18- 691 C.M.R. ch. 4, § 14

Current through 2024-51, December 18, 2024

Section 691-4-14 - Enforcement

14.1 - General Provisions

A. Unless otherwise specified, the Compliance and Enforcement procedures specified in 10-144 CMR, chapter 122, section 10 also apply to manufacturing facilities. Any conduct not authorized under this rule or Chapter 122 is prohibited. If there is a conflict between Chapter 122 and this rule, this rule applies.(APA Office Note: 10-144 chapter 122 has been relocated to 18-691 chapter 2.)

B. Any person or entity required to enroll in the track and trace system or register as a manufacturing facility under this rule has 60 days from the effective date of this rule to enroll and complete an application and obtain local approval. After that time no person or entity may manufacture marijuana or make concentrates using IHS except as permitted in this rule.

C. Conduct not authorized is prohibited. Violation of these rules or of 22 MRS, chapter 558-C may result in compliance and enforcement actions including directed corrective action; suspension, revocation and denial of a registry identification card or registration certificate; civil penalties; and referral to the appropriate agency, department or entity if the Department determined that the conduct is not appropriate for agency directed corrective action or the violation or deficiency has not been rectified through corrective action.

14.2 - Compliance InspectionThe Department may require an inspection prior to issuance of a manufacturing facility registration. As stated in 22 MRS §2430-G(2)(D), the Department may, without prior notice, inspect premises to ensure compliance with conduct authorized under this rule during regular business hours and hours of apparent activity. The Department will show proof of identity when requesting entry and to inspect an area reportedly used for conduct described under this rule. Prior to entry, the Department will also provide a written statement of the reason for inspection in a standard form.

A. A registered manufacturing facility or other entity authorized under this rule is required to make available any records, forms, protocols, documents or any other type of information required by the statute and this rule to the Department within ten (10)business days of a request from the Department. Delay may result in progressive enforcement action.

B. The Department may audit any registered manufacturing facility or other entity authorized under this rule to manufacture medical use marijuana to ensure compliance. The audit may include the tracking system used by the person or entity to record transactions and transfers and the Department's chosen tracking and tracing system.

C. When the Department is conducting an inspection, the Department will consider refusal to permit entry or access to inspect records or premises or willful avoidance of inspection a failure to comply with provisions of this rule, and upon a second failure to comply with inspections, the Department may take further enforcement action.

(1) The Department may refer to law enforcement as a progressive enforcement action when compliance cannot be determined.

(2) If denied entry more than one time by a cardholder, the Department may take action to revoke the registry identification card, individual identification card or registration certificate.

14.3 - Court Ordered Fines

A. The Department may seek a court order imposing fines.

B. A person who knowingly violates the confidentiality of information protected by 22 MRS, chapter 558-C commits a civil violation for which a fine of up to $1,000 may be imposed. This provision does not apply to a physician, staff of a hospice provider or nursing facility named as a primary caregiver or any other person directly associated with a physician or a hospice provider or nursing facility that provides services to a registered qualifying patient.

C. A person who is employed by or is a principal officer or board member of a manufacturing facility, if that person has been convicted of a disqualifying drug offense, commits a civil violation for which a fine of not more than $1,000 may be adjudged.

14.4 - Department Disciplinary Actions The Department has the authority pursuant to Title 22, chapter 558-C and Title 5, chapter 375, subchapter 7 to administer disciplinary actions for violations of the statute and this rule.

A. When taking action, the Department will issue a written notice that includes the following information:

(1) The nature of the violation and the specific rule violated;

(2) The date the department's action takes effect; and

(3) If the Department is taking action to revoke a registration or certificate issued under this rule, the term of revocation for which the person is not eligible to apply for registrations issued by the Department.

B. A person or entity aggrieved by the Department's actions may pursue the right to appeal the Department's action as provided in the notice by requesting an administrative hearing or informal review.

18- 691 C.M.R. ch. 4, § 14