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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsOctober 2013

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16 DE Admin. Code 4470
Copies of the proposed regulations are available for review in the October 1, 2013 edition of the Delaware Register of Regulations, accessible online at: http://regulations.delaware.gov or by calling the Health Systems Protection Section at 302-744-4705.
The Secretary of Delaware Health and Social Services adopts these Regulations in response to the authority vested in the Secretary by 16 Delaware Code Del.C. Chapter Ch. 49A, The Delaware Health and Social Services Medical Marijuana Act. These Regulations establish the standards for the procedures for issuing a certificate of registration to qualified patients and primary caregivers. These Regulations provide a system of permitting and inspection, as well as governing confidentiality, payments of fees, and enforcement of these rules.
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.
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.
Debilitating medical condition means one or more of the following:
(a) 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), and agitation of Alzheimer’s disease or the treatment of these conditions;
(b) a chronic or debilitating disease, medical condition or symptom listed in these rules and as defined in 16 Del.C. §4902A(3) that qualifies for the medical use of marijuana by a registered patient 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) 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..
Department” means the Delaware Department of Health and Social Services.
Designated caregiver means a person who:
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
(2) an offense that consisted of conduct for which this chapter 16 Del.C. Ch. 49A would likely have prevented a conviction, but the conduct either occurred prior to the enactment of this chapter July 1, 2011, or was prosecuted by an authority other than the sState of Delaware.
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.
Marijuana” means the same as defined in 16 Del.C. §4701 (23).
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 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.
Onsite assessment means a visit by an employee of the Department for the purpose of ensuring compliance with the requirements of these rules.
Physician means a properly licensed physician subject to 24 Del.C. Chs. 17 and 19, except as otherwise provided in this subsection. If the qualifying patient’s debilitating medical condition is post-traumatic stress disorder, the physician must also be a licensed psychiatrist. In relation to a visiting qualifying patient, “physician” means a person who is licensed with authority to prescribe drugs to humans and who may issue a written certification or its equivalent in the state of the patient’s residence.
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.
Qualifying patientmeans a person who has been diagnosed by a physician as having a debilitating medical condition.
“Registry identification card means a document issued by the Department that identifies a person as a registered patient or registered designated caregiver.
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. 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.
Visiting qualifying patient means a patient who:
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 her or his the qualifying patient’s primary care or for her or his 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 Pphysician, supporting application documents and a non-refundable application fee with a personal check or a cashier’s check made out to “State of Delaware, Medical Marijuana Program.” 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.
3.2.2 the Pphysician’s clinical licensure;
3.2.4 the medical justification for the Pphysician’s certification of the patient’s debilitating medical condition;
3.2.5 the Pphysician’s signature and date;
3.2.9 the length of time the applicant has been under the care of the Pphysician providing the medical provider certification for patient eligibility;
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.
5.1.1.2 contacting the Delaware Division of Professional Regulation to verify that the Pphysician is licensed to practice medicine in Delaware and is in good standing; and
5.1.1.3 contacting the Pphysician to obtain further documentation that the applicant’s medical diagnosis and medical condition qualify the applicant for enrollment in the medical use marijuana program.
7.3.11 a description of the documentation that will accompany a registered compassion center agent when transporting marijuana on behalf of the registered compassion center. In response to 16 Del.C. §4918A(b), the documentation must specify, at least, the amount of marijuana being transported, the date the marijuana is being transported, the registry identification number of the registered compassion center, and a contact number to verify that the marijuana is being transported on behalf of the registered compassion center.
7.5.2.2 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.
78.0 Registration and Operation of Testing Facility Centers
78.1 General Requirements for Operation of a Testing Facility Center. RESERVED
78.2 Security Requirements: RESERVED
78.3 Operations Manual. RESERVED
78.4 Required Training. RESERVED
78.5 Personnel Records. RESERVED
78.6 Application for Operation of Testing Facility Center. RESERVED
78.7 Complete Application Required. RESERVED
78.8 Testing Facility Center Application Review Criteria. RESERVED
78.9 Issuance of Registration Certificate Authorizing Operation of a Testing Facility Center. RESERVED
78.10 Registry Identification Cards for Principal Officers, Board Members, Agents, Volunteers or Employees of a Testing Facility Center. RESERVED
78.11 Expiration Date. RESERVED
78.12 Expiration, Termination or Renewal of a Registration Certificate Authorizing Operation of a Testing Facility Center. RESERVED
78.13 Non-transferable Registration Certificate Authorizing Operation of a Testing Facility Center. RESERVED
78.14 Inspection. RESERVED
89.0 Monitoring and Corrective Actions
89.1 On-site Vvisits/Iinterviews
89.1.1 The Department or its designee may perform on-site interviews of a qualified patient or primary caregiver to determine eligibility for the program. The Department may enter the premises of a qualified patient or primary caregiver during business hours for purposes of interviewing a program applicant. Twenty-four (24) hours’ notice will be provided to the qualified patient or primary caregiver prior to an on-site interview.
