Source: http://regulations.delaware.gov/register/february2019/proposed/22%20DE%20Reg%20652%2002-01-19.htm?utm_source=Delaware+Healthcare+Association&amp;utm_campaign=a0c6e27be8-EMAIL_CAMPAIGN_2019_02_06_09_31&amp;utm_medium=email&amp;utm_term=0_dfe48014f6-a0c6e27be8-282103009
Timestamp: 2019-04-22 18:34:41+00:00

Document:
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.
“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.
“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.
“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.
(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.
(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.
“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.
(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.
“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.
“Nonfood-contact surface” means all exposed surfaces other than food and splash zones.
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.
“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.
“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.
“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.
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.
3.2.11	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.
3.3.3.23.3.3.3	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.
3.3.5	Responsible Parties for qualifying patients under the age of 18 will be issued an identification card with the same 10-digit alphanumeric identifier provided on the patient card issued to the minor in question.
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.
4.1.74.1.6	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.
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.
5.3.1.4	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.
5.3.8	When a registered qualifying pediatric patient attains 18 years of age, the patient may request a new patient card releasing them from the pediatric restrictions. The new patient ID Card card will be issued at the card replacement cost $20 and maintain the original expiration date.
5.4.1.3	provided Provided false or falsified information.
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.
6.4.4.2	DPH will post notice of a public hearing no fewer than 10 days prior to the public hearing.
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.
7.1.1.1.1	All employees of a compassion center must have an ID badge issued by the Office of Medical Marijuana. Anyone with access to marijuana or marijuana concentrates must have an ID badge issued by the Office of Medical Marijuana.
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 Section subsection 7.2.7 of these Regulations 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.
7.1.3.2.3	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.
7.2.2.1.3	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.
7.2.2.3.2	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.
7.2.2.4.3	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.
7.2.4.2.6	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.
7.2.7.3	The Department will inspect the facility for the presence of pesticides listed in Section subsection 7.1.1.4, fungus and molds.
7.2.7.5	The Department will review the facility for compliance with applicable Federal, State and Local standards.
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.
7.2.8.1.1	Marijuana shall be dispensed in sealed, tamperproof containers clearly identified as having been issued by the compassion center and that meet the requirements in Section subsection 7.3.10 of these regulations.
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 Section subsection 7.2.4.1.2 of these regulations.
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.
7.2.8.3.1.4.1	Any change in the oil formulation must be made by the Department based upon the recommendation of the Medical Marijuana Act Oversight Committee.
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.
7.3.9.4	potential Potential side effects and how this information shall be communicated.
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.
7.3.12	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.
7.3.12.5	Compassion Centers will coordinate directly with the Safety and Compliance Center on invoicing and payment for testing services.
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.
7.5.2.1.7	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”.
7.5.2.3	The Department may verify information on each application and the accompanying documentation as set forth in section subsection 5.1 of these regulations.
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.
7.6.5.2	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.
7.6.12	the 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.
7.8.10	the The applicant’s ability to grow marijuana without use of pesticides.
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.
7.11.1.3	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.
7.11.3.2	two Two or more legal entities merge and the entity to whom the registration certificate authorizing operation of a compassion center was issued survives.
8.1.1	A Safety Compliance Facility may only operate if they have been issued a valid registration certificate from the Department.
8.1.2	A Safety Compliance Facility must be operated in accordance with the International Organization for Standardization 17025 (ISO 17025) standards as confirmed by accreditation by a third party accrediting body such as American Association for Laboratory Accreditation (A2LA) or ANSI-ASQ National accreditation Board (ACLASS); or Certified under the Clinical Laboratory Improvement Act (CLIA) or a qualified auditing organization using ISO 17025 criteria approved by the Department.
8.2.1.1.1.3	Entry into any area(s) where marijuana is held shall be limited to authorized personnel.
8.2.1.2.1.3	When appropriate, the security system shall provide protection against tampering with computers or electronic records done to conceal theft or diversion.
