16 Del. Admin. Code § 4470-7.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4470-7.0 - Registration and Operation of Compassion Centers

7.1 Requirements for operation of a compassion center.

7.1.1 General requirements

7.1.1.1 No person shall operate a compassion center without a Department-issued certificate of registration. The application and renewal requirements for a certificate of registration are in subsections 7.6 and 7.10 of these regulations.

7.1.1.2 A compassion center shall be operated on a not-for-profit basis. A compassion center need not be recognized as a tax-exempt organization by the Internal Revenue Service and is not required to incorporate in response to Title 8; however, a compassion center shall maintain appropriate documentation of its not-for-profit status, and such documentation shall be available for inspection in response to subsection 7.2.7 of these regulations.

7.1.1.3 A compassion center shall not acquire, possess, cultivate, manufacture, deliver, transfer, transport, supply or dispense marijuana for any purpose except to assist registered qualifying patients with the medical use of marijuana directly or through the qualifying patient's registered designated caregiver.

7.1.1.4 Use of pesticides is prohibited:

7.1.1.4.1 There are no pesticides authorized for use on marijuana; as such, a compassion center shall not apply pesticides in the cultivation of marijuana.

7.1.1.4.2 Prohibited pesticides include but are not limited to the following:

7.1.1.4.2.1 Organochlorines;

7.1.1.4.2.2 Organophosphates;

7.1.1.4.2.3 Carbamates; and

7.1.1.4.2.4 Insecticidal, fungicidal or growth regulatory compounds.

7.1.1.5 Packaging of medical marijuana

7.1.1.5.1 All marijuana products shall be in tamper resistant packaging.

7.1.1.6 Labeling of medical marijuana

7.1.1.6.1 All medical marijuana product labels will contain these minimum requirements:

7.1.1.6.1.1 Name of the patient, patient number and date of sale.

7.1.1.6.1.2 Name of the strain, cannabinoid profile, and quantity of the medical marijuana dispensed.

7.1.1.6.1.3 A statement providing that "this product is for medical use only, not for resale" and indicating the medical marijuana is free of contaminants.

7.1.1.7 Labeling shall include recommendations and instructions for use, including daytime or nighttime use and dosing.

7.1.1.8 Online advertising and marketing are permitted subject to the limitations listed in 16 Del.C. Ch. 49A.

7.1.2 Location of a compassion center: A compassion center shall not be located within 500 feet of the property line of a preexisting public or private school.

7.1.3 Bylaws

7.1.3.1 A compassion center shall, as part of its initial application, provide to the Department a true, correct, and current copy of its bylaws, and shall maintain such bylaws in accordance with the Act and these regulations.

7.1.3.2 The bylaws of a compassion center shall include at a minimum:

7.1.3.2.1 The ownership structure of the compassion center;

7.1.3.2.2 The composition of the board of directors; and

7.1.3.2.3 Such provisions relative to the disposition of revenues to establish and maintain the not-for-profit character of the compassion center.

7.1.4 Maintenance of accurate books and records

7.1.4.1 Registered compassion centers shall keep detailed financial reports of proceeds and expenses.

7.1.4.2 Registered compassion centers shall maintain all inventory, sales and financial records in accordance with generally accepted accounting principles ("GAAP").

7.1.4.3 An annual financial audit must be conducted by an independent audit firm and submitted to the Department with the compassion center's annual report.

7.1.4.4 The Department or an audit firm contracted by the Department shall at all times have access to all books and records kept by any compassion center.

7.1.5 Disposal of Unusable Marijuana

7.1.5.1 The medical marijuana inventory system must be updated immediately when a plant is pulled out of inventory for destruction, starting the 72-hour destruction quarantine. The plant number, date and reason must be recorded. This information must be available for auditing by the department.

7.1.5.2 Medical marijuana waste must be stored, secured, and managed in accordance with these regulations and approved operations manual procedures. Medical marijuana waste must be made unusable prior to the waste leaving a registered facility.

7.1.5.3 Liquid waste from medical marijuana facilities shall be disposed of in compliance with the applicable County statutes and regulations including the International Plumbing Code.

