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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsFebruary 2019


Regulatory Flexibility Act Form

Authenticated PDF Version

16 DE Admin. Code 4470
Pursuant to 16 Del.C. Ch. 49A, Office of Medical Marijuana (OMM), Division of Public Health, Department of Health and Social Services, is proposing revisions to the regulations governing the State of Delaware Medical Marijuana Code. On February 1, 2019, the Division of Public Health plans to publish as “proposed” revisions to the State of Delaware Medical Marijuana Code. The revisions include the establishment of requirements for Safety Compliance facilities, provisions for the production of edible medical marijuana products and limitations therein, compliance and enforcement procedures, random sampling procedures, and the addition of specific definitions and technical corrections.
Copies of the proposed regulations are available for review in the February 1, 2019 edition of the Delaware Register of Regulations, accessible online at: http://regulations.delaware.gov or by calling the Division of Public Health at (302) 744-4951.
The Secretary of Delaware Health and Social Services adopts these Regulations regulations in response to the authority vested in the Secretary by 16 Del.C. Ch. 49A, The Delaware Medical Marijuana Act. These Regulations regulations establish the standards for the procedures for issuing a certificate of registration to qualified patients and primary caregivers. These Regulations regulations provide a system of permitting and inspection, as well as governing confidentiality, payments of fees, and enforcement of these rules.
These Regulations regulations shall be liberally construed and applied to promote their underlying purpose of protecting the public’s health.
These Regulations regulations shall hereby be known as the “State of Delaware Medical Marijuana Code.”
The following words and terms, when used in these Regulations regulations, should have the following meaning, unless the context clearly indicates otherwise:
Act” means the Delaware Marijuana Act, 16 Del.C. §§4901A et seq.
Adulterated means made impure or inferior by adding extraneous ingredients. Goods that are prepared in food establishments that are licensed facilities in response to 16 Del.C. §122(3)(u) and 16 Del.C. §134, and that contain marijuana for medical use by a registered patient, are not considered to be adulterated.
Advisory board means a nine member committee established, chaired, and appointed by the General Assembly of Delaware to evaluate and make recommendations to the state legislature and the Department.
Applicant” means any person applying to participate in the Delaware Office of Medical Marijuana Program, hereinafter OMMP MMP.
"Background check" means any person required to obtain a background check under this chapter shall submit fingerprints and other necessary information to the State Bureau of Identification in order to obtain a report of the person's entire criminal history record from the State Bureau of Identification or a statement that the State Bureau of Identification Central Repository contains no such information relating to that person. The report will include the person's entire federal criminal history record from the Federal Bureau of Investigation pursuant to Federal Bureau of Investigation appropriation of Title II of Public Law 92-544 (28 U.S.C. §534) or a statement that the Federal Bureau of Investigation's records contain no such information relating to that person. A person required to obtain a background check under this chapter is responsible for any costs associated with obtaining the background check.
"Bona fide physician-patient relationship" means a treatment or counseling relationship between a physician and patient in which all the following are present:
Butane Hash Oil” or “(BHO)” means a cannabis concentrate produced using an alkane or petroleum hydrocarbon.
Cannabidiol” or “CBD” is a cannabinoid found in cannabis with mild psychoactive properties which does not induce an euphoric high.
Cardholder means a registered patient or a registered designated caregiver who has been issued and possesses a valid registry identification card.
Compassion center agent” means a principal officer, board member, employee, or agent of a registered compassion center who is 21 years of age or older and has not been convicted of an excluded felony offense, and has not been convicted of a drug misdemeanor within five years.
Concentrate” means any product created when marijuana flowers are refined into something more pure and potent. This umbrella term includes any type of hash (water hash, pressed hash), dry sieve (kief), as well as hash oils (CO2 oil, shatter, wax, and rosin) and indicates that these products are a concentrated form of cannabis, carrying a higher potency.
Consumer” means a person who is a patient in the Medical Marijuana Program, takes possession of marijuana, and is not functioning in the capacity of an operator of a marijuana business.
Debilitating medical condition means one or more of the following:
(a) Terminal illness, cancer, positive status for human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), decompensated cirrhosis (hepatitis C), amyotrophic lateral sclerosis (ALS or Lou Gehrig’s Disease), post-traumatic stress disorder (PTSD), intractable epilepsy, autism with self-injurious or aggressive behavior, seizure disorder, glaucoma, debilitating migraines, and agitation of Alzheimer’s disease or the treatment of these conditions;
(b) a A chronic or debilitating disease medical condition or its treatment that produces one or more of the following: cachexia or wasting syndrome; severe, debilitating pain that has not responded to previously prescribed medication or surgical measures for more than three months or for which other treatment options produced serious side effects; intractable nausea; seizures; or severe and persistent muscle spasms, including but not limited to those characteristic of multiple sclerosis;
(c) Pediatric qualifying conditions are limited to any of the following related to a terminal illness; pain; anxiety; depression; seizure disorder; severe debilitating autism; or a chronic or debilitating disease or medical condition where they have failed treatment involving one or more of the following symptoms: cachexia or wasting syndrome; intractable nausea; severe, painful and persistent muscle spasms.
