• English
    X

    Google Translate Disclaimer

    The Maryland Department of Information Technology (“DoIT”) offers translations of the content through Google Translate. Because Google Translate is an external website, DoIT does not control the quality or accuracy of translated content. All DoIT content is filtered through Google Translate which may result in unexpected and unpredictable degradation of portions of text, images and the general appearance on translated pages. Google Translate may maintain unique privacy and use policies. These policies are not controlled by DoIT and are not associated with DoIT’s privacy and use policies. After selecting a translation option, users will be notified that they are leaving DoIT’s website. Users should consult the original English content on DoIT’s website if there are any questions about the translated content.

    DoIT uses Google Translate to provide language translations of its content. Google Translate is a free, automated service that relies on data and technology to provide its translations. The Google Translate feature is provided for informational purposes only. Translations cannot be guaranteed as exact or without the inclusion of incorrect or inappropriate language. Google Translate is a third-party service and site users will be leaving DoIT to utilize translated content. As such, DoIT does not guarantee and does not accept responsibility for, the accuracy, reliability, or performance of this service nor the limitations provided by this service, such as the inability to translate specific files like PDFs and graphics (e.g. .jpgs, .gifs, etc.).

    DoIT provides Google Translate as an online tool for its users, but DoIT does not directly endorse the website or imply that it is the only solution available to users. All site visitors may choose to use alternate tools for their translation needs. Any individuals or parties that use DoIT content in translated form, whether by Google Translate or by any other translation services, do so at their own risk. DoIT is not liable for any loss or damages arising out of, or issues related to, the use of or reliance on translated content. DoIT assumes no liability for any site visitor’s activities in connection with use of the Google Translate functionality or content.

    The Google Translate service is a means by which DoIT offers translations of content and is meant solely for the convenience of non-English speaking users of the website. The translated content is provided directly and dynamically by Google; DoIT has no direct control over the translated content as it appears using this tool. Therefore, in all contexts, the English content, as directly provided by DoIT is to be held authoritative.

    PROPOSAL

    Maryland Register

    Issue Date:  April 26, 2019

    Volume 46 • Issue 9 • Page 450-459

     

    Title 10 
    MARYLAND DEPARTMENT OF HEALTH

    Subtitle 62 NATALIE M. LAPRADE MEDICAL CANNABIS COMMISSION

    Notice of Proposed Action

    [19-075-P]

    The Secretary of Health proposes to:

    (1) Amend Regulation .01 under COMAR 10.62.01 Definitions;

    (2) Amend Regulation .04 under COMAR 10.62.02 General Regulations;

    (3) Amend Regulations .01—.03 under COMAR 10.62.03 Certifying Providers;

    (4) Amend Regulations .01 and .02 under COMAR 10.62.05 Written Certifications;

    (5) Amend Regulations .01.05, and .07 under COMAR 10.62.06 Patient and Caregiver Identification Cards;

    (6) Amend Regulations .02.03, and .06 under COMAR 10.62.07 New Condition Approval Process;

    (7) Amend Regulations .04.06, and .08 under COMAR 10.62.08 Medical Cannabis Grower License;

    (8) Amend Regulation .03 under COMAR 10.62.09 Medical Cannabis Grower Agent;

    (9) Amend Regulations .05 and .07 under COMAR 10.62.15 Medical Cannabis Grower Quality Control;

    (10) Adopt new Regulation .06 under COMAR 10.62.16 Independent Testing Laboratory Registration;

    (11) Amend Regulation .02 under COMAR 10.62.17 Complaints, Adverse Events, and Recall;

    (12) Amend Regulations .01—.06 and adopt new Regulations .07—.10 under COMAR 10.62.18 Shipment of Products Between Licensees;

    (13) Amend Regulations .03 and .05—.07 under COMAR 10.62.19 Medical Cannabis Processor License;

    (14) Amend Regulation .03 under COMAR 10.62.20 Medical Cannabis Processor Agent;

    (15) Amend Regulation .03 under COMAR 10.62.22 Medical Cannabis Processor Operations;

    (16) Amend Regulations .04 and .06 under COMAR 10.62.23 Medical Cannabis Concentrates and Medical Cannabis-Infused Products;

    (17) Amend Regulations .04 and .06—.08 under COMAR 10.62.25 Medical Cannabis Dispensary License;

    (18) Amend Regulation .03 under COMAR 10.62.26 Registered Dispensary Agent;

    (19) Amend Regulation .03 under COMAR 10.62.28 Licensed Dispensary Operations;

    (20) Amend Regulation .02 under COMAR 10.62.29 Licensed Dispensary Packaging and Labeling for Distribution;

    (21) Amend Regulations .03 and .04 under COMAR 10.62.30 Dispensing Medical Cannabis;

    (22) Amend Regulations .02 and .03 under COMAR 10.62.32 Records; and

    (23) Amend Regulations .01—.04 and adopt new Regulations .05—.07 under COMAR 10.62.34 Discipline and Enforcement.

    Statement of Purpose

    The purpose of this action is to implement:

    (1) The requirements of Ch. 598 (H.B. 2), Acts of 2018, Natalie M. LaPrade Medical Cannabis Commission Reform Act, permitting certain individuals who have been convicted of a drug felony to work in the medical cannabis industry;

    (2) The requirements of Ch. 601 (S.B. 874), Acts of 2018, Natalie M. LaPrade Medical Cannabis Commission — Immunity, authorizing third-party vendors registered with the Maryland Medical Cannabis Commission (MMCC) to test, transport, and dispose of medical cannabis;

    (3) The requirements of Ch. 474, Acts of 2016, expanding the qualifying professions to certify medical cannabis patients to include dentists, podiatrists, nurse practitioners, and certified nurse midwives;

    (4) The requirements of Ch. 240, Acts of 2014, requiring the issuance of an identification card to every certified medical cannabis patient;

    (5) Laboratory testing requirements for contaminants, including toxic heavy metals; and

    (6) Notice, hearing, and penalty provisions for individuals and entities violating COMAR 10.62.

