A. The following definitions are for terms used in this Part, including but not limited to many of the relevant definitions from R.I. Gen. Laws §§ 21-28.6-3 and 21-28-1.02.
- 1. “Act” means R.I. Gen. Laws Chapter 21-28.6 entitled, “The Edward O. Hawkins and Thomas C. Slater Medical Marijuana Act,” as amended.
- 2. "Advertising" means the act or practice of calling public attention to one’s product or service.
- 3. “Agent” means an agent of a marijuana establishment licensee including but not limited to “testing agents.”
- 4. "Authorized purchaser" means a natural person who is at least twenty-one (21) years old and who is registered with DOH for the purposes 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. An authorized purchaser shall be registered with DOH and shall possesses a valid registry identification card.
- 5. "Cannabis" means all parts of the plant of the genus marijuana, also known as marijuana sativa L., whether growing or not; the seeds thereof; 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 regardless of cannabinoid content or cannabinoid potency including "marijuana," and "industrial hemp" or "industrial hemp products" which satisfy the requirements of R.I. Gen. Laws Chapter 2-26.
- 6. "Cannabis testing laboratory" means a third-party analytical testing laboratory licensed by DOH, in coordination with the DBR regulations, to collect and test samples of cannabis.
7. “Cardholder" means a person who has been registered or licensed with DOH or DBR pursuant to the Act and possesses a valid registry identification card or license. As used in this regulation, “cardholder” includes:
- a. A registered primary caregiver, or
- b. A person registered with DBR as a principal officer, board member, employee, volunteer, or agent of a compassion center, licensed medical marijuana cultivator, cannabis testing lab or any other DBR medical marijuana licensee.
- 8. “CBD” means cannabidiol, which is a cannabinoid found in the cannabis plant.
- 9. “Child-Resistant” shall mean packaging in accordance with the Poison Prevention Packaging Act of 1970, 16 C.F.R. Part 1700, incorporated below at § 1.1.7(A) of this Part.
- 10. "Commercial unit" means a building or other space within a commercial or industrial building, for use by one business or person and that is rented or owned by that business or person.
- 11. "Compassion center" means a not-for-profit corporation, subject to the provisions of R.I. Gen. Laws Chapter 7-6, and is licensed under R.I. Gen. Laws § 21-28.6-12, that acquires, possesses, cultivates, manufactures, delivers, transfers, transports, supplies, or dispenses medical marijuana, and or related supplies and education materials, to patient cardholders and/or their registered caregiver, cardholder or authorized purchaser.
- 12. "Compassion center cardholder" means a principal officer, board member, employee, volunteer, or agent of a compassion center who has registered with DBR and has been issued and possesses a valid registry identification card.
- 13. “DBR,” “Department” or “Office” shall refer to the Office of Cannabis Regulation within the Rhode Island Department of Business Regulation or its successor agency.
- 14. “DBR regulations” means these Regulations, the Rules and Regulations Related to the Medical Marijuana Program Administered by the Office of Cannabis Regulation at the Department of Business Regulation.
15. "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 DOH, as provided for in R.I. Gen. Laws § 21-28.6-5.
- 16. “DEM” means the Rhode Island Department of Environmental Management or its successor agency.
- 17. “Department of Public Safety” or “RISP” means the Rhode Island Department of Public Safety, Division of State Police, or its successor agency.
- 18. “DOH” means the Rhode Island Department of Health or its successor agency.
- 19. “DOH regulations” means the Rules and Regulations related to the Medical Marijuana Program Administered by the Department of Health, 216-RICR-20-10-3, as the same may be amended from time to time, and the DOH Testing Regulations.
- 20. “DOH testing regulations” means the testing requirements, standards, and procedures for conduct of testing through “approved third party testing providers” to be promulgated by DOH, including but not limited to 216-RICR-60-05-6.
- 21. "Dwelling unit" means the room, or group of rooms, within a residential dwelling used or intended for use by one family or household, or by no more than (3) unrelated individuals, with facilities for living, sleeping, sanitation, cooking, and eating.
- 22. "Handbill" means a flyer, leaflet or sheet that advertises marijuana.
23. “Interest holders” or "Key persons" means with respect to an applicant or licensed entity, the following persons or entities:
- a. All persons and/or entities with any ownership interest with respect to the applicant/licensee, including parent companies if the applicant licensee is a subsidiary of another entity, and
- b. All officers, directors, members, managers or agents of the applicant/licensee, and any other entities described in § 1.1(A)(23)(a) of this Part, and
- c. All persons or entities with managing or operational control with respect to the applicant/licensee, its operation, any other entities described in §§ 1.1(A)(23)(a) and (b) of this Part, the license and/or licensed facilities whether they have an ownership interest or not, and
- d. All investors or other persons or entities with any financial interest with respect to the applicant/licensee, any other entities described in §§ 1.1(A)(23)(a), (b) and (c) of this Part, its operations, the license, and/or licensed facilities, whether they have ownership interest or not, and
- e. All persons or entities that hold interest(s) arising under shared management companies, management agreements, or other agreements that afford third-party management or operational control with respect to the applicant/licensee, its operations, the license and/or the licensed facilities, and
- f. To the extent that any Interest Holder is an entity (corporation, partnership, LLC, etc.), all Interest Holders in that entity and all Interest Holders therein down to the individual person level.
- 24. “Licensed cooperative cultivation” means a cooperative cultivation that is required to obtain a license from DBR pursuant to R.I. Gen. Laws § 21-28.6-14.
- 25. "Licensed medical marijuana cultivator" means a person or entity, as identified in R.I. Gen. Laws § 43-3-6, who has been licensed by DBR to cultivate medical marijuana pursuant to R.I. Gen. Laws § 21-28.6-16.
26. "Marijuana" means 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. Marijuana shall not include hemp as defined in R.I. Gen. Laws § 2-26-3. Marijuana sub-categories include but are not limited to:
- a. “Mature marijuana plant” means a marijuana plant that has flowers or buds that are readily observable by an unaided visual examination.
- b. “Immature marijuana plant” means a marijuana plant, rooted or unrooted with no observable flowers or buds.
- c. “Plant” means collectively or independently “mature marijuana plants” and/or “immature marijuana plants” as the context requires.
- d. “Unusable marijuana” means marijuana seeds, stalks, unusable roots and shall not count towards any weight-based possession limits established in the Act.
- e. “Usable marijuana” means the leaves and flowers of the marijuana plant, and any mixture or preparation thereof, but does not include the sterilized seeds, stalks, and roots of the plant.
f. “Dried marijuana” means the leaves and flowers of the marijuana plant after the wet harvested leaves and flowers of the marijuana plant have undergone the drying process and may be capable of combustion.
- (1) A batch of dried marijuana means marijuana that is cultivated utilizing the same growing practices, harvested within a 72-hour period at the same location and cured under uniform conditions.
- (2) A batch of dried marijuana shall not exceed 10 pounds for the purpose of sampling for required testing and shall not consist of more than one strain, cultivars, or genetic composition.
- g. “Wet marijuana” means the harvested leaves and flowers of the marijuana plant before they have reached a dry state. Pursuant to § 1.14 of this Part, marijuana that has been dried and shall be assumed to have yielded twenty percent (20%) of the weight of the wet marijuana.
h. “Marijuana infused products” means product infused with medical marijuana or an extract of medical marijuana that is intended for use or consumption other than by smoking or vaping, including but not limited to ingestible and edible products.
- (1) “Medical edibles” or “Edible” means any product consumed orally that is not otherwise considered an ingestible and is approved for sale by DBR.
- (2) “Medical ingestible” or “Ingestible” means any topical, transdermal patch, tincture, capsule or other non-edible product approved for sale by DBR.
- i. “Concentrate,” synonymous with “extract,” is any type of medical marijuana product that is refined from usable marijuana into a more homogenized form of usable marijuana including but not limited to hash, supercritical CO2 oil, hash oil, shatter, budder, wax, infused butter, and rosin.
- 27. "Medical marijuana" means marijuana and marijuana products which satisfy the requirements of R.I. Gen. Laws Chapter 21-28.6 and have been given the designation of "medical marijuana" by DBR due to dose, potency, form or other characteristic. Medical marijuana products are only available for use by patient cardholders and may only be sold to or possessed by patient cardholders, or their registered caregiver, or authorized purchaser in accordance with the Act. Medical marijuana may not be sold to, possessed by, manufactured by, or used except as permitted under R.I. Gen. Laws Chapter 21-28.6 and any regulations promulgated thereunder.
- 28. "Medical marijuana emporium" means any establishment, facility or club, whether operated for-profit or nonprofit, or any commercial unit, at which the sale, distribution, transfer or use of medical marijuana or medical marijuana products is proposed and/or occurs to, by or among registered patients, registered caregivers, authorized purchaser cardholders or any other person. This shall not include a compassion center regulated and licensed by DBR pursuant to the terms of R.I. Gen. Laws Chapter 21-28.6.
- 29. “Marijuana establishment licensee” means any person or entity licensed by DBR or DOH under the Act whose license permits it to engage in or conduct activities in connection with the medical marijuana program. “Marijuana establishment licensees” shall include compassion centers, medical marijuana cultivators, and cannabis testing laboratories.
30. “Material financial interest or control” means:
- a. Any ownership interest, regardless of the size of the holding, and including any ownership interest through a subsidiary or affiliate;
- b. Trusteeship, mortgage, guarantor, endorser or surety relationship, or loan relationship, except that loan relationship for the purposes of this definition shall exclude accounts payable and accounts receivable on account of a medical marijuana purchase order;
- c. Any other beneficial financial interest as determined by DBR such that the holder bears the risk of loss (other than as an insurer) or has an opportunity to gain profit from the operation or sale of the regulated medical marijuana business; and/or
- d. Managerial or operational control, including but not limited to interlocking directors or officers or through a management agreement.
31. “Medical marijuana plant tag set” or “plant tag” or “plant tag certificate” means any tag, identifier or registration certificate or inventory tracking system authorized or issued by DBR or which DBR requires be used for the lawful possession and cultivation of medical marijuana plants in accordance with R.I. Gen. Laws Chapter 21-28.6.
- a. A “plant set” or “set” is defined as one (1) mature plant and one (1) immature plant.
- 32. “Medical marijuana program tracking system” means any system(s) designated by DBR and/or DOH designed and used to record and track all “seed to sale” activities and transactions which may include the use of unique identifiers. The Medical Marijuana Program Tracking System may also be used for registration, licensing, and tagging applications, renewals, change of information, and communications, as well as to record and/or report any other additional information directed by DBR and/or DOH.