(cd) any Any other medical condition or its treatment added by the Department, as provided for in 16 Del.C. §4906A and Section 6.0 of this code.
Delaware Enterprise Consolidated Cannabis Control System” is the state-wide application which serves as patient registry, point of sale monitor, seed to sale inventory tracker and repository of medical marijuana product test results, hereinafter known as DEC3S.
Delaware Food Code” means the current State of Delaware Food Code.
Department” means the Delaware Department of Health and Social Services.
Designated caregiver means a person who:
(a) is Is at least 21 years of age unless the person is the parent or legal guardian of a minor who is a qualifying patient,
(b) has Has agreed to assist with a patient's medical use of marijuana
(c) has Has not been convicted of an excluded felony offense; and
(d) assists Assists no more than five qualifying patients with their medical use of marijuana.
Direct Sales” means sales of marijuana products within the State of Delaware directly to the registered patients without the use of an independent retailer or other intermediary.
Division” means the Delaware Division of Public Health
Drinking Water” means water that meets criteria as specified in 40 CFR 141 National Primary Drinking Water Regulations. "Drinking water" is traditionally known as "potable water." "Drinking water" includes the term "water" except where the term used connotes that the water is not potable, such as "boiler water," "mop water," "rainwater," "wastewater," and "nondrinking" water.
Employee” or “Agent” refers to an individual having supervisory or management duties; an individual on the payroll; a volunteer; an individual performing work under contractual agreement; or any other individual working in a marijuana business.
Excluded felony offense” means:
(a) a A violent crime defined in 11 Del.C. §4201(c), that was classified as a felony in the jurisdiction where the person was convicted; or
(b) a A violation of a state or federal controlled substance law that was classified as a felony in the jurisdiction where the person was convicted, not including:
(1) an An offense for which the sentence, including any term of probation, incarceration, or supervised release, was completed 10 or more years earlier; or
(2) an An offense that consisted of conduct for which 16 Del.C. Ch. 49A would likely have prevented a conviction, but the conduct either occurred prior to July 1, 2011, or was prosecuted by an authority other than the State of Delaware.
Food-Contact Surface” means a surface of equipment or a utensil with which food normally comes into contact; or a surface of equipment or a utensil from which food may drain, drip or splash into a food or onto; or a surface normally in contact with food.
Food Equipment” means an article that is used in the operation of a marijuana infused food establishment such as a freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, and table, temperature measuring device for ambient air, vending machine, or ware washing machine. Equipment may be defined as a food-contact surface or non-food contact surface. "Equipment" does not include apparatuses used for handling or storing large quantities of packaged foods that are received from a supplier in a cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets, racks, and skids.
Imminent Health Hazard” means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on: the number of potential injuries, and the nature, severity, and duration of the anticipated injury.
Incidental amount of marijuanameans marijuana seeds, stalks and roots of the plant that are not included when calculating the allowable amounts of marijuana specified in these rules. This includes the weight of any non-marijuana ingredients combined with marijuana, such as ingredients added to prepare a topical ointment, food or drink.
"Intractable epilepsy" means an epileptic seizure disorder for which standard medical treatment does not prevent or significantly ameliorate recurring, uncontrolled seizures or for which standard medical treatment results in harmful side effects.
Marijuana” means the same as defined in 16 Del.C. §4701 (23).
Marijuana Infused Food Products” refers to a non-time/temperature controlled (non-TCS) for safety food as specified in these Regulations that is offered for sale directly to consumers and only at a licensed Compassion Center.
Marijuana paraphernalia is limited to equipment, products and materials that are ordinarily used in planting, propagating, cultivating, growing, harvesting, processing, preparing, testing, analyzing, packaging, repackaging, storing, containing, ingesting, inhaling or otherwise introducing marijuana into the human body. It includes:
"Medical marijuana oil" means a resinous matrix of cannabinoids obtained from the Cannabis plant by solvent extraction, formed into oil.
"Medical marijuana waste" means unused, surplus, returned, or out of date medical marijuana, recalled medical marijuana, and any plant debris, including dead plants, all unused plant parts, and roots.
Medical use means the acquisition, possession, use, delivery, transfer or transportation of marijuana or paraphernalia relating to the administration of marijuana to treat or alleviate a registered patient’s debilitating medical condition or symptoms associated with the registered patient’s debilitating medical condition.
Nonfood-contact surface means all exposed surfaces other than food and splash zones.
Onsite assessment means a visit by an employee of the Department for the purpose of ensuring compliance with the requirements of these rules.
"Pediatric Medical marijuana oil" means:
c. any Any change in the oil formulation which is made by the Department based upon the recommendation of the advisory council Medical Marijuana Act Oversight Committee" Committee.