7.1.5.4 Medical marijuana waste shall be rendered unusable through grinding and incorporating the medical marijuana waste with non-consumable, solid wastes listed below such that the resulting mixture is at least 50% non-marijuana waste:

7.1.5.4.1 Paper waste,

7.1.5.4.2 Plastic waste,

7.1.5.4.3 Cardboard waste,

7.1.5.4.4 Food waste,

7.1.5.4.5 Soil,

7.1.5.4.6 Grease or other compostable oil waste,

7.1.5.4.7 Other wastes approved by the Division of Public Health that will render the medical marijuana waste unusable.

7.1.5.5 After the medical marijuana waste is made unusable, the solid waste shall be:

7.1.5.5.1 Disposed of as a solid waste at a solid waste site and disposal facility that has a Certificate of Designation from the local governing body,

7.1.5.5.2 Deposited at a compost facility that has a Certificate of Designation from the Department of Natural Resources and Environmental Control (DNREC), or

7.1.5.5.3 Composted on-site at a facility owned by the generator and operated in compliance with applicable County statutes and regulations.

7.2 Security requirements: A compassion center shall implement appropriate security and safety measures to deter and prevent the unauthorized entrance into areas containing marijuana and the theft of marijuana. Such measures shall include the following:

7.2.1 Exterior of premises: With respect to the exterior of a compassion center:

7.2.1.1 Access from outside the premises shall be kept to a minimum and be well controlled.

7.2.1.2 The outside perimeter of the premises shall be well lighted.

7.2.1.3 Entry into any area where marijuana is held shall be limited to authorized personnel.

7.2.2 Alarm system:

7.2.2.1 A compassion center shall have a fully operational security alarm system at each authorized physical address that will provide suitable protection against theft and diversion. For the purpose of these regulations, a fully operational security alarm system shall include:

7.2.2.1.1 Immediate automatic or electronic notification to alert local or municipal law enforcement agencies to an unauthorized breach of security at the compassion center or at any other authorized physical address;

7.2.2.1.2 Immediate automatic or electronic notification to local or municipal public safety personnel of a loss of electrical support backup system; and

7.2.2.1.3 When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

7.2.2.2 A compassion center shall conduct a maintenance inspection/test of the alarm system for each authorized location at intervals not to exceed 30 days from the previous inspection/test. A compassion center shall promptly make all necessary repairs to ensure the proper operation of the alarm system.

7.2.2.3 In the event of a failure of the security system, due to loss of electrical support or mechanical malfunction, that is expected to exceed an eight-hour period, a compassion center shall:

7.2.2.3.1 Within 24 hours of discovery of the event, notify the Department by telephone; and

7.2.2.3.2 Provide alternative security measures approved by the Department or close the authorized physical addresses impacted by the failure/malfunction until the security alarm system has been restored to full operation.

7.2.2.4 A compassion center shall maintain documentation in an auditable form for a period of at least 24 months after the event for:

7.2.2.4.1 All maintenance inspections/tests conducted in response to subsection 7.2.2.2 of these regulations, and any servicing, modification or upgrade performed on the security alarm system. The record shall include, as a minimum, the date of the action, a summary of the actions performed and the name, signature and title of the individual who performed the actions;

7.2.2.4.2 Any alarm activation or other event which requires response by public safety personnel; and

7.2.2.4.3 Any unauthorized breach of security.

7.2.3 Video surveillance: A compassion center shall provide an appropriate video surveillance system that includes the following areas and access to recorded surveillance.

7.2.3.1 Video surveillance should record access areas, customer service areas, growing areas, and anywhere the marijuana is handled, to include processing and packaging areas.

7.2.3.2 Video footage will be digitally recorded and held for 90 days for routine footage or up to 36 months if video contains information of significance.

7.2.3.3 A compassion center shall provide the Department with access to the video 24-hours a day, seven days a week through a secure internet connection.

7.2.4 Inventory controls

7.2.4.1 Coding and computer interface: A compassion center shall:

7.2.4.1.1 Employ a barcoding inventory control system to track batch, strain and amounts of marijuana in inventory and amounts sold, to include patients' card registration numbers. All plants, regardless of stage of growth must have the strain and barcode label affixed to the plant or container for immature plants.

