The Administration, licensees, and certifying providers shall establish a procedure to receive, organize, store, and respond to all oral, written, electronic, or other complaints regarding any cannabis product and severe adverse events. In the event a licensee or certifying provider receives a complaint regarding the quality or safety of a product, including a report of a serious adverse event, the licensee or certifying provider shall report the complaint within 24 hours to: The Administration; If applicable, the licensed grower or processor from which the cannabis originated; and If applicable, the licensed dispensary that dispensed the cannabis. Complaint Investigation Process. After notifying the Administration about a complaint as required in §B of this regulation, a licensee or certifying provider shall: Promptly identify the batch number or lot number of the cannabis or cannabis product, or any other product that is the subject of the complaint; Investigate the production of the batch or lot to determine if there was a deviation from the standard operating procedure in the production of the batch or lot; Send part of the retention sample of the batch or lot to an independent testing laboratory to determine if it meets quality and safety standards; and If there is reasonable cause to suspect communicable disease transmission from or by an agent, collect morbidity history from any suspected agents. If the sample analysis conducted under §C(1) of this regulation reveals that the batch or lot fails to meet quality and safety standards, the licensee shall: Order a recall of all products derived from or included in the batch or lot; To the extent possible, notify all adult-use consumers, patients, caregivers, and dispensaries who may have obtained cannabis products from such a batch or lot of the recall; and Pay reimbursement for any returned cannabis. In the case of a report of a serious adverse event, if the investigation reveals a deviation from the standard operating procedure in the production of the batch or lot, the licensee shall: Order a recall of all products derived from or included in the batch or lot; Notify all adult-use consumers, patients, caregivers, and dispensaries who may have obtained cannabis from such a batch or lot of the recall; and Pay reimbursement for any returned cannabis. If the licensee’s investigation reveals there is reasonable cause to suspect communicable disease transmission from or by an agent, the licensee shall ensure that appropriate follow-up action is taken, whenever applicable, including but not limited to: Immediately excluding any indicated agent from the licensed facility; Issuing an order to recall all products derived from, or included in, any affected batch or lot; To the extent possible, notifying all adult-use consumers, patients, caregivers, and dispensaries who may have obtained cannabis from any affected batch or lot of the recall; Reimbursing for any returned cannabis; Immediately closing the licensed premises until medical and epidemiological evidence shows that the likelihood of further disease transmission is low; and In accordance with COMAR 10.06.01, conducting an investigation, a report, and control of a communicable disease outbreak. Custody of Returned Recalled Cannabis Products. The licensee shall develop a procedure to ensure cannabis that is recalled is stored and segregated until disposal of recalled material is authorized by the Administration. Within 24 hours of the receipt of notice from the Administration that the disposal of recalled cannabis is authorized, the licensee shall dispose of the recalled cannabis according to its standard operating procedure. A licensee shall maintain: Independent of the seed-to-sale tracking system, a searchable, secure, tamper-evident record of each distribution that contains: If applicable, the name and address of the patient; The quantity delivered; and The product name, strength, batch number, and lot number. To ensure uniformity, for each batch and lot: Records of production and distribution; and Daily checklists; A record of test methods and test results for each batch and lot; A log of individuals visiting each premises; and A duplicate set of all records at a secure, off-site location. Unless otherwise specified, a licensee, or a certifying provider shall retain a record for a period of 2 years. Definition. In this regulation, the following term has the meaning indicated. Term Defined. “Investigator” means any Administration employee or contractor designated by the Administration to carry out an inspection under this regulation. Submission of an application to be a licensee or registrant irrevocably gives the Administration consent to conduct all inspections to ensure compliance with State law and regulations. The Administration may inspect all of a cannabis business applicant’s premises and operations to ensure conformity with its application, State law, and regulations. In the case of an inspection before the issuance of a license, the Administration shall arrange the inspection to take place at a mutually agreeable time. Announced and Unannounced Inspections. The Administration may conduct announced and unannounced inspections of a licensee or registrant subject to the Administration’s regulation, mission, and function, to determine compliance with statute and regulations. Failure by a licensee or registrant to provide the Administration with immediate access to any part of a premises, requested material, information, or agent as part of an inspection may result in the imposition of a civil fine, suspension of license, or revocation of license. During an inspection, the Administration may: Review and make copies of any and all records, including but not limited to financial data, sales data, employment data, or other material that would otherwise be considered proprietary; Enter any place, including but not limited to vehicles in which cannabis is held, dispensed, sold, produced, tested, delivered, transported, manufactured, or otherwise disposed of; Inspect all equipment, raw and processed material, containers, and labeling; Inventory any cannabis; Inspect any equipment, instruments, tools, or machinery used to process: Cannabis; or Cannabis product; Investigate complaints; and Question personnel present at the location and any agent of the