216-RICR-20-10-3. Medical Marijuana Program (version Amendment, 01/03/2017 to 01/03/2017)

RULES AND REGULATIONS RELATED TO THE MEDICAL MARIJUANA PROGRAM ADMINISTERED BY THE DEPARTMENT OF HEALTH [R21-28.6-MMP] STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS DEPARTMENT OF HEALTH March 2006 (E) As Amended: July 2006 (E) August 2006 January 2007 (re-filing in accordance with the provisions of § 42-35-4.1 of the Rhode Island General Laws, as amended) January 2008 March 2010 January 2012 (re-filing in accordance with the provisions of § 42-35-4.1 of the Rhode Island General Laws, as amended) December 2012 February 2014 (T) January 2017 THIS PAGE INTENTIONALLY LEFT BLANK i INTRODUCTION These amended Rules and Regulations Related to the Medical Marijuana Program Administered by the Department of Health [R21-28.6-MMP] are promulgated1, 2 pursuant to the authority conferred under § 21-28.6-5 of the General Laws of Rhode Island, as amended, and are established for the purpose of updating standards for the implementation of a medical marijuana program, and other changes mandated pursuant to PL 2014-515, PL 2014-145, Article 15, § 3, PL 2016-415, PL 2016-416 and PL 2016-142, Article 14. Pursuant to the provisions of § 42-35-3(a)(3) and § 42-35.1-4 of the General Laws of Rhode Island, as amended, the following were given consideration in arriving at the amended regulations: (1) alternative approaches to the regulations; (2) duplication or overlap with other state regulations and (3) significant economic impact on small business. Based on the available information, no known alternative approach, duplication or overlap was identified. These amended regulations shall be effective January 1, 2017 and shall supersede all previous Rules and Regulations Related to the Medical Marijuana Program promulgated by the Rhode Island Department of Health and filed with the Secretary of State. 1 Compiler’s Note: All editions of the Rules and Regulations Related to the Medical Marijuana Program Administered by the Department of Health prior to January 2017 were promulgated pursuant to authority under Chapter 21-28.6 of the General Laws of Rhode Island, as amended, with the title Rules and Regulations Related to the Medical Marijuana Program. Chapter 21-28.6 was amended pursuant to PL 2016-142, Article 14 to transfer certain responsibilities from the RI Department of Health to the RI Department of Business Regulation. In addition, the amended Chapter 21-28.6 assigned new responsibilities to both the RI Department of Health and the RI Department of Business Regulation. These amended Rules and Regulations Related to the Medical Marijuana Program Administered by the Department of Health only address the portions of Chapter 21-28.6 administered by the RI Department of Health as of 1 January 2017. The RI Department of Business Regulation has promulgated a separate set of regulations which address their authority pursuant to Chapter 21-28.6 of the General Laws of Rhode Island, as amended. ii TABLE OF CONTENTS Page 1.0 Definitions 1 2.0 General Requirements 4 3.0 Application for Department of Health Registration Identification Cards and Fees 8 4.0 Issuance and Renewal of Department of Health Registration Identification Cards 9 5.0 Compassion Center Inspection 11 6.0 Protections for the Medical Use of Marijuana 11 7.0 Confidentiality Provisions 12 8.0 Scope of the Act 13 9.0 Penalties for Violations 14 10.0 Purchase and Issuance of Medical Marijuana Plant Tags 14 11.0 Practices and Procedures 15 12.0 Severability 15 Appendix A 16 1 Section 1.0 Definitions Wherever used in these Regulations the following terms shall be construed as follows: 1.1 “Act” means RIGL Chapter 21-28.6 entitled “The Edward O. Hawkins and Thomas C. Slater Medical Marijuana Act.” 1.2 “Authorized purchaser” means a natural person, who is at least twenty-one (21) years old, and who is registered with the department of health for the purpose of assisting a qualifying patient in purchasing marijuana from a compassion center. An authorized purchaser may assist no more than one patient, and is prohibited from consuming marijuana obtained for the use of the qualifying patient. 1.3 “Cardholder" means a person who has registered with the department of health pursuant to RIGL Chapter 21-28.6 and has been issued and possesses a valid registry identification card or license. 1.4 “Commercial Unit” means a building, office, suite or room within a commercial or industrial building for use by one business and is rented or owned by that business or person. 1.5 “Compassion center” means a not-for-profit corporation subject to the provisions of RIGL Chapter 7-6, and registered under § 21-28.6-12 of the Act that acquires, possesses, cultivates, manufactures, delivers, transfers, transports, supplies or dispenses marijuana, and/or related supplies and educational materials, to patient cardholders and/or their registered caregiver cardholder and authorized purchaser. 1.6 “Debilitating medical condition” means: (a) Cancer, glaucoma, positive status for human immunodeficiency virus, acquired immune deficiency syndrome, Hepatitis C, post-traumatic stress disorder; or the treatment of these conditions; (b) A chronic or debilitating disease or medical condition or its treatment that produces one or more of the following: cachexia or wasting syndrome; severe, debilitating, chronic pain; severe nausea; seizures, including but not limited to, those characteristic of epilepsy; or severe and persistent muscle spasms, including but not limited to, those characteristic of multiple sclerosis or Crohn’s disease; or agitation of Alzheimer's Disease; or (c) Any other medical condition or its treatment approved by the Department of Health pursuant to §§ 2.6, 2.7 and 2.8 of these Regulations. 