    Comparison to Federal Standards

    There is no corresponding federal standard to this proposed action.

    Estimate of Economic Impact

    The proposed action has no economic impact.

     

    Economic Impact on Small Businesses

    The proposed action has minimal or no economic impact on small businesses.

    Impact on Individuals with Disabilities

    The proposed action has no impact on individuals with disabilities.

    Opportunity for Public Comment

    Comments may be sent to Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through May 28, 2019. A public hearing has not been scheduled.

     

    10.62.01 Definitions

    Authority: Health-General Article, §§13-3301—13-3303, Annotated Code of Maryland

    .01 Definitions.

    A. (text unchanged)

    B. Terms Defined.

    (1)—(2) (text unchanged) 

    (3) “Bona fide [physicianprovider-patient relationship” means a treatment or counseling relationship between a [physician] provider and a patient in which the [physician] provider has:

    (a)—(b) (text unchanged)

    (c) A reasonable expectation that the [physician] provider will monitor the progress of the patient while using medical cannabis and take any medically indicated action:

    )

    (4)—(5) (text unchanged)

    (6) “Certifying [physician] provider” [means a physician, as defined in Health Occupations Article, §14-101(i), Annotated Code of Maryland, who is registered by the Commission] has the meaning stated in Health-General Article, §13-3301(c), Annotated Code of Maryland.

    (7)—(26) (text unchanged)

    [(27) “Medical cannabis transport vehicle” means a vehicle owned, or leased by a licensee, for the purpose of transporting products containing cannabis that meets the criteria specified in Regulation .06 of this chapter.]

    [(28)(27) [(29)(28) (text unchanged)

    [(30)(29) “Qualifying patient” means an individual who:

    (a) Lives in the State [or, during that time an individual is present in the State, is physically present in the State for the purpose of receiving medical care from a medical facility in the State;] and:

    [(b)] (i) Has been provided with a written certification by a certifying [physician] provider in accordance with a bona fide [physician] provider-patient relationship; and

    [(c)] (ii) If younger than 18 years old, has a caregiver[.]; or

    (b) Is physically in the State and:

    (i) Has been provided with a written certification by a certifying provider in accordance with a bona fide provider-patient relationship;

    (ii) Is admitted to a Joint Commission accredited medical facility;

    (iii) Will be dispensed medical cannabis at the medical facility during an inpatient stay;

    (iv) Will complete the treatment with medical cannabis prior to release; and

    (v) If younger than 18 years old, has a caregiver.

    [(31)] (30)—[(33)(32) (text unchanged)

    (33) “Secure medical cannabis transport vehicle” means a vehicle owned or leased by a licensee or a secure transportation company for the purpose of transporting medical cannabis that:

    (a) Meets the criteria specified in COMAR 10.62.18;

    (b) Is equipped with:

    (i) A secure area within the body or compartment of the vehicle containing solid or locking metal partitions, cages, or high strength shatterproof acrylic; and

    (ii) Locked and secure storage containers anchored to the inside of the vehicle;

    (c) Conceals medical cannabis, products containing medical cannabis, or locked and secure storage containers so they are not visible or identifiable from outside of the vehicle; and

    (d) Is registered with the Commission.

    (34)—(35) (text unchanged) 

    (36) “Transportation agent” means[:

    (a) A registered grower agent, registered processor agent or a registered dispensary agent, authorized by the licensee to transport products containing medical cannabis, who meets the criteria specified in COMAR 10.62.18; or

    (b) A licensed and bonded courier of a secure transportation company] an owner, a member, an employee, a volunteer, an officer, or a director of a registered secure transportation company.

    (37)—(38) (text unchanged) 

    (39) “Written certification” means a certification that is issued by a certifying [physician] provider for a qualifying patient with whom the [physician] provider has a bona fide [physician] provider-patient relationship.

    (40) “30-day supply” means:

    (a) 120 grams of usable cannabis unless the [physician] provider determines this amount would be inadequate to meet the medical needs of the qualifying patient; or

    (b) In the case of a medical cannabis-infused product, 36 grams of Δ9-Tetrahydrocannabinol (THC) unless the [physician] provider determines this amount would be inadequate to meet the medical needs of the qualifying patient.

     

    10.62.02 General Regulations

    Authority: Health-General Article, §§13-3301—13-3316, Annotated Code of Maryland

    .04 Encouragement of Applications.

    A. The Commission shall broadly publicize that the Commission will be seeking:

    (1) (text unchanged)

    (2) The submission of applications to register patients, [physicians] providers, and independent testing laboratories from all interested persons throughout the State.

    B.—C. (text unchanged)

     

    10.62.03 Certifying [Physicians] Providers

    Authority: Health-General Article, §§13-3301, 13-3302, and 13-3307, Annotated Code of Maryland

    .01 [Physician] Provider Application for Registration.

    A. A [physician] provider seeking registration as a certifying [physician] provider shall submit an application provided by the Commission that includes:

    (1) The [physician’s] provider’s:

    (a)—(d) (text unchanged) 

    (e) Maryland Board of Physicians, Board of Dental Examiners, Board of Podiatric Medical Examiners, or Board of Nursing license number; and

    (f) (text unchanged)

    (2) An attestation that the:

    (a) [Physician’s] Provider’s Maryland license [to practice medicine] is active, unrestricted, and in good standing;

    (b) [Physician] Provider is registered to prescribe controlled substances by the State; and

    (c) (text unchanged)

    (3) The medical conditions for which the [physician] provider may issue written certifications for medical cannabis;

    (4) The [physician’s] provider’s other inclusion criteria; and

    (5) The reasons the [physician] provider may deny issuing a written certification of medical cannabis.

    B. The Commission encourages [physiciansproviders to apply to register as a certifying [physician] provider to treat patients who:

    (1)—(3) (text unchanged) 

    C. A [physician] provider may be registered as a certifying physician to treat a patient who has a condition that is:

    (1)—(3) (text unchanged) 

    D. A certifying [physician] provider may apply to amend the approval at any time.

    E. (text unchanged)

    .02 Compensation from a Licensed Grower, Licensed Processor, or Licensed Dispensary.