7.2.4.1.2 Be responsible for developing and hosting a secure computer interface to connect with DEC3S.

7.2.4.2 Storage of marijuana: A compassion center shall ensure that usable marijuana is stored in a locked area with adequate security. For purpose of these regulations "adequate security," at a minimum, should be assessed, established and maintained based on:

7.2.4.2.1 The quantity of usable marijuana that will be kept on hand at each authorized location;

7.2.4.2.2 The compassion center's inventory system for tracking and dispensing usable marijuana;

7.2.4.2.3 The number of principal officers, board members, agents, volunteers or employees who have or could have access to the usable marijuana;

7.2.4.2.4 The geographic location of the compassion center (i.e.: high-crime or low-crime area);

7.2.4.2.5 The scope and sustainability of the alarm system; and

7.2.4.2.6 The root cause analysis of any breach of security and/or inventory discrepancy for usable marijuana at that location.

7.2.5 Comprehensive and monthly inventories

7.2.5.1 A compassion center shall:

7.2.5.1.1 Notify the Department and local law enforcement within 24 hours any time there is a suspected loss of marijuana and shall cooperate fully with any investigation into the suspected loss.

7.2.5.1.2 Conduct an initial comprehensive inventory of all medical marijuana, including usable marijuana available for dispensing, mature marijuana plants and unusable marijuana, at each authorized location on the date the compassion center first dispenses medical marijuana.

7.2.5.1.3 Conduct the comprehensive inventory required by subsection 7.2.5 of these regulations at intervals not to exceed 24 months from the date of the previous comprehensive inventory.

7.2.5.1.4 Conduct a monthly inventory review of stored, usable marijuana.

7.2.5.2 If an inventory conducted in response to subsection 7.2.5.1 of these regulations identifies a discrepancy, the Department and appropriate local law enforcement authorities will be notified of the discrepancy within 24 hours of discovery of the event.

7.2.5.3 Documentation of all inventories conducted in response to subsection 7.2.5.1 of these regulations shall include, as a minimum, the date of the inventory, a summary of the inventory findings and the name, signature and title of the individual or individuals who conducted the inventory.

7.2.6 Maximum amount of compassion center inventory. A registered compassion center:

7.2.6.1 Shall grow an amount of marijuana sufficient to meet the qualifying patient population demands as determined by the Division.

7.2.6.2 Shall possess no more than 1,000 pounds of usable marijuana regardless of formulation unless a variance is approved by the OMM Director.

7.2.6.3 May not purchase usable marijuana or mature marijuana plants from any person other than another registered compassion center.

7.2.7 Compassion centers are subject to random inspection by the Department's Office of Medical Marijuana.

7.2.7.1 During an inspection, the Department may review the compassion center's confidential records, including its financial and dispensing records, which may track transactions according to qualifying patients' registry identification numbers to protect their confidentiality and its security protocols.

7.2.7.2 The Department will review the facility to ensure compliance with subsections 7.2 and 7.3 of these regulations.

7.2.7.3 The Department will inspect the facility for the presence of pesticides listed in subsection 7.1.1.4, fungus and molds.

7.2.7.4 The Department may collect samples for random quality sampling by a laboratory selected by the Department.

7.2.7.4.1 The compassion center will be invoiced for the cost of random sampling testing.

7.2.7.5 The Department will review the facility for compliance with applicable federal, state and local standards.

7.2.7.6 Hazard Chemical Storage

7.2.7.6.1 The Department will inspect the facility for the presence of butane, hexane, pentane, and propane; or extraction techniques that may produce hazardous conditions. Any form of alkane or petroleum hydrocarbon extraction is unauthorized in Delaware.

7.2.8 Dispensing marijuana

7.2.8.1 Design and security features of medical marijuana containers.

7.2.8.1.1 Marijuana shall be dispensed in sealed, tamperproof containers clearly identified as having been issued by the compassion center and that meet the requirements in subsection 7.3.10 of these regulations.