Physician means a properly licensed physician subject to 24 Del.C. Ch. 17, except as otherwise provided in this definition. If the qualifying patient’s debilitating medical condition is post-traumatic stress disorder, the physician must also be a licensed psychiatrist. If the qualifying patient is younger than 18 years of age, the physician must be a pediatric neurologist, pediatric gastroenterologist, pediatric oncologist, pediatric psychiatrist, developmental pediatrician or pediatric palliative care specialist.
Poisonous and Toxic Materials” means substances that are not intended for ingestion, including cleaners and sanitizers, pesticides, necessary maintenance substances, such as non-food grade lubricants, and personal care items, such as medicines, first aid supplies, cosmetics and toiletries.
Post-Traumatic Stress Disorder” means that a patient meets the diagnostic criteria for Post-Traumatic Stress Disorder (PTSD), per DSM-5 or subsequent current edition, including symptoms of intense physical reactions such as tachycardia, shortness of breath, rapid breathing, muscle-tension, and sweating.
Processing area” refers to the area of the marijuana business where marijuana is prepared, trimmed, packaged or food prep and other food service activities occur.
Qualifying patientmeans a person who has been diagnosed by a physician as having a debilitating medical condition.
Registration Holder” means the entity that is legally responsible for the operation of the marijuana compassion center such as the owner, the owner’s agent, or other person; and possesses a valid registration to operate a marijuana business.
“Registry identification card means a document issued by the Department that identifies a person as a registered patient or registered designated caregiver.
Regulatory Authority” means the Secretary, Delaware Department of Health and Social Services (DHSS), or authorized designee.
"Responsible Party" means the parent or legal guardian with responsibility and decision-making capability for a qualifying patient or applicant. The Responsible Party will have primary responsibility for purchase, handling and dispensing of the medical marijuana products for the person under the Responsible Party’s charge.
"Safety Compliance Facility'' means a nonprofit organization permitted to test marijuana produced for medical use for potency and contaminants.
Sanitization” refers to a heat or chemical treatment on cleaned food contact surfaces that is sufficient to yield a 99.999 percent reduction of the number of representative disease microorganisms of public health significance.
Temperature Measuring Device” or “TMD” means a thermometer, thermocouple, thermistor or other device that indicates the temperature of food, air or water.
Terminal Illness” means any disease, illness or condition sustained by a human being for which there is no reasonable medical expectation of recovery and as medical probability, will result in the death of such human being regardless of the use or discontinuance of medical treatment implemented for the purpose of sustaining life or the life process; and as a result of which, the human being’s health-care practitioner would not be surprised if death were to occur within 12 months.
Tetrahydrocannabinol Delta 9” or “THC” is a decarboxylated cannabinoid found in cannabis with strongly psychoactive properties that induces a euphoric high.
Time/Temperature Control for Safety Food” or “TCS” means a food that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation.
Tincture” means a mixture created from a concentrated extract of marijuana.
Topical treatment means a mixture or extract of marijuana made into a balm, lotion, ointment or rubbing alcohol solution, that is applied transcutaneously.
Usable amount of medical marijuana for medical use means six ounces or less of usable marijuana as defined below.
Usable marijuana means the dried leaves and flowers of the marijuana plant, and any mixture or preparation of those dried leaves and flowers, including but not limited to tinctures, ointments, and other preparations including medical marijuana oil, but does not include the seeds, stalks, and roots of the plant. It does not include the weight of any non-marijuana ingredients combined with marijuana, such as ingredients added to prepare a topical administration, food, or drink.
Verification system means a phone or web-based system established and maintained by the Department that is available to law enforcement personnel and compassion center agents on a twenty-four-hour basis for verification of registry identification cards.
Written certification means a document dated and signed by a physician, stating that in the physician’s opinion the patient is likely to receive therapeutic or palliative benefit from the medical use of marijuana to treat or alleviate the patient’s debilitating medical condition or symptoms associated with the debilitating medical condition. A written certification shall be made only in the course of a bona fide physician-patient relationship where the qualifying patient is under the physician’s care for the qualifying patient’s primary care or for the qualifying patient’s debilitating condition after the physician has completed an assessment of the qualifying patient’s medical history and current medical condition. The bona fide physician-patient relationship may not be limited to authorization for the patient to use medical marijuana or consultation for that purpose. The written certification shall specify the qualifying patient’s debilitating medical condition.
3.1 The Department shall issue a registry identification card to an applicant for the purpose of participating in the medical marijuana program upon the written certification of the applicant’s physician, supporting application documents and a non-refundable application fee with a personal check or a cashier’s check made out to “Division of Public Health, Medical Marijuana Program.” “State of Delaware-MMP”. The following information shall be provided in the participant enrollment form submitted to the Department in order for a registry identification card to be obtained and processed.