    A. A certifying [physician] provider may not receive compensation, including promotion, recommendation, advertising, subsidized rent, or anything of value, from a licensed grower, licensed processor, or a licensed dispensary unless the certifying [physician] provider submits an application to the Commission for approval for the compensation.

    B. The application shall disclose:

    (1) (text unchanged)

    (2) An attestation that the compensation does not violate [the]:

    (a) [Maryland Medical Practice Act, codified at Health Occupations Article, §14-101 et seq., Annotated Code of Maryland] Any compensation restrictions established by the provider’s licensing board; or

    (b) (text unchanged)

    C. The Commission shall deny an application for compensation if:

    (1) The compensation is based on any agreement or arrangement for the certifying [physician] provider to refer, direct, or recommend qualifying patients to the licensed grower, licensed processor, or licensed dispensary to obtain medical cannabis;

    (2) The [physician] provider refuses to attest that the compensation would not violate [the Maryland Medical Practice Act, codified at Health Occupations Article, §14-101 et seq., Annotated Code of Maryland] any compensation restrictions established by the provider’s licensing board or the patient referral laws codified at Health Occupations Article, §1-301 et seq., Annotated Code of Maryland; or

    (3) The compensation would violate [the]:

    (a) [Maryland Medical Practice Act, codified at Health Occupations Article, §14-101 et seq., Annotated Code of Maryland] Any compensation restrictions established by the provider’s licensing board; or

    (b) (text unchanged)

    D. The Commission may deny an application for compensation if the compensation agreement may create an appearance that the compensation compromises the independent judgment of the certifying [physician] provider in the treatment of a patient.

    E. If the Commission denies an application for compensation, the Commission shall [provide the physician with] give the provider written notice pursuant to State Government Article, §§10-201—10-226, Annotated Code of Maryland. The [physician] provider shall be entitled to a hearing to review the denial pursuant to State Government Article, §§10-201—10-226, Annotated Code of Maryland.

    .03 Renewal of Certifying [Physician] Provider Registration to Certify.

    A. (text unchanged)

    B. A certifying [physician] provider shall apply to renew a registration to certify at the time of renewal of the [physician’s] provider’s license [to practice medicine by the Maryland Board of Physicians].

    C. The Commission shall provide a certifying [physician] provider with notice of renewal 90 business days before expiration of the registration.

    D. The Commission shall grant the application for renewal of registration if:

    (1) The certifying [physician] provider attests that:

    (a) The certifying [physician’sprovider’s license to practice medicine in Maryland is active, unrestricted, and in good standing; and

    (b) The certifying [physician’s] provider’s registration by the State to prescribe controlled dangerous substances is valid; and

    (2) The certifying [physician] provider has otherwise complied with this chapter.

    E. If a certifying [physician] provider fails to obtain a renewal of a registration to issue written certifications, the certifying [physician] provider may not issue written certifications.

     

    10.62.05 Written Certifications

    Authority: Health-General Article, §§13-3301, 13-3302, and 13-3307, Annotated Code of Maryland

    .01 Issuing a Written Certification.

    A. A certifying [physician] provider may determine that a patient qualifies for a written certification only:

    (1) (text unchanged)

    (2) [For whom] If the certifying [physician] provider has a bona fide [physician] provider-patient relationship with the qualifying patient;

    (3) If the qualifying patient meets the certifying [physician’s] provider’s inclusion criteria;

    (4) If the qualifying patient does not meet the certifying [physician’sprovider’s exclusion criteria; and

    (5) If the certifying [physician] provider has determined that the potential benefits of the medical use of cannabis likely outweigh the health risks for the patient.

    B. The certifying [physician] provider shall:

    (1)—(2) (text unchanged)

    C. A written certification shall include the:

    (1) [Physician’s] Provider’s name, Maryland Board of Physicians, Board of Dental Examiners, Board of Podiatric Medical Examiners, or Board of Nursing license number, and office telephone number;

    (2)—(4) (text unchanged)

    D. A written certification may contain, if applicable, a written statement certifying that, in the [physician’s] provider’s professional opinion, a 30-day supply of medical cannabis would be inadequate to meet the medical needs of the qualifying patient.

    E. A certifying [physician] provider may discuss the use of medical cannabis with a patient.

    F. A certifying [physicianprovider shall terminate a written certification if:

    (1) The qualifying patient meets the [physician’s] provider’s exclusion criteria;

    (2)—(4) (text unchanged)

    G. A certifying [physician] provider may terminate a written certification if the qualifying patient demonstrates abuse of any substance of abuse.

    H. A certifying [physician] provider shall notify the Commission within 1 business day of the termination of a written certification.

    I. A qualifying patient shall have only one certifying [physician] provider at any time.

    .02 Written Certification Renewal.

    A. A qualifying patient may seek renewal of a written certification not less than 30 calendar days after it was issued by notifying the patient’s certifying [physician] provider.

    B. A certifying [physician] provider may renew the written certification for a qualifying patient if the certifying [physician] provider determines the patient still meets the criteria set forth in Regulation .01A of this chapter.

    C. Upon renewing a written certification for a qualifying patient, a certifying [physician] provider shall notify the Commission.

    D. A certifying [physician] provider may not renew a written certification unless the [physician] provider has made a full, in-person assessment of the qualifying patient within the 365 days before the reissuance.

     

    10.62.06 Patient and Caregiver Identification Cards

    Authority: Health-General Article, §§13-3301, 13-3302(d), 13-3303(g), and 13-3307(f)(3), Annotated Code of Maryland

    .01 Patient Identification Cards.

    A. A qualifying patient [may] shall apply to the Commission for an identification card as part of the qualifying process by logging onto the Commission website and submitting:

    (1)—(4) (text unchanged)

    B. An identification card shall contain:

    (1) (text unchanged)

    (2) An expiration date [2 years from the date of issue;]:

    (a) 2 years from the date the card is issued; and

    (b) Beginning January 1, 2019, 3 years from the date the card is issued;

    (3)—(4) (text unchanged)

    C. (text unchanged)

    .05 Circumstances Requiring Return of Identification Card to Commission.