- 33. "Medical use" means the acquisition, possession, cultivation, manufacture, use, delivery, transfer, or transportation of medical 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 in accordance with the provisions of R.I. Gen. Laws Chapter 21-28.6.
- 34. “Print media” means any publication made physically available.
- 35. “Process validation” means the collection and evaluation of data from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
- 36. "Qualifying patient" means a person who has been certified by a practitioner as having a debilitating medical condition and is a resident of Rhode Island.
- 37. “Quarantine” means the storage and/or identification of marijuana, marijuana product, medical marijuana or medical marijuana product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures as defined by DBR.
- 38. "Radio" means a system for transmitting sound without visual images, and includes broadcast, cable, on-demand, satellite or internet programming. Radio includes any audio programming downloaded or streamed via the internet such as podcasts.
39. “Related party transactions” means and includes, but is not limited to, transactions between and/or among:
- a. An entity/applicant/licensee and its principal owners, management, key persons/interest holders and/or parent, affiliates, or members of “any person within his or her family,” as defined in 520-RICR-00-00-1.3;
- b. Parties with which the entity/applicant/licensee may deal if one party controls or can materially influence the management or operating policies of the other to an extent that one of the transacting parties might be prevented from fully pursuing its own separate interests; or
- c. Other parties that can materially influence the management or operating policies of the transacting parties or that have an ownership interest in one of the transacting parties and can materially influence the other to an extent that one or more of the transacting parties might be prevented from fully pursuing its own separate interests.
- 40. “Registry identification card” means a document issued by DOH or DBR, as applicable, that identifies a person as a registered qualifying patient, a registered primary caregiver, or authorized purchaser, or a document issued by DBR or DOH that identifies a person as a registered principal officer, board member, employee, volunteer, or agent of a compassion center, licensed medical marijuana cultivator, cannabis testing lab or any other marijuana establishment licensee.
- 41. “Seed to sale” means all medical marijuana program regulated activities and transactions from point of origin to the point of 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; any other transfers of marijuana as permitted by the Act and any regulations promulgated thereunder; any instances of destruction of marijuana; and testing compliance tracking.
- 42. "Television" means a system for transmitting visual images and sound that are reproduced on screens, and includes broadcast, cable, on-demand, satellite, or internet programming. Television includes any video programming downloaded or streamed via the internet.
- 43. “Testing agent” means an employee of an approved cannabis testing laboratory or other entity who performs independent testing of medical marijuana and/or marijuana products in accordance with the DOH Testing Regulations.
- 44. "THCA” means tetrahydrocannabinolic acid, which is a cannabinoid found in the cannabis plant.
- 45. “THC” means delta-9-tetrahydrocannabinol, which is a psychoactive cannabinoid found in the cannabis plant.
- 46. “Total potential THC” means the potential amount of total THC found in a cannabis plant or product by using the equation Total Potential THC = (.877 x THCA%) + THC% or another equation or methodology approved by DBR and/or DOH.
- 47. “Volunteer” is a registration that only applies to compassion centers and shall be limited to compassion center persons whose volunteer activities and use of compassion center resources is strictly limited to participation in educational programming conducted for compassion center cardholders and registered qualifying patients, primary caregivers, and authorized purchasers. Volunteers shall not be permitted to be otherwise involved in the growth, cultivation, weighing, packaging or labeling, manufacturing, processing, dispensing or sale of medical marijuana.
B. All other terms used herein shall have the same meanings as set forth in the Act, including particularly the definitions under R.I. Gen. Laws § 21-28.6-3, and as may be further defined within the Act, any DBR regulations under this Chapter and the DOH Regulations.
1.1.2 Limitations on Scope of the Rhode Island Medical Marijuana Program
- A. These DBR Regulations apply to all activities requiring authorization, registration and/or licensure under the Act to ensure the safe and regulated use of medical marijuana. See R.I. Gen. Laws § 21-28.6-3(22) (defining “medical use”) and R.I. Gen. Laws § 21-28.6-2(5) (legislative findings making distinction between medical and non-medical use).
B. The protections and immunities for participation in the Rhode Island Medical Marijuana Program set forth in R.I. Gen. Laws §§ 21-28.6-4 (patient and caregivers), 21-28.6-12(h) (compassion centers), and 21-28.6-16(m) (cultivators) do not apply to any activities beyond the borders of the state of Rhode Island.
1.1.3 DBR’s Role in Administration of the Rhode Island Medical Marijuana Program
DBR is responsible for the administrative functions required to implement the provisions of the Act and the DBR Regulations related to compassion centers, licensed cultivators, cooperative cultivations, registered caregivers and patients who grow their own medical marijuana plants including but not limited to licensing, operational requirements, and enforcement to ensure the state’s interest in public health and public safety. See R.I. Gen. Laws §§ 21-28.6-2 and 42-14-2.
1.1.4 DBR General Rulemaking Authority
R.I. Gen. Laws § 42-14-17 provides that DBR may promulgate such rules and regulations as are necessary and proper to carry out the duties assigned to it by any provision of law.
1.1.5 Procedural Rules
All hearings and enforcement actions shall be conducted in accordance with DBR’s Rules of Procedure for Administrative Hearings, Part 10-00-2 of this Title, and the Rhode Island Administrative Procedures Act, R.I. Gen. Laws Chapter 42-35.
1.1.6 Acceptance of Electronic Records and Signatures
In accordance with the Uniform Electronic Transactions Act (UETA), R.I. Gen. Laws Chapter 42-127.1, DBR may determine whether, and the extent to which, it will accept electronic records, documents, notifications, and signatures from other persons or entities where the Act or DBR administered regulations refer to written records, documents, notifications, and signatures.
1.1.7 Incorporated Materials
- A. These regulations hereby adopt and incorporate 16 C.F.R. Part 1700 (2019) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
- B. These regulations hereby adopt and incorporate 21 C.F.R. Part 101 (2019) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
- C. These regulations hereby adopt and incorporate under 40 C.F.R. § 152.25(f) (2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
- D. These regulations hereby adopt and incorporate the EPA’s Active Ingredients Eligible for Minimum Risk Pesticide Products (December 2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
- E. These regulations hereby adopt and incorporate EPA’s Inert Ingredients Eligible for FIFRA 25(b) Pesticide Products (November 2016) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.
- A. These retail-ready medical marijuana product packaging and labeling requirements for compassion centers and licensed cultivators are promulgated pursuant to R.I. Gen. Laws §§ 21-28.6-12(f)(11) and 21-28.6-16(g).
- B. Compassion centers and licensed cultivators shall have ninety (90) calendar days from the effective date of these regulations to comply with these requirements.
C. The compassion center is responsible for ensuring all medical marijuana products are retail-ready prior to sale to a qualifying patient, registered primary caregiver or authorized purchaser.
1.5.2 General Packaging Requirements
- A. All retail-ready medical marijuana products must be in compliant packaging upon entering the compassion center retail sale space.
B. In addition to any other requirements pursuant to § 1.5 of this Part, any package containing retail-ready medical marijuana product must:
1. Be opaque, of a neutral color, and light resistant;
- a. Neutral colors include but are not limited to: black, white, gray, beige, brown, and tan. Neutral colors do not include primary and secondary colors (such as red, orange, yellow, green, blue, or purple) or any variant of primary or secondary colors.
- 2. Fully enclose the product;
- 3. Protect the product from contamination;
- 4. Not impart any toxic or deleterious substance to the medical marijuana product;
- 5. Be Child Resistant as defined in § 1.1 of this Part; and
- 6. Be able to be resealed in a Child Resistant manner unless the package contains a single-serving medical marijuana edible or ingestible pursuant to § 1.5.2(D) and (E) of this Part respectively.
C. Exit Package
- 1. Except for medical marijuana edibles and ingestibles, upon DBR approval, any other retail-ready medical marijuana product placed into a container that is not child-resistant shall be placed into a child-resistant Exit Package at the point of sale.
- 2. The Exit Package is not required to be labeled pursuant to § 1.5 of this Part if the package(s) within the Exit Package containing the retail-ready medical marijuana product comply with all labeling requirements pursuant to § 1.5 of this Part.
D. Additional Packaging Requirements for Retail-Ready Medical Marijuana Edibles
- 1. A single serving unit shall not exceed ten (10) milligrams (“mgs”) of active THC.
- 2. A single serving unit, if sold individually, shall be placed into a child-resistant container that may or may not be resealable.
- 3. Multiple single serving units may be placed together into a single child resistant and resealable package, so long as the active THC per package does not exceed one hundred (100) mgs.
4. Multiple packages may be bundled and sold together so long as the:
- a. Total amount of THC per serving unit does not exceed ten (10) mgs;
- b. Total amount of THC per package does not exceed one hundred (100) mgs; and
- c. Total amount of THC per bundled package does not exceed the maximum amount a patient can possess pursuant to the Act and the equivalency table in § 1.14 of this Part.
- 5. For Medical Marijuana Edibles in liquid form packaged as a single serving unit, the container may be sealed using a metal crown cork style bottle cap.
- 6. For Medical Marijuana Edibles in liquid form containing multiple serving units, the container must have a resealing cap or closure which maintains child resistance compliance.
- 7. Medical Marijuana Edibles in liquid form containing multiple serving units must include a measuring device such as a measuring cap, cup or dropper with the package containing the medical marijuana product. Hash marks on the package do not qualify as a measuring device.
E. Additional Packaging Requirements for Medical Marijuana Ingestibles
- 1. A single serving unit, if sold individually, of a Medical Marijuana Ingestible must be placed into a child-resistant container that may or may not be resealable.
- 2. Multiple single serving units may be placed together into a single child resistant and resealable package.
- 3. Multiple packages may be bundled and sold together so long as the total amount of THC per bundled package does not exceed the maximum amount a patient can possess pursuant to the Act and the equivalency table in § 1.14 of this Part.
- 4. For Medical Marijuana Ingestibles in liquid form packaged as a single serving unit, the container may be sealed using a metal crown cork style bottle cap.
- 5. For Medical Marijuana Ingestibles in liquid form with multiple serving units, the container must have a resealing cap or closure.
6. Medical Marijuana Ingestibles in liquid form with multiple serving units must include within the package:
- a. A measuring device such as a measuring cap, cup or dropper that is capable of dispensing a ten (10) mg serving unit;
- b. Hash marks on the package do not qualify as a measuring device.
