted from the applicant’s total score if the 12 applicant’s governance structure does not include a school, hospital, 13 facility, or pharmacy that meets the requirements of this paragraph. 14 (3) If the applicant submits evidence that the applicant, or an 15 entity with common ownership or control with the applicant, has 16 executed a collective bargaining agreement in the cannabis industry 17 that has been in effect for at least six months as of the submission 18 date of the application, the department shall award 15 bonus points, 19 which shall be added to the applicant’s total score. No points shall 20 be deducted from the applicant’s total score if the applicant has not 21 executed a collective bargaining agreement in the cannabis industry 22 that meets the requirements of this paragraph. 23 f. In reviewing a medical marijuana cultivator-processor or 24 medical marijuana dispensary initial permit application, unless the 25 information is otherwise solicited by the department in a specific 26 application question, the department’s evaluation of the application 27 shall be limited to the experience and qualifications of the 28 applicant’s organization, including any entities with common 29 ownership or control of the applicant’s organization, controlling 30 owners or interest holders in the applicant’s organization, and the 31 officers, directors, and actual full-time existing employees of the 32 applicant’s organization. Responses pertaining to consultants, 33 independent contractors, and prospective or part-time employees of 34 the entity shall not be considered or scored. Each applicant shall 35 certify as to the status of the individuals and entities included in the 36 application. 37 g. To the extent possible, the department shall seek to ensure 38 that at least 15 percent of the total number of new medical 39 marijuana dispensary permits issued on or after the effective date of 40 P.L. , c. (C. ) (pending before the Legislature as this bill) 41 are issued to a qualified applicant that: 42 (1) has been certified as a minority business or as a women’s 43 business by the Division of Development for Small Businesses and 44 Women’s and Minority Businesses in the New Jersey Commerce 45 and Economic Growth Commission pursuant to P.L.1986, c.195 46 (C.52:27H-21.18 et seq.); 47 (2) has been certified as a veteran-owned business by the 48 Department of the Treasury pursuant to P.L.2011, c.147 (C.52:32- 49 49 et seq.); or
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1 (3) is a disabled-veteran business, as defined in section 2 of 2 P.L.2015, c.116 (C.52:32-31.2). 3 In selecting among applicants who meet these criteria, the 4 Department of Health shall grant a higher preference to applicants 5 with up to two groups in its ownership composition that meet the 6 criteria described in this subsection. 7 h. No employee of the department shall have any direct or 8 indirect financial interest in the cultivation, processing, or 9 dispensing of medical marijuana or related paraphernalia, or 10 otherwise receive anything of value from a medical marijuana 11 cultivator-processor or medical marijuana dispensary permit 12 applicant in exchange for reviewing, processing, or making any 13 recommendations with respect to a permit application. 14 i. Application materials submitted to the department pursuant 15 to this section not be considered a public record pursuant to 16 P.L.1963, c.73 (C.47:1A-1 et seq.), P.L.2001, c.404 (C.47:1A-5 et 17 al.), or the common law concerning access to public records. 18 j. If the department notifies an applicant that it has scored 19 sufficiently high on multiple applications to be awarded more than 20 one medical marijuana cultivator-processor or medical marijuana 21 dispensary permit by the department, the applicant shall notify the 22 department, within seven business days after receiving such notice, 23 as to which permit it will accept. For any permit award declined by 24 an applicant pursuant to this subsection, the department shall, upon 25 receiving notice from the applicant of the declination, award the 26 permit to the applicant with the next highest score on an application 27 for that permit in the same region. If an applicant fails to notify the 28 department as to which permit it will accept, the department shall 29 have the discretion to determine which permit it will award to the 30 applicant, based on the department’s determination of Statewide 31 need and the scores awarded to other applications in the affected 32 regions. 33 34 9. (New section) a. An alternative treatment center may 35 appoint a medical advisory board to provide advice to the 36 alternative treatment center on all aspects of its business. 37 b. A medical advisory board appointed pursuant to this section 38 shall comprise five members: three health care professionals 39 licensed to practice in New Jersey, at least one of whom shall be a 40 physician; one qualifying patient; and one individual who owns a 41 business in the same region in which the alternative treatment 42 center is located. If the alternative treatment center is a medical 43 marijuana dispensary, the qualifying patient member shall be 44 registered with the dispensary; if the alternative treatment center is 45 a medical marijuana cultivator-processor, the qualifying patient 46 shall be registered with a medical marijuana dispensary located in 47 the same region as the medical marijuana cultivator-processor. No 48 ATC identification card holder may serve on a medical advisory 49 board.