    A. If a certifying [physicianprovider fails to renew a qualifying patient certification, a qualifying patient shall return an identification card to the Commission within 5 business days.

    B. A caregiver shall return his or her identification card with respect to a qualifying patient to the Commission within 5 business days if:

    (1) A certifying [physicianprovider terminates or fails to renew a written certification of a qualifying patient; or

    (2) (text unchanged)

    .07 Misuse of Identification Card. 

    A.—B. (text unchanged)

    C. The Commission may notify the certifying [physician] provider and revoke the identification card of a qualifying patient or caregiver who allows another person to use an identification card which has been issued to the qualifying patient or caregiver.

     

    10.62.07 New Condition Approval Process 

    Authority: Health-General Article, §§13-3304(d) and (e), Annotated Code of Maryland

    .02 Hearing.

    At least once per year if needed, the Commission shall conduct a public hearing to evaluate any petition to consider other medical conditions, medical treatments, or diseases that may be treated by using medical cannabis and included in certifying [physician] provider applications.

    .03 Petition Contents.

    The Commission shall consider a petition that may include:

    A.—D. (text unchanged)

    E. Letters of support from [physicians] providers or other licensed health care professionals knowledgeable about the condition, treatment, or disease.

    .06 Commission Determination.

    A. (text unchanged)

    B. The Commission may conclude that [physicians] providers will be encouraged to apply to register with the Commission to treat the medical condition[, medical treatment,] or disease upon a determination that:

    (1) The medical condition[, medical treatment,] or disease is debilitating;

    (2) The pain, suffering, and disability of the medical condition[,] or disease [or medical treatment thereof] can reasonably be expected to be relieved by medical cannabis; and

    (3) (text unchanged)

     

    10.62.08 Medical Cannabis Grower License

    Authority: Health-General Article, §§13-3301, 13-3302, 13-3306, and 13-3312, Annotated Code of Maryland

    .04 Consent for Investigation.

    A.—B. (text unchanged)

    C. An applicant shall release all financial institutions, fiduciaries, and other parties from any contractual, statutory or common law obligation of confidentiality to provide financial, personal and background information to the Commission relevant to the applicant’s capacity to manage a licensed growing facility [and the applicant’s good moral character].

    .06 Pre-Approval of Application.

    A.—B. (text unchanged)

    C. The Commission may deny issuing a pre-approval of a license if[, for] any individual identified in the application specified in Regulation .02B(1) of this chapter:

    (1) [The criminal history record information or any other evidence that demonstrates an absence of good moral character; or] Is convicted of or pleads nolo contendere to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;

    (2) [The payment of] Is in arrears on taxes due in any jurisdiction [is in arrears.]; or

    (3) Fraudulently or deceptively attempts to obtain a license.

    D.—E. (text unchanged)

    .08 Change of Ownership of License.

    A. (text unchanged)

    B. The Commission may deny transfer of an interest in a license for any proposed transferee if the:

    (1) [Criminal history record information or the background investigation demonstrate an absence of good moral character] Transferee is convicted of or pleads nolo contendere to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside; or

    (2) (text unchanged)

     

    10.62.09 Medical Cannabis Grower Agent

    Authority: Health-General Article, §§13-3301, 13-3302, 13-3306, and 13-3312, Annotated Code of Maryland

    .03 Grower Agent Registration and Criminal History Record.

    A.—B. (text unchanged)

    C. A prospective grower agent may not be registered if the prospective grower agent has ever been convicted of a felony drug offense[.], except as provided in Health-General Article, §13-3306(5)(iii), Annotated Code of Maryland.

    D. The Commission, after review of the criminal history record information, may disqualify from registration any prospective grower agent [from registration for an absence of good moral character] who is convicted of or pleads nolo contendere to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside.

     

    10.62.15 Medical Cannabis Grower Quality Control

    Authority: Health-General Article, §§13-3301, 13-3302, 13-3306, and 13-3311, Annotated Code of Maryland

    .05 Contents of Certificate of Analysis.

    An independent testing laboratory shall issue to the licensed grower a certificate of analysis for each batch, with supporting data, to report:

    A. [Whether the chemical profile of the batch conforms to the variety for] The concentrations of the following compounds:

    (1)—(7) (text unchanged)

    B. That the presence of the following contaminants does not exceed the levels [as required by the AHP monograph] provided in the Commission’s current version of technical authority for medical cannabis testing:

    (1)—(2) (text unchanged)

    (3) [Any microbiological impurity, including] Microbiological impurities such as:

    (a) (text unchanged)

    (b) Total yeast and mold count (TYMC);

    (c) [P. aeruginosa] Escherichia

    coli;

    (d) [Aspergillus] Salmonella

     spp.;

    [(e) S. aureus;]

    [(f)] (e) (text unchanged)

    [(g)] (f) Ochratoxin A.; [and]

    [(h)]

    (g) (text unchanged)

    (h) Heavy metals; and

    (4) (text unchanged)

    .07 Stability Testing and Retention Sampling.

    A. (text unchanged)

    B. [A licensed grower shall retain a sample from each released batch] Retention samples retained from each released batch shall be:

    (1) [Sufficient to provide for follow-up testing if necessary] Tested by a registered independent testing laboratory other than the original certifying laboratory following an adverse event reported to the Commission; and

    (2) [Properly store the sample for one year past the date of expiration of the batch] Properly stored by the licensed grower.

     

    10.62.16 Independent Testing Laboratory Registration

    Authority: Health-General Article, §§13-3301, 13-3302, and 13-3311, Annotated Code of Maryland

    .06 Transportation of Products Containing Medical Cannabis.

    A. A registered independent testing laboratory may transport samples of medical cannabis and products containing medical cannabis from the premises of a licensed grower, processor, or dispensary to the independent testing laboratory.