F. Additional Packaging Requirements for Retail-Ready Medical Concentrates
- 1 Cartridges and any other devices, as determined by DBR, shall receive a consumer testing certificate which is subject to DBR review.
- 2. Electronic vaporization devices must have internal or external temperature controls to prevent combustion and have a heating element made of inert material.
3. The total THC per package shall not exceed 500 mgs.
1.5.3 General Labeling Requirements
- A. Each package containing retail-ready medical marijuana products must be labeled with all required information pursuant to § 1.5 of this Part before being sold to a registered patient, registered primary caregiver or authorized purchaser.
B. Labeling text must be:
- 1. No smaller than size 6 font, unless otherwise specified.
- 2. In Times New Roman, Calibri, Arial, Helvetica or any other font determined by DBR to be easily read.
- 3. In black or white, unless otherwise specified.
4. Clearly written or printed in the English language.
- a. In addition to the required English label, licensees may include an additional, accurate foreign language translation on the label that otherwise complies with these rules.
- C. All required information must be unobstructed and conspicuous. Multiple labels may be affixed to the package, provided that none of the information required is obstructed.
- D. Required information may be stated in a peel-back accordion, expandable, or extendable style so long as the label can be easily identified by a consumer as containing important information.
E. All packages containing retail-ready medical marijuana products must be clearly labeled with the following information:
- 1. The business(es) or tradename(s) and license number(s) of the licensee(s) who produced the product;
- 2. The business or tradename and license number of the compassion center selling the product;
- 3. The unique identifier generated by the Medical Marijuana Program Tracking System;
4. Total THC and Total CBD as provided by a licensed cannabis testing laboratory;
- a. Upon request, a compassion center must disclose the name of the licensed cannabis testing lab that conducted the tests and provide the results of all required tests for any medical marijuana or medical marijuana product.
5. A DBR-selected universal warning symbol must appear on the front or most predominantly displayed area of the package, no smaller than one (1) inch by one (1) inch;
- a. Vape cartridges sold containing medical marijuana product must include the DBR-approved symbol in a manner that is clear and conspicuous;
- 6. If applicable, the recommended expiration date, or “use by” date;
- 7. Poison Control Contact Information “American Association of Poison Control Center (800) 222-1222”; and
- 8. For smokable and vapable products, the net weight of the medical marijuana product prior to its placement in the package, using a standard of measure compatible with the tracking system.
F. Additional Labeling Requirements for Retail-Ready Medical Marijuana Infused Products:
- 1. Total contents of THC and CBD must be stated per serving unit in milligrams (mgs), and in font larger than size 6, bolded, underlined and in red, so as to stand from surrounding text to the consumer;
- 2. Total contents of THC and CBD must be stated per package, in milligrams (mgs), in font larger than size 6, bolded, underlined and in red, so as to stand out from surrounding text to the consumer;
- 3. The serving size; and
- 4. The number of servings per package.
G. The following information may be placed on an insert but must accompany each retail-ready medical marijuana product sold:
- 1. A complete list of all nonorganic pesticides, herbicides, and fertilizers that were used in the cultivation and production of the medical marijuana product;
- 2. For medical marijuana infused products, the net weight of the medical marijuana or medical marijuana product prior to its placement in a package, using a standard of measure compatible with the tracking system;
- 3. For medical marijuana products consisting in whole or in part of marijuana flower or marijuana trim, the date of the harvest batch;
- 4. For marijuana products including concentrates and marijuana infused products that were manufactured, the date on which the manufacturing batch was created;
- 5. For processed medical marijuana products, the processing technique or solvent(s) used to produce the product;
- 6. For processed medical marijuana products, a list of all chemicals, diluents, additives, ingredients and/or excipients used to produce the medical marijuana product or that were added to the medical marijuana product;
- 7. For medical marijuana infused products, a list of all ingredients used to manufacture the marijuana infused product, including identification of any major allergens contained in the product in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004, 21 U.S.C. § 343 (2010), specifically milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans;
- 8. For medical marijuana edibles and ingestibles, a nutritional fact panel in accordance with 21 C.F.R. Part 101, incorporated above at § 1.1.7(B) of this Part;
- 9. For medical marijuana topicals, a list of all ingredients in descending order of predominance by weight or volume as applicable; and
10. For medical marijuana topicals, the amount recommended for use at any one time.
1.5.4 Imprinting of the Universal Symbol
A. As directed by DBR, unless deemed impracticable by DBR, each single standardized serving unit of a medical marijuana infused product shall be marked, stamped or otherwise imprinted with a DBR-selected universal symbol directly on at least one side of the medical marijuana infused product in a manner to cause the universal symbol to be distinguishable and easily recognizable. The universal symbol marking shall:
- 1. Be centered either horizontally or vertically on each standardized serving of marijuana; and
- 2. If only imprinted on one-side, the imprinted side must be the front or most predominantly displayed area of medical marijuana infused product; and
- 3. If centered horizontally on a serving, the height and width of the universal symbol shall be of a size that is at least 25% of the serving’s width, but not less than ¼ inch by ¼ inch; or
- 4. If centered vertically on a serving, the height and width of the universal symbol shall be of a size that is at least twenty-five percent (25%) of the serving’s height, but not less than ¼ inch by ¼ inch.
B. Unless determined by DBR to be impractical, the following categories of marijuana infused product are considered to be per se practicable to mark with the universal symbol:
- 1. Chocolate;
- 2. Soft confections;
- 3. Hard confections or lozenges;
- 4. Consolidated baked goods (e.g. cookie, brownie, cupcake, granola bar); and
5. Pressed pills and capsules.
1.5.5 Prohibitions
A. Medical marijuana products shall not:
- 1. Be in the shape of a human, animal, fruit, cartoon character, or any other shape that is especially attractive to children as determined by DBR;
- 2. Imitate or have a resemblance to any existing branded consumer products, including foods and beverages that do not contain marijuana;
- 3. Be in the shape of a marijuana plant or leaf; and
- 4. Cause a reasonable consumer confusion as to whether the medical marijuana product is a trademarked product.
B. All logos or graphics are prohibited unless prior to use are approved by DBR.
1. The logo or graphic submitted to DBR for approval:
- a. Must not be larger than the required universal symbol;
- b. Can be colored; and
- c. Must only be used for the purpose of identifying the compassion center selling and/or the cultivator(s) producing the product.
2. The logo or graphic submitted to DBR for approval must not:
- a. Reasonably appear to target individuals under the age of twenty-one (21), including but not limited to, the use of animal characters, toys, cartoon characters or similar images.
- b. Imitate or have a resemblance to any existing branded consumer products, including foods and beverages that do not contain marijuana.
- c. Include images of children or minors.
- d. Include images of a marijuana plant, marijuana leaf or marijuana product or any person using or consuming the product.
- e. Include words, a design or brand that resembles a product that is commonly associated with children or minors or marketed to children or minors.
- f. Include symbols or celebrities that are commonly used to market products to minors.
- g. Include the word or make any reference to “candy” or “candies”.
- h. Include any false or misleading statements, including any statements regarding health or physical benefits to the consumer.
- i. Include any seal, flag, crest, coat of arms, or other insignia that could reasonably mislead any reasonably prudent person to believe that the product has been endorsed or manufactured by the State of Rhode Island or any agency or municipality thereof.
- j. Cause a reasonable consumer confusion as to whether the medical marijuana or medical marijuana product is a trademarked product.
k. Violate any state or federal trademark law or regulation.
1.5.6 Warnings
A. Warnings on all retail-ready medical marijuana products must:
- 1. Be in the English language;
- 2. Be in Times New Roman, Calibri, Arial, Helvetica or any other font that can be easily read;
- 3. Be in text no smaller than size 8 font and bolded;
- 4. Not be covered or obscured; and
- 5. Be displayed in a bright yellow box as to stand out from other labeling requirements, unless otherwise stated.
B. The following warnings must be displayed on all medical marijuana products, when applicable;
- 1. “Warning: For Medical use ONLY. This product contains marijuana. Store in a securely locked cabinet away from children.”
- 2. “Warning: It is unlawful to transport this product outside of Rhode Island.”
- 3. “Warning: For medical use by a registered patient only. Not for resale.”
4. For medical marijuana products intended to be smoked or vaporized:
- a. “Warning: Smoking and Vaping is hazardous to your health.”
- b. “Warning; Vaping can expose you to toxic chemicals that may lead to death”.
5. For all medical marijuana infused products, it must state in slightly larger or bolded font as to stand out from surrounding text, with priority placement,
- a. “Effects of this product may be delayed by 3 or more hours.”
6. For all topical products, it must state:
- a. “For Topical Application – Do Not Eat or Smoke.”
- C. In addition to the warnings above, rotating warnings must accompany all retail-ready medical marijuana products at the point of sale.
D. Rotating warnings shall:
- 1. Be in the English language;
- 2. Be in Times New Roman, Calibri, Arial, Helvetica or any other font that can be easily read;
- 3. Be in text no smaller than size 10 font and bolded; and
- 4. Not cover or obscure any required information pursuant to § 1.5 of this Part.
- 5. Accompany all retail-ready medical marijuana products at the point of sale based on a rotating schedule as determined by DBR.
E. The rotating warnings are:
- 1. “Warning: Marijuana has intoxicating effects and may be habit forming and addictive.”
- 2. “Warning: Do not operate a vehicle or machinery under the influence of marijuana.”
- 3. “Warning: Marijuana should not be used by women that are pregnant or breastfeeding.”
- 4. “Warning: Early and frequent cannabis use has been associated with the onset of psychosis.”
- F. Compassion Centers shall post any additional warnings at the point of sale as determined by DBR.
R.I. Gen. Laws §§ 21-28.6-12(b)(1)(ii)-(iv) and 21-28.6-16(b)(2)-(4) authorize DBR to promulgate regulations regarding minimum oversight requirements, minimum record-keeping requirements and minimum security requirements for compassion centers and licensed cultivators. The operational requirements set forth in this section are promulgated in accordance with that statutory duty of general regulatory supervision over licensed compassion centers and licensed cultivators and in accordance with other provisions of the Act. R.I. Gen. Laws §§ 21-28.6-12 and 21-28.6-16.
1.6.1 Medical Marijuana Program Tracking System
- A. Upon direction by the DBR and in accordance with R.I. Gen. Laws §§ 21-28.6-12(g)(3), and 21-28.6-16(d) each compassion center and licensed cultivator shall be required to utilize the state approved Medical Marijuana Program Tracking System to document and monitor compliance with the Act and all regulations promulgated thereunder. Applicable licensees may be required to pay costs associated with use of the Medical Marijuana Program Tracking System which may be assessed on an annual, monthly, per use, or per volume basis and payable to the state or to its approved vendor.