89.1.2 All qualified patients or primary caregivers shall provide the Department or the Department’s designee immediate access to any material and information necessary for determining eligibility with these requirements.
89.1.3 Failure by the qualified patient or primary caregiver to provide the Department access to the premises or information may result in action up to and including the revocation of the qualified patient or primary caregiver registry identification card and referral to state law enforcement.
89.1.4 Any failure to adhere to these rules, documented by the Department during an interview, may result in sanction(s), including suspension, revocation, non-renewal or denial of licensure and referral to state or local law enforcement.
89.1.5 The Department shall refer credible criminal complaints against a qualified patient or primary a caregiver to the appropriate Delaware state or appropriate local authorities.
89.2 Corrective action:
89.2.1 If violations of these requirements are cited as a result of monitoring, the qualified patient or primary caregiver shall be provided with an official written report of the findings following the monitoring visit.
89.2.2 Unless otherwise specified by the Department, the qualified patient or primary caregiver shall correct the violation within 5 calendar days of receipt of the official written report citing the violation(s).
89.2.3 The violation shall not be deemed corrected until the Department verifies in writing after receiving notice of the corrective action that the corrective action is satisfactory.
89.2.4 If the violation has not been corrected, the Department may issue a notice of contemplated action to revoke the qualified patient’s or designated caregiver’s registry identification card.
89.2.5 Suspension of registry identification card without prior hearing: In accordance with the 16 Delaware Code Chapter 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.
89.2.5.1 A qualified patient or primary caregiver whose registry identification card has been summarily suspended is entitled to a record review not later than 30 calendar days after the registry identification card was summarily suspended.
89.2.5.2 The record review requested subsequent to a summary suspension shall be conducted by the Department.
89.2.5.3 The Department shall conduct the record review on the summary suspension by reviewing all documents submitted by both card holder and the Department.
89.2.5.4 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.
89.2.5.5 A card holder given notice of summary suspension by the division may submit a written request for a record review. To be effective, the written request shall:
89.2.5.5.1 be made within 30 calendar days, as determined by the postmark, from the date of the notice issued by the Department;
89.2.5.5.2 be properly addressed to the medical marijuana program;
89.2.5.5.3 state the applicant’s name, address, and telephone number(s);
89.2.5.5.4 provide a brief narrative rebutting the circumstances of the suspension, and
89.2.5.5.5 additional documentation must be included with the request for a record review.
89.3 Summary Suspension, Revocation and Appeal Process:
89.3.1 Participation in the medical marijuana program by a qualified patient or primary caregiver does not relieve the qualified patient or primary caregiver from:
89.3.1.1 criminal prosecution or civil penalties for activities not authorized in this rule and act;
89.3.1.2 liability for damages or criminal prosecution arising out of the operation of a vehicle while under the influence of marijuana; or
89.3.1.3 criminal prosecution or civil penalty for possession, distribution or transfers of marijuana or use of marijuana:
89.3.1.3.1 in a school bus or public vehicle;
89.3.1.3.2 on school grounds or property;
89.3.1.3.3 in the workplace of the qualified patient's or primary caregiver's employment;
89.3.1.3.4 at a public park, recreation center, youth center or other public place;
89.3.1.3.5 to a person not approved by the Department pursuant to this rule;
89.3.1.3.6 outside Delaware or attempts to obtain or transport marijuana from outside Delaware; or
89.3.1.3.7 that exceeds the allotted amount of usable medical use marijuana.
89.3.2 Revocation of registry identification card: 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.
89.3.3 Grounds for revocation or suspension of registry identification card, denial of renewal application for registry identification card. A registry identification card may be revoked or suspended, and a renewal application may be denied for:
89.3.3.1 failure to comply with any provisions of these requirements;
89.3.3.2 failure to allow a monitoring visit by authorized representatives of the Department;
89.3.3.3 the discovery of repeated violations of these requirements during monitoring visits.
89.4 Request for hearing: 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:
89.4.1 a statement of the facts relevant to the review of the action;
89.4.2 a statement of the provision of the act and the rules promulgated under the act that are relevant to the review of the action;
89.4.3 a statement of the arguments that the qualified patient/primary caregiver considers relevant to the review of the action; and
89.4.4 any other evidence considered relevant.
89.5 Hearing process:
89.5.1 All formal adjudicatory hearings held in response to these Regulations shall be conducted by a hearing officer duly appointed by the DHSS Secretary.
89.5.2 Except for telephonic hearings, hearings shall be conducted in Dover or, upon written request by an aggrieved person, in the place or area affected.
89.5.3 All hearings held pursuant to this section shall be open to the public.
89.5.4 The hearing shall be recorded on audiotape or other means of sound reproduction, or by a certified court reporter. The decision as to the type of recording shall be at the discretion of the Department.