8.2.1.2.2	A Safety Compliance Facility 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 Safety Compliance Facility shall promptly make all necessary repairs to ensure the proper operation of the alarm system.
8.2.1.2.3.2	Provide alternative security measures approved by the Department or close the authorized physical address(es) affected by the failure/malfunction until the security alarm system has been restored to full operation.
8.2.1.2.4.3	Any unauthorized breach(es) of security.
8.2.1.3.1	A Safety Compliance Facility shall provide an appropriate video surveillance system that includes the following areas and access to recorded surveillance.
8.2.1.3.1.3	A Safety Compliance Facility shall provide the Department with access to the video 24-hours a day, seven days a week through a secure internet connection.
8.2.1.4.1.1	A Safety Compliance Facility shall employ a bar coding inventory control system to track the source, strain, batch and weight of marijuana sample in inventory.
8.2.1.4.2.1.3	The scope and sustainability of the alarm system.
8.3.1.9.1	Each batch of medical marijuana harvested by a compassion center shall be tested in accordance with this regulation.
8.3.1.10.6	The number of samples tested.
8.3.1.12	What levels or combination of contaminants mandate elimination of a batch.
8.4.1.3	Specific procedural instructions for responding to an emergency, including robbery or an accident resulting in injury, fire or damage to critical equipment.
8.5.1.3	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.
8.6.1.4	Any information required by the Department to evaluate the applicant pursuant to the competitive bidding process.
8.7.1.4	The proposed Safety Compliance Facility’s plan for operations and services, including its staffing and training plans, and whether it has sufficient capital to operate.
8.8.1.3	Applicant does not meet the requirements of 16 Del.C. §4919A.
8.8.2	After a Safety Compliance Facility is approved, but before it begins operations, it shall submit a registration fee paid to the Department in the amount of $40,000 and, if a physical address had not been finalized when it applied, its physical address.
8.8.3	The Department shall issue a renewable registration certificate with an identification number after a satisfactory compliance inspection by the Department.
8.9.1.3	If the principal officer or board members is younger than 21 years of age.
8.9.2	A record of the source of any funds that will be used to open or maintain the Safety Compliance Facility, including the name, address, and date of birth of any investor contributing more than $5,000.
8.9.3	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.
8.10.1	A Safety Compliance Facility registration shall expire two years after its registration certificate is issued. The Safety Compliance Facility 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.
8.11.1.6	Approval of the Division Director after review of all factors including performance and customer service reviews.
8.11.2.1	The Department may suspend a registration certificate authorizing the operation of a Safety Compliance Facility for any violation of an applicable law or regulation.
8.11.3.1.2	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.
8.12.1.3	The Safety Compliance Facility discontinues its operation.
8.12.2	A Safety Compliance Facility shall provide the Department with a written notice of any change described in subsection 8.12.1 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.
8.12.3.2	Two or more legal entities merge and the entity to whom the registration certificate authorizing operation of a Safety Compliance Facility was issued survives.
8.12.3.3	Management agreements are generally not considered a change in ownership if the entity to whom the registration certificate authorizing operation of a Safety Compliance Facility was issued continues to retain ultimate authority for the operation of the Safety Compliance Facility. However, if the ultimate authority is surrendered and transferred from the entity to whom the registration certificate authorizing operation of a Safety Compliance Facility was issued to a new manager, then a change of ownership has occurred.
8.13.1	The Safety Compliance Facility will be available to State regulators for inspections, both scheduled and unscheduled, during normal business hours.
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.
9.2.5.5.59.2.5.1.5.5	additional Additional documentation must be included with the request for a record review.
9.3.1.3.7	that That exceeds the allotted amount of usable medical use marijuana.
9.3.1.4	Criminal prosecution or civil penalties related to growing or cultivating 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	Grounds for revocation or suspension of registry identification card, denial of renewal application for registry identification card.
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.
9.4.49.4.1.4	any Any other evidence considered relevant.
9.5.1	As soon as possible, but in no event later than 60 calendar days after the request for hearing is received, the Department shall convene a hearing.