B. All information related to the acquisition, propagation, cultivation, transfer, manufacturing, processing, testing, storage, destruction, wholesale and/or retail sale of all marijuana and medical marijuana products possessed by licensees and/or distributed to registered cardholders in accordance with the Act must be kept completely up-to-date in the Medical Marijuana Program Tracking System, including but not limited to:
- 1. Planting and propagation of plants;
- 2. Transition of immature to mature plants;
- 3. Harvest dates with yield documentation;
- 4. Destructions of immature plants, mature plants and medical marijuana products;
- 5. Transportation of immature plants, mature plants, and medical marijuana products;
- 6. Theft of immature plants, mature plants, and medical marijuana products;
- 7. Adjustment of product quantities and/or weights;
- 8. Conversion of product types including waste documentation;
- 9. Required test results as reported by a cannabis testing laboratory;
- 10. Retail and wholesale transaction data;
- 11. Product compliance data;
12. A complete inventory including, but not limited to:
- a. Batches or lots of useable marijuana;
- b. Batches or lots of concentrates;
- c. Batches or lots of extracts;
- d. Batches or lots of marijuana infused products;
- e. Immature plants,
- f. Mature plants;
- g. Marijuana waste; and
13. Any other information or technical functions DBR deems appropriate.
1.6.2 Tagging of Plants and Medical Marijuana Products
A. Unique identifier tags shall be placed in a manner to clearly display their association with a particular plant, plant material, or product as approved by DBR. For example:
- 1. Affixed to the plant itself or the plant receptacle;
- 2. By labeling drying racks and other receptacles that wet marijuana dries on;
- 3. On a label affixed to a storage/transport package and/or retail-ready package; and/or
- 4. Any other means DBR deems appropriate.
B. All immature plants, usable marijuana, medical marijuana products and waste must be tagged with the following information unless otherwise approved by DBR:
- 1. The licensee’s license number and tradename/business name;
- 2. The unique identifier generated by the Medical Marijuana Program Tracking System;
- 3. Strain name or product name (waste excluded);
- 4. The quantity of the product; and
- 5. Any other information or technical functions DBR deems appropriate.
C. Each mature marijuana plant must be physically tagged and tracked individually with the following information unless otherwise approved by DBR:
- 1. The licensee’s license number and tradename or business name;
- 2. The unique identifier generated by the Medical Marijuana Program Tracking System;
- 3. Strain name;
- 4. Date of creation; and
- 5. Any other information or technical functions DBR deems appropriate.
- D. The unique identifier tags may not be transferred or assigned except when affixed to marijuana plants, usable marijuana, or medical marijuana products which are being sold/transferred/transported in accordance with §§ 1.6.3 and 1.6.8 of this Part.
E. Return of unique identifier tags upon revocation or abandonment of the license shall be specifically governed by DBR order or agreement which may include coordinated efforts with law enforcement. Disposal of unique identifier tags by the compassion center or licensed cultivator as may be required by DBR, such as in the regular course of tagging if different stages will require different tag forms or such as recall of tags due to new technology, shall be handled in accordance with further instructions provided by DBR.
1.6.3 Permitted and Prohibited Sources of Marijuana; Contract Requirements; Sales and Transfers
A. Licensed cultivators shall only sell to and receive medical marijuana and marijuana products from Rhode Island licensed compassion centers and Rhode Island licensed cultivators, as authorized by R.I. Gen. Laws § 21-28.6-16(a).
- 1. As part of such sales transactions, the licensed cultivator may transfer and transport medical marijuana and medical marijuana products to a registered compassion center or licensed cultivator in accordance with § 1.6.8 of this Part.
- 2. A licensed cultivator may only receive medical marijuana and marijuana products from a Rhode Island registered compassion center if the receipt is pursuant to a written contract or purchase order for the licensed cultivator to process the medical marijuana into a product to be furnished back to the compassion center. R.I. Gen. Laws § 21-28.6-16(e).
B. Pursuant to R.I. Gen. Laws § 21-28.6-16(e), a compassion center shall only purchase or otherwise receive marijuana from a Rhode Island licensed cultivator, with which it has a “formal agreement.”
- 1. Compassion centers shall not transfer medical marijuana or medical marijuana products to another compassion center. R.I. Gen. Laws § 21-28.6-12(d)(5)(v).
C. The requirements for a “formal agreement” shall be as follows:
1. A written executed contract or purchase order shall be required for all sales or services from a licensed cultivator to a compassion center and from a licensed cultivator to licensed cultivator and shall contain the following minimum terms:
- a. Date of execution/placement of the contract/purchase order;
- b. Description and amount of product to be sold and/or services to be provided;
- c. The total price and per unit price of the product to be sold and/or services to be provided;
- d. The specific date or date range not spanning more than thirty (30) calendar days for fulfillment of the order, performance of the services, and delivery or pickup;
- e. The payment due date, as specifically agreed between the parties, but if no date is specifically agreed to, payment shall be made within thirty (30) calendar days of delivery or pickup; and
- f. Contracts/purchase orders pursuant to this paragraph may not be modified but may be cancelled or voided by the creation of a new replacement contract/purchase order.
- D. In accordance with R.I. Gen. Laws §§ 21-28.6-4(c) and (j), a marijuana establishment licensee shall not purchase or otherwise receive marijuana from any qualifying patient cardholder or primary caregiver after December 31, 2016. This prohibition extends to purchases and transfers from cooperative cultivations.
E. Permitted and Prohibited Sales and Transfers
- 1. Compassion center sales to qualifying patients, directly or through their caregivers or authorized purchasers, are only permitted if those qualifying patients, caregivers, or authorized purchasers are registered and compliant with the Act and all regulations promulgated thereunder. Only marijuana products that have been designated as medical marijuana in accordance with § 1.7 of this Part may be sold or distributed. For such sales, a compassion center shall be strictly bound by the dispensing limits of R.I. Gen. Laws § 21-28.6-12(g).
2. Sales to out-of-state patients
- a. Compassion centers may conduct sales to out-of-state patient cardholders in accordance with R.I. Gen. Laws § 21-28.6-4(o), provided the receiving or purchasing patient has a valid medical marijuana card, or its equivalent, which has been issued by the applicable regulating authority for the medical marijuana program of the issuing U.S. state/jurisdiction/territory. The patient must also possess and present valid government issued identification matching the name on their medical marijuana card.
- b. Each patient verified pursuant to § 1.6.3(E)(2)(a) of this Part, shall complete an intake form (upon a form acceptable to DBR) which includes at minimum the home state card registration number (or if the home state registration number is not available, a unique identifier assigned by the compassion center).
- c. The compassion center shall log and track all transactions with each out-of-state patient cardholder in the Medical Marijuana Program Tracking System according to the issuing state’s patient card registration number or the unique identifier assigned to that person by the compassion center.
- d. Out-of-state patient information shall be maintained confidentially in accordance with § 1.6.6(D)(2) of this Part.
- e. The compassion center shall provide each out-of-state patient cardholder with a notice regarding the requirements and prohibitions under the Act and any regulations promulgated thereunder that apply to dispensing and use of medical marijuana within the State of Rhode Island, including without limitation notice of medical marijuana dispensing and possession limits, prohibition of taking medical marijuana and medical marijuana products across state lines and prohibition of smoking in public places.
- 3. Sales for delivery to a qualifying patient cardholder’s residence are deemed permitted provided that such sales comply with § 1.6.9 of this Part.
- 4. Any transfer to or from a third-party testing provider shall be in accordance with § 1.11 of this Part, the Act and any regulations promulgated thereunder.
5. Unless specifically permitted by § 1.6 of this Part, no other compassion center or licensed cultivator sales or transfers of marijuana or marijuana products or services are permitted.
1.6.4 Inventory Limit, Sources and Control
A. Inventory Limit
1. Pursuant to R.I. Gen. Laws § 21-28.6-12(i)(1), a compassion center must limit its inventory of marijuana, including but not limited to immature plants, mature plants, and medical marijuana products, to reflect the projected needs of qualifying patients.
- a. Compassion centers shall not expand or increase the size, scope, scale or capacity of their previously approved and licensed medical marijuana cultivation facility, or cultivation, manufacturing or processing activities without prior approval from DBR in accordance with the variance procedures set forth in § 1.2(I) of this Part.
- b. A compassion center may apply to relocate their existing licensed medical marijuana cultivation facility, or cultivation activities to a new premises provided that the size, scope, scale and capacity of the cultivation or cultivation activities are not increased or expanded unless approved by DBR pursuant to § 1.6.4(A)(1)(e) of this Part.
- c. Compassion centers licensed after July 1, 2019, shall not engage in the cultivation of medical marijuana unless approved by DBR pursuant to § 1.6.4(A)(1)(e) of this Part.
d. A compassion center applicant may propose to cultivate medical marijuana. Any compassion center applicant that is approved to cultivate marijuana in accordance with the Act and the DBR regulations may only cultivate medical marijuana at one address or location. If approved, the cultivation of medical marijuana may occur at:
- (1) The same licensed address or location where the compassion center is authorized to or proposes to conduct retail sales of medical marijuana; or
- (2) If the address or location where an applicant or licensee is authorized to or proposes to conduct retail sales of medical marijuana does not permit or is not suitable for medical marijuana cultivation, then the applicant may propose to use a second location for cultivation in accordance with § 1.2(I) of this Part.
- e. DBR shall only consider requests, in its discretion, to establish, expand or increase the size, scope, scale or capacity of a compassion center’s new or previously approved and licensed medical marijuana cultivation facility, or cultivation activities after DBR has completed a recent market demand assessment to project the needs of qualifying patients and DBR has determined that the proposed establishment expansion, or increase in size, scope, scale or capacity is in the best interest of and for the mutual benefit of program participants and required to meet the projected needs of qualifying patients.
- f. Any licensed compassion center in violation of the Act, the DBR Regulations, and the cultivation limits established therefrom shall be ineligible to apply to establish, expand, or relocate a medical marijuana cultivation facility, or medical marijuana cultivation activities, in addition to having their compassion center license suspended and subject to revocation pursuant to R.I. Gen. Laws § 21-28.6-12(d)(5).