1.7 “Department of Business Regulation” means the Rhode Island Department of Business Regulation or its successor agency. 1.8 “Department of Health” means the Rhode Island Department of Health or its successor Agency. 1.9 “Department of Public Safety” means the Rhode Island Department of Public Safety or its successor agency. 2 1.10 “Dried usable marijuana” means the dried leaves and flowers of the marijuana plant after the wet harvested leaves and flowers of the marijuana plant have undergone the drying process. 1.11 “Dwelling Unit” means a room or group of rooms within a dwelling used or intended for use by one family or household, or by no more than three (3) unrelated individuals, for living, sleeping, cooking and eating. 1.12 “Equivalent amount” means the portion of usable marijuana, be it extracted, edible, concentrated or any other form, found to be equal to a portion of dried usable marijuana, as defined in Appendix A of these Regulations. 1.13 “Full assessment” means evaluation by practitioner which at a minimum documents in the medical record: history of present illness, social history, past medical and surgical history, alcohol and substance use history, physical exam and documentation of therapies with inadequate response. 1.14 “Marijuana” has the meaning given that term in RIGL § 21-28-1.02(26) and is as follows: all parts of the plant (Cannabis sativa, L.), whether growing or not; the seeds of the plant; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin, but shall not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of mature stalks, (except the resin extracted from it), fiber, oil or cake, or the sterilized seed from the plant which is incapable of germination. 1.15 “Marijuana Infused Products” means a product infused with medical marijuana or an extract of medical marijuana that is intended for use or consumption other than by smoking, including, but not limited to edible products, ointments, oils and tinctures. These products when manufactured or sold by a licensed medical marijuana compassion center shall not be considered a food or drug. 1.16 "Mature marijuana plant" means a marijuana plant that has flowers or buds that are readily observable by an unaided visual examination. 1.17 “Medical Marijuana Program Tracking System” shall refer to any system designated by the Department of Business Regulation and the Department of Health designed and used to record all medical marijuana program regulated activities with unique identifiers to track all activities and transactions from point of origin to point of sale (“seed to sale”), “Seed to sale” activities and transactions include but are not limited to: all cultivation, harvest, processing, manufacturing, and packaging and labeling; all purchases, acquisitions or third party supply of marijuana; all sales and dispensing transactions, and any other transfers of marijuana as permitted by the Department of Business Regulations; any instances of destruction of marijuana; and testing compliance tracking. The Medical Marijuana Program Tracking System may also be used to record and/or report any other additional information directed by the Department of Business Regulation or the Department of Health consistent with the Department of Business Regulation regulations and/or Department of Health regulations. 3 1.18 “Medical use” means the acquisition, possession, cultivation, manufacture, use, delivery, transfer, or transportation of marijuana or paraphernalia relating to the consumption of marijuana to alleviate a patient cardholder's debilitating medical condition or symptoms associated with the medical condition. 1.19 “Paraphernalia” , as used in these Regulations, means any equipment, product, or material of any kind that is primarily intended or designed for use in planting, propagating, growing, cultivating, harvesting, manufacturing, compounding, converting, producing, processing, preparing, inhaling, or otherwise introducing into the human body marijuana, including but not limited to: metal, wooden, acrylic, glass, stone, plastic, or ceramic pipes with or without screens, permanent screens, or punctured metal bowls; water pipes, roach clips: meaning objects used to hold burning material, such as a marijuana cigarette, that has become too small or too short to be held in the hand; bongs; ice pipes or chillers. 1.20 “Parent or legal guardian” means the custodial parent for a person under eighteen (18) years of age or the legal guardian with responsibility for health care decisions for a person of any age. 1.21 “Practitioner” means a person who is licensed to practice medicine with authority to prescribe drugs pursuant to RIGL Chapter 5-37 or a physician licensed with authority to prescribe drugs in Massachusetts or Connecticut. 1.22 “Primary caregiver” means a natural person who is at least twenty-one (21) years old and is a resident of Rhode Island. A primary caregiver may assist no more than five (5) qualifying patients with their medical use of marijuana. 1.23 “Qualifying patient” means a person who has been diagnosed by a practitioner as having a debilitating medical condition and is a resident of Rhode Island. 1.24 “Registry identification card” means a document issued by the Department of Health that identifies a person as a registered qualifying patient, a registered primary caregiver, or an authorized purchaser. 1.25 “RIGL” means the General Laws of Rhode Island, as amended. 1.26 "Seedling" means a marijuana plant with no observable flowers or buds. 1.27 “These Regulations” mean all parts of Rhode Island Rules and Regulations Related to the Medical Marijuana Program Administered By The Department of Health [R21-28.6- MMP]. 