9.5.2	Notice of the hearing shall be issued in accordance with §10122 of Title 29.
9.5.2.1	There shall be no public notice of the hearing in accordance with §4920A of Title 16.
9.5.3	A written copy of the determination and the reasons upon which it is based shall be sent to the patient or caregiver cardholder within 30 calendar days.
9.5.4	An individual may request an expedited hearing.
9.5.4.1	The Department shall schedule the hearing on an expedited basis provided that the Department receives the individual's written request for an expedited hearing within five (5) calendar days from the date on which the individual received notification of the Department's decision to summarily suspend the individual’s card.
9.5.4.2	The Department shall convene an expedited hearing within 15 calendar days of the receipt by the Department of such a request.
9.5.4.3	The Department shall make a determination based upon the evidence presented.
9.5.4.4	A written copy of the determination and the reasons upon which it is based shall be sent to the individual within 30 calendar days.
9.5.5.1	An individual cardholder may request a telephonic hearing at the time of the request for a hearing. 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.
9.5.5.2	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.
9.5.5.3	The location or locations of the parties during the hearing shall have a speaker telephone and technology available so that all shall hear the proceedings and documents shall be transmitted between witnesses and the hearing officer.
9.5.5.4	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.
9.5.5.5	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.
9.5.6.1	The individual has the right to be represented by counsel.
9.5.6.2	All statements made shall be under oath.
9.5.6.3	The individual has the right to examine and cross-examine witnesses.
9.5.7	A stenographic recording will be made by a qualified court reporter. At the request and expense of any party, such record shall be transcribed with a copy to the other party.
9.5.8	Following the hearing, the Department shall make a determination based upon the evidence presented.
9.5.9	Upon reaching its conclusion of law and determining an appropriate disciplinary action, the Department shall issue a written decision and order in accordance with §10128 of Title 29.
9.5.10	All decisions of the Department shall be final and conclusive. Where the individual is in disagreement with the action of the Department, the individual may appeal the Department's decision to the Superior Court within 30 days of service or of the postmarked date of the copy of the decision mailed to the individual. The appeal shall be on the record to the Superior Court and shall be as provided in §§10142 - 10145 of Title 29.
10.1.2	If the marijuana business prepares edible marijuana products, ensure that the edible marijuana products are prepared according to the applicable requirements set forth in these regulations.
10.2.4	Are packaged and labeled in such a manner as to allow tracking by the statewide cannabis inventory control system called Delaware Enterprise Consolidated Cannabis Control System (DEC3S).
10.3.1	Establishments registered as marijuana infused food establishments in Delaware shall be exempt from the Cottage Food Regulations.
10.3.2	Establishments registered under these regulations shall be exempt from the Delaware Food Code.
10.4.1.3	Is otherwise in substantial compliance with these regulations.
10.4.2	Additional inspections both scheduled and no-notice will be conducted at the discretion of the Division and as deemed necessary by the Division.
11.1.1	Marijuana Infused Food Establishments are only permitted to engage in direct sales with consumers in the State of Delaware.
11.1.2	Online sales are not permitted. Online advertising and marketing are permitted subject to the limitations listed in 16 Del.C. Ch. 49A.
11.1.3	Wholesale or other sales to resellers or food establishments are not permitted by a Marijuana Infused Food Establishment.
11.1.4	A Marijuana Infused Food Establishments shall only produce those specific food products listed on their registration.
11.1.5.1	Each facility for the production of edible marijuana products or marijuana-infused products shall ensure that it obtains non-marijuana ingredients for edible marijuana products or marijuana-infused products from sources that comply with the requirements of federal and state law and regulations and are approved by the Division, including, without limitation, commercial and retail businesses.
11.1.6	The production of edible marijuana products or marijuana-infused products for sale shall not use non-marijuana ingredients prepared or stored in a private home.