- g. A licensed cultivator which has applied for and been approved or selected to hold a compassion center license after July 1, 2019, shall be able to continue their previously licensed operations under a newly issued compassion center license, provided that the cultivator license shall be surrendered to DBR, in accordance with R.I. Gen. Laws § 21-28.6-12(b)(10).
- h. Licensed cultivators shall be subject to the limitations of the class of their issued license. Licensed cultivators may cultivate, manufacture, process and possess medical marijuana and medical marijuana products within the confines of the class size of their licensed facility, provided that all medical marijuana and medical marijuana products are tracked in the Medical Marijuana Program Tracking System and in accordance with § 1.6.1 of this Part.
B. Inventory Sources
1. Legal Pre-Existing Inventory:
- a. A licensed cultivator or compassion center, whose officers, directors, members/managers, or employees possessed medical marijuana plants in compliance with the provisions of the Act before the license was granted, may transfer such marijuana plants to the licensee’s inventory through a one-time transaction upon licensure provided such marijuana plants are properly tagged in compliance with § 1.12 of this Part and tracked in compliance with §§ 1.6.1 and 1.6.2 of this Part.
- b. Except as provided in § 1.6.4(B)(1)(a) of this Part or through the regulated sale of medical marijuana to a qualifying patient, their registered caregiver or authorized purchaser, transfers of marijuana and marijuana product between the licensed marijuana establishment and its officers, directors, members/managers, and/or employees is strictly prohibited.
C. Inventory Control
- 1. Upon direction by DBR, each compassion center and licensed cultivator shall utilize the state approved Medical Marijuana Program Tracking System for all inventory tracking from seed to sale as defined in § 1.6.1 of this Part.
2. If the compassion center or licensed cultivator is notified by DBR that the Medical Marijuana Program Tracking System is not available, the compassion center or licensed cultivator will be provided with direction as to alternative inventory control measures, which may include but are not necessarily limited to the compassion center or licensed cultivator being directed to:
- a. Conduct an initial comprehensive inventory of all medical marijuana, including usable marijuana available for dispensing and/or sale, marijuana plants and seedlings, unusable marijuana, and wet marijuana, at each authorized location on the date the compassion center first dispenses, or the licensed cultivator first cultivates medical marijuana or as of another date certain set by DBR.
- b. Conduct daily subsequent comprehensive inventories.
- c. Conduct a monthly inventory review of stored, usable marijuana, seedlings, plants, and wet marijuana.
3. Upon request, DBR may require a compassion center or licensed cultivator to conduct and provide the results of alternative inventory control measures outlined above, regardless of the availability and use of the Medical Marijuana Program Tracking System.
1.6.5 Minimum Security Requirements
- A. R.I. Gen. Laws §§ 21-28.6-12(b)(1)(iv) and 21-28.6-16(b)(4) authorize DBR to promulgate regulations regarding the minimum-security requirements for compassion centers and licensed cultivators.
B. General Security Requirements shall include:
- 1. Each compassion center or licensed cultivator shall implement appropriate security and safety measures to deter and prevent the unauthorized entrance into areas containing medical marijuana and the theft of marijuana.
- 2. Use or carry of firearms on the premises and/or perimeter of the compassion center or licensed cultivator is a prohibited form of security, except by security guards licensed by the Office of the Rhode Island Attorney General pursuant to R.I. Gen. Laws Chapter 5-5.1 and who are under written contract to provide security services to the compassion center or licensed cultivator and by law enforcement personnel during duty.
3. The outside perimeter shall be lighted as follows:
- a. The compassion center retail premises shall be well-lit at all times. For any alternative cultivation only site, the outside perimeter shall have adequate lighting to deter theft which may include motion activated lighting acceptable to DBR.
- b. The outside perimeter of the licensed cultivator shall have adequate lighting to deter theft which may include motion activated lighting acceptable to DBR.
- 4. Except for persons whose visit falls within § 1.6.5(B)(6) of this Part, any person who does not have a valid registry identification card who enters any area where marijuana and marijuana products are grown, cultivated, stored, weighed, packaged, processed, manufactured or sold shall be considered a “visitor” and must be escorted at all times by a registry identification card holder. However, visitors are only permitted for a legitimate business-related purpose such as building maintenance, repairs or installation of equipment, or provision of goods or services. Any visitor that regularly gains access to the facility may be required by DBR to obtain a registry identification card. The compassion center or licensed cultivator must maintain a visitor log for any such activity as detailed in § 1.6.5(H)(1)(d) of this Part.
- 5. Each compassion center or licensed cultivator shall ensure that the storage of marijuana and any marijuana products is in a locked area. At all points of ingress and egress, the compassion center or licensed cultivator shall ensure the use of a working commercial-grade, non-residential door lock.
- 6. Registered qualifying patients, primary caregivers, and authorized purchasers who do not hold compassion center registration cards are only permitted within point of sale areas of a compassion center. In such areas, the compassion center shall ensure that all marijuana and marijuana products are kept behind the sales counter or other partition and make reasonable efforts to limit the number of registered qualifying patients, primary caregivers, and authorized purchasers present in relation to the number of compassion center cardholders to assure adequate monitoring and control of point of sale area activities.
C. Security Alarm Requirements
- 1. Each compassion center or licensed cultivator shall have a fully operational security alarm system of an appropriate commercial standard as deem acceptable by DBR at each authorized physical address that will provide suitable protection against theft and diversion, including alarms at all outside perimeter entry points and outside perimeter windows.
- 2. A fully operational security alarm system may include a combination of hard-wired systems and systems interconnected with a radio frequency method such as cellular or private radio signals that emit or transmit a remote or local audible, visual, or electronic signal; motion detectors, pressure switches, duress alarms (a silent system signal generated by the entry of a designated code into the arming station to indicate that the user is disarming under duress); panic alarms (an audible system signal to indicate an emergency situation); and hold-up alarms (a silent system signal to indicate that a robbery is in progress).
- 3. A fully operational security alarm system shall at a minimum provide for immediate automatic or electronic notification to alert municipal and/or state law enforcement agencies or public safety personnel to an unauthorized breach or attempted unauthorized breach of security at the compassion center or licensed cultivator or any other authorized physical address and to any loss-of-electrical support backup system to the security alarm system.
- 4. Each compassion center or licensed cultivator shall establish a protocol for the testing and maintenance of the security alarm system, which shall at a minimum provide for a maintenance inspection/test of the alarm system for each authorized location at intervals not to exceed thirty (30) calendar days from the previous inspection/test and prompt completion of all necessary repairs to ensure the proper operation of the alarm system.
- 5. If the compassion center or licensed cultivator suffers a failure of the security alarm system, due to loss of electrical support, mechanical function, or otherwise, that is expected to exceed an eight (8) hour period, in addition to the notice requirements provided in §§ 1.6.5(C)(3) and 1.6.5(I) of this Part, the compassion center or licensed cultivator must also close the authorized physical address(es) impacted by the failure/malfunction until the security alarm system has been restored to full operation, or, if approved by DBR, provide alternative security.
D. Video Surveillance Requirements
1. Each compassion center or licensed cultivator must have a fully operational video surveillance and camera recording system with appropriate protocols, which shall, at a minimum, comply with all of the below requirements:
- a. Video surveillance equipment shall, at a minimum, consist of digital or network video recorders, video monitors, and digital archiving devices capable of playback quality sufficient to identify and monitor all individuals (including sufficient clarity of facial features) and activities in the monitored areas.
- b. The recording system must record in digital format.
- c. The date and time must be embedded on the recording without significantly obscuring the picture. Time is to be measured in Eastern Standard Time.
- d. All video surveillance systems must be equipped with a failure notification system that provides prompt notification of any surveillance interruption and/or the complete failure of the surveillance system. Said notification must be routed to compassion center or licensed cultivator personnel specifically designated by management and to DBR.
- e. All video surveillance equipment shall have sufficient battery backup to support a minimum of four (4) hours of recording in the event of a power outage.
- f. Video recordings must be archived in a format and maintained in a manner that ensures authentication of the recording as legitimately-captured video and guarantees that no alteration of the recorded image has taken place.
- g. Remote access to a continuous live feed video on a real time basis must be available at all times to compassion center or licensed cultivator personnel specifically designated by management and to DBR. Additionally, all video surveillance records and recordings must be made available upon request to DBR. DBR employees and representatives will hold video surveillance records and recordings of point-of-sale areas confidential except for authorized release in accordance with applicable law.
- h. The system must include a color printer or similar equipment capable of printing still photos of a quality sufficient to identify individuals and activities in the monitored areas.
- i. The licensee must ensure that DBR has continuous access to live feed video. Failure to maintain ongoing access by DBR may result in enforcement proceedings pursuant to § 1.13 of this Part.
E. Placement of Cameras and Required Camera Coverage
- 1. Camera coverage is required for all areas where marijuana and marijuana products are grown, cultivated, stored, weighed, packaged, processed, manufactured or sold, including all areas of ingress and egress thereto, point-of-sale areas, security rooms (as defined below), all points of ingress and egress to the exterior of the compassion center or licensed cultivator, and any computer or other digital access points.
- 2. Camera views of required coverage areas shall be continuously recorded twenty (24) hours a day, (7) seven days per week.
- 3. Camera placement shall be capable of identifying activity occurring within twenty (20) feet of all points of ingress or egress and shall allow for the clear and certain identification of any individual and activities on the licensed premise.
- 4. All entrances and exits to the facility shall be recorded from both indoor and outdoor vantage points.
- 5. The system shall be capable of recording all pre-determined surveillance areas in any lighting conditions.
F. Location and Maintenance of Surveillance Equipment
- 1. Surveillance recording equipment and all video surveillance records and recordings must be housed in a designated, locked and secured room or other enclosure with access limited to compassion center or licensed cultivator personnel specifically authorized by management (the “security room”). The compassion center or licensed cultivator must keep on site a current list of all authorized employees and service personnel who have access to the security room and a video surveillance equipment maintenance activity log.
- 2. If the compassion center or licensed cultivator suffers a failure of the video surveillance system, due to loss of electrical support, mechanical function, or otherwise, that is expected to exceed an eight (8) hour period, in addition to the notice requirements provided in § 1.6.5(I) of this Part, the compassion center or licensed cultivator must also close the authorized physical address(es) impacted by the failure/malfunction until the video surveillance system has been restored to full operation, or, if approved by DBR, provide alternative premises monitoring.