1.28 "Unusable marijuana" means marijuana seeds, stalks, seedlings, and unusable roots. 1.29 “Usable marijuana” means the dried leaves and flowers of the marijuana plant, and any mixture or preparation thereof, but does not include the seeds, stalks, and roots of the plant. 1.30 “Wet marijuana” means the harvested leaves and flowers of the marijuana plant before they have reached a dry usable state. Marijuana that has been dried to a usable state shall be assumed to have yielded twenty percent (20%) of the weight of the wet marijuana as defined in Appendix A of these Regulations. 4 1.31 “Written certification” means the qualifying patient’s medical records, and a statement signed by a practitioner, stating that in the practitioner’s professional opinion the potential benefits of the medical use of marijuana would likely outweigh the health risks for the qualifying patient. A written certification shall be made only in the course of a bona fide practitioner-patient relationship after the practitioner has completed a full assessment of the qualifying patient's medical history. The written certification shall specify the qualifying patient's debilitating medical condition or conditions. Section 2.0 General Requirements 2.1 Administration of the Program. The Division of Customer Services within the Department of Health shall be responsible for the administrative functions required to implement the provisions of the Act and these Regulations related to qualified patients, primary caregivers and authorized purchasers, as they apply to the implementation of the medical marijuana program in Rhode Island. Written Certifications 2.2 Practitioners shall provide written certifications for their patients on such forms as shall be provided by the Department of Health. 2.3 The written certification shall specify the qualifying patient's debilitating medical condition or conditions and include a copy of the relevant patient medical records as specified in § 1.31 of these Regulations, documenting the debilitating medical condition or conditions. 2.4 A written certification shall be made only in the course of a bona fide practitioner-patient relationship after the practitioner has completed a full assessment of the qualifying patient's medical history. 2.5 Practitioners Responsibility (a) The certifying practitioner shall obtain three (3) hours or equivalent of Category 1 CME regarding medical marijuana every two (2) years as part of usual CME/CE requirement. (b) The certifying practitioner shall document in the medical record the basis for issuance of a written certification regarding use of medical marijuana, specifically identifying the debilitating condition(s) being met. (c) Patient Education: The certifying practitioner shall document in the medical record and provide in written or verbal format, that patient was educated regarding maximum daily dose of active ingredient, minimum interval between doses, possible drug interactions – including risk of co-ingesting alcohol. (d) The certifying practitioner must document after examination, the patient’s response to conventional medical therapies and explain the risks and benefits of the use of marijuana to the qualifying patient. (e) The certifying practitioner must be committed to the continual assessment of the patient and the patient’s response to the use of marijuana. This must be demonstrated through follow-up appointments, semi-annually at minimum, before the card is renewed. The practitioner will send updates to the primary care provider (if not the PCP), at intervals 5 not to exceed twelve (12) months, documenting patients progress or experience using medical marijuana. (f) The certifying practitioner must have a current license to practice medicine, as specified in § 1.21 of these regulations, and current DEA registration and appropriate state controlled substance registration. (g) Before issuing a written certification, a certifying physician must review the Rhode Island Prescription Drug Monitoring Program, review the patients’ prescription history and make a judgement about the potential for drug interaction, adverse events or untoward clinical outcome from adding medical marijuana. (h) Document in the medical record a full assessment as defined in § 1.13 of these Regulations Addition of Debilitating Medical Conditions 2.6 The Department of Health shall accept a written petition from any person requesting that a particular disease or condition be included among the diseases and conditions that qualify as “debilitating medical conditions” contained in § 1.6 of these Regulations. 2.7 The petitioner shall provide to the Department of Health, as available: (a) An explanation stating the reason(s) why the condition should be included; (b) Any scientific peer reviewed literature supporting the addition of the condition to the list; (c) Letter(s) of support from physicians or other licensed health care professional knowledgeable about the condition and its treatment; 2.8 In considering such petitions, the Department shall include public notice of, and an opportunity to comment in a public hearing, upon such petitions. 2.8.1 The Department shall, after hearing, approve or deny such petitions within one hundred eighty (180) days of submission. 2.8.2 The approval or denial of such a petition shall be considered a final Department of Health action, subject to judicial review. Jurisdiction and venue for judicial review are vested in the Superior Court. 2.8.3 The denial of a petition shall not disqualify qualifying patients with that condition, if they have a debilitating medical condition as defined in subdivision 21-28.6-3(3) of the Act and § 1.6 of these Regulations. 