7.2.8.1.2 Patients and designated caregivers should receive written instruction that the marijuana shall remain in this container when it is not being prepared for ingestion or being ingested.

7.2.8.2 No marijuana shall be dispensed unless or until the patient or caregiver identification card has been verified as valid in the computer system identified in subsection 7.2.4.1.2 of these regulations.

7.2.8.3 Maximum amount of usable marijuana to be dispensed.

7.2.8.3.1 A compassion center or principal officer, board member, agent, volunteer or employee of a compassion center:

7.2.8.3.1.1 Shall not dispense, deliver or otherwise transfer marijuana to a person other than a qualifying patient or to such patient's other designated caregiver.

7.2.8.3.1.2 Shall not dispense more than three ounces of usable marijuana to a qualifying patient directly or through a qualifying patient's caregiver during a 14-day period.

7.2.8.3.1.3 Shall not dispense an amount of usable marijuana to a qualifying patient or a qualifying patient's caregiver that the compassion center principal officer, board member, agent, volunteer or employee knows would cause the recipient to possess more marijuana than is permitted under the Act or these regulations.

7.2.8.3.1.4 Shall dispense pediatric medical marijuana oils as described in Section 2.0 of these regulations to qualified patients under the age of 18 years. Patients under the age of 18 are restricted from purchasing products other than pediatric medical marijuana oil.

7.2.8.3.1.4.1 Any materials used in production of marijuana products will have Generally Recognized As Safe (GRAS) documentation and used as directed.

7.2.8.3.1.5 Cannabidiol-Rich medical marijuana must contain near equal concentrations of tetrahydrocannabinol and Cannabidiol, regardless of the form.

7.2.8.3.1.5.1 Flower strains produced to be compliant as CBD-Rich marijuana must be clearly identified.

7.2.8.3.1.5.2 Concentrates, vapes, capsules and edibles produced to be CBD-Rich compliant must be clearly identified.

7.2.8.3.2 In addition to any other penalties that may be applicable under the Act or these regulations, any person found to have violated subsection 7.2.8 of these regulations is not eligible to be an employee, agent, principal officer or board member of any compassion center and such person's registry identification card shall be immediately revoked.

7.3 Operations manual. A compassion center shall, as part of its initial application, provide to the Department a true, correct and current copy of its operating manual, and shall maintain such operating manual in accordance with the Act and these regulations. Such manual shall include, as a minimum, the following requirements:

7.3.1 Procedures for the oversight of the compassion center including, but not limited to, documentation of the reporting and management structure of the compassion center;

7.3.2 Procedures for safely dispensing medical marijuana to registered qualifying patients or their registered designated caregiver;

7.3.3 Procedures to ensure accurate record keeping, including protocols to ensure that quantities purchased do not suggest re-distribution;

7.3.4 Employee security policies;

7.3.5 Safety and security procedures, including a disaster plan with procedures to be followed in case of fire or other emergencies;

7.3.6 Personal safety and crime prevention techniques;

7.3.7 A job description or employment contract developed for all employees and a volunteer agreement for all volunteers which includes duties, responsibilities, authority, qualification and supervision;

7.3.8 The compassion center's alcohol and drug free workplace policy;

7.3.9 A description of the compassion center's outreach activities to registered qualifying patients or their registered designated caregiver, which shall as a minimum include:

7.3.9.1 Providing each new registered patient who visits the compassion center with frequently asked questions, designed by the Department, that explain the limitations on the right to use medical marijuana under state law;

7.3.9.2 Ingestion options of usable marijuana provided by the compassion center;

7.3.9.3 Safe smoking techniques that shall be provided to registered qualifying patients; and

7.3.9.4 Potential side effects and how this information shall be communicated.

7.3.10 A description of the packaging of the useable marijuana that the compassion center shall be utilizing which shall, as a minimum, include:

7.3.10.1 The name of the strain, batch, and quantity;

7.3.10.2 The statement "this product is for medical use only, not for resale"; and

7.3.10.3 Details indicating (1) the medical marijuana is free of contaminants and (2) the levels of active ingredients in the product.