11.2.1	Products produced in a Marijuana Infused Food Establishment are limited to non-TCS baked goods and candy.
11.2.2	Production of food in a Marijuana Infused Food Establishment is limited to foods that are non-TCS.
11.2.3	The manufacturing of baked goods shall be allowed in a Marijuana Infused Food Establishment. Items include, but are not limited to: cookies, muffins and brownies. Bakery items which as a finished product contain components such as fruit filling, cream filling or meat are not allowed.
11.2.4	Candy products such as fudge, lollipops, chocolates, and hard candy, are allowed to be manufactured in a Marijuana Infused Food Establishment provided the final products are non-TCS.
11.2.5	All labeling requirements set forth in subsection 16.2 must be met before the product is sold.
11.2.6	Products may not exceed 10mg of THC-Delta 9 or 25mg of CBD per serving.
11.2.7	Marijuana infused products will be limited to five servings per package.
11.2.8	Products infused with THC, must have the letters “THC” molded into the product.
11.3.1.5.3	Allow the Division access to the establishment as specified under subsection 10.4 and to the records specified under subsection 7.5.
11.3.2	Producers may first apply to the Division for registration as a Marijuana Infused Food Establishment on or after July 1, 2018.
11.3.3	Following the submission of an application demonstrating that all requirements of these regulations have been met, up to and including the on-site inspection, the producer may begin sales to consumers in accordance with these regulations.
11.3.4	Upon registration by the Division, a Marijuana Infused Food Establishment and associated activities shall comply with the standards established by these regulations.
11.3.5	It shall be a violation of these regulations to operate in Delaware as a Marijuana Infused Food Establishment, as defined by these regulations, if not registered with the Division.
11.3.6	Registration with the Division does not exempt the Marijuana Infused Food Establishment from other state, county or local codes unless specifically listed in subsection 2.4.
11.3.7	If the proposed Marijuana Infused Food Establishment uses a private well as a source of potable water the well must be in compliance with State of Delaware Regulations Governing Public Drinking Water Systems.
11.3.7.1	Private wells shall comply with chemical and bacteriological standards; a satisfactory analysis is required before a registration may be issued. Completion of any required sampling is the responsibility of the producers.
11.3.7.2	Tests conducted within 60 days of the date of the initial or renewal application will be accepted to demonstrate compliance.
11.3.8	Establishments served by a public water supply and sewage systems do not require further evaluation.
11.4.1	Registration must be renewed bi-annually.
11.4.1.1	Marijuana Infused Food Establishments must maintain a Medical Marijuana Compassion Center License through the Division.
12.1.1.6.3	The surfaces and equipment are replaced in the normal course of operation.
12.1.1.7	Prepare and maintain a current written contingency plan for use in initiating and affecting a product recall.
12.2.1.1	Pasteurized eggs or egg products are substituted for raw eggs in the preparation of edible marijuana products or marijuana-infused products.
12.2.1.2.2	Single-service and single-use articles that have not previously been used.
12.2.1.3	All ingredients must be cooked thoroughly to a safe temperature for the proper time.
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.
14.1.1	Only approved food items shall be made in the registered Marijuana Infused Food Establishment.
14.1.7	Producers and employees are informed in a verifiable manner of their responsibility to report to the producer, information about their health and activities as they relate to diseases that are transmissible through food.
14.2.1.4	Is responsible for approving or rejecting all procedures or specifications which may impact the identity, strength, quality and purity of the marijuana or marijuana products.
14.2.2.2	Follow the written responsibilities and procedures set forth pursuant to subsection 7.3.12.3.
15.1.1.1.1.3	The surfaces of equipment that do not have direct contact with marijuana products are kept free of an accumulation of dust, dirt, residue and other debris.
15.1.1.2.1.4	If they come into contact with potentially hazardous marijuana products and ingredients, surfaces and utensils are cleaned throughout the day at least once every 4 hours.
15.1.1.2.1.5.3	If the manufacturer does not specify a frequency, at a frequency necessary to prevent the accumulation of soil or mold.