2.9 Primary Caregiver Cardholder, Authorized Purchaser Cardholder and Patient Cardholder Possession Limits3 The following possession limits are established for each primary caregiver cardholder, authorized purchaser card holder and patient cardholder: 3 The wet marijuana limits included in § 2.9 were developed jointly by the Department of Health and the Department of Business Regulation. 6 2.9.1 Pursuant to § 21-28.6-4(e) of the Act, a primary caregiver cardholder may possess an amount of marijuana which does not exceed twelve (12) mature marijuana plants, that are accompanied by valid medical marijuana tags purchased from the Department of Business Regulation, and two and one-half (2.5) ounces of dried usable marijuana or its equivalent amount and twelve and one-half (12.5) ounces of wet marijuana for each patient cardholder to whom he or she is connected through the Department of Health’s registration process established pursuant to these Regulations. 2.9.2 Notwithstanding the provisions of § 2.9.1 of these Regulations, and pursuant to § 21-28.6-4(o) of the Act, no primary caregiver cardholder shall possess an amount of marijuana in excess of: (a) Twenty-four (24) mature marijuana plants, that are accompanied by valid medical marijuana tags purchased from the Department of Business Regulation, (b) Five (5) ounces of dried usable marijuana or its equivalent amount and twenty- five (25) ounces of wet marijuana for patient cardholders to whom the primary caregiver is connected through the Department of Health’s registration process established pursuant to these Regulations. 2.9.3 Pursuant to § 21-28.6-4(b) of the Act, an authorized purchaser cardholder may possess an amount of marijuana that does not exceed two and one-half (2.5) ounces of dried usable marijuana or its equivalent amount purchased legally from a compassion center for their designated patient. 2.9.4 Pursuant to § 21-28.6-4(a) of the Act, a patient cardholder may possess an amount of marijuana that does not exceed twelve (12) mature marijuana plants, that are accompanied by valid medical marijuana tags purchased from the Department of Business Regulation and two and one-half (2.5) ounces of dried usable marijuana or its equivalent amount, and twelve and one half (12.5) ounces of wet marijuana. Said plants shall be stored in an indoor facility. 2.9.5 Pursuant to § 21-28.6-4(f) of the Act, a patient cardholder shall be allowed to possess a reasonable amount of unusable marijuana, including up to twelve (12) seedlings that are accompanied by valid medical marijuana tags purchased from the Department of Business Regulation. 2.9.6 Pursuant to § 21-28.6-4(f) of the Act, a primary caregiver cardholder shall be allowed to possess a reasonable amount of unusable marijuana, including up to twenty-four (24) seedlings that are accompanied by valid medical marijuana tags purchased from the Department of Business Regulation. 2.9.7 Pursuant to § 21-28.6-4(q) of the Act, no more than twenty-four (24) mature marijuana plants that are accompanied by valid medical marijuana tags shall be grown or otherwise located at any one dwelling unit or commercial unit. The number of qualifying patients or primary caregivers residing, owning, renting, growing or otherwise operating at a dwelling or commercial unit does not affect this limit. 7 2.10 Primary Caregiver and Authorized Purchaser Eligibility (a) The primary caregiver and authorized purchaser applicant must apply to the Bureau of Criminal Identification of the Department of Attorney General, State Police, or local police department for a national criminal records check that shall include fingerprints submitted to the Federal Bureau of Investigation. Upon the discovery of any disqualifying information as defined in § 21-28.6-6(e)(1) of the Act, and in accordance with the rules promulgated by the Director, the Bureau of Criminal Identification of the Department of Attorney General, State Police, or the local police department shall inform the applicant, in writing, of the nature of the disqualifying information; and, without disclosing the nature of the disqualifying information, shall notify the Department of Health, in writing, that disqualifying information has been discovered. (b) In those situations in which no disqualifying information has been found, the Bureau of Criminal Identification of the Department of Attorney General, State Police, or the local police shall inform the applicant and the Department of Health, in writing, of this fact. (c) (1) The Department of Health shall maintain on file evidence that a criminal records check has been initiated on all applicants seeking a primary caregiver registry identification card and the results of the checks. (2) The primary caregiver cardholder shall not be required to apply for a national criminal records check for each patient he or she is connected to through the Department of Health’s registration process, provided that he or she has applied for a national criminal records check within the previous two (2) years in accordance with the Act and these Regulations. (3) The Department of Health shall not require a primary caregiver cardholder or an authorized purchaser to apply for a national criminal records check more than once every two (2) years. (4) The primary caregiver cardholder must notify the Department of Health of any disqualifying information that occurs during the two year time period between the national criminal records check required in § 2.10(a) of this section. The disqualifying information must be reported to the Department of Health within ten (10) days of any conviction defined in § 2.10(d)(1) and § 2.10(f) of these Regulations. (d) (1) Information produced by a national criminal records check pertaining to a conviction for any felony offense under RIGL Chapter 21-28 ("Rhode Island Controlled Substances Act"), murder, manslaughter, rape, first degree sexual assault, second degree sexual assault, first degree child molestation, second degree child molestation, kidnapping, first degree arson, second degree arson, mayhem, robbery, burglary, breaking and entering, assault with a dangerous weapon, assault or battery involving grave bodily injury, and/or assault with intent to commit any offense punishable as a felony or a similar offense from any other jurisdiction shall result in a letter to the applicant and the Department of Health disqualifying the applicant. 