    B. A registered independent laboratory shall transport samples of medical cannabis and products containing medical cannabis:

    (1) With oversight by at least one independent testing laboratory employee registered with the Commission; and

    (2) Using a secure medical cannabis transport vehicle as defined in COMAR 10.62.01.

     

    10.62.17 Complaints, Adverse Events, and Recall

    Authority: Health-General Article, §§13-3301, 13-3302, 13-3304—13-3307, 13-3309, and 13-3311, Annotated Code of Maryland

    .02 Report of Serious Adverse Event to Commission and Interested Parties. 

    In the event a complaint associated with a serious adverse event is received, a licensee, or certifying [physician] provider, shall promptly report the complaint to:

    A.—B. (text unchanged)

    C. The certifying [physician] provider caring for the qualifying patient.

     

    10.62.18 Shipment of Products Between Licensees

    Authority: Health-General Article, §§13-3301, 13-3302, 13-3306(b) and (e), 13-3307(f), 13-3309(f), [and13-3311(c), and 13-3313(a), Annotated Code of Maryland

    .01 Definitions.

    A. (text unchanged)

    B. Terms Defined.

    (1) (text unchanged)

    (2) “Secure transportation company” means a business that is [licensed] registered with the Commission, whose employees are bonded, and that provides highly secure vehicles for the transportation of valuables, and can assure that medical cannabis is secured at all times during transport.

    (3) (text unchanged)

    .02 Electronic Manifest System.

    A. (text unchanged)

    B. An electronic manifest system shall include a chain of custody that records:

    (1)—(3) (text unchanged)

    (4) The name of the registered grower agent, processor agent, or [registered] dispensary agent that prepared the shipment;

    (5)—(6) (text unchanged)

    .03 Creation of Manifest.

    A. (text unchanged)

    B. The electronic manifest shall contain, at a minimum, the following entries as a chain of custody, in the order listed:

    (1) An entry by [the] a registered grower agent, registered processor agent, or registered dispensary agent who has prepared the shipment, including the date and time of preparation;

    (2) An entry by a [shipping licensee’s transportation agent] registered grower agent, processor agent, or dispensary agent of the date and time of the placement of the shipment into the secure medical cannabis transport vehicle;

    (3) An entry by the receiving licensee’s agent receiving the shipment, including the date and time of the acceptance; and

    (4) (text unchanged)

    .04 Transportation Agents.

    A. A registered grower agent, processor agent, dispensary agent, or transportation agent driving a secure medical cannabis transport vehicle shall have a current driver’s license.

    B. While [on duty a] in transita registered grower agent, processor agent, dispensary agent, or transportation agent may not wear any clothing or symbols that may indicate ownership or possession of cannabis.

    .05 Transportation of Products Containing Medical Cannabis.

    A. Either a secure transportation company or a [shipping licensee] licensed grower, processor, or dispensary shall transport products containing medical cannabis.

    B. [A shipping licensee shall use one transportation agent, who shall carry identification approved by the Commission, to] A secure transportation company or a licensed grower, processor, or dispensary shall comply with all of the following:

    (1) [Accompany shipment of products containing medical cannabis] Each secure medical cannabis transport vehicle shall be operated with at least two registered grower, processor, dispensary, or transportation agents[and]

    (2) [Ensure that the product is secured at all times during transport.] At least one registered grower, processor, dispensary, or transportation agent shall remain with the vehicle at all times during the transport of medical cannabis; and

    (3) All medical cannabis shall be transported in one or more locked and secure storage containers and may not be accessible while in transit.

    .06 Secure Medical Cannabis Transport Vehicle.

    secure medical cannabis transport vehicle:

    A.—C. (text unchanged)

    .07 Registration.

    A. A secure transportation company shall register with the Commission.

    B. To register, a secure transportation company shall submit:

    (1) A completed secure transportation company registration form;

    (2) The name, address, and date of birth and Social Security number of each transportation agent and a copy of the registration form completed by each transportation agent;

    (3) A security plan, including protocol in case of emergency; and

    (4) Any secure medical cannabis transport vehicle for inspection by the Commission.

    C. The registration is valid for 2 years.

    D. The registration may be renewed by submitting to the Commission:

    (1) A copy of the secure transportation company registration form;

    (2) Proof that fingerprints have been submitted to CJIS and the FBI for every transportation agent; and

    (3) Proof that each secure transport vehicle has been inspected by the Commission.

    .08 Transportation Agent Registration and Criminal History Record.

    A. Each transportation agent shall be registered with the Commission before the agent may volunteer or work for a secure transportation company.

    B. A registered secure transportation company shall apply to register a transportation agent by submitting to the Commission:

    (1) The name, address, date of birth, and Social Security number of a transportation agent;

    (2) Documentation of the submission of fingerprints of the transportation agent to the Central Registry; and

    (3) The request for the criminal history record information of the transportation agent to be forwarded to the Commission.

    C. A prospective transportation agent may not be registered if the prospective transportation agent has ever been convicted of a felony drug offense, except as provided in Health-General Article, §13-3310(d), Annotated Code of Maryland.

    D. The Commission, after review of the criminal history record information, may disqualify from registration any prospective transportation agent who is convicted of or pleads nolo contendere to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside.

    .09 Registered Transportation Agent Identification Cards.

    A. The Commission shall issue to each registered transportation agent an identification card which includes a photograph of the face of the registered transportation agent taken no more than 6 months before the date of the application.

    B. While transporting medical cannabis, every registered transportation agent shall visibly wear the identification card issued to the registered transportation agent by the Commission.

    C. The identification card shall be renewed every 2 years.

    D. If a registered transportation agent’s identification card is lost, destroyed, or stolen, within 24 hours of becoming aware of the loss, destruction, or theft, the secure transportation company shall:

    (1) Report the loss, destruction, or theft to the Commission;

    (2) Apply for a replacement card; and

    (3) Pay a replacement card fee.

    E. An identification card remains the property of the Commission, and the Commission may order the return or seizure of an identification card if the registration is revoked or expires.