3.2.1 the The name, address and telephone number of the applicant’s physician;
3.2.2 the The physician’s clinical licensure;
3.2.3 the The patient applicant’s name and date of birth;
3.2.4 the The medical justification for the physician’s certification of the patient’s debilitating medical condition;
3.2.5 the The physician’s signature and date;
3.2.6 the The name and address of the applicant as they appear on the applicant's government issued ID card, and date of birth of the applicant;
3.2.7 the The name, address and date of birth of the applicant’s primary caregiver(s), if any;
3.2.8 a A reasonable xerographic copy of the applicant’s Delaware driver’s license or comparable State of Delaware or federal issued photo identification card verifying Delaware residence; State of Delaware issued identification card must be available for inspection/verification;
3.2.9 the The length of time the applicant has been under the care of the physician providing the medical provider certification for patient eligibility;
3.2.10 the The applicant’s signature and date; and
3.2.11 a A signed consent for release of medical information related to the patient’s debilitating medical condition, on a form provided by the medical marijuana program.
3.3.2 If the qualifying patient is of an age where an ID to meet subsections 3.2.6 and 3.2.8 above has not been issued, the Responsible Party's ID shall be used. If the qualifying patient has a government issued ID, information and IDs for both individuals shall meet subsections 3.2.6 and 3.2.8 above.
3.3.3.1 The qualifying patient has intractable epilepsy pain, anxiety or depression related to terminal illness; or
3.3.3.2 The qualifying patient has intractable epilepsy or a seizure disorder; severe debilitating autism or;
3.3.3.23.3.3.3 The qualifying patient has a chronic or debilitating disease or medical condition where the patient has failed treatment involving 1 one or more of the following symptoms: cachexia or wasting syndrome; intractable nausea; seizures; severe, painful and persistent muscle spasms.
4.1.1 birth certificate verifying Proof that the applicant is at least (21) 21 years of age unless the person is the parent or legal guardian of a minor who is a qualifying patient;
4.1.2 a A reasonable xerographic copy of the applicant’s Delaware license or comparable State of Delaware or federal issued photo identification card verifying Delaware residence; State of Delaware issued identification card must be available for inspection/verification.
4.1.3 written Written approval by the qualified patient(s) authorizing responsibility for managing the well-being of a qualified patient(s) with respect to the use of marijuana;
4.1.4 the The name(s), address(es), telephone number(s) and date of birth of the qualified patient(s);
4.1.64.1.5 the The name and address of the applicant as they appear on the applicant's government issued ID card, telephone number of the applicant; and
4.1.74.1.6 the The applicant’s signature and date.
4.2.1.1 All designated caregiver applicants are required to consent to a nationwide and statewide criminal history screening background check every three years. All applicable application fees associated with the nationwide and statewide criminal history screening background check shall be paid by the primary caregiver applicant.
4.2.1.2 Individuals convicted of an excluded felony offense, as described in the definitions Section 2.0, and 16 Del.C. §4902A(7) are prohibited from serving as a designated caregiver. The applicant and qualified patient shall be notified by registered mail of his or her disqualification from being a designated caregiver.
5.1.1.1 contacting Contacting each applicant by telephone, mail, or if proof of identity is uncertain, the Department shall require a face-to-face meeting and the production of additional identification materials materials;
5.1.1.2 contacting Contacting the Delaware Division of Professional Regulation to verify that the physician is licensed to practice medicine in Delaware and is in good standing; and
5.1.1.3 contacting Contacting the physician to obtain further documentation that the applicant’s medical diagnosis and medical condition qualify the applicant for enrollment in the medical use marijuana program.
5.3.1.1 a A change in card holder's cardholder’s name or address,
5.3.1.2 knowledge Knowledge of a change that would render the patient no longer qualified to participate in the program, such as a cure of the debilitating condition causing the need for Medical Marijuana,
5.3.1.3 knowledge Knowledge of a change that renders the patient's physician no longer a qualified "physician" as defined in 2.0 of these regulations,
5.3.1.4 knowledge Knowledge of a change that renders the patient's caregiver no longer eligible as defined in these regulations.
5.3.4 When a cardholder notifies the Department of items listed in Section subsection 5.3 but remains eligible, the Department shall issue the cardholder a new registry identification card with a new random 10-digit alphanumeric identification number within 10 days of receiving the updated information and the cardholder shall pay a $20 fee. If the person notifying the Department is a registered qualifying patient, the Department shall also issue his or her registered designated caregiver, if any, a new registry identification card within 10 days of receiving the updated information.
5.3.6 A cardholder who fails to make a notification to the Department that is required by Section subsection 5.3 is subject to a civil infraction, punishable by a penalty of no more than $150.00 and is also subject to the immediate revocation of the registry identification card and all lawful privileges provided under the act.
5.4.1.1 did Did not provide the required information and materials;
5.4.1.2 previously Previously had a registry identification card revoked; or
5.4.1.3 provided Provided false or falsified information.
5.4.2.1 the The designated caregiver does not meet the requirements of Section subsection 4.2;
5.4.2.2 the The applicant did not provide the information required;
5.4.2.3 the The designated caregiver previously had a registry identification card revoked; or
5.4.2.4 the The applicant or the designated caregiver provides false or falsified information.
5.5 Registry identification card renewal application: Each registry identification card issued by the Department is valid in accordance to Section with subsection 5.2. A qualified patient or primary caregiver shall apply for a registry identification card renewal no less than 45 calendar days prior to the expiration date of the existing registry identification card in order to prevent interruption of possession of a valid (unexpired) registry identification card.