8 (2) If disqualifying information has been found, the Department of Health may use its discretion to issue a primary caregiver registry identification card or an authorized purchaser registry identification card if the applicant's connected patient is an immediate family member and the card is restricted to that patient only. (e) The primary caregiver or authorized purchaser applicant shall be responsible for any expense associated with the national criminal records check. (f) For purposes of § 2.10 of these Regulations "conviction" means, in addition to judgments of conviction entered by a court subsequent to a finding of guilty or a plea of guilty, those instances where the defendant has entered a plea of nolo contendere and has received a sentence of probation and those instances where a defendant has entered into a deferred sentence agreement with the Attorney General. Section 3.0 Application for Department of Health Registry Identification Cards and Fees 3.1 Registry Identification Cards for Qualifying Patients, Primary Caregivers and Authorized Purchasers. The Department of Health shall issue registry photo identification cards to qualifying patients, primary caregivers and authorized purchasers who submit the following: 3.1.1 Written certification as defined in § 1.31 of these Regulations; 3.1.2 Non-returnable, non-refundable application or renewal fee as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health for each qualifying patient, primary caregiver, or authorized purchaser of the qualifying patient identified on the application; (a) Provided, however, for a qualifying patient or primary caregiver who submits satisfactory evidence to the Department of Health of being a recipient of Medicaid, Supplemental Security Income (SSI), Social Security Disability Insurance (SSDI), Veteran Disability, or Railroad Disability, a non-returnable, non-refundable application or renewal fee as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health shall be submitted. 3.1.3 Name, address, and date of birth of the qualifying patient. If the qualifying patient is homeless, no address is required. 3.1.4 Name, address, and telephone number of the qualifying patient’s practitioner; and 3.1.5 Name, address, and date of birth of one primary caregiver and one authorized purchaser, for the qualifying patient, if any. 3.1.6 Whether the qualifying patient elects to grow medical marijuana plants for himself or herself. 3.1.7 Each applicant for qualifying patient registry identification card shall also indicate if he or she would like the Department of Health to notify him or her of any clinical studies about marijuana's risk or efficacy. 9 3.1.8 Individuals licensed by the Department of Business Regulation shall obtain registry photo identification cards from the Department of Health. 3.2 Registry Identification Cards for Minors. The Department of Health shall not issue a registry identification card to a qualifying patient under the age of eighteen (18) unless: 3.2.1 The qualifying patient's practitioner has explained the potential risks and benefits of the medical use of marijuana to the qualifying patient and to a parent, guardian or person having legal custody of the qualifying patient; and 3.2.2 A parent, guardian or person having legal custody consents in writing to: (a) Allow the qualifying patient's medical use of marijuana; (b) Serve as the qualifying patient's primary caregiver or authorized purchaser; and (c) Control the acquisition of the marijuana, the dosage, and the frequency of the medical use of marijuana by the qualifying patient. Section 4.0 Issuance and Renewal of Department of Health Registry Identification Cards 4.1 The Department of Health shall verify the information contained in an application or renewal as a qualified patient, a primary caregiver or an authorized purchaser submitted pursuant to the Act, and shall approve or deny an application or renewal within thirty-five (35) days of receiving it. 4.2 The Department of Health shall issue registry identification cards within five (5) days of approving an application or renewal that shall expire one (1) year after the date of issuance. 4.2.1 If the Department of Health fails to issue a valid registry identification card in response to a valid application submitted pursuant to the Act or these Regulations within thirty-five (35) days of its submission, the registry identification card shall be deemed granted and a copy of the registry identification application shall be deemed a valid registry identification card. Patients who are currently receiving chemotherapy or have been admitted to hospice will be expedited and their applications will be approved within seventy-two (72) hours. 4.2.2 The Department of Health shall issue a registry identification card to one primary caregiver and one authorized purchaser, if any, who is named in a qualifying patient's approved application. 