7.3.11 A description of the documentation that will accompany a registered compassion center agent when transporting marijuana on behalf of the registered compassion center. In response to 16 Del.C. § 4918A(b), the documentation must specify, at least, the amount of marijuana being transported, the date the marijuana is being transported, the registry identification number of the registered compassion center, and a contact number to verify that the marijuana is being transported on behalf of the registered compassion center.

7.3.12 Detailed procedures regarding the random sampling of medical marijuana. OMM staff will supervise selection of samples from the curing vessels with the Compassion Center staff.

7.3.12.1 Compassion Center staff will prepare additional barcode labels and tamper-proof containers for each plant scheduled to be sampled and develop a transportation manifest, initiating the chain of custody process for the batch of plants being tested;

7.3.12.2 The Compassion Centers will not sell or prepare products from the batch being tested until the Safety and Compliance Center enter the values into the DEC3S program, releasing the material for use or sale;

7.3.12.3 Any concentrates or other infused products must be sent to the Safety and Compliance Center for testing, using the manifest process listed above before the batch being tested is cleared for sale;

7.3.12.4 Sample results will be loaded into the DEC3S system by the Safety and Compliance Center allowing Compassion Centers to sell the material or incorporate it into other products; and

7.3.12.5 Compassion Centers will coordinate directly with the Safety and Compliance Center on invoicing and payment for testing services.

7.4 Required training. Each compassion center 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 volunteer training needs. Each employee, agent or volunteer, at the time of initial appointment, shall receive, as a minimum, training in the following:

7.4.1 Professional conduct, ethics, and state and federal laws regarding patient confidentiality;

7.4.2 Informational developments in the field of medical use of marijuana;

7.4.3 The proper use of security measures and controls that have been adopted; and

7.4.4 Specific procedural instructions for responding to an emergency, including robbery or violent accident.

7.5 Personnel

7.5.1 Records. Each compassion center shall maintain:

7.5.1.1 A personnel record for each employee, agent or volunteer for a period of at least six months after termination of the individual's affiliation with the compassion center. The record shall include, as a minimum, the following:

7.5.1.1.1 An application for employment or to volunteer;

7.5.1.1.2 A record of any disciplinary action taken;

7.5.1.1.3 Documentation of all required training. Documentation shall include a signed statement from the individual indicating the date, time and place of said training and topics discussed, including the name and title of presenters;

7.5.1.2 A record of the source of any funds that will be used to open or maintain the compassion center, including the name, address, and date of birth of any investor contributing more than $5,000; and

7.5.1.3 A record of any instances in which a business or not-for-profit that any of the prospective board members managed or served on the board of was convicted, fined, censured, or had a registration or license suspended or revoked in any administrative or judicial proceeding.

7.5.2 Registry identification cards and background checks for principal officers, board members, agents, volunteers or employees of a compassion center.

7.5.2.1 In response to the requirements of this rule, and upon the approval of the submitted application, the Department shall issue a registry photo identification card to each principal officer, board member, agent, volunteer or employee of a compassion center who is associated with the compassion center and meets the requirements under these regulations. In order for a registry identification card to be obtained, the following items shall be submitted to the medical marijuana program.

7.5.2.1.1 Documentation verifying that the applicant is at least 21 years of age;

7.5.2.1.2 A reasonable xerographic copy of the applicant's Delaware license or comparable State of Delaware or federal issued photo identification card verifying Delaware residence; identification card must be available for inspection/verification;

7.5.2.1.3 A written and signed statement from an officer or executive staff member of the compassion center stating that the applicant is associated with the compassion center and in what capacity;

7.5.2.1.4 The name, address and telephone number of the applicant;

7.5.2.1.5 The name, address and telephone number of the compassion center with which the agent is associated;

7.5.2.1.6 The applicant's signature and date;

7.5.2.1.7 A non-refundable, non-returnable application or renewal fee of $125 in the form of a check made out to "State of Delaware-MMP".

7.5.2.2 In response to 16 Del.C. §§ 4914A and 4915A, each principal officer, board member, agent, volunteer or employee of a compassion center shall consent to a full nationwide and statewide criminal history screening background check.