licensee. During an inspection, a material misstatement, omission, misrepresentation, or untruth by the cannabis business applicant, licensee, registrant, or agent may result in: Denial of the application; The imposition of a civil fine; Suspension of a license or registration; or Revocation of a license or registration. Sample Collection and Testing as Part of Inspection. During an inspection, the Administration may obtain samples for testing of any: Cannabis; Cannabis product; Media used to grow cannabis; Chemicals or solvents used to process cannabis concentrate; Labels or containers for cannabis; Paraphernalia; Environmental swabs; Any waste material; and Raw or processed material. An investigator may contract with an independent testing laboratory or the State Cannabis Testing Laboratory to analyze the samples for any deviation from specification questioned by the investigator. Investigative Actions. In the event that an investigator has cause to suspect an operational failure or conditions that create a likelihood of diversion, contamination, or a risk to the public health: An investigator may: Suspend the distribution of some or all cannabis from the cannabis licensee; Order immediate evacuation of the premises and seal the entry door; or Quarantine some or all cannabis; The Administration shall undertake a review of the inspection findings and may: Request a recall of the cannabis; Request independent testing of affected cannabis; Approve a procedure to reprocess the cannabis; Notify law enforcement if diversion is suspected; or Order the destruction of contaminated or substandard cannabis; and The Administration may notify the local fire department or police department, or appropriate regulatory agency, regarding a risk to public health and safety. During an inspection or any investigation, a licensee, registrant, or agent, or employee shall comply with an Administration request to: Appear for a sworn statement; or Submit documents responsive to any Administration request. The Administration shall leave a receipt and create a documented chain of custody for anything removed from the premises during an inspection. Report of an Inspection and Letter of Non-Compliance. An investigator shall: Prepare an investigative report; and Deliver a copy of the report and obtain a receipt for the delivery. Within 10 business days from the receipt of a letter of non-compliance imposing a fine or demanding corrective action, a licensee shall: Respond in writing to each demand for corrective action; Set forth a plan for corrective action to be taken and the timetable for correction; and Pay the fine set forth in the letter of non-compliance. Upon receipt of a letter of non-compliance, a licensee or registrant may request an evidentiary hearing on the same provided such request is made in writing within 30 days of receipt of the letter of non-compliance in accordance with COMAR 14.17.22. If a licensee or registrant does not submit a request for a hearing in writing within the 30-day period, the agency action becomes a final determination and is not subject to appeal. Diversion. A licensee, registrant, or agent may not: Divert cannabis or cannabis products for any unauthorized sale or distribution; Fail to maintain records in accordance with this subtitle or the licensee’s standard operating procedures; Fail to accurately track, tag, or otherwise record inventory in the seed-to-sale tracking system; or Sell or dispense cannabis or cannabis products in a manner that: Exceeds the personal use amount of cannabis or cannabis products; Is reasonably expected to be in violation of the personal use amount; or Could otherwise reasonably give rise to any other violation of law. A licensee, registrant, or agent may not conduct a series of transactions that would be in violation of §A(1)(d) of this regulation. Health Endangerment. A licensee, registrant, or agent may not: Apply any contaminant to cannabis or cannabis products; Handle cannabis or cannabis products in a manner that would endanger health and safety; Store cannabis or cannabis products in a manner that would endanger health and safety; or Otherwise risk the health and safety of a patient or consumer. A licensee, registrant, or agent may not sell, dispense, or otherwise distribute cannabis or cannabis products to an individual younger than 21 years old unless the individual is a qualifying patient 18 years old or older. A licensee or registrant may not substantially deviate or demonstrate a pattern of deviation from: Its standard operating procedures; Its application; or State, federal, or local: Law; Regulations; or Ordinances. The Administration may fine, suspend, restrict, revoke, or otherwise sanction any cannabis licensee, registrant, or agent for: Any violation of Alcoholic Beverages and Cannabis Article, Title 36, Annotated Code of Maryland; Any violation of this subtitle; Restricting, limiting, or otherwise impeding an inspection or investigation by the Administration; A material misstatement, omission, misrepresentation, or untruth by the licensee, registrant, registered agent, or other employee; or Any other violation of State, federal, or local: Law; Regulations; or Ordinances. Definitions. In this regulation, the following terms have the meanings indicated. Terms Defined. “Letter of non-compliance” means a written communication from the Administration to a licensee or registrant that imposes a fine or demands corrective action. “Respondent” means a licensee, registrant, or selected applicant who is issued a letter of non-compliance, notice of intent to summarily suspend, or order of summary suspension. “Show cause hearing” means a non-evidentiary hearing to provide the parties involved with an opportunity for oral argument on a notice of intent to summarily suspend or a summary suspension. A licensee, registrant, or agent who violates Regulation .04 of this chapter or COMAR 14.17.20 is subject to a fine of up to $10,000 per violation. Each day a violation continues is a separate violation under this section. The licensee, registrant, or agent assessed a fine under this regulation may: Elect to pay the imposed fine; or Request an evidentiary hearing in accordance with COMAR 14.17.22 not later than 30 days after the receipt of the notice of the fine. If a respondent does not submit a request for an