4.3 The Department of Health may deny an application or renewal only if the applicant did not provide the information required pursuant to the Act, or if the Department of Health determines that the information provided was falsified. 4.4 Rejection of an application or renewal is considered a final Department of Health action, subject to judicial review. Jurisdiction and venue for judicial review are vested in the Superior Court. 4.5 A registry identification card shall not be transferable. 10 4.6 Registry identification cards shall contain: (a) The date of issuance and expiration date of the registry identification card; (b) The name of the qualifying patient, primary caregiver or authorized purchaser; (c) A random registry identification number; (d) A photograph; and (e) Any additional information as required by these Regulations or the Department of Health. Requirements Related to Department of Health Registry Identification Cards 4.7 Persons issued registry identification cards shall be subject to the following: 4.7.1 A patient cardholder must notify the Department of Health of any change in the patient cardholder's name, address, primary caregiver, or authorized purchaser; or if he or she ceases to have his or her debilitating medical condition, within ten (10) days of such change. 4.7.2 If a patient cardholder has ceased to suffer from a debilitating medical condition, the card shall be deemed null and void and the person shall be liable for any other penalties that may apply to the person's non-medical use of marijuana. 4.7.3 A registered primary caregiver cardholder or authorized purchaser cardholder shall notify the Department of Health of any change in his or her name or address within ten (10) days of such change. 4.7.4 When a patient cardholder, primary caregiver cardholder or authorized purchaser cardholder notifies the Department of Health of any changes listed in § 4.7 of these Regulations, the Department of Health shall issue the patient cardholder, primary caregiver cardholder or authorized purchaser cardholder a new registry identification card within ten (10) days of receiving the updated information and a non-returnable, non-refundable fee as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health for each new registration card to be issued. 4.7.5 When a patient cardholder changes his or her primary caregiver or authorized purchaser, the Department of Health shall notify the primary caregiver cardholder or authorized purchaser cardholder within ten (10) days. The primary caregiver cardholder’s protections as provided in the Act as to that patient shall expire ten (10) days after notification by the Department of Health. If the primary caregiver cardholder is connected to no other patient cardholders in the program, he or she must return his or her registry identification card to the Department of Health. 4.7.6 If a patient cardholder, caregiver cardholder or authorized purchaser card holder loses his or her registry identification card, he or she shall notify the Department of Health and submit a non-returnable, non-refundable fee as set forth in the Rules and Regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health within ten (10) days 11 of losing the card. Within five (5) days of receiving this notification, the Department of Health shall issue a new registry identification card with new random identification number. Patient Cardholder and Primary Caregiver Cardholder Marijuana Grow Location 4.8 The premise where the patient cardholder or primary caregiver cardholder elects to grow marijuana must register with the Department of Health. The patient cardholder or primary caregiver cardholder must notify the Department of Health of any changes to this registered grow location information. 4.9 Registered patient cardholders and primary caregiver cardholders who elect to grow marijuana are subject to regulations promulgated by the Department of Business Regulation.4 4.10 Effective January 1, 2019, if a patient cardholder chooses to alter his or her registration with regard to the growing of medical marijuana for himself or herself, he or she must notify the Department of Health prior to the purchase of medical marijuana tags from the Department of Business Regulation or the growing of medical marijuana plants. Section 5.0 Compassion Center Inspection 5.1 Compassion centers are subject to reasonable inspection by the Department of Health5. During an inspection, the Department of Health may review the compassion center's confidential records, including its dispensing records, which shall track transactions according to qualifying patients' registry identification numbers to protect their confidentiality. 5.2 Compassion centers are subject to testing requirements for usable marijuana promulgated in regulation by the Department of Health. Section 6.0 Protections for the Medical Use of Marijuana 6.1 A practitioner shall not be subject to arrest, prosecution, or penalty in any manner, or denied any right or privilege, including, but not limited to, civil penalty or disciplinary action by the Rhode Island Board of Medical Licensure and Discipline or by any other business or occupational or professional licensing board or bureau solely for providing written certifications or for otherwise stating that, in the practitioner's professional opinion, the potential benefits of the medical marijuana would likely outweigh the health risks for a patient. 4 DBR and DOH have jointly determined that DBR will primarily administer all aspects of the medical marijuana plant tag program to fulfill the state obligation to monitor and verify compliance with the statutory requirements that patients and cardholders electing to grow and primary caregiver cardholders do not exceed plant limits, properly tag all permitted plants, and do not grow at more than one location. See R.I. Gen. Laws § 21-28.6-15 and § 21-28.6-4. 