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1 c. A medical advisory board appointed pursuant to this section 2 shall meet at least two times per calendar year. 3 4 10. Section 10 of P.L.2009, c.307 (C.24:6I-10) is amended to 5 read as follows: 6 10. a. A physician shall provide written instructions for a 7 registered qualifying patient or [his] the patient’s primary caregiver 8 to present to [an alternative treatment center] a medical marijuana 9 dispensary concerning the form and total amount of usable 10 marijuana that a patient may be dispensed, in weight, in a 30-day 11 period, which amount shall not exceed [two] four ounces in dried 12 form or the equivalent amount, as established by the commissioner 13 by regulation, in any other form, including, but not limited to, oral 14 lozenges, topical formulations, transdermal form, sublingual form, 15 tincture form, edible form, or any other authorized form. If no 16 amount is noted, the maximum amount that may be dispensed at 17 one time is [two] four ounces in dried form or the equivalent 18 amount, as established by the commissioner by regulation, in any 19 other form, including, but not limited to, oral lozenges, topical 20 formulations, transdermal form, sublingual form, tincture form, 21 edible form, or any other authorized form. If no form is noted, the 22 dispensary shall return the instructions to the physician in order to 23 specify the form. 24 b. A physician may issue multiple written instructions at one 25 time authorizing the patient to receive a total of up to a 90-day 26 supply, provided that the following conditions are met: 27 (1) Each separate set of instructions shall be issued for a 28 legitimate medical purpose by the physician, as provided in [this 29 act] P.L.2009, c.307 (C.24:6I-1 et al.); 30 (2) Each separate set of instructions shall indicate the earliest 31 date on which a [center] dispensary may dispense the marijuana, 32 except for the first dispensation if it is to be filled immediately; and 33 (3) The physician has determined that providing the patient with 34 multiple instructions in this manner does not create an undue risk of 35 diversion or abuse. 36 c. A registered qualifying patient or [his] the patient’s primary 37 caregiver shall present the patient's or caregiver's registry 38 identification card, as applicable, and these written instructions to 39 the [alternative treatment center] medical marijuana dispensary, 40 which shall verify and log the documentation presented. A 41 physician may provide a copy of a written instruction by electronic 42 or other means, as determined by the commissioner, directly to [an 43 alternative treatment center] a medical marijuana dispensary on 44 behalf of a registered qualifying patient. The dispensation of 45 marijuana pursuant to any written instructions shall occur within 46 one month of the date that the instructions were written or the 47 instructions are void.
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1 d. [A] Medical marijuana may be dispensed to a patient or the 2 patient’s primary caregiver [may be registered at only one 3 alternative treatment center at any time] by any medical marijuana 4 dispensary in the State. Prior to dispensing medical marijuana to a 5 qualifying patient or the patient’s primary caregiver, the medical 6 marijuana dispensary shall access the system established pursuant 7 to section 11 of P.L.2009, c.307 (C.45:1-45.1) to ascertain whether 8 medical marijuana was dispensed to the patient or the patient’s 9 primary caregiver by any medical marijuana dispensary within the 10 preceding 30 days. Upon dispensing medical marijuana to a 11 qualifying patient or the patient’s primary caregiver, the medical 12 marijuana dispensary shall transmit to the patient’s physician 13 information concerning the amount, strain, and form of medical 14 marijuana that was dispensed. 15 (cf: P.L.2009, c.307, s.10) 16 17 11. Section 14 of P.L.2009, c.307 (C.24:6I-12) is amended to 18 read as follows: 19 14. a. The commissioner shall report to the Governor, and to the 20 Legislature pursuant to section 2 of P.L.1991, c.164 (C.52:14-19.1): 21 (1) no later than one year after the effective date of [this act] 22 P.L.2009, c.307 (C.24:6I-1 et al.), on the actions taken to 23 implement the provisions of [this act] P.L.2009, c.307 (C.24:6I-1 24 et al.) and P.L.2015, c.158 (C.18A:40-12.22 et al.); and 25 (2) annually thereafter on the number of applications for registry 26 identification cards, the number of qualifying patients registered, 27 the number of primary caregivers registered, the nature of the 28 [debilitating] qualifying medical conditions of the patients, the 29 number of registry identification cards revoked, the number of 30 alternative treatment center permits issued and revoked, and the 31 number of physicians [providing certifications for] authorizing 32 patients for the medical use of marijuana. 