7.5.2.2.1 Each applicant shall submit a full State Bureau of Identification (SBI) criminal history screening check and a full nationwide criminal history screening check to demonstrate compliance with the eligibility requirements of these regulations.

7.5.2.2.2 All applicable fees associated with the required criminal history screening background checks shall be paid by the compassion center or the applicant.

7.5.2.2.3 In response to 16 Del.C. § 4919A(n), individuals convicted of an excluded felony offense, as described in the definitions Section 2.0, and 16 Del.C. § 4902A(7), within five years from the date of application, are prohibited from being a compassion center agent.

7.5.2.3 The Department may verify information on each application and the accompanying documentation as set forth in subsection 5.1 of these regulations.

7.5.2.4 The Department shall notify the compassion center in writing of the purpose for denying the registry identification card in accordance with § 4918A of the Act. The DHSS Secretary or designee shall deny an application if the applicant fails to provide the information required or if the Department determines that the information provided is false. Denial of an application or renewal is considered a final Department action, subject to judicial review. Jurisdiction and venue for judicial review are vested in the Superior Court.

7.5.2.5 The Department shall issue each principal officer, board member, agent, volunteer or employee of a compassion center a registry identification card within 30 days of receipt of the information required by subsections 7.5.2.1 and 7.5.2.2. The registry identification card shall contain such information as set forth in §4911A of the Act and subsection 7.5.2 of these regulations.

7.5.2.6 Each compassion center shall notify the Department in writing within ten days of when a principal officer, board member, agent, volunteer or employee ceases to work at the compassion center. The individual's registry identification card shall be deemed null and void and the individual shall be liable for any other penalties that may apply to the individual's nonmedical use of marijuana.

7.5.3 Expiration date of registry identification cards. The registry identification card of a principal officer, board member, agent, volunteer or employee shall expire one year after its issuance, or upon the expiration of the compassion center's registration certificate, whichever comes first.

7.5.3.1 Every principal officer, board member, agent, volunteer or employee of a compassion center must have a valid, unexpired registry identification card issued by the Office of Medical Marijuana.

7.6 Application for operation of a compassion center. Applicants shall only be accepted during an open application period announced by the Department and shall include the following items:

7.6.1 A non-refundable application fee, made payable to the Division of Public Health, Medical Marijuana Program, in the amount of $5,000;

7.6.2 The proposed legal name, articles of incorporation and bylaws of the compassion center;

7.6.3 The proposed physical address or addresses of the compassion center, including any additional addresses to be used for the secure cultivation of medical marijuana, and with the following details:

7.6.3.1 If precise addresses are known, evidence of compliance to the following rules shall be included:

7.6.3.1.1 Compliance to the local zoning laws for each physical address to be utilized as a compassion center or for the secure cultivation of medical marijuana;

7.6.3.1.2 Evidence that all of the physical addresses identified in this subsection are not located within 500 feet of a property line of a preexisting public or private school;

7.6.3.2 If precise addresses have not been determined, identification of the general locations where it would be sited, and when it would be established;

7.6.4 A description of the enclosed, locked facility, meeting all requirements of subsection 7.2 that would be used in the cultivation of marijuana, including steps to ensure that the marijuana production shall not be visible from the street or other public areas;

7.6.5 Evidence of the compassion center's not-for-profit status, which can be:

7.6.5.1 Documentation of recognition as a tax-exempt organization by the United States Internal Revenue Service; or

7.6.5.2 Other written materials which will allow the Department to determine the compassion center's ability to comply with the revenue criteria contained in 16 Del.C. § 4914A and § 4915A.