6.3.7 The evidence must indicate the intended patient population and whether it is generally accepted for both adult and pediatric use or limited to a particular population.
6.4.1 Upon review of materials submitted in response to Section subsection 6.3 above, the Division of Public Health (DPH) shall make a determination as to whether the petition has merit.
6.4.2 A petition will be determined to have merit if it contains all of the material required in Section subsection 6.3 above and the debilitating condition that is the subject of the petition has not been considered through this process in the prior two years, unless significant, generally accepted, scientific discoveries have been made that are substantially likely to reverse the prior decision.
7.1.1.1 No person shall operate a compassion center without a Department issued Department-issued certificate of registration. The application and renewal requirements for a certificate of registration are in Sections subsections 7.6 and 7.10 of these regulations.
7.1.2 Location of a compassion center: A compassion center shall not be located within 1,000 500 feet of the property line of a preexisting public or private school.
7.1.3.2.1 the The ownership structure of the compassion center;
7.1.3.2.2 the The composition of the board of directors; and
7.1.3.2.3 such Such provisions relative to the disposition of revenues to establish and maintain the not-for-profit character of the compassion center.
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.
7.1.4.37.1.4.4 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.
7.1.5.1 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.
7.1.5.4.7 Other wastes approved by the Division of Public Health, Health Systems Protection Section that will render the medical marijuana waste unusable.
7.2.2.1.1 immediate 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 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 When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.
7.2.2.3.1 within Within 24 hours of discovery of the event, notify the Department by telephone; and
7.2.2.3.2 provide Provide alternative security measures approved by the Department or close the authorized physical address(es) impacted by the failure/malfunction until the security alarm system has been restored to full operation.
7.2.2.4.1 all All maintenance inspections/tests conducted in response to Section 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 action(s) performed and the name, signature and title of the individual who performed the action(s);
7.2.2.4.2 any Any alarm activation or other event which requires response by public safety personnel; and
7.2.2.4.3 any Any unauthorized breach(es) of security.
7.2.3.2 Video footage will be digitally recorded and held for an appropriate time period consistent with the Division of Public Health's Records Retention Policy 90 days for routine footage or up to 36 months if video contains information of significance.
7.2.4.1.1 employ Employ a bar coding 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 Be responsible for developing and hosting a secure computer interface to receive patient card user data from the Department connect with DEC3S.
7.2.4.2.1 the The quantity of usable marijuana that will be kept on hand at each authorized location;
7.2.4.2.2 the The compassion center’s inventory system for tracking and dispensing usable marijuana;
7.2.4.2.3 the 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 The geographic location of the compassion center (i.e.: high-crime or low-crime area);
7.2.4.2.5 the The scope and sustainability of the alarm system; and
7.2.4.2.6 the The root cause analysis of any breach of security and/or inventory discrepancy for usable marijuana at that location.
7.2.5.1.1 notify 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 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 Conduct the comprehensive inventory required by Section 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 Conduct a monthly inventory review of stored, usable marijuana.
7.2.5.2 If an inventory conducted in response to Section 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 Section 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(s) who conducted the inventory.
7.2.6.1 shall 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 2,000 ounces of usable marijuana regardless of formulation.
7.2.6.3 may May not purchase usable marijuana or mature marijuana plants from any person other than another registered compassion center.
7.2.7.2 The Department will review the facility to ensure compliance with Section subsections 7.2 and Section 7.3 of these regulations.
7.2.7.4.1 Sample results will be compared to compassion center test results.
7.2.7.3.2 The compassion center will be invoiced for the cost of random sampling testing.
7.2.8 Dispensing marijuana. marijuana
7.2.8.3.1.1 shall Shall not dispense, deliver or otherwise transfer marijuana to a person other than a qualifying patient or to such patient’s other primary caregiver.
7.2.8.3.1.2 shall 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 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 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.
7.2.8.3.2 In addition to any other penalties that may be applicable under the Act or these regulations, any person found to have violated Section 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.
7.3.1 procedures 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 Procedures for safely dispensing medical marijuana to registered qualifying patients or their registered primary caregiver;
7.3.3 procedures Procedures to ensure accurate record keeping, including protocols to ensure that quantities purchased do not suggest re-distribution;
7.3.4 employee Employee security policies;
7.3.5 safety Safety and security procedures, including a disaster plan with procedures to be followed in case of fire or other emergencies;
7.3.6 personal Personal safety and crime prevention techniques;
7.3.7 a 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 The compassion center’s alcohol and drug free work place policy;
7.3.9 a A description of the compassion center’s outreach activities to registered qualifying patients or their registered primary caregiver, which shall as a minimum include:
7.3.9.1 providing 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 Ingestion options of usable marijuana provided by the compassion center;
7.3.9.3 safe Safe smoking techniques that shall be provided to registered qualifying patients; and
7.3.9.4 potential Potential side effects and how this information shall be communicated.