33 b. The reports shall not contain any identifying information of 34 patients, caregivers, or physicians. 35 c. Within two years after the effective date of [this act] 36 P.L.2009, c.307 (C.24:6I-1 et al.) and every two years thereafter, 37 the commissioner shall: evaluate whether there are sufficient 38 numbers of alternative treatment centers to meet the needs of 39 registered qualifying patients throughout the State; evaluate 40 whether the maximum amount of medical marijuana allowed 41 pursuant to [this act] P.L.2009, c.307 (C.24:6I-1 et al.) is sufficient 42 to meet the medical needs of qualifying patients; and determine 43 whether any alternative treatment center has charged excessive 44 prices for marijuana that the center dispensed. 45 The commissioner shall report his findings no later than two 46 years after the effective date of [this act] P.L.2009, c.307 (C.24:6I- 47 1 et al.), and every two years thereafter, to the Governor, and to the
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1 Legislature pursuant to section 2 of P.L.1991, c.164 (C.52:14-19.1). 2 (cf: P.L.2009, c.307, s.14) 3 4 12. Section 15 of P.L.2009, c.307 (C.24:6I-13) is amended to 5 read as follows: 6 15. a. The Department of Health is authorized to exchange 7 fingerprint data with, and receive information from, the Division of 8 State Police in the Department of Law and Public Safety and the 9 Federal Bureau of Investigation for use in reviewing applications 10 for individuals seeking to serve as primary caregivers who are not 11 an immediate family member of the patient pursuant to section 4 of 12 P.L.2009, c.307 (C.24:6I-4), applications for an ATC identification 13 card pursuant to section 7 of P.L.2009, c.307 (C.24:6I-7), and 14 applications for permits to operate as [, or to be a director, officer, 15 or employee of,] alternative treatment centers pursuant to section 7 16 of P.L.2009, c.307 (C.24:6I-7). 17 b. The Division of State Police shall promptly notify the 18 Department of Health in the event an applicant seeking to serve as a 19 primary caregiver who is not an immediate family member of the 20 patient, an applicant for an ATC identification card, or an applicant 21 for a permit to operate as [, or to be a director, officer, or employee 22 of,] an alternative treatment center, who was the subject of a 23 criminal history record background check conducted pursuant to 24 subsection a. of this section, is convicted of a crime involving 25 possession or sale of a controlled dangerous substance. 26 (cf: P.L.2012, c.17, s.91) 27 28 13. Section 18 of P.L.2009, c.307 (C.24:6I-16) is amended to 29 read as follows: 30 18. a. Pursuant to the "Administrative Procedure Act," 31 P.L.1968, c.410 (C.52:14B-1 et seq.), the commissioner shall 32 promulgate rules and regulations to effectuate the purposes of [this 33 act] P.L.2009, c.307 (C.24:6I-1 et al.), in consultation with the 34 Department of Law and Public Safety. 35 b. Notwithstanding any provision of P.L.1968, c.410 36 (C.52:14B-1 et seq.) to the contrary, the commissioner shall adopt, 37 immediately upon filing with the Office of Administrative Law and 38 no later than the 90th day after the effective date of [this act] 39 P.L.2009, c.307 (C.24:6I-1 set al.), such regulations as the 40 commissioner deems necessary to implement the provisions of [this 41 act] P.L.2009, c.307 (C.24:6I-1 set al.). Regulations adopted 42 pursuant to this subsection shall be effective until the adoption of 43 rules and regulations pursuant to subsection a. of this section and 44 may be amended, adopted, or readopted by the commissioner in 45 accordance with the requirements of P.L.1968, c.410 (C.52:14B-1 46 et seq.). 47 c. No later than 90 days after the effective date of P.L. , c. 48 (C. ) (pending before the Legislature as this bill), the
