16 Del. Admin. Code § 4470-2.0
The following words and terms, when used in these regulations, should have the following meaning, unless the context clearly indicates otherwise:
"Act" means the Delaware Marijuana Act, 16 Del.C. §§ 4901Aet seq.
"Applicant" means any person applying to participate in the Delaware Medical Marijuana Program, hereinafter 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.
"Batch" A batch is a collection of plants of the same strain and genetics, grown in the same room at the same time. The maximum batch size is five (5) pounds or 2268 grams.
"Bona fide physician-patient relationship" means a treatment or counseling relationship between a physician and patient in which all the following are present:
(1) The physician has reviewed the patient's relevant medical records and completed a full assessment of the patient's medical history and current medical condition, including a relevant, in-person, medical evaluation of the patient.
(2) The physician has created and maintained records of the patient's condition in accord with medically accepted standards.
(3) The patient is under the physician's continued care for primary medical care or the debilitating condition that qualifies the patient for the Medical Marijuana Program.
(4) The physician has a reasonable expectation that he or she will provide follow-up care to the patient to monitor the efficacy of the use of medical marijuana as a treatment of the patient's debilitating medical condition.
(5) The relationship is not for the sole purpose of certifying for medical marijuana.
"Cannabidiol" or "CBD" is a cannabinoid found in cannabis with mild psychoactive properties that does not induce a euphoric high.
"Cannabidiol-Rich medical marijuana" or "CBD-Rich" means a marijuana strain or product formulization that has elevated levels of cannabidiol ("CBD") and contains the profile of CBD and tetrahydrocannabinol ("THC") concentrations approved by the Department, based upon the recommendation of the Medical Marijuana Act Oversight Committee.
"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.
"Compassionate use card" means a card issued by the Department for conditions not covered in the Act or regulations. The compassionate use card has additional requirements for approval.
"Concentrate" means any product created when marijuana flowers are refined into something purer and more 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, 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, chronic debilitating migraines, new daily persistent headache, and agitation of Alzheimer's disease or the treatment of these conditions;
(b) 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, or 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; and chronic debilitating migraines and new daily persistent headache that are refractory to conventional treatment and interventions;
(d) 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; or
(e) Anxiety, which is restricted to CBD-Rich medical marijuana products.
"Delaware Enterprise Consolidated Cannabis Control System" or "DEC3S" is the statewide application which serves as patient registry, point of sale monitor, seed to sale inventory tracker and repository of medical marijuana product test results.
"Department" means the Delaware Department of Health and Social Services.
"Designated caregiver" means a person who:
(a) 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 agreed to assist with a patient's medical use of marijuana;
(c) Has not been convicted of an excluded felony offense; and
(d) 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.
"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 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 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 offense for which the sentence, including any term of probation, incarceration, or supervised release, was completed 10 or more years earlier; or
(2) 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.
"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.
"Inspection" means a visit by an employee of the Department for the purpose of ensuring compliance with the requirements of these rules.
"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.
"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 Infused Food Establishment" refers to a licensed Compassion Center that has received an endorsement from the Department to make non-time/temperature controlled (non-TCS) marijuana infused food products.
"Medical Marijuana Act Oversight Committee" means the committee established to evaluate and make recommendations regarding the implementation of 16 Del.C. Ch. 49A.
"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.
"Pediatric Medical marijuana oil" means:
a. "Cannabidiol oil" which is a processed Cannabis plant extract that contains at least 15% cannabidiol but no more than 7% tetrahydrocannabinol, or a dilution of the resin of the Cannabis plant that contains at least 50 milligrams of cannabidiol per milliliter but not more than 7% tetrahydrocannabinol.
b. "THC-A oil" which is a processed Cannabis plant extract that contains at least 15% tetrahydrocannabinol acid but not more than 7% tetrahydrocannabinol, or a dilution of the resin of the Cannabis plant that contains at least 50 milligrams of tetrahydrocannabinol acid per milliliter but not more than 7% tetrahydrocannabinol.
c. Any change in the oil formulation which is made by the Department based upon the recommendation of the Medical Marijuana Act Oversight 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 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.
"Producer" refers to employees of the Marijuana Infused Food Establishment involved with the production of marijuana infused products.
"Qualifying patient" means an individual who meets the qualifications to receive a registry identification card under this chapter.
"Registry identification card" means a document issued by the Department that identifies a person as one of the following:
a. A registered qualifying adult patient.
b. A registered designated caregiver for a qualifying adult patient.
c. A registered designated caregiver for a pediatric patient.
d. A registered adult compassionate use patient.
e. A registered designated caregiver for an adult compassionate use patient.
f. A registered designated caregiver for a pediatric compassionate use patient.
g. A registered CBD-Rich patient.
h. A registered designated caregiver for a CBD-Rich patient.
"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% 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 any human being for which there is no reasonable medical expectation of recovery; which, as a 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 processes; 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 " means a mixture or extract of marijuana made into a balm, lotion, ointment or rubbing alcohol solution, that is applied transcutaneously for treatment.
"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.
"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.
16 Del. Admin. Code § 4470-2.0
19 DE Reg. 409(11/1/2015)
23 DE Reg. 667(2/1/2020)
24 DE Reg. 485( 11/1/2020) (Final)