    F. If a registered transportation agent’s identification card is lost, destroyed, or stolen, a copy of notification to the Commission shall be evidence of registration until a new card is obtained from the Commission.

    .10 Termination.

    A. As soon as possible upon termination of a registered transportation agent’s association with a secure transportation company, the secure transportation company shall:

    (1) Take custody of a terminated registered transportation agent’s identification card;

    (2) Obtain any keys or other entry devices from a terminated registered transportation agent; and

    (3) Ensure a terminated registered transportation agent can no longer gain access to the premises of the secure transportation company.

    B. Within 1 business day of a termination of a registered transportation agent’s association with a secure transportation company, a secure transportation company shall:

    (1) Notify the Commission:

    (a) Of a termination and the circumstances of a termination; and

    (b) Whether a terminated registered transportation agent has returned the agent’s identification card; and

    (2) Initiate delivery of a terminated registered transportation agent’s identification card to the Commission.

    C. The Commission shall revoke a registration of a transportation agent upon receiving notification that a transportation agent is no longer associated with a secure transportation company.

    D. If a registered transportation agent did not return the agent’s identification card within 30 days of the termination, the Commission shall notify the Maryland State Police and place a notice in the register of that fact.

     

    10.62.19 Medical Cannabis Processor License

    Authority: Health-General Article, §§13-3301, 13-3302, 13-3309, and 13-3310, Annotated Code of Maryland

    .03 Consent for Investigation.

    A.—B. (text unchanged) 

    C. An applicant shall release all financial institutions, fiduciaries, and other parties from any contractual, statutory, or common law obligation of confidentiality to provide financial, personal, and background information to the Commission relevant to the applicant’s capacity to manage a licensed processor [and the applicant’s good moral character].

    .05 Pre-Approval of License Application.

    A.—B. (text unchanged) 

    C. The Commission may deny issuing a pre-approval of a license if[, forany individual identified in the application specified in COMAR 10.62.19.02B(1) and (2) of this chapter:

    (1) [The criminal history record information or background information demonstrates an absence of good moral character; or] Is convicted of or pleads nolo contendere to a felony or to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;

    (2) [The payment of] Is in arrears on taxes due in any jurisdiction [is in arrears]; or

    (3) Fraudulently or deceptively attempts to obtain a license.

    D.—E. (text unchanged) 

    .06 Issuance of License.

    A. (text unchanged)

    B. The Commission may issue a license to be a licensed processor on a determination that:

    (1) [The criminal history background check and background investigation reveal no evidence that demonstrates the absence of good moral character] The applicant has not been convicted of or pleads nolo contendere to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;

    (2)—(4) (text unchanged) 

    .07 Change of Ownership of License.

    A. (text unchanged)

    B. The Commission may deny transfer of an interest in a license if, for any proposed transferee:

    (1) [The criminal history record information or the background investigation demonstrate an absence of good moral character] The transferee is convicted of or pleads nolo contendere to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside; or

    (2) (text unchanged)

     

    10.62.20 Medical Cannabis Processor Agent

    Authority: Health-General Article, §§13-3301, 13-3302, 13-3309, and 13-3310, Annotated Code of Maryland

    .03 Processor Agent Registration and Criminal History Record.

    A.—B. (text unchanged) 

    C. A prospective registered processor agent may not be registered by the Commission if the prospective registered processor agent has ever been convicted of a felony drug offense, except as provided in Health-General Article, §13-3310(d), Annotated Code of Maryland.

    D. The Commission, after review of the criminal history record information, may disqualify from registration any prospective registered processor agent [from registration for an absence of good moral character] who is convicted of or pleads nolo contendere to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside.

     

    10.62.22 Medical Cannabis Processor Operations

    Authority: Health-General Article, §§13-3301, 13-3302, 13-3306(b) and (e), 13-3307(f), 13-3309, and 13-3311(c), Annotated Code of Maryland

    .03 Receipt of Products Containing Cannabis.

    A.—B. (text unchanged)

    C. Upon arrival of a secure medical cannabis transport vehicle, the transportation agent shall notify an appropriate registered processor agent to continue the chain of custody of the shipment of products containing cannabis.

    D.—H. (text unchanged)

     

    10.62.23 Medical Cannabis Concentrates and Medical Cannabis-Infused Products

    Authority: Health-General Article, §§13-3301, 13-3302, 13-3309, and 13-3311, Annotated Code of Maryland

    .04 Contents of Certificate of Analysis.

    A. An independent testing laboratory shall issue to the licensed processor a certificate of analysis for each lot, with supporting data, to report:

    (1) [Whether the chemical profile of the lot conforms to the specifications for the lot for] The concentrations of the following compounds:

    (a)—(g) (text unchanged)

    (2) That the presence of the following contaminants [do] does not exceed the levels [as required by the AHP monograph] provided in the Commission’s current version of technical authority for medical cannabis testing:

    (a)—(b) (text unchanged)

    (c) [Any microbiological impurity, including] Microbiological impurities such as:

    (i) (text unchanged)

    (ii) Total yeast and mold count (TYMC);

    (iii) [P. aeruginosa] Escheric

    hia coli;

    (iv) [Aspergillus] Salmone

    lla spp.;

    [(v) S. aureus;]

    [(vi)] (v) (text unchanged)

    [(vii)] (vi) Ochratoxin A.; [and

    ]

    (d)

    Pesticide residue;

    (e) Heavy metals; and

    [(d)] (f) (text unchanged)

    B. Residual levels of volatile organic compounds (VOCs) shall be below the [specifications as set by the United States Pharmacoepeia (USP Chapter 467)] levels provided in the Commission’s current version of technical authority for medical cannabis testing.

    .06 Stability Testing and Retention Sampling.

    A. (text unchanged)

    B. [A licensee shall retain a sample from each released lot] Retention samples retained from each released lot shall:

    (1) [Sufficient to provide for follow-up testing if necessary] Be tested by a registered independent testing laboratory other than the original certifying laboratory following an adverse event reported to the Commission[and]

    (2) [Properly store the sample for 1 year past the date of expiration of the lot.] Be properly stored by the licensed processor; and

    (3) Be properly discarded 6 months after the expiration date of the lot.