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1 commissioner shall establish, by regulation, dosage amounts for 2 medical marijuana in each form available to qualifying patients that 3 are equivalent to four ounces of medical marijuana in dried form. 4 The commissioner shall periodically review and update the dosage 5 amounts as appropriate, including to establish equivalent dosage 6 amounts for new forms of medical marijuana that become available. 7 (cf: P.L.2009, c.307, s.18) 8 9 14. Section 11 of P.L.2009, c.307 (C.45:1-45.1) is amended to 10 read as follows: 11 11. a. A physician who [provides a certification] authorizes a 12 patient for the medical use of marijuana or who provides a written 13 instruction for the medical use of marijuana to a qualifying patient 14 pursuant to P.L.2009, c.307 (C.24:6I-1 et al.) and any [alternative 15 treatment center] medical marijuana dispensary shall furnish to the 16 Director of the Division of Consumer Affairs in the Department of 17 Law and Public Safety such information, on a daily basis and in 18 such a format [and at such intervals,] as the director shall prescribe 19 by regulation, for inclusion in a system established to monitor the 20 dispensation of marijuana in this State for medical use as authorized 21 by the provisions of P.L.2009, c.307 (C.24:6I-1 et al.), which 22 system shall serve the same purpose as, and be cross-referenced 23 with, the electronic system for monitoring controlled dangerous 24 substances established pursuant to section 25 of P.L.2007, c.244 25 (C.45:1-45). 26 b. The Director of the Division of Consumer Affairs, pursuant 27 to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B- 28 1 et seq.), and in consultation with the Commissioner of Health 29 [and Senior Services], shall adopt rules and regulations to 30 effectuate the purposes of subsection a. of this section. 31 c. Notwithstanding any provision of P.L.1968, c.410 32 (C.52:14B-1 et seq.) to the contrary, the Director of the Division of 33 Consumer Affairs shall adopt, immediately upon filing with the 34 Office of Administrative Law and no later than the 90th day after 35 the effective date of P.L.2009, c.307 (C.24:6I-1 et al.), such 36 regulations as the director deems necessary to implement the 37 provisions of subsection a. of this section. Regulations adopted 38 pursuant to this subsection shall be effective until the adoption of 39 rules and regulations pursuant to subsection b. of this section and 40 may be amended, adopted, or readopted by the director in 41 accordance with the requirements of P.L.1968, c.410 (C.52:14B-1 42 et seq.). 43 (cf: P.L.2009, c.307, s.11) 44 45 15. Section 5 of P.L.2009, c.307 (C.24:6I-5) is repealed. 46 47 16. The Commissioner of Health shall adopt, pursuant to the 48 “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et
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1 seq., such rules and regulations as may be necessary to effectuate 2 the purposes of this act. 3 4 17. This act shall take effect 90 days after the date of enactment, 5 except that the Commissioner of Health may take any advance 6 administrative action as may be necessary to implement the 7 requirements of this act.
Hugh O’Beirne has served as President and Chairman of the Board of Trustees of the New Jersey Cannabis Industry Association since November 2017, and has been a trustee since its inception. A resident of Princeton, NJ and an attorney, Hugh has been involved in cannabis reform advocacy since the late 1980s. He has been an investor in the cannabis industry on the east coast since 2016.
Hugh has 10 years of executive experience in the real estate and financial services industries. Prior to serving as NJCIA President, Hugh was a consultant to national and international private equity and asset management firms. He has served as Executive Vice President and Chief Legal Officer for Chambers Street Properties, an NYSE publicly traded REIT, through its merger with Gramercy Property Trust in December of 2015. Prior to his role with Chambers Street, Mr. O’Beirne served as product General Counsel for CB Richard Ellis Realty Trust, a non-traded REIT and predecessor company to Chambers Street Properties, and Senior Counsel to its then external manager, CBRE Global Investors. Before joining CBRE in 2007, he was a senior associate at Alston + Bird's REIT and non-traded product practice, and prior to that, a Corporate Securities and Market Regulatory associate in the NY office of Sidley Austin from 2000-2005.
Mr. O’Beirne earned a B.A. from Merrimack College, an M.A. from Boston College, and a J.D. from Vanderbilt University.