5 Pursuant to § 21-28.6-12(e) of the Act, a compassion center may also be subject to inspection by the Department of Business Regulation. 12 6.2 A practitioner, nurse, nurse practitioner, physician’s assistant, or pharmacist shall not be subject to arrest, prosecution or penalty in any manner, or denied any right or privilege, including, but not limited to, civil penalty or disciplinary action by a business or occupational or professional licensing board or bureau solely for discussing the benefits or health risks of medical marijuana or its interaction with other substances with a patient. 6.3 A registry identification card, or its equivalent, issued under the laws of another state, U.S. territory, or the District of Columbia to permit the medical use of marijuana by a patient with a debilitating medical condition, or to permit a person to assist with the medical use of marijuana by a patient with a debilitating medical condition, shall have the same force and effect as a registry identification card issued by the Department of Health pursuant to the Act and these Regulations. 6.4 For the purposes of medical care, including organ transplants, a patient cardholder’s authorized use of marijuana shall be considered the equivalent of the authorized use of any other medication used at the direction of a physician, and shall not constitute the use of an illicit substance. 6.5 No state employee shall be subject to arrest, prosecution or penalty in any manner, or denied any right or privilege, including, but not limited to, civil penalty, disciplinary action, termination, or loss of employee or pension benefits, for any and all conduct that occurs within the scope of his or her employment regarding the administration, execution and/or enforcement of the Act, and the provisions of RIGL § 9-31-8 and § 9-31-9 shall be applicable to § 6.0 of these Regulations. 6.6 A patient cardholder or primary caregiver cardholder may give marijuana to another patient cardholder or primary caregiver cardholder to whom they are not connected by the Department of Health’s registration process, provided that no consideration is paid for the marijuana, and that the recipient does not exceed the limits specified in § 2.9 of these Regulations. 6.7 The manufacture of marijuana by a patient cardholder or primary caregiver cardholder using a solvent extraction process that includes the use of a compressed, flammable gas as a solvent shall not be subject to the protections specified by the Act and these Regulations. Section 7.0 Confidentiality Provisions 7.1 Applications and supporting information submitted by qualifying patients, including information regarding their primary caregivers, authorized purchasers, and practitioners, are confidential and protected under the federal Health Insurance Portability and Accountability Act (HIPAA) of 1996, as amended. 7.2 The Department of Health shall maintain a confidential list of the persons to whom the Department of Health has issued registry identification cards. 7.2.1 Individual names and other identifying information on the list: (a) Shall be confidential and not be considered a public record pursuant to RIGL § 38-2-2(4); and 13 (b) Shall not subject to disclosure, except to authorized employees of the Department of Health as necessary to perform official duties of the Department of Health, and pursuant to § 7.3 of these Regulations. 7.3 The Department of Health shall verify to law enforcement personnel whether a registry identification card is valid solely by confirming the random registry identification number or name. This verification may occur through the use of shared database, provided that any confidential information in this database is protected in accordance with § 7.0 of these Regulations. 7.4 All records maintained by a compassion center which pertain to one or more registered qualifying patients, registered primary caregivers or authorized purchasers shall be considered: 7.4.1 Confidential health care information under applicable Rhode Island law; and 7.4.2 Protected health care information for purposes of the Federal Health Insurance Portability and Accountability Act of 1996, as amended. 7.5 Pursuant to § 21-28.6-6(k) of the Act, the Department of Health may notify law enforcement personnel about falsified or fraudulent information submitted to the Department of Health. Section 8.0 Scope of the Act 8.1 The Act and these Regulations shall not permit: 8.1.1 Any person to undertake any task under the influence of marijuana, when doing so would constitute negligence or professional malpractice; 8.1.2 The smoking of marijuana: (a) In a school bus or other form of public transportation; (b) On any school grounds; (c) In any correctional facility; (d) In any public place; (e) In any licensed drug treatment facility in this state; or (f) Where exposure to the marijuana smoke significantly adversely affects the health, safety, or welfare of children. 8.1.3 Any person to operate, navigate, or be in actual physical control of any motor vehicle, aircraft, or motorboat while under the influence of marijuana. However, a registered qualifying patient shall not be considered to be under the influence solely for having marijuana metabolites in his or her system. 8.2 Nothing in the Act or these Regulations shall be construed to require: 8.2.1 A government medical assistance program or private health insurer to reimburse a person for costs associated with the medical use of marijuana; or 14 8.2.2 An employer to accommodate the medical use of marijuana in any workplace. Section 9.0 Penalties for Violations 9.1 Fraudulent representation to a law enforcement official of any fact or circumstance relating to the medical use of marijuana to avoid arrest or prosecution shall be punishable by a fine of five hundred dollars ($500) which shall be in addition to any other penalties that may apply for making a false statement for the non-medical use of marijuana. 