G. Emergency Plan
- 1. The compassion center or licensed cultivator shall develop and maintain an emergency plan with procedures to be followed to prevent and, if not prevented, to adequately address and mitigate consequences of theft or burglary or attempts thereof, fire, natural disasters, and other emergencies, including cybersecurity and data breach procedures to prevent a compromise of the integrity of the Medical Marijuana Program Tracking System.
- 2. The plan shall include training for employees on crime prevention and personal safety techniques.
H. Security-Related Record-Keeping
1. The compassion center or licensed cultivator shall maintain the following documentation on-site and with digital back-up for a period of at least twenty-four (24) months after the event:
- a. Inventory records including, at a minimum, the date the inventory was conducted, a summary of the inventory findings and the name, signature and title of the individual who conducted the inventory.
- b. All records of maintenance, inspections, and tests of the security alarm and video surveillance systems and of servicing, modifications, or upgrades performed on said systems. These records shall include, at a minimum, the date of the action, a summary of the action(s) performed and the purpose therefor, and the name, signature and title of the individual who performed the action(s).
- c. Emergency notification reports as required by § 1.6.5(I) of this Part.
- d. Visitor logs which shall include the name of each visitor, a photocopy of the visitor’s government issued ID upon first visit, the date and time of the beginning and end of the visit, the reason for the visit (i.e. maintenance, authorized pickup, etc.), and the name of the escorting registry identification cardholder.
- e. All surveillance recordings must be kept for a minimum of sixty (60) calendar days. Video recordings shall not be destroyed if the compassion center or licensed cultivator knows or should have known of a pending criminal, civil or administrative investigation or any other proceeding for which the recording may contain relevant information.
- f. All records applicable to the surveillance system shall be maintained on the compassion center or licensed cultivator premises. However, a backup record may be stored and maintained offsite. At a minimum, licensees shall maintain a map of the camera locations, direction of coverage, camera numbers, surveillance equipment maintenance activity log, user authorization list and operating instructions for the surveillance equipment. This information shall be limited to key personnel only.
I. Emergency Notifications and Reports
- 1. Compassion centers or licensed cultivators shall provide notification of emergency events to DBR and municipal and/or state law enforcement as outlined below.
2. Immediately upon discovery of the event, the compassion center or licensed cultivator shall provide telephone notification to the appropriate municipal and/or state law enforcement authorities and first responders regarding any of the following “emergency events”:
- a. Theft or burglary or an attempt thereof;
- b. Any fire;
- c. A natural disaster that results in the destruction of or damage to medical marijuana or marijuana products;
- d. A failure of the security alarm system or video surveillance system, due to loss of electrical support, mechanical function, or otherwise, that is expected to exceed an eight (8) hour period;
- e. A security alarm activation; or
- f. Any other event which requires response by law enforcement or public safety personnel.
- 3. The compassion center or licensed cultivator shall provide e-mail notification to DBR immediately upon discovery of any data breach or cybersecurity threat to the Medical Marijuana Program Tracking System and immediately after notification to law enforcement/first responders of any other emergency event as defined above in § 1.6.5(I)(2) of this Part. A follow-up telephone notification to DBR shall be provided no later than the next business day.
- 4. The compassion center or licensed cultivator shall submit a follow-up written report to DBR within twenty-four (24) hours for each emergency event. The written report shall include, at a minimum, a description of the event(s), identification of known or suspected cause(s) for the event(s), any corrective action(s) taken to prevent a recurrence, and the name, title, and signature of the individual preparing the report.
- 5. Any notification and report of an emergency event required to be made to DBR pursuant to these DBR Regulations shall be made using the mailing address, telephone number, and/or e-mail address provided by DBR to approved licensees, as applicable.
6. Upon written direction to the compassion center or licensed cultivator, DBR may require that the written and telephone notifications and reporting must be replaced or supplemented by notifications and reporting through the Medical Marijuana Program Tracking System or any other electronic system or means DBR mandates the compassion center or licensed cultivator to utilize.
1.6.6 Record-Keeping and Reporting
- A. R.I. Gen. Laws §§ 21-28.6-12(b)(1)(iii) and 21-28.6-16(b)(3) authorizes DBR to promulgate regulations regarding the minimum record-keeping requirements for compassion centers and licensed cultivators.
B. Operations Manual. Each compassion center or licensed cultivator shall develop, implement, and maintain on the premises an operations manual which addresses, at a minimum, all of the following subject areas and requirements.
- 1. Procedures for the organization, administration, command, and control of the compassion center or licensed cultivator (including but not limited to organizational chart, chain of command protocols, etc.).
2. Procedures to ensure accurate record-keeping, including but not limited to protocols to ensure that:
- a. All acquisitions, dispensing, and sales of marijuana are logged into the Medical Marijuana Program Tracking System on a real time basis.
b. All dispensing and sales transactions:
- (1) Are to registered qualifying patients, primary caregivers, authorized purchasers and verified out-of-state patient cardholders; and
- (2) Adhere to the limits for usable marijuana prescribed by statute and the marijuana product equivalency limits set by § 1.14 of this Part.
- c. Procedures on proper training and use of the Medical Marijuana Program Tracking System and any other tracking system used by the compassion center or licensed cultivator.
3. Policies and procedures for handling voluntary and mandatory recalls of marijuana.
- a. Such procedures shall be adequate to deal with recalls due to any action initiated at the request or order of DBR, and any voluntary action by a compassion center or licensed cultivator to remove defective or potentially defective medical marijuana or medical marijuana delivery devices from the market, as well as any action undertaken to promote public health and safety.
- 4. Policies and procedures for ensuring that any outdated, damaged, deteriorated, mislabeled, or contaminated marijuana is quarantined from other marijuana and destroyed.
- 5. Records retention policies.
- 6. Ethics and compliance policies.
- 7. Alcohol and drug free workplace policy.
- 8. If applicable, medical marijuana manufacturing protocols, safety measures, process validation for smokable and vapable products, and training information.
- 9. Odor control and mitigation plan.
- 10. Policies and procedures for pesticide use (see § 1.6.15(E) of this Part).
11. Applicable for compassion centers only:
- a. A description of the compassion center’s outreach activities to registered qualifying patients, registered primary caregivers, and authorized purchasers.
- b. Customer service protocols, including the handling of complaints.
- c. Procedures for safely dispensing medical marijuana only to registered qualifying patients, registered primary caregivers, and authorized purchasers, including procedures for verifying authenticity of registry identification cards and other forms of identification.
C. Personnel Records
1. Each compassion center or licensed cultivator shall maintain a personnel record for each employee, agent or volunteer for a period of at least one (1) year after termination of the individual’s affiliation with the compassion center or licensed cultivator. Said personnel record shall contain the following minimum documentation and information:
- a. An application for employment or to volunteer or offers to provide services as an agent.
- b. An employment or engagement description detailing duties, responsibilities, authority, qualifications and supervision.
- c. If applicable, a copy of any employment or engagement contract, including salary or compensation terms, or for volunteers, volunteer agreement.
- d. A record of any disciplinary action taken.
- e. Documentation of all required training, which shall include a signed statement from the individual indicating the date, time and place he or she received said training, topics discussed, and the name and title of presenters.
- 2. Each compassion center or licensed cultivator shall maintain a current list of all cardholders associated with that compassion center or licensed cultivator.
D. Additional Records to be Maintained
1. In addition to all other specific record-keeping requirements of the Act, the DBR Regulations, and the DOH Regulations, the compassion center or licensed cultivator shall maintain the following records for a minimum of five (5) years:
- a. All contracts and purchase orders, including documentation of any cancelled contracts or purchased orders and any contracts and purchase orders voided by replacement contracts.
- b. Invoices and any supporting documentation of all marijuana purchases, acquisitions, transfers, and payments.
- c. Contracts pertaining to the security alarm and security camera systems.
- d. Contracts with vendors, including any approved third-party testing providers.
- e. All records normally retained for tax purposes.
- f. Complaints.
- g. Management contracts.
- h. Compensation records and financial statements.
- i. Compassion Centers Only – Nonprofit corporate records including, but not limited to articles of organization, bylaws, meeting agendas, minutes and corporate resolutions.
2. All records maintained by a compassion center which pertain to one or more registered qualifying patients, registered primary caregivers or authorized purchasers shall be:
- a. Considered confidential health care information under applicable Rhode Island law; and
- b. Protected as health care information in accordance with the Federal Health Insurance Portability and Accountability Act of 1996, as amended.
E. Records Storage and Responsibility for Loss of Records and Data
- 1. Records pertaining to transactions occurring within the last six (6) months shall be stored on the licensed premises. Records dating further back may be stored off the premises with DBR’s approval.
2. The compassion center or licensed cultivator shall exercise due diligence and reasonable care in preserving and maintaining all required records to guard against loss of records and data, including cybersecurity of electronically-maintained records.
1.6.7 Use on Premises Prohibited
Compassion centers or licensed cultivators shall not permit the use of marijuana or marijuana products on the premises of the compassion center or licensed cultivator, including any parking areas that are designated for compassion center clients or otherwise within the control of the compassion center or licensed cultivator.
1.6.8 Transportation of Medical Marijuana Products
A. Authorized Transport Vehicle Requirements
- 1. Authorized transports shall be conducted in such a manner as to ensure that marijuana and marijuana products are secured and safe at all times during transport.
2. In order to qualify as an “authorized transport vehicle” the marijuana establishment licensee shall use a vehicle meeting all the following criteria:
- a. The vehicle bears no markings that indicate that the vehicle is being used to transport marijuana nor indicates the name of the marijuana establishment licensee;
- b. The vehicle is equipped with a global positioning system monitoring device that is monitored by the originating marijuana establishment licensee during an authorized transport;
- c. The vehicle is equipped with an alarm system;
- d. The vehicle is equipped with functioning heating and air conditioning systems appropriate for maintaining correct temperatures for storage of marijuana products;
- e. Marijuana products must not be visible from outside the vehicle; and
- g. Marijuana products must be stored and transported in a secure, locked storage compartment that is a part of the vehicle transporting the marijuana products. However, the trunk of a vehicle does not qualify as a “locked storage compartment.”
- 3. When transporting marijuana products, no other products may be transported or stored in the same vehicle.
- 4. No firearms may be located within the vehicle or on the person of the authorized transport cardholder.
- 5. Any other security and safety requirements as determined by DBR.
B. Detailed Transport Manifests
- 1. All marijuana establishment licensees shall create and maintain detailed transport manifests for all authorized transports, which DBR may require be generated through and/or maintained in the Medical Marijuana Program Tracking System.