7.3.10 a 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 The name of the strain, batch, and quantity;
7.3.10.2 the The statement “this product is for medical use only, not for resale;” and
7.3.10.3 details Details indicating (1) the medical marijuana is free of contaminants and (2) the levels of active ingredients in the product.
7.3.11 a 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.
7.4.1 professional Professional conduct, ethics, and state and federal laws regarding patient confidentiality;
7.4.2 informational Informational developments in the field of medical use of marijuana;
7.5.1.1 a 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 An application for employment or to volunteer;
7.5.1.1.2 a A record of any disciplinary action taken;
7.5.1.1.3 documentation 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 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 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.
7.5.2.1.1 birth certificate Documentation verifying that the applicant is at least 21 years of age;
7.5.2.1.2 a 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 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 The name, address and telephone number of the applicant;
7.5.2.1.5 the The name, address and telephone number of the compassion center with which the agent is associated;
7.5.2.1.6 the The applicant’s signature and date date;
7.5.2.1.7 a A non-refundable, non-returnable application or renewal fee of $125 in the form of a check made out to “Division of Public Health, Medical Marijuana Program.” “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.
7.5.2.2.3 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.
7.5.2.5 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 Section subsections 7.5.2.1 and Section 7.5.2.2. The registry identification card shall contain such information as set forth in §4911A of the Act and Section subsection 7.5.2 of these regulations.
7.6.1 a 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 The proposed legal name, articles of incorporation and bylaws of the compassion center;
7.6.3 the The proposed physical address(es) of the compassion center, including any additional address(es) to be used for the secure cultivation of medical marijuana, and with the following details:
7.6.3.1 if If precise addresses are known, evidence of compliance to the following rules shall be included:
7.6.3.1.1 compliance 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 Evidence that all of the physical addresses identified in this section subsection are not located within 1,000 500 feet of a property line of a preexisting public or private school;
7.6.3.2 if If precise addresses have not been determined, identification of the general location(s) where it would be sited, and when it would be established;
7.6.4 a A description of the enclosed, locked facility, meeting all requirements of section 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 Evidence of the compassion center’s not-for-profit status, which can be:
7.6.5.1 documentation Documentation of recognition as a tax-exempt organization by the United States Internal Revenue Service; or
7.6.5.2 other 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 The name, address, and date of birth of each principal officer and board member of the compassion center;
7.6.7 a A description of proposed security and safety measures which demonstrate compliance with Section subsection 7.2 of these regulations;
7.6.8 a A draft operations manual which demonstrates compliance with Section subsection 7.3 of these regulations;
7.6.9 an An example of the design and security features of medical marijuana containers which demonstrates compliance with Section subsection 7.2.8 of these regulations;
7.6.10 a 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 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 The identities of all creditors holding a security interest in the premises, if any.
7.8.1 documentation Documentation of not-for-profit status, consistent with § subsection 7.6.5 of these regulations;
7.8.2 the 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 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 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 The sufficiency of the applicant’s plans for record keeping;
7.8.6 the 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 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 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 The name of the strain, batch, and quantity of the medical marijuana;
7.8.8.2 a A statement providing that “this product is for medical use only, not for resale”;
7.8.8.3 details Details indicating the medical marijuana is free of contaminants; and
7.8.8.4 details Details indicating the levels of active ingredients in the product;
7.8.9 the applicant’s plan for testing medical marijuana for contaminants and potency of active ingredients; and
7.8.10 the The applicant’s ability to grow marijuana without use of pesticides.
7.9.1 a A certification fee, made payable to the Division of Public Health, Medical Marijuana Program, “State of Delaware-MMP” in the amount of $40,000;
7.9.2 the The legal name, articles of incorporation, and bylaws of the compassion center;
7.9.3 the The physical address of the compassion center and any additional address(es) to be used for the secure cultivation of marijuana, including:
7.9.3.1 evidence Evidence demonstrating the following:
7.9.3.1.1 compliance 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 That none of the physical addresses identified in Section subsection 7.9.3 of these regulations are located within 1,000 500 feet of the property line of preexisting public or private schools;
7.9.3.2 it It is not necessary to resubmit any information provided in response to Section subsection 7.6.3.1 of these regulations unless there has been a change in that information;
7.9.4 any Any updates to previously submitted information including, but not limited to, information about officers, principals, board members, agents, employees, and compliance with Sections subsections 7.2 and 7.3 of these regulations;
7.9.5 a 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.
7.10.2 Renewal: Renewal. The Department shall grant a compassion center’s renewal application within 30 days of its submission if the following conditions are all satisfied. satisfied:
7.10.2.1 The compassion center submits materials required under Section subsection 7.9 of these regulations, including a summary annual report with financial audit attached, and a comprehensive inventory with a cover letter and the $40,000 fee, which shall be refunded if the renewal application is rejected;
7.10.2.3 Inspections conducted pursuant to the Act and these Regulations regulations do not raise any serious concerns about the continued operation of the registered compassion center applying for renewal. renewal; and
7.11.1.1 a A change in ownership of the compassion center;
7.11.1.2 a A change in one or more authorized physical locations; or
7.11.1.3 the 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 Section 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.