15.1.1.3.1	All elements involved in the production of marijuana infused products will be stored at least 12 inches off the floor on shelving or other generally recognized food storage container.
15.1.3	Utility lines shall be installed inside walls, above ceiling or below floors, where possible.
15.1.4	Insect control devices shall not be installed over food preparation surfaces.
15.2.1.1	At least 50 foot candles at a surface where a producer or employee is working with food or working with utensils or equipment such as knives, slicers, and grinders or where the producer or employee safety is a factor.
15.3.1	No animals/pets shall be permitted in the Marijuana Infused Food Establishment during the preparation, packaging, or handling of any marijuana infused food products.
15.4.1	Toxic substances shall be stored so they cannot contaminate food preparation or cooking equipment in kitchen areas.
15.4.2	Rodent bait shall be contained in covered, tamper-resistant bait stations. Toxic tracking powders shall not be used as a pesticide and nontoxic tracking powders shall not contaminate food, equipment or utensils.
15.4.3	All medicines and first aid supplies shall be labeled and stored in a kit or container out of food preparation areas.
15.5.1	The plumbing shall meet the requirements of all municipal, county or state codes.
15.5.2	Marijuana Infused Food Establishments shall have convenient access to permanent restroom facilities equipped with running potable water, paper towels and soap.
15.6.1	Individual sewage disposal systems require the approval of the Department of Natural Resources and Environmental Control prior to operating the establishment.
15.7.1	In mechanically refrigerated food storage units, TMD shall be located to measure the air temperature in the warmest part of the unit.
15.7.2	TMD shall be readily accessible for use in ensuring attainment and maintenance of required food temperatures.
15.7.3	TMD shall be accurate to ±1o Celsius or ±2o Fahrenheit to measure food temperatures.
15.7.4	TMD shall not have sensors constructed of glass, except if encased in shatterproof coating.
15.8.1	Freezer units shall be capable of maintaining stored food solidly frozen.
15.8.2	Refrigeration and cold holding units shall be capable of maintaining stored foods at 41o Fahrenheit or below.
16.1.1	All batches of food is required by the Division to be laboratory tested. Testing of food products shall be the financial responsibility of the producer.
16.2.1	Products shall be properly labeled with the following: Name of Compassion Center, name of product, net weight, date of production / lot number, barcode, and cannabinoid profile.
16.2.2	Labels shall include a list of ingredients in decreasing order by weight. If the product label is too small to allow for printing of ingredients, the list shall be available at the request of the consumer.
16.2.3	Labels shall include the following statement “This food is made in a Marijuana Infused Food Establishment and is NOT subject to routine Government Food Safety Inspections”.
16.2.4	Labels shall be printed in at least 10-point type in a color that provides a clear contrast to the background label.
16.3.1	The immediate food contact surface of any product packaging material shall be food grade in quality, and therefore meet the food safety requirements of 16 Del.C. Ch. 33.
16.3.2	Any product containing marijuana must be packaged in child-resistant packaging in accordance with 16 C.F.R. §1700.
16.3.3	Marijuana-infused products must be packaged in plastic which is 4 millimeters or more in thickness and must be heat-sealed without an easy-open tab, dimple, and corner or flap so that it is difficult for a child to open and as a tamperproof measure.
16.3.4	Any container or packaging containing usable marijuana, edible marijuana products or marijuana-infused products must protect the contents from contamination and must not impart any toxic or deleterious substance to the usable marijuana or marijuana product.
16.4.1.3	Maintain such product distribution records as are necessary to facilitate location of products that are being recalled. Such records shall be maintained for 3 years.
16.5.1	A Marijuana Infused Food Establishment must maintain records for each batch of product indicating type of finished product, date of production, lot number, and date and location of sales. These records shall be maintained for 3 years.
17.1	A person may not operate a Marijuana Infused Food Establishment without a valid registration to operate issued by the Division.
17.2.1.1.1.1	If a Marijuana Infused Food Establishment is found operating without a registration as required by subsection 8.1 of this regulation, the Division shall order the establishment immediately closed.