89.5.5 Any hearing provided for in this rule may be held telephonically, in the interest of a speedy resolution.
89.5.6 The Department shall schedule and hold the hearing as soon as practicable, however; in any event no later than 60 calendar days from the date the Department receives the request for hearing. The hearing officer shall extend the 60 day time period upon motion for good cause shown or the parties shall extend the 60 day time period by mutual agreement. The Department shall issue notice of hearing, not less than 20 days prior to the hearing, which shall include:
89.5.6.1 a statement of the time, place and nature of the hearing;
89.5.6.2 a statement of the legal authority and jurisdiction under which the hearing is to be held;
89.5.6.3 a short and plain statement of the matters of fact and law asserted;
89.5.6.4 notice to any other parties to give prompt notice of issues controverted in fact or law; and
89.5.6.5 all necessary telephone numbers if a telephonic hearing shall be conducted.
89.6 All parties shall be given the opportunity to respond and present evidence and argument on all relevant issues.
89.7 Record of proceeding: The record of the proceeding shall include the following:
89.7.1 all pleadings, motions and intermediate rulings;
89.7.2 evidence received or considered;
89.7.3 a statement of matters officially noticed;
89.7.4 questions and offers of proof, objections and rulings thereon;
89.7.5 proposed findings and conclusions; and
89.7.6 any action recommended by the hearing officer.
89.8 A party may request a transcription of the proceedings. The party requesting the transcript shall bear the cost of transcription.
89.9 Procedures and evidence:
89.9.1 Any party shall be represented by a person licensed to practice law in Delaware or an individual may represent him or herself.
89.9.2 The rules of evidence as applied in the courts do not apply in these proceedings. Any relevant evidence shall be admitted and such evidence shall be sufficient in itself to support a finding if the evidence is reliable, regardless of the existence of any statutory or common law rule that shall make admission of such evidence improper in a civil action. Irrelevant, immaterial or unduly repetitious evidence shall be excluded at a party’s request or on the hearing officer’s own initiative.
89.9.3 Documentary evidence shall be received in evidence in the form of true copies of the original.
89.9.4 Documentary and other physical evidence shall be authenticated or identified by any reasonable means that shows that the matter in question is what the proponent claims it to be.
89.9.5 The experience, technical competence and specialized knowledge of the hearing officer, the Department or the Department’s staff shall be used in the evaluation of evidence.
89.9.6 Evidence on which the hearing officer shall base his or her decision is limited to the following:
89.9.6.1 all evidence, including any records, investigation reports and documents in the Department’s possession of which the Department desires to avail itself as evidence in making a decision that is offered and made a part of the record of the proceeding; and
89.9.6.2 testimony and exhibits introduced by the parties.
89.9.7 The record shall include all briefs, proposed findings and exceptions and shall show the ruling on each finding, exception or conclusion presented.
89.9.8 A party to a hearing shall submit to the hearing officer, and to all other parties to the hearing, all documents to be introduced at the hearing no later than five business days from the scheduled hearing date to insure the hearing officer and other parties receive the documents prior to the hearing.
89.9.9 The Department may choose to:
89.9.9.1 issue subpoenas for witnesses and other sources of evidence, either on the agency’s initiative or at the request of any party; and
89.9.9.2 administer oaths to witnesses; limit unduly repetitive proof, rebuttal and cross-examination.
89.10 Conduct of proceeding: Unless the hearing officer reasonably determines a different procedure is appropriate, the hearing shall be conducted in accordance with the procedures set forth in this rule. The following procedures shall apply:
89.10.1 the Division shall present an opening statement on the merits and the Cardholder shall make a statement of the defense or reserve the statement until presentation of that party’s case;
89.10.2 after the opening statements, if made, the Division shall present its case in chief in support of the Division’s petition;
89.10.3 upon the conclusion of the Division’s case, the Cardholder shall present its case in defense;
89.10.4 upon conclusion of the Cardholder’s case, the Division shall present rebuttal evidence;
89.10.5 after presentation of the evidence by the parties, the Division shall present a closing argument; the Cardholder then shall present its closing argument and the Division shall present a rebuttal argument; and
89.10.6 thereafter, the matter shall be submitted for recommendation by the hearing officer.
89.11 Continuances: The hearing officer shall not grant a continuance except for good cause shown. A motion to continue a hearing shall be made at least 10 calendar days before the hearing date.
89.12 Telephonic hearings:
89.12.1 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.
89.12.2 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.
89.12.3 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.
89.12.4 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.
89.12.5 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.
89.13 Recommended action and final decision:
89.13.1 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.
89.13.2 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.
89.13.3 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:
89.13.3.1 a brief summary of the evidence,
89.13.3.2 a statement of findings of fact based upon the evidence,
89.13.3.3 conclusions and the reasons thereof, on all material issues of fact, law or discretion involved,
89.13.3.4 any other conclusions required by law of the Department, and
89.13.3.5 a concise statement of the Department’s specific determination or action taken to sustain, modify or reverse the initial decision of the Department or the Department’s agent.
89.13.3.6 Service shall be made by registered or certified mail.
89.13.4 The final decision or order shall be public information and shall become a part of the record.
910.0 Severability
Last Updated: December 31 1969 19:00:00.
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