9.2 If a patient cardholder, primary caregiver cardholder or authorized purchaser cardholder willfully violates any provision of the Act or these Regulations, as determined by the Department of Health, his or her registry identification card may be revoked. 9.3 A patient cardholder who fails to notify the Department of Health of any changes required pursuant to § 4.7 of these Regulations shall be responsible for a civil infraction, punishable by a fine of no more than one hundred fifty dollars ($150) 9.4 A primary caregiver cardholder or authorized purchaser cardholder, who fails to notify the Department of Health of any changes required pursuant to § 4.7 of these Regulations shall be responsible for a civil infraction, punishable by a fine of no more than one hundred fifty dollars ($150). 9.5 The registry identification card shall be revoked and shall not be reissued for any cardholder who is convicted of; placed on probation; whose case is filed pursuant to RIGL § 12-10-12 where the defendant pleads nolo contendere; or whose case is deferred pursuant to RIGL § 12-19-19 where the defendant pleads nolo contendere for any felony offense under RIGL Chapter 21-28 ("Rhode Island Controlled Substances Act") or a similar offense from any other jurisdiction. 9.6 A cardholder shall be subject to arrest and prosecution under RIGL Chapter 21-28 if he or she exceeds the possession limits set forth in § 2.9 of these Regulations. Section 10.0 Purchase and Issuance of Medical Marijuana Plant Tags 10.1 Pursuant to § 21-28.6-15(a) of the Act, effective April 1, 2017, every marijuana plant, possessed by a qualified patient or primary caregiver cardholder must be accompanied by a physical medical marijuana plant tag purchased through the Department of Business Regulation and issued by the Department of Health. Plant tags being issued by the Department of Health shall mean the following: (a) The Department of Health has approved the application of the qualified patient or primary caregiver and issued a registry photo identification card to the applicant; or for qualified patients and primary caregivers who are renewing their medical marijuana registration, the Department of Health has approved the renewal application of the qualified patient or primary caregiver and issued a registry photo identification card to the applicant. (b) The Department of Business Regulation verifies with the Department of Health the status of the card and any information submitted on the Department of Business 15 Regulation plant tag purchasing form in accordance with § 21-28.6-15(a)(2) of the Act. For plant tags issued to qualified patient cardholders after January 1, 2019 the Department of Business Regulation will verify both the status of the card and the election to grow with the Department of Health in accordance with § 21-28.6-15(a)(3). (c) The plant tag set fee is paid to the Department of Business Regulation and the plant tag is distributed by the Department of Business Regulation to the qualified patient or primary caregiver cardholder. Section 11.0 Practices and Procedures 11.1 All hearings and reviews required under the provisions of the Act or these Regulations shall be held in accordance with the provisions of the Rules and Regulations Pertaining to Practices and Procedures before the Rhode Island Department of Health [R42-35-PP]. Section 12.0 Severability 12.1 If any provision of the Act or these Regulations or its application thereof to any person or circumstance is held invalid, such invalidity shall not affect other provisions or applications of the Act or these Regulations, which can be given effect without the invalid provision or application, and to this end the provisions of the Act and these Regulations are declared to be severable. MMP_Final_13December2016 Tuesday, December 13, 2016 16 APPENDIX A The processing of finished plant material used to derive cannabis resin or concentrates alters the physical form and quantity (i.e., weight and volume) of the usable marijuana. To enable the comparison of usable marijuana in the various product types the Department of Health reviewed the Colorado Department of Revenue (2015) scientific study commissioned under HB14-1361, and developed assumptions based on the 2015 Colorado study titled “Marijuana Equivalency and Dosage”. The Department of Health will use this document to express the quantity of usable marijuana in cannabis resins or concentrates in terms of the equivalent ounces of plant material. Equivalency Amount6 Conversion Factors between Marijuana Flower Weight and Non-Flower Product Units Marijuana Flower Weight Equivalent number of 10 mg Edible Units 1 Oz of Flower 83 0.25 Oz of Flower 21 1 Gram of Flower 3 Marijuana Flower Weight Equivalent grams of Concentrate 1 Oz of Flower 7.7 0.25 Oz of Flower 1.9 1 Gram of Flower 0.3 Conversion Amounts7 Conversion of Wet Flower Amounts to Dry Flower Amounts Wet Flower Weight Dry Flower Weight (20% of Wet Flower Weight) 12.5 Oz of Wet Flower 2.5 Oz of Dry Flower 25 Oz of Wet Flower 5.0 Oz of Dry Flower 37.5 Oz of Wet Flower 7.5 Oz of Dry Flower 50 Oz of Wet Flower 10.0 Oz of Dry Flower 6 The wet marijuana limits were developed jointly by the Department of Health and the Department of Business Regulation. 7 Wet flower weight to dry flower weight conversion amounts were developed jointly by the Department of Health and the Department of Business Regulation.