17.2.1.1.2.1	The closure shall be effective upon receipt of a written notice by the producer or employee of the Marijuana Infused Food Establishment. A closure notice statement recorded on the inspection report by a representative of the Division constitutes written notice.
17.2.1.1.3.1	The Marijuana Infused Food Establishment shall remain closed until a registration application; applicable fees and any required plans have been received and approved by the Division.
17.2.1.2.1.1	If some condition is determined to exist in a marijuana business which presents an imminent health hazard to the public, the Division may suspend the registration of the marijuana establishment without a prior hearing. The suspension shall be effective upon receipt of written notice by the producer or employee of the marijuana establishment. A suspension statement recorded on an inspection report by the Division constitutes written notice.
17.2.1.3.1	When conditions exist in a marijuana establishment that represent serious violations, repeat violations or general unsanitary conditions, the Division may initiate a corrective action plan.
17.2.2.1	Take no action, in which case the order to close shall remain in effect.
17.2.2.1.1	Take action to correct the unsafe and unsanitary practices identified during the survey.
17.2.2.1.1.1	The facility may submit evidence through a written plan of correction showing that the deficient practices, identified during the investigation, have been addressed and corrected.
17.2.2.1.1.2	A change of location for the facility does not nullify an order to close and an acceptable plan of correction must still be submitted.
17.2.2.1.1.3	The Department shall determine if the plan of correction is acceptable.
17.2.2.1.1.4	Once accepted, the Department shall schedule a revisit as soon as possible.
17.2.2.2	Request, in writing, an administrative hearing with the Hearing Officer of the Division to contest the order to close.
17.2.2.2.1	Such request must be received within 10 calendar days from the date on which the order to close was issued.
17.2.2.2.1.1	As soon as possible, but in no event later than 60 calendar days after the issuance of the closure order, the Department shall convene a hearing on the reasons for closure.
17.2.2.2.1.2	The Department shall make a determination based upon the evidence presented.
17.2.2.2.1.2.1	A written copy of the determination and the reasons upon which it is based shall be sent to the facility within 30 calendar days of the hearing.
17.2.2.2.2.5	The decision of the Department shall be based upon sufficient legal evidence. If the charges are supported by such evidence, the Department may continue, modify or revoke the closure order.
17.2.2.2.3	Upon reaching its conclusion of law and determining an appropriate disciplinary action, the Department shall issue a written decision and order in accordance with §10128 of Title 29.
17.2.2.2.4	All decisions of the Department shall be final and conclusive. Where the facility is in disagreement with the action of the Department, the facility may appeal the Department's decision to the Superior Court within 30 days of service or of the postmarked date of the copy of the decision mailed to the facility. The appeal shall be on the record to the Superior Court and shall be as provided in §§10142 - 10145 of Title 29.
17.2.3.1	Food may be examined or tested by the Division contract lab as often as necessary for enforcement of this regulation.
17.2.3.2	All food shall be wholesome and free from spoilage. Food that is spoiled or unfit for human consumption shall not be kept on the premises.
17.3.1.1	Any person who violates a provision of this regulation, and any person who is the holder of a permit or who otherwise operates a food establishment that does not comply with the requirements of this regulation shall be subject to the penalties found in 16 Del.C. §107.
17.4.1	The Division may seek to enjoin violations of the regulation.
18.1	The Office of Medical Marijuana (OMM) has set the maximum batch size as five (5) pounds or 2268 grams. Compassion centers may create any size batch they deem appropriate, but not more than 5 pounds. A batch is considered a collection of plants of the same strain and genetics, grown in the same room at the same time. The minimum sample size is set at 0.5% of batch weight. A 1 pound batch would require a 2 gram sample and a 5 pound batch would require an 11 gram sample. The minimum sample size for testing is 1 gram.