     

    10.62.25 Medical Cannabis Dispensary License

    Authority: Health-General Article, §§13-3301, 13-3302, and 13-3307, Annotated Code of Maryland

    .04 Consent for Investigation.

    A.—B. (text unchanged) 

    C. An applicant shall release all financial institutions, fiduciaries, and other parties from any contractual, statutory, or common law obligation of confidentiality to provide financial, personal, and background information to the Commission relevant to the applicant’s capacity to manage a licensed dispensary[and the applicant’s good moral character].

    .06 Pre-Approval of License Application.

    A.—B. (text unchanged) 

    C. The Commission may deny issuing a pre-approval of a license if[, for] any individual identified in the application specified in Regulation .02B(1) and (2) of this chapter:

    (1) [The criminal history record information or background information demonstrate an absence of good moral character; or] Is convicted of or pleads nolo contendere to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;

    (2) [The payment of] Is in arrears on taxes due in any jurisdiction [is in arrears.]; or

    (3) Fraudulently or deceptively attempts to obtain a license.

    D.—E. (text unchanged)

    .07 Issuance of a License.

    A. (text unchanged)

    B. The Commission may issue a dispensary license on a determination that:

    (1) [The criminal history background check and background investigation reveal no evidence that demonstrates the absence of good moral character] The applicant has not been convicted of or pled nolo contendere to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;

    (2)—(4) (text unchanged) 

    .08 Change of Ownership of License.

    A. (text unchanged)

    B. The Commission may deny transfer of an interest in a license if, for any proposed transferee:

    (1) [The criminal history record information or the background investigation demonstrate an absence of good moral character] The transferee is convicted of or pleads nolo contendere to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside; or

    (2) (text unchanged)

     

    10.62.26 Registered Dispensary Agent

    Authority: Health-General Article, §§13-3301, 13-3302, 13-3307, and 13-3308, Annotated Code of Maryland 

    .03 Dispensary Agent Registration and Criminal History Record.

    A.—B. (text unchanged)

    C. A prospective registered dispensary agent may not be registered by the Commission if the prospective registered dispensary agent has ever been convicted of a felony drug offense, except as provided in Health-General Article, §13-3308(d), Annotated Code of Maryland.

    D. The Commission, after review of the criminal history record information, may disqualify from registration any prospective registered dispensary agent [from registration for an absence of good moral character] who is convicted of or pleads nolo contendere to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside.

     

    10.62.28 Licensed Dispensary Operations

    Authority: Health-General Article, §§13-3301, 13-3302, and 13-3307, Annotated Code of Maryland

    .03 Receipt of Products Containing Cannabis.

    A.—B. (text unchanged)

    C. Upon arrival of a secure medical cannabis transport vehicle, the transportation agent shall notify an appropriate registered dispensary agent or registered grower agent to continue the chain of custody of the shipment of products containing cannabis.

    D.—H. (text unchanged)

     

    10.62.29 Licensed Dispensary Packaging and Labeling for Distribution 

    Authority: Health-General Article, §§13-3301, 13-3302, and 13-3307, Annotated Code of Maryland

    .02 Label for Distribution to a Qualifying Patient.

    A.—B. (text unchanged)

    C. A licensee shall state on a label of a package of medical cannabis:

    (1) (text unchanged)

    (2) The name of the certifying [physician] provider;

    (3)—(9) (text unchanged)

    D.—E. (text unchanged)

     

    10.62.30 Dispensing Medical Cannabis  

    Authority: Health-General Article, §§13-3301, 13-3302, 13-3307, 13-3313, and 13-3314, Annotated Code of Maryland

    .03 Procedure for Dispensing Medical Cannabis. 

    A. A registered dispensary agent shall dispense medical cannabis only to a qualifying patient or caregiver who has presented a [government-issued] Commission-issued patient or caregiver identification card. 

    B. Before any distribution of medical cannabis, a dispensary agent shall query the Commission data network and verify that:

    (1) (text unchanged)

    (2) A certifying [physician] provider issued a valid written certification to the qualifying patient; and

    (3) (text unchanged)

    C.—G. (text unchanged)

    .04 Delivery of Medical Cannabis to a Qualifying Patient or Caregiver.

    A.—F. (text unchanged)

    G. A registered agent shall deliver medical cannabis using a secure medical cannabis transport vehicle that:

    (1) Shall have and display a current registration from the State;

    (2) Shall be insured as required by law; and

    (3) May not display any sign or illustration related to medical cannabis or a licensee.

     

    10.62.32 Records

    Authority: Health-General Article, §§13-3301, 13-3302, 13-3306, 13-3309, and 13-3311, Annotated Code of Maryland

    .02 Licensee Records.

    A. (text unchanged)

    B. Upon request, a licensee shall provide in a reasonable time and manner to a certifying [physician] provider a copy of the record of each distribution by the licensee to a qualifying patient of the certifying [physician] provider of the quantity delivered, name, strength, batch number, and lot number of medical cannabis.

    C.—F. (text unchanged)

    .03 Records Retention.

    Unless otherwise specified, a licensee, or a certifying [physician] provider shall retain a record for a period of 5 years.

     

    10.62.34 Discipline and Enforcement

    Authority: Health-General Article, §§13-3301, 13-3302, 13-3306, 13-3307, 13-3309, and 13-3311, Annotated Code of Maryland

    .01 Operational Failure Risking Diversion or Endangering Health.

    [In the event the Commission finds there is a reasonable likelihood of diversion, contamination of medical cannabis, or any risk to the health of a patient or any other individual, after written notice and a hearing in accordance with the State Government Article, §§10-201—10-226, Annotated Code of Maryland, the Commission may:

    A. Impose a fine of up to $10,000 per violation on a licensed grower, licensed processor, licensed dispensary or registered independent testing laboratory;

    B. Deny the license or registration;

    C. Suspend the license, licensee, agent, employee, registration or registrant; or

    D. Revoke the licenses, licensee, agent, employee, registration or registrant.]

    A. A licensee, registrant, agent, or employee may not divert or contaminate medical cannabis, or otherwise risk the health of a patient or any other individual.