- 2. The detailed transport manifest shall be prepared by the originating marijuana establishment licensee and transmitted in advance to the receiving license. Both licensees shall retain copies of detailed transport manifests as part of their record retention responsibilities.
3. The detailed transport manifest shall include the following minimum information:
- a. Departure date and approximate time of departure.
- b. Names, location addresses, and registration/license numbers of the originating and receiving marijuana establishment facilities.
- c. Unique identifier generated by the Medical Marijuana Program Tracking System.
- d. If for transport to a registered qualifying patient pursuant to an approved patient home delivery plan, as set forth in § 1.6.9 of this Part, the patient registry identification card number and any such other information pursuant to approved delivery plan.
- e. Product names or descriptions.
- f. Quantities (by weight or unit) of each product to be delivered.
- g. Product name or descriptions and quantities (by weight or unit) of each product which was received by the marijuana establishment licensee.
- h. Arrival date and approximate time of arrival.
- i. Delivery vehicle make, model and license plate number.
- j. Names, registry identification card numbers, and signatures of the authorized transport cardholders.
C. Authorized Transportation Requirements
- 1. The originating marijuana establishment licensee shall ensure that all delivery times and routes are randomized.
- 2. The originating marijuana establishment licensee shall ensure that all transport routes remain within the state of Rhode Island.
- 3. Authorized transports may only be made by authorized transport cardholders affiliated with the particular marijuana establishment licensee that is the source or recipient party to an authorized transaction.
- 4. If using one authorized transport vehicle, the vehicle shall be operated/occupied by a minimum of two authorized transport cardholders and at least one such cardholder shall remain in the authorized transport vehicle at all times until the vehicle returns to the originating marijuana establishment licensee.
- 5. If using two authorized transport vehicles, the authorized transport vehicles shall travel together at all times during the authorized transport and each vehicle shall be operated/occupied by at least one authorized transport cardholder. These vehicles shall not be left unattended for any period of time during any authorized transportation.
6. During all authorized transports:
- a. The authorized transport cardholders must have on their persons their compassion center or licensed cultivator registry identification cards and the detailed transport manifest; and
- b. A copy of the detailed transport manifest shall also accompany the marijuana and marijuana products in the locked storage compartment of the authorized transport vehicle.
- 7. Any authorized transport vehicle carrying marijuana and marijuana products shall travel directly from the originating marijuana establishment licensee to the receiving marijuana establishment licensee.
- 8. In case of an emergency stop, a detailed written account must be maintained describing the reason for the event, the duration, the location, any activities occurring during the stop, and any personnel exiting the vehicle during the stop.
- 9. Prior to leaving the originating marijuana establishment licensee for an authorized transport to another marijuana establishment licensee, the originating marijuana establishment licensee must weigh, inventory, and account for on video all marijuana and marijuana product to be transported.
- 10. For authorized transports to and from a marijuana establishment licensee, the transport manifest shall be accompanied by a copy of any contract/purchase order for which the transport is being made and documentation of the actual payment date, if prepaid.
- 11. Upon arrival at the destination marijuana establishment licensee, the receiving party shall confirm receipt of each item in the presence of the delivering authorized transport cardholder and then initial each received line item on both the originating licensee’s manifest and the receiving licensee’s manifest. The receiving party shall then immediately re-weigh, re-inventory, and account on video for all marijuana and marijuana product transported.
- 12. Both the originating and recipient marijuana establishment licensees shall timely adjust their records to reflect in its records the completed authorized transport of marijuana, including logging such information in the Medical Marijuana Program Tracking System. All records and entries in the Medical Marijuana Program Tracking System shall be easily reconciled by unique identifier, product name and quantity, with the applicable detailed transport manifest.
- 13. Any unusual discrepancies in the quantity described in the detailed transport manifest and the quantities received shall be reported to DBR and municipal and/or state law enforcement within twenty-four (24) hours.
- 14. Any vehicle accidents, diversions, or losses during authorized transports of marijuana shall be reported to DBR and law enforcement as an “emergency event” pursuant to § 1.6.5(I) of this Part.
15. Transportation to or from a third-party testing provider shall be in accordance with the DOH Testing Regulations.
1.6.9 Home Delivery – Compassion Centers Only
A. Home delivery of medical marijuana by licensed compassion centers shall be deemed “permitted sales” and “permitted compassion center activity” provided medical marijuana is sold and delivered in compliance with the Act and the DBR Regulations, including but not limited to the following:
- 1. The compassion center’s proposed home delivery plan has been approved by DBR.
- 2. Medical marijuana shall only be delivered to a valid qualifying patient cardholder who has been issued a valid patient card by DOH.
- 3. The Rhode Island patient cardholder must register in advance with the compassion center’s delivery program through a process clearly identified in the proposed delivery plan which has been approved by DBR.
- 4. Medical marijuana deliveries shall only be made to the Rhode Island patient cardholder’s home address or to the hospice, treatment, or other medical care facility where the patient cardholder is admitted, provided the facility permits the patient’s possession and/or use of medical marijuana on the premises.
- 5. Medical marijuana deliveries shall only be made to or accepted by the Rhode Island patient cardholder registered with the compassion center’s delivery program. This must be verified and documented by the compassion center through a process clearly identified in the proposed delivery plan which has been approved by DBR.
B. Until otherwise approved by DBR, home delivery of medical marijuana shall be limited to Rhode Island patient cardholders who:
- 1. Do not have a caregiver or authorized purchaser registered with the compassion center to make purchases on their behalf;
- 2. Are eligible for hospice care, or who are currently undergoing chemotherapy or radiation treatment; or
- 3. Are homebound and unable to travel or have a valid disability parking license, placard or permit.
- 4. In addition, patients who qualify for home delivery under § 1.6.9(B)(2) or (3) of this Part must submit a letter to the compassion center to that effect signed by a practitioner licensed to practice medicine in Rhode Island when registering for home delivery.
C. Transportation requirements for home delivery of medical marijuana include but are not limited to the following:
- 1. Compassion centers may only conduct home delivery between the hours of 8:00 a.m. and 8:00 p.m.
- 2. All home delivery vehicles must be qualified as an “authorized transport vehicle” pursuant to § 1.6.8(A) of this Part and shall be operated by transport cardholders authorized by the compassion center.
- 3. All home delivery vehicles shall comply with the detailed transport manifest requirements in § 1.6.8(B) of this Part.
- 4. A home delivery vehicle may not possess more than seven thousand five hundred dollars ($7,500) worth of medical marijuana products at a time.
- 5. A home delivery vehicle shall comply with the personnel requirements in §§ 1.6.8(C)(4) and (5) of this Part.
- 6. In order to obtain and maintain DBR approval of the home delivery plan, compassion centers must make delivery available to eligible Rhode Island patient cardholders statewide and may not refuse delivery to a patient based on the location of their home unless it is for a reason approved by DBR.
- 7. Compassion centers must make delivery available to each of their eligible Rhode Island patients at least once every fifteen (15) days.
D. Home Delivery product and payment requirements include but are not limited to:
- 1. Any compassion center authorized transport vehicle carrying marijuana and marijuana products to patients pursuant to an approved patient home delivery plan shall only stop at the patient addresses listed on the detailed transport manifests.
- 2. All home deliveries must be paid for in advance or through electronic payment at the time of delivery. Compassion centers may not accept any non-electronic payment at the time of delivery.
- 3. Authorized transport cardholders may not accept tips or compensation of any kind from the Rhode Island patient to whom they are delivering or otherwise in connection with delivery.
- 4. All orders, payments, and deliveries must be tracked in the compassion center’s Medical Marijuana Program Tracking System and within the limits of the Act. DBR must have real time, and if requested, remote access to these systems and any other logs or systems tracking home deliveries which are approved by DBR.
- 5. Compassion centers may not charge a delivery fee in excess of twenty dollars ($20.00) per delivery and must implement a discounted or free delivery policy for patients who qualify under § 1.6.9(B)(2) or (3) of this Part.
- 6. Products available for delivery must follow the same pricing structure as products sold through the compassion center’s retail location.
7. If a patient requires a medical marijuana product that is available at the compassion center’s retail location, but is not offered for delivery, the compassion center must make that product available for delivery to that patient upon their request, provided the requested product is in stock.
1.6.10 Manufacturing and Extraction
- A. Any manufacturing method using a solvent extraction process must be approved by DBR. If the manufacturing method uses a flammable/combustible material or heat source, the method must also be approved by the State Fire Marshall and/or local fire department.
- B. Only registered cardholder employees and agents of a licensee may manufacture medical marijuana products on the premises. A registered volunteer for a compassion center may do so only as part of educational programming under the direct supervision of a licensed employee.
- C. Each compassion center and licensed cultivator must maintain written standard operating procedures for each manufacturing process, including step-by-step instructions.
- D. Each compassion center and licensed cultivator must ensure that for each manufacturing process, all safety and sanitary equipment appropriate for that manufacturing process, including any personal protective equipment, is provided to any authorized cardholder who will be involved in that manufacturing process.
- E. All medical marijuana product manufacturing areas must be adequately lit during manufacturing, cleaning, or other use.
- F. All work surfaces on which medical marijuana products are manufactured and the walls and floors in the areas in which such products are manufactured shall be non-porous, non-absorbent, and easily cleanable.
- G. No eating or smoking shall be permitted in the manufacturing area.
H. The compassion center or licensed cultivator must provide a training manual and instructional training on each manufacturing process to any authorized cardholder who will be involved in that manufacturing process.
1.6.11 Required Patient Outreach Activities - Compassion Centers
A. The compassion center’s outreach activities to registered qualifying patients, registered primary caregivers, and authorized purchasers shall, at a minimum, include:
- 1. Providing each new registered qualifying patient who visits the compassion center with a frequently asked questions sheet that explains the limitations on the right to use medical marijuana under state law in accordance with R.I. Gen. Laws § 21-28.6-12(f)(9);
- 2. Providing a list of ingestion options for usable marijuana;
- 3. Providing applicable usage techniques and any corresponding safety information to registered qualifying patients;
- 4. Communicating potential side effects; and
5. Upon the request of DOH and/or DBR, e-mailing or otherwise disseminating information to compassion center clients regarding changes in the medical marijuana program, or disseminating customer surveys.