7.6.6 The name, address, and date of birth of each principal officer and board member of the compassion center;

7.6.7 A description of proposed security and safety measures which demonstrate compliance with subsection 7.2 of these regulations;

7.6.8 A draft operations manual which demonstrates compliance with subsection 7.3 of these regulations;

7.6.9 An example of the design and security features of medical marijuana containers which demonstrates compliance with subsection 7.2.8 of these regulations;

7.6.10 A list of all persons or business entities having direct or indirect authority over the management or policies of the compassion center;

7.6.11 A list of all persons or business entities having 5.0% or more ownership in the compassion center, whether direct or indirect and whether the interest is in profits, land or building, including owners of any business entity which owns all or part of the land or building; and

7.6.12 The identities of all creditors holding a security interest in the premises, if any.

7.7 Complete application required. Only applications which the Department has determined to be complete (i.e. adequately addresses all requirements in these regulations and 16 Del.C. §§ 4914A and 4915A) shall be eligible for review in response to subsection 7.8 of these regulations.

7.8 Compassion center application review criteria. The Department shall evaluate applications for a compassion center registration certificate using an impartial and numerically scored competitive bidding process developed by the Department in accordance with 16 Del.C. § 4914A(b) and these regulations. The Department shall consider the following criteria:

7.8.1 Documentation of not-for-profit status, consistent with subsection 7.6.5 of these regulations;

7.8.2 The suitability of the proposed location or locations, including but not limited to compliance with any local zoning laws and the geographic convenience to patients from throughout the State of Delaware to compassion centers if the applicant were approved;

7.8.3 The principal officer and board members' character and relevant experience, including any training or professional licensing related to medicine, pharmaceuticals, natural treatments, botany, or marijuana cultivation and preparation and their experience running business or not-for-profit entities;

7.8.4 The proposed compassion center's plan for operations and services, including its staffing and training plans, whether it has sufficient capital to operate, and its ability to provide an adequate supply and variety of medical marijuana and medical marijuana based products to the registered patients in the State;

7.8.5 The sufficiency of the applicant's plans for record keeping;

7.8.6 The sufficiency of the applicant's plans for safety, security, and the prevention of diversion, including proposed locations and security devices employed;

7.8.7 The applicant's plan for making medical marijuana available on an affordable basis to registered qualifying patients enrolled in Medicaid or receiving Supplemental Security Income or Social Security Disability Insurance;

7.8.8 The applicant's plan for safe and accurate packaging and labeling of medical marijuana, which shall include, without limitations, these minimum requirements for packaging and labeling:

7.8.8.1 The name of the strain, batch, and quantity of the medical marijuana;

7.8.8.2 A statement providing that "this product is for medical use only, not for resale";

7.8.8.3 Details indicating the medical marijuana is free of contaminants;

7.8.8.4 Details indicating the levels of active ingredients in the product; and

7.8.9 The applicant's ability to grow marijuana without use of pesticides.

7.9 Issuance of a registration certificate authorizing operation of a compassion center. When an applicant to operate a compassion center is notified that the Department has approved its application, it shall submit the following additional items to the Department before the registration certificate authorizing operation of a compassion center will be issued.

7.9.1 A certification fee, made payable to "State of Delaware-MMP" in the amount of $40,000;

7.9.2 The legal name, articles of incorporation, and bylaws of the compassion center;

7.9.3 The physical address of the compassion center and any additional addresses to be used for the secure cultivation of marijuana, including:

7.9.3.1 Evidence demonstrating the following:

7.9.3.1.1 Compliance with all local zoning laws for each physical address to be utilized as a compassion center or for the secure cultivation of medical marijuana; and

7.9.3.1.2 That none of the physical addresses identified in subsection 7.9.3 of these regulations are located within 500 feet of the property line of preexisting public or private schools;

7.9.3.2 It is not necessary to resubmit any information provided in response to subsection 7.6.3.1 of these regulations unless there has been a change in that information;

7.9.4 Any updates to previously submitted information including, but not limited to, information about officers, principals, board members, agents, employees, and compliance with subsections 7.2 and 7.3 of these regulations;

7.9.5 A current certificate of occupancy, or equivalent document, to demonstrate compliance with the provisions of the State Fire Code for each physical address to be utilized as a compassion center or for the secure cultivation of medical marijuana.

7.10 Expiration, termination, or renewal of a registration certificate authorizing operation of a compassion center.

7.10.1 Expiration: A compassion center's registration shall expire two years after its registration certificate is issued. The compassion center may submit a renewal application at any time beginning 90 days prior to the expiration of its registration certificate. Such renewal application must be submitted a minimum of 30 days prior to the expiration of its registration certificate to avoid suspension of the certificate.