7.11.3.1 changes Changes in the membership of the board of directors or board of trustees; or
7.11.3.2 two Two or more legal entities merge and the entity to whom the registration certificate authorizing operation of a compassion center was issued survives.
8.0 Registration and Operation of Testing Facility Centers Safety Compliance Facilities
8.1 General Requirements for Operation of a Testing Facility Center. RESERVED Safety Compliance Facility
8.3.1.8 A description of the documentation that will accompany a registered Safety Compliance Facility agent when transporting marijuana on behalf of the registered Safety Compliance Facility. 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 Safety Compliance Facility, and a contact number to verify that the marijuana is being transported on behalf of the registered Safety Compliance Facility;
8.4 Required Training. RESERVED
8.6 Application for Operation of Testing Facility Center. RESERVED a Safety Compliance Facility
8.88.7 Testing Facility Center Safety Compliance Facility Application Review Criteria. RESERVED
8.98.8 Issuance of Registration Certificate Authorizing Operation of a Testing Facility Center. RESERVED Safety Compliance Facility
8.108.9 Registry Identification Cards for Principal Officers, Board Members, Agents, Volunteers or Employees of a Testing Facility Center. RESERVED Safety Compliance Facility
8.118.10 Expiration Date. RESERVED
8.128.11 Expiration, Termination or Renewal of a Registration Certificate Authorizing Operation of a Testing Facility Center. RESERVED Safety Compliance Facility
8.11.1.3 The inspections authorized by 16 Del.C. §4919A(u) do not raise serious concerns about the continued operation of the registered Safety Compliance Facility applying for renewal;
8.11.1.4 The Annual Report provided pursuant to 16 Del.C. §4922A, confirms a continued need for the center;
8.138.12 Non-transferable Registration Certificate Authorizing Operation of a Testing Facility Center. RESERVED Safety Compliance Facility
8.148.13 Inspection. RESERVED
9.1 On-site visits/interviews
9.2 Corrective action: action
9.2.1 If violations of these requirements are cited as a result of monitoring or civil police contact, the qualified patient or primary caregiver shall be provided with an official written report of the findings within 30 days following the monitoring visit.
9.2.5.1 In accordance with the 16 Del.C. Ch. 49A, if immediate action is required to protect the health and safety of the general public, the Department may suspend the qualified patient or designated caregiver registry identification card without notice.
9.2.5.19.2.5.1.1 A qualified patient or primary caregiver whose registry identification card has been summarily suspended is entitled to may request a record review not later than 30 calendar days after the registry identification card was summarily suspended.
9.2.5.29.2.5.1.2 The record review requested subsequent to a summary suspension shall be conducted by the Department.
9.2.5.39.2.5.1.3 The Department shall conduct the record review on the summary suspension by reviewing all documents submitted by both card holder and the Department.
9.2.5.49.2.5.1.4 The sole issue at a record review on a summary suspension is whether the card holder’s registry identification card shall remain suspended pending a final adjudicatory hearing and ruling.
9.2.5.59.2.5.1.5 A card holder given notice of summary suspension by the division Division may submit a written request to the Department for a record review. To be effective, the written request shall:
9.2.5.5.19.2.5.1.5.1 be Be made within 30 calendar days, as determined by the postmark, from the date of the notice issued by the Department;
9.2.5.5.29.2.5.1.5.2 be Be properly addressed to the medical marijuana program;
9.2.5.5.39.2.5.1.5.3 state State the applicant’s name, address, and telephone number(s);
9.2.5.5.49.2.5.1.5.4 provide Provide a brief narrative rebutting the circumstances of the suspension, suspension; and
9.2.5.5.59.2.5.1.5.5 additional Additional documentation must be included with the request for a record review.
9.3 Summary Suspension, Revocation and Appeal Process: Process
9.3.1.1 criminal Criminal prosecution or civil penalties for activities not authorized in this rule and act;
9.3.1.2 liability Liability for damages or criminal prosecution arising out of the operation of a vehicle while under the influence of marijuana; or
9.3.1.3 criminal Criminal prosecution or civil penalty for possession, distribution or transfers of marijuana or use of marijuana:
9.3.1.3.1 in In a school bus or public vehicle;
9.3.1.3.2 on On school grounds or property;
9.3.1.3.3 in In the workplace of the qualified patient's or primary caregiver's employment;
9.3.1.3.4 at At a public park, recreation center, youth center or other public place;
9.3.1.3.5 to To a person not approved by the Department pursuant to this rule;
9.3.1.3.6 outside Outside Delaware or attempts to obtain or transport marijuana from outside Delaware; or
9.3.1.3.7 that That exceeds the allotted amount of usable medical use marijuana.
9.3.2.1 Violation of any provision of this rule may result in either the summary suspension of the qualified patient’s or primary caregiver’s registry identification card, or a notice of contemplated action to suspend or revoke the qualified patient’s or primary caregiver’s registry identification card, and all lawful privileges under the act.