1.6.12 Required Employee, Agent, and Volunteer Training
A. In accordance with R.I. Gen. Laws §§ 21-28.6-12(f)(14) and 21-28.6-16(b), each compassion center or licensed cultivator shall develop, implement and maintain on the premises an on-site training curriculum, or enter into contractual relationships with outside resources capable of meeting employee, agent and, if applicable, volunteer training needs. Each employee, agent or volunteer, at the time of his or her initial appointment and every year thereafter, shall receive, at a minimum, training in the following:
1. Only applicable to compassion centers:
- a. Professional conduct, ethics, and state and federal laws regarding patient confidentiality;
- b. Informational developments in the field of medical use of marijuana; and
- c. Policies and procedures for dispensing to and transactions with out-of-state patient cardholders.
- 2. The proper use of security measures and controls that have been adopted.
- 3. Training on use of the Medical Marijuana Program Tracking System and any other tracking systems used by the compassion center for persons responsible for using the system.
4. Specific procedural instructions for responding to an emergency, including robbery or violent accident.
1.6.13 Minimum Sanitation and Workplace Safety Conditions
- A. Each compassion center and licensed cultivator shall be maintained in a safe, sanitary, and clean manner, with all operations in the cultivation, receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of medical marijuana and marijuana products conducted in accordance with adequate sanitation principles, as further detailed below.
B. The facility must meet the following minimum specifications, including having and maintaining:
- 1. An adequate supply of potable hot and cold water;
- 2. Non-porous, non-absorbent and easily cleanable floors, walls, and ceilings in areas where marijuana is cultivated, manufactured, and stored;
- 3. Lavatory facilities that are readily-accessible to employees and that comply with the Rhode Island State Plumbing Code, 510-RICR-00-00-3;
- 4. Adequate hand-washing area(s) with hand washing sinks with effective hand-cleaning and sanitizing preparations (such as soap dispensers) and disposable towels or an air dryer for hands; and
- 5. Adequate screening or other protection against the entry of pests and environmental contaminants.
- C. All mechanical and electrical equipment shall be maintained in a safe operating condition.
- D. Waste disposal equipment shall be adequate and removal schedules timely so as to minimize the risk of contamination to medical marijuana and marijuana products, including the risk of the waste becoming an attractant, harborage, or breeding place for pests.
- E. All waste (including all liquid, chemical, hazardous, pesticide, manufacturing solvent and chemical waste) must be stored, secured, and managed in accordance with all applicable DEM laws and regulations and all applicable federal, state, and local statutes, regulations, ordinances, or other legal requirements. Specific instructions for safe destruction of any marijuana required to be destroyed and proper disposal of medical marijuana waste are set forth in § 1.6.16 of this Part.
- F. Floors, walls, and ceilings shall be kept clean and in good repair, free from dust, debris, mold, mildew, and other contaminants and potentially hazardous materials.
- G. Lavatory facilities and hand washing areas shall be kept clean and sanitary and in working condition at all times.
- H. Toxic cleaning compounds, sanitizing agents, and other chemicals shall be identified, held, stored and disposed of in a manner that protects against contamination of medical marijuana and marijuana products and in a manner that is in accordance with all applicable DEM laws and regulations and any applicable local, state, or federal law, rule, regulation, or ordinance.
- I. Each compassion center and licensed cultivator shall comply with all relevant statutes, regulations, and requirements administered by the Federal Occupational Safety and Health Administration (OSHA), including but not necessarily limited to standards for toxic and flammable compounds and air contaminants. DBR may require licensees to undergo third-party inspections or audits to ensure compliance with OSHA.
- J. All persons working in direct contact with medical marijuana and marijuana products shall conform to hygienic practices while on duty, including but not limited to maintaining adequate personal cleanliness and washing hands thoroughly in an adequate hand-washing area before starting work and at any other time when the hands may have become soiled or contaminated.
- K. Any person whose medical condition, as determined by medical examination or as observed by a supervisor, poses or reasonably appears to pose a risk of contamination of medical marijuana and/or medical marijuana products shall be excluded from medical marijuana operations until the condition is cleared. Medical conditions posing a risk of contamination include but are not necessarily limited to open lesions, including boils, sores, or infected wounds, or any other abnormal source of microbial infection.
- L. Each compassion center and licensed cultivator shall not permit the entry of any animal into the premises. Service animals (as defined in the Americans with Disabilities Act) are exempted from this prohibition in retail areas or other areas where there is no cultivation, manufacturing or packaging of medical marijuana products.
M. In addition to the safety and sanitary equipment including personal protective equipment that the compassion center or licensed cultivator is required to furnish its employees involved in marijuana manufacturing and extraction pursuant to § 1.6.10(D) of this Part, the compassion center or licensed cultivator must also furnish its employees with proper safety equipment for other types of work assigned as part of the compassion center or licensed cultivator operations.
1.6.14 Odor Control and Mitigation
- A. Cultivation, manufacturing, packaging and any other area(s) deemed necessary by DBR shall have ventilation and filtration systems installed that prevent medical marijuana plant odors from exiting the interior of the structure to an extent that would significantly alter the environmental odor outside, while addressing the potential for mold.
- B. The ventilation and filtration system, along with any plumbing improvements, shall be installed in compliance with all applicable codes and ordinances, including obtaining any necessary permits, and inspected by the municipality.
C. Measures to assure compliance with this section shall be documented in an odor control and mitigation plan acceptable to DBR.
1.6.15 Pesticide Use and Records
- A. The cultivation process shall use best practices to limit contamination of medical marijuana and marijuana products, including but not limited to mold, mildew, fungus, bacterial diseases, rot, pests, pesticides, and any other contaminant identified as posing potential harm.
B. The use of pesticides on marijuana plants in Rhode Island by registered compassion centers or licensed cultivator will not be considered a violation of these regulations provided that the products satisfy all of the following criteria:
- 1. The product must be a “minimum risk pesticide” under 40 C.F.R. § 152.25(f), incorporated above at § 1.1.7(C) of this Part.
- 2. The product must be labelled for use on all plants, other plants, bedding plants, unspecified plants, or unspecified crops.
- 3. The label must not prohibit indoor or greenhouse use, as applicable.
- 4. All active ingredients must be eligible for food use as determined by the federal Environmental Protection Agency’s list of (EPA) Active Ingredients Eligible for Minimum Risk Pesticide Products, incorporated above at § 1.1.7(D) of this Part. https://www.epa.gov/sites/production/files/2015-12/documents/minrisk-active-ingredients-tolerances-2015-12-15.pdf.
- 5. All inert/other ingredients must be eligible for food use in accordance with EPA’s Inert Ingredients Eligible for FIFRA 25(b) Pesticide Products, incorporated above at § 1.1.7(E) of this Part. https://www.epa.gov/sites/production/files/2016-11/documents/minrisk_inert_ingredients_w_tolerances_2016-11-16.pdf.
- 6. The product must be a currently registered pesticide product eligible for sale in Rhode Island as determined by DEM. To verify a product’s registration in Rhode Island, please consult the online National Pesticide Information Retrieval System through the Center for Environmental and Regulatory Information Systems. http://npirspublic.ceris.purdue.edu/state/state_menu.aspx?state=RI.
- 7. The product must be used in accordance with any and all use instructions on the label.
- C. No application of pesticides shall be made after the vegetative stage of growth of the cannabis plant. The vegetative stage of growth should be determined by visual buds or flower or by proxy of the plant receiving less than eighteen (18) hours of light in a twenty-four (24) hour period.
- D. Pesticides shall be identified, held, stored and disposed of in a manner that protects against contamination of medical marijuana and marijuana products and in a manner that is in accordance with any applicable local, state, or federal law, rule, regulation, or ordinance.
E. As a DBR record-keeping requirement, compassion centers and licensed cultivators must keep detailed records of any pesticide products used and application regiments, including video recording during pesticide applications which must cease if there is a failure or disruption of the video surveillance system. This record-keeping requirement is independent of that required of commercial pesticide applicators by DEM and is intended to apply in addition to that requirement, where relevant.
1.6.16 Safe Disposal of Medical Marijuana Waste and Safe Destruction of Usable Medical Marijuana
- A. Marijuana and marijuana product waste (including all liquid, chemical, hazardous, pesticide, manufacturing solvent and chemical waste containing any traces of marijuana) must be stored, secured, and managed in accordance with all applicable federal, state, and local statutes, regulations, ordinances, or other legal requirements.
- B. Prior to disposal, marijuana and marijuana product waste must be made unusable and any marijuana plant material made indistinguishable from other plant material. This may be accomplished by grinding and incorporating the marijuana plant waste with other non-consumable solid waste or other ground materials, so the resulting mixture is at least fifty percent non-marijuana waste by volume. Other methods to render marijuana waste unusable must be approved by DBR before implementing. Marijuana waste rendered unusable following an approved method may be delivered to a licensed solid waste disposal facility in Rhode Island for final disposition or disposed of in an alternative manner approved by DBR.
- C Destruction of marijuana and marijuana materials other than waste generated in the regular course of processing and/or manufacturing (such as destruction of whole plants, wet, or usable marijuana that are found to be in excess of statutory possession limits or destruction of a contaminated batch of medical marijuana product) shall be in a manner acceptable to DBR, which may include consultation with law enforcement.
- D. Destruction of marijuana and marijuana materials upon revocation or abandonment of the license shall be specifically governed by DBR order or agreement and/or coordinated efforts with law enforcement.
- E. Each compassion center and licensed cultivators must maintain accurate and comprehensive records regarding waste material that accounts for, reconciles, and evidences all waste activity related to the disposal of marijuana and marijuana products (including any waste material produced through the trimming or pruning of a marijuana plant prior to harvest). DBR may mandate storage of any such records or summaries of such records to be through the Medical Marijuana Program Tracking System or any other electronic system DBR designates.
G. All actions in compliance with § 1.6.16 of this Part must comply with any applicable DEM laws, regulations or policies.
1.6.17 Nonprofit Compliance
- A. All compassion centers have a continuing obligation to be organized, structured and operated as a nonprofit in compliance with R.I. Gen. Laws Chapter 7-6.
- B. A compassion center shall at all times be operated on a not-for-profit basis for the mutual benefit of its patients in accordance with R.I. Gen. Laws § 21-28.6-12(f).
- C. Compassion centers shall not be organized, structured or operated in a manner that violates R.I. Gen. Laws § 21-28.6-12(f), or which would cause medical marijuana and medical marijuana products to be priced at unreasonable rates, as determined by DBR, in accordance with R.I. Gen. Laws § 21-28.6-12(d)(2)(iii).
- D. All licensed compassion centers have a continuing obligation to satisfy the requirements for licensure set forth in § 1.2 of this Part.