    B. A licensee, registrant, agent, or employee who violates §A of this regulation is subject to a fine of up to $10,000 per violation. The licensee, registrant, agent, or employee may:

    (1) Elect to pay the imposed fine; or

    (2) Request a hearing not later than 30 days after receipt of notice of the fine.

    C. In accordance with the hearing provisions of Regulation .05 of this chapter, the Commission may deny, suspend, or revoke the license or registration of a licensee, registrant, agent, or employee who violates §A of this regulation.

    .02 Pattern of Deviation from Standard Operating Procedure.

    [In the event the Commission finds there is a pattern of deviations from standard operating procedures or the terms set forth in the application or the license but the pattern does not directly create a risk of endangering the health or safety of a patient, after written notice and a hearing in accordance with the State Government Article, §§10-201—10-226, Annotated Code of Maryland, the Commission may:

    A. Impose a fine of up to $5,000 per violation on a licensed grower, licensed processor, licensed dispensary, or independent testing laboratory;

    B. Deny the license or registration;

    C. Suspend the license, registration, licensee, registrant, or agent; or

    D. Revoke the license or registration.]

    A. A licensee or registrant may not substantially deviate or demonstrate a pattern of deviation from the standard operating procedures or the terms set forth in the license.

    B. A licensee, registrant, agent, or employee who violates §A of this regulation is subject to a fine of up to $5,000 per violation. The licensee, registrant, agent, or employee may:

    (1) Elect to pay the imposed fine; or

    (2) Request a hearing not later than 30 days after receipt of notice of the fine.

    C. In accordance with the hearing provisions of Regulation .05 of this chapter, the Commission may deny, suspend, or revoke the license or registration of a licensee, registrant, agent, or employee who violates §A of this regulation.

    .03 Violation of Requirements.

    [In the event the Commission finds that a licensee, registrant, agent or employee violated a requirement of this subtitle, after written notice and a hearing in accordance with the State Government Article, §§10-201—10-226, Annotated Code of Maryland, the Commission may:

    A. Impose a fine of up to $5,000 per violation on a licensed grower, licensed processor, licensed dispensary or independent testing laboratory;

    B. Suspend the license, registration, licensee, registrant, employee or agent; or

    C. Revoke the license or registration.]

    A. A licensee, registrant, agent, or employee may not violate a requirement of this subtitle or Health-General Article, §§13-3301—13-3316, Annotated Code of Maryland.

    B. A licensee, registrant, agent, or employee who violates §A of this regulation is subject to a fine of up to $5,000 per violation. The licensee, registrant, agent, or employee may:

    (1) Elect to pay the imposed fine; or

    (2) Request a hearing not later than 30 days after receipt of notice of the fine.

    C. In accordance with the hearing provisions of Regulation .05 of this chapter, the Commission may deny, suspend, or revoke the license or registration of a licensee, registrant, agent, or employee who violates §A of this regulation.

    .04 Action Against a [Physician] Provider.

    A. After written notice and a hearing in accordance with the State Government Article, §§10-201—10-226, Annotated Code of Maryland, the Commission may deny a certifying [physician’s] provider’s application for registration, or revoke registration to certify if the physician:

    (1)—(3) (text unchanged)

    B. The Commission shall report to the [Maryland Board of Physicians] licensing board of the provider any instance of fraud or conduct that threatens public health by a certifying [physician] provider.

    .05 Hearing Procedures.

    A hearing held by the Commission or a designee of the Commission will use the procedures set forth in COMAR 10.01.03.

    .06 Summary Suspension.

    A. The Commission shall order the summary suspension of a license or registration if the Commission determines that the threat to public health, safety, or welfare requires the immediate suspension of the license or registration. 

    B. The Commission shall promptly give the licensee or registrant:

    (1) Written notice of the suspension, the findings, and the reasons that support the findings; and 

    (2) An opportunity for a hearing before the Commission. 

    C. Service of the notice of intent to summarily suspend a license or registration shall be made by:

    (1) Hand delivery;

    (2) Certified mail to the address the licensee or registrant is required to maintain with the Commission; or

    (3) Other reasonable means to effect service.

    D. A licensee or registrant aggrieved by the action of the Commission under this regulation may appeal the Commission’s action by filing a request for a hearing not later than 30 days after receipt of notice of the Commission’s action.

    E. Show Cause Hearing.

    (1) In addition to the right to request a hearing provided in §D of this regulation, a licensee or registrant aggrieved by the action of the Commission under this regulation shall be provided with the opportunity for a hearing to show cause why the Commission should lift the summary suspension.

    (2) If requested in writing, the show cause hearing shall be held promptly within a reasonable time after the effective date of the order of summary suspension.

    (3) The show cause hearing will be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the summary suspension.

    (4) The show cause hearing shall be conducted before the Commission or a designee of the Commission who:

    (a) Shall determine procedural issues;

    (b) May impose reasonable time limits on each party’s oral argument; and

    (c) Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing.

    (5) At the conclusion of the show cause hearing, the Commission or the Commission’s designee may:

    (a) Affirm the order of summary suspension;

    (b) Rescind the order of summary suspension;

    (c) Enter into a consent order; or

    (d) Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension, subject to certain conditions.

    (6) After the show cause hearing, if the Commission or the Commission’s designee decides to continue the summary suspension, the licensee or registrant aggrieved by the decision may request an evidentiary hearing.

    F. If, after due notice, the licensee or registrant against whom the action is contemplated does not appear, nevertheless the Commission may hear and determine the matter.

    .07 Payment of Penalty. 

    The Commission shall remit any penalty collected under this subtitle into the Natalie M. LaPrade Medical Cannabis Commission Fund.

    ROBERT R. NEALL
    Secretary of Health

     ​