evidentiary hearing within 30 days from receipt of the letter of non-compliance or administrative charges, the agency determination becomes final and is not subject to appeal. The Administration may impose late fees on respondents who do not pay fines by the date indicated in a Letter of Non-Compliance or in a final agency determination, as described in COMAR 14.17.22.10. The Administration shall remit any penalty collected under this regulation to the: Medical Cannabis Compassionate Use Fund; Cannabis Business Assistance Fund; Community Reinvestment and Repair Fund; or Cannabis Public Health Fund. Funds from fines remitted under §F of this regulation shall be distributed at the discretion of the Administration by evaluating: Available fund balances; Uses of the fund; and Future needs of the fund. Summary Suspension. The Administration shall order the summary suspension of a license or registration if the Administration determines that the threat to public health, safety, or welfare requires immediate suspension of a license or registration. The Administration shall promptly give the licensee or registrant: Written notice of the suspension, the findings, and the reasons that support the findings; and An opportunity for a hearing before the Administration. Service of notice of intent shall be made by: Serving the notice of intent via hand delivery to the point of contact on file; Sending the notice of intent via certified mail to the address the licensee or registrant is required to maintain with the Administration; or Other reasonable means to effect service. A licensee or registrant aggrieved by the action of the Administration under this regulation may request a show cause hearing by filing a written request for a hearing not later than 30 days after receipt of notice of the Administration's action. Notice of Intent to Summarily Suspend a License or Registration. The Administration may issue a Notice of Intent to Summarily Suspend a cannabis license or registration if the Administration determines that a suspension of a license or registration is necessary to protect the health and welfare of the public. The Administration shall promptly give the licensee or registrant: Written notice of the suspension, the findings, and the reasons that support the findings; and An opportunity for a hearing before the Administration. Service shall be made by: Serving the Notice of Intent via hand delivery to the point of contact on file; Sending the Notice of Intent via certified mail to the address the licensee or registrant is required to maintain with the Administration; or Other reasonable means to effect service. A licensee or registrant aggrieved by the action of the Administration under this regulation may request a show cause hearing by filing a request for a hearing in writing not later than 30 days after receipt of notice of the Administration's action. Show Cause Hearing. If requested in writing, the show cause hearing shall be held promptly within a reasonable time after the effective date of the action. The show cause hearing shall be conducted before the Administration’s director or a designee who: Shall determine procedural issues; May impose reasonable time limits on each party’s oral argument; and Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing. At the conclusion of the show cause hearing, the Administration director or a designee may: Affirm the order of summary suspension or notice of intent to summarily suspend; Rescind the order of summary suspension; Enter into a consent order with the respondent on behalf of the Administration; or Enter into an interim order with the respondent on behalf of the Administration warranted by the circumstances of the case, including one providing for a stay of the summary suspension, subject to certain conditions. After the show cause hearing, if the Administration Director or a designee decides to continue the summary suspension, the licensee or registrant aggrieved by the decision may pursue a hearing in accordance with COMAR 14.17.22. Contesting a summary suspension or notice of intent to summarily suspend through a show cause hearing does not toll or otherwise excuse the requirement that an aggrieved party request a hearing within 30 days of notice of intent to summarily suspend, as set forth in §I(4) or §J(4) of this regulation. If the licensee or registrant against whom the action is contemplated does not appear, the Administration may hear and determine the matter. A show cause hearing is not subject to the hearing procedures set forth in COMAR 14.17.22. All advertisements for cannabis products, businesses, licensees, or other cannabis-related services shall comply with the requirements of Alcoholic Beverages and Cannabis Article, §§36-901—36-903, Annotated Code of Maryland. A licensee, registrant, agent, or certifying provider who violates §A of this regulation: Is subject to a fine not exceeding: $1,000 for the first violation; $10,000 for the second violation occurring within 24 months after the first violation; $25,000 the third violation occurring within 24 months after the second violation; and $50,000 for each subsequent violation occurring within 24 months after the preceding violation; and May elect to: Pay the imposed fine; or Request a hearing not later than 30 days from the receipt of the fine. Any violations that occurred between May 3, 2023, and the effective date of these regulations count for purposes of calculating the appropriate fine. In accordance with the hearing provisions in Regulation .05 of this chapter, the Administration may deny, suspend, or revoke the license or registration of a licensee, registrant, agent, or certifying provider who violates §A of this regulation. Alcoholic Beverages and Cannabis Article, §§36-202, 36-203, and 36-901, Annotated Code of Maryland Effective date: Regulations .01—.06 adopted as an emergency provision effective July 1, 2023 (50:14 Md. R. 559); emergency status expired June 30, 2024 Regulations .01—.06 adopted as an emergency provision effective June 7, 2024 (51:14 Md. R. 676) Regulations .01—.06 adopted effective July 22, 2024 (51:14 Md. R. 678) Regulation .02 amended effective April 14, 2025 (52:7 Md. R. 324) Regulation .04D amended effective March 16, 2026 (53:5 Md. R. 244) Regulation .06B, D amended effective April 14, 2025 (52:7 Md. R. 324)