Ala. Admin. Code r. 538-X-4-.08

Current through Register Vol. 43, No. 1, October 31, 2024

Section 538-X-4-.08 - Duty To Notify Or Seek Permission Regarding Material Change In Licensing Information

(1)Generally. A licensee has an ongoing duty to notify the Commission or to seek the Commission's permission regarding any "material change" (as defined at Rule 538-X-4-.19) in licensing information, particularly where such change will or could pose a risk to employees, patients, caregivers, or members of the public.

(2)Procedure for Reporting Material Change. Licensees shall notify the Commission within 30 days of any material change in the information provided at the time of its application for license, in accordance with the procedures and documentation for doing so set forth in Chapter 3 of these Rules. A "material change" is one that in any way affects or relates to (a) the licensee's eligibility or suitability to maintain a license; (b) the licensee's personnel, ownership, management, or facilities; (c) the licensee's role in the cultivation, processing, packaging, transportation, dispensing or testing of cannabis; or (d) which was or could have been a consideration of the Commission in the decision to award the licensee a license. Guidance as to whether a particular change is "material" so as to warrant notification may be provided through the AMCC website.

(3)Self-Reporting. A licensee's duty to report is mandatory in the event of "injury," "loss," or a "material breach" of the licensee's policies and procedures as affirmed to the Commission in the application or any amendment thereto; reports should be made promptly to the Commission, and, as applicable, law enforcement, in no event more than 24 hours after its occurrence or discovery, to allow for swift investigation and remediation.

(4)Waivers. The licensee may request a waiver to excuse it from noncompliance with its verified plans as previously communicated to the Commission (as opposed to noncompliance with the Rules, warranting a variance (see below)) where the requested change is needed only for a temporary period due to an identifiable reason, after which the licensee expects to return to operations as set forth in its previously provided documentation, the licensee may seek a waiver, identifying the