9.3.3.1 A registry identification card may be revoked or suspended, and a renewal application may be denied for:
9.3.3.19.3.3.1.1 failure Failure to comply with any provisions of these requirements;
9.3.3.29.3.3.1.2 failure Failure to allow a monitoring visit by authorized representatives of the Department;
9.3.3.39.3.3.1.3 the The discovery of repeated related criminal misconduct or criminal law violations of these requirements during monitoring visits.
9.4 Request for hearing: hearing
9.4.1 A qualified patient or primary caregiver whose registry identification card has been summarily suspended, or who has received a notice of contemplated action to suspend or revoke, may request a hearing, in addition to a request for a record review, for the purpose of review of such action. The request for hearing shall be filed within 30 calendar days of the date the action is taken or the notice of contemplated action is received. The request shall include the following:
9.4.19.4.1.1 a A statement of the facts relevant to the review of the action;
9.4.29.4.1.2 a A statement of the provision of the act and the rules promulgated under the act that are relevant to the review of the action;
9.4.39.4.1.3 a A statement of the arguments that the qualified patient/primary caregiver considers relevant to the review of the action; and
9.4.49.4.1.4 any Any other evidence considered relevant.
9.12.1 Any party requesting a telephonic hearing shall do so within 10 business days of the date of the notice. Immediately after the parties agree to conduct the hearing by telephone, notice of the telephonic hearing shall be made to all parties and shall include all necessary telephone numbers.
9.12.2 Any party that has agreed to a telephonic hearing, but subsequently requests an in-person hearing shall do so in writing to the hearing officer no later than 10 calendar days before the scheduled date of the hearing. The decision to grant or deny the request for an in-person hearing shall be at the discretion of the hearing officer for good cause shown. The hearing officer’s decision to grant or deny the hearing shall be issued in writing and shall include the specific reasons for granting or denying the request. Should the hearing officer grant the request, the hearing shall be rescheduled to a time convenient for all parties. Should the hearing officer deny the request, the telephonic hearing shall proceed as scheduled.
9.12.3 The location or locations of the parties during the hearing shall have a speaker telephone and facsimile machine available so that all shall hear the proceedings and documents shall be transmitted between witnesses and the hearing officer.
9.12.4 The Cardholder shall initiate the telephone call. The Division is responsible for ensuring the telephone number to the Division’s location for the telephonic hearing is accurate and the Division representative is available at said telephone number at the time the hearing is to commence. Failure to provide the correct telephone number or failure to be available at the commencement of the hearing shall be treated as a failure to appear and shall subject the petitioner to a default judgment.
9.12.5 The in-person presence of some parties or witnesses at the hearing does not prevent the participation of other parties or witnesses by telephone with prior approval of the hearing officer.
9.13.1 At the request of the hearing officer or upon motion by either party granted by the hearing officer, and before the hearing officer recommends action by the Secretary, the parties shall submit briefs including findings of fact and conclusions of law for consideration by the hearing officer. The hearing officer holds the discretion to request briefs or grant a motion to submit briefs on any point of law deemed appropriate by the hearing officer. Briefs submitted shall include supporting reasons for any findings or legal conclusions and citations to the record and to relevant law. Should the hearing officer request briefs or grant a party’s motion to submit briefs, the hearing shall be continued until the hearing officer has given the briefs sufficient consideration and brings the hearing to a close. The hearing, however, shall be completed no later than 45 calendar days from the date of continuance.
9.13.2 No more than 30 calendar days after completion of the hearing, the hearing officer shall prepare a written decision containing recommendation of action to be taken by the Secretary. The recommendation shall propose to sustain, modify or reverse the initial decision of the Department or the Department’s agent.
9.13.3 The Secretary shall accept, reject or modify the hearing officer’s recommendation no later than 10 calendar days after receipt of the hearing officer’s recommendation. The final decision or order shall be issued in writing and shall include:
9.13.4 The final decision or order shall be public information and shall become a part of the record.
10.1 Delaware Department of Health and Social Services adopts these regulations pursuant to the authority vested by 16 Del.C. §122. These regulations establish registration procedures and standards of practice for conducting marijuana infused food processing operations in Compassion Center kitchens that safeguard public health and provide to consumers food that is tested for safety, potency and consistency. A marijuana infused food establishment that prepares, sells or dispenses edible marijuana products must:
11.3.1.3 Floor plan of the processing area identifying appliances to be used, food contact surfaces (types of materials used for contact surfaces must be described,) areas for refrigeration and dry good storage, and restroom facilities.;
At least one employee during hours of operation shall be on location and have shown proficiency in food safety through passing a test that is part of a program approved by the Office of Food Protection.
15.7.3 TMD shall be accurate to ±1o Celsius or ±2o Fahrenheit to measure food temperatures.
18.4.1.7 That the presence of contaminants does not exceed the levels in the American Herbal Pharmacopoeia Monograph, Revision 2014, or the guidance from the Division of Public Health.
Last Updated: December 31 1969 19:00:00.
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