7.10.2 Renewal. The Department shall grant a compassion center's renewal application within 30 days of its submission if the following conditions are all satisfied:

7.10.2.1 The compassion center submits materials required under subsection 7.9 of these regulations, including a summary annual report with financial audit attached, a comprehensive inventory with a cover letter and the $40,000 fee, which shall be refunded if the renewal application is rejected;

7.10.2.2 The Department has not ever suspended the compassion center's registration for violations of the Act or these regulations;

7.10.2.3 Inspections conducted pursuant to the Act and these regulations do not raise any serious concerns about the continued operation of the registered compassion center applying for renewal; and

7.10.2.4 The applicant continues to meet all of the requirements for the operation of a compassion center as set forth in the Act and in these regulations.

7.10.3 Suspension: The Department will suspend a registration certificate authorizing the operation of a compassion center, with or without notice, for any violation of an applicable law or regulation.

7.10.4 Termination: Upon receipt of written notice that a registration certificate has been terminated, the compassion center has 30 business days to request, in writing, a hearing, for the purpose of review of such action. The hearing process shall follow the procedures in subsections 9.4 through 9.5.10 of these regulations:

7.10.4.1 A written decision will be issued by the Department within 30 days of the completion of the hearing. The decision will lift the suspension or terminate a registration certificate. The written decision will state with specificity the reasons for the decision.

7.10.4.2 The termination of a registration certificate is a final decision of the Department, subject to judicial review. Jurisdiction and venue are vested in the Superior Court.

7.11 Non-transferable registration certificate authorizing operation of a compassion center.

7.11.1 A registration certificate authorizing operation of a compassion center shall not be transferred by assignment or otherwise to other persons or locations. Unless the compassion center applies for and receives an amended registration certificate authorizing operation of a compassion center, the registration certificate shall be void and returned to the Department when one or more of the following situations occur:

7.11.1.1 A change in ownership of the compassion center;

7.11.1.2 A change in one or more authorized physical locations; or

7.11.1.3 The compassion center discontinues its operation.

7.11.2 A compassion center shall provide the Department with a written notice of any change described in subsection 7.11 of these regulations at least 60 days prior to the proposed effective date of the change. The Department may waive all or part of the required advance notice to address emergent or emergency situations.

7.11.3 Transactions which usually do not constitute a change of ownership include the following:

7.11.3.1 Changes in the membership of the board of directors or board of trustees; or

7.11.3.2 Two or more legal entities merge and the entity to whom the registration certificate authorizing operation of a compassion center was issued survives.

7.11.4 Management agreements are generally not considered a change in ownership if the entity to whom the registration certificate authorizing operation of a compassion center was issued continues to retain ultimate authority for the operation of the compassion center; however, if the ultimate authority is surrendered and transferred from the entity to whom the registration certificate authorizing operation of a compassion center was issued to a new manager, then a change of ownership has occurred.

7.12 Compassion centers that offer medical marijuana home delivery to registered patients must develop and field a computer inventory system that integrates with DEC3S.

7.12.1 Compassion centers must pre-register qualified patients for home delivery.

7.12.2 Compassion centers must establish protocols for identifying the patient and receiving payment.

7.12.3 Compassion centers must use a comprehensive manifest and invoicing program to ensure the correct products are delivered to the appropriate, positively identified patient.

7.12.4 Compassion centers will be responsible for submitting a plan to the Office of Medical Marijuana detailing how safe transportation and delivery services will be accomplished. This plan must be approved by OMM before delivery services can begin.

7.12.4.1 The Office of Medical Marijuana may rescind approval of the home delivery plan for failure to comply with the approved plan, these regulations or the Medical Marijuana Act.

16 Del. Admin. Code § 4470-7.0

17 DE Reg. 738(1/1/2014)
19 DE Reg. 409(11/1/2015)
23 DE Reg. 667(2/1/2020)
24 DE Reg. 485( 11/1/2020) (Final)