18.1.1	All medical marijuana products will be tested to identify any non-organic residual solvents, processing chemicals or foreign material, including, but not limited to, hair, insects, or similar or related adulterant. Quantification of cannabinoid profiles and potency is needed to determine appropriate dosing for an individual use. Additionally the lab will test for microbiological impurity, including total aerobic microbial count, total yeast mold count, P. aeruginosa, aspergillus spp., s. aureus, aflatoxin B1, B2, G1, G2, or ochratoxin A. Safety testing shall include E. coli, Salmonella and Streptococcus.
18.1.2	Compassion Centers will coordinate with the Office of Medical Marijuana (OMM) for collection of samples by State Regulators, who will supervise randomly chosen samples of each batch for testing by the Testing Center. Sample results will be loaded into the DEC3S system by the testing center allowing Compassion Centers to sell the material or incorporate it into other products.
18.2.1	Compassion Centers will coordinate harvest schedules with the Office of Medical Marijuana (OMM) and the Testing Center. After the marijuana has been harvested, dried and cured, the OMM staff will supervise selection of random samples from the curing vessels with the Compassion Center staff. Compassion Center staff will prepare additional barcode labels and tamper-proof containers for each batch and develop a transportation manifest, initiating the chain of custody process for the batch of plants being tested.
18.2.2	Compassion Centers will not sell or prepare products from the batch being tested until the testing centers enter the values into the DEC3S program, releasing the material for use or sale. Compassion Centers will be invoiced for payment of testing services directly from the Testing Center. All concentrates or other infused products must be sent to the Testing Center using the process listed above before they are cleared for sale.
18.3.1	The Office of Medical Marijuana (OMM) will arrive at the Compassion Centers at a pre-designated time and date for the collection of samples. OMM staff will monitor Compassion Center staff, pull random samples from each batch harvested, and place the material into tamper-proof containers for testing. OMM staff will verify the sample container barcodes against the prepared manifest and co-sign the document to initiate the chain of custody.
18.3.1.1	Office of Medical Marijuana staff will transport samples to the testing center and acknowledge the transfer of the samples to the testing center. The testing center staff will verify the sample barcodes against the manifest by co-signing the manifest with the OMM staff.
18.3.1.2	OMM staff will secure and transport the sample material in an appropriate locked container.
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.
18.4.2.4	Residual levels of volatile organic compounds shall be below the lesser of either the specifications set by the United States Pharmacopeia (U.S.P. Chapter 467) or those set by the Division of Public Health.
18.4.3	Terpenes described in Revision 2014 of the cannabis inflorescence monograph published by the American Herbal Pharmacopoeia. Terpene testing will be done as required by the compassion centers to inform patients of the products formulization.
18.4.4.2	Testing Center will certify destruction of the sample after DEC3S is updated.
18.5.1	The Delaware Consolidated Cannabis Control System (DEC3S) will be used throughout the sample collection, manifest and barcode verification procedures.
18.5.2	Batches will be listed as unavailable for sale until the Testing Center completes the sample testing and enters the results into DEC3S, unlocking them for sale.
18.5.3	The cannabinoid profile values will be available for the Compassion Centers to list on the packaging of the medical marijuana product.
18.5.4	If a sample tested fails one or more of the standards listed above, the DEC3S will lockout those barcodes until remediation or corrective action is completed. If remediation is not possible, the compassion center will coordinate with the Office of Medical Marijuana on disposition or the batch must be destroyed.
20.1	A licensee may seek a variance from these regulations by making a request for variance to the Division. The Division may grant a variance by modifying or waiving the requirements of these regulations if, in the opinion of the Division, a health hazard or nuisance will not result from the variance.
20.2	A variance shall not be transferable from person to person, nor from location to location.
20.3.3	Any other information requested by the Division that may be deemed necessary to render judgment.
20.4	A variance is rendered void upon occurrence of one or more of the following: the physical facility is demolished; a remodeling project in the facility includes the area(s) addressed in the variance.

References: §534
 §4906
 §4918
 §4911
 §4914
 §4915
 §4919
 §10122
 §4920
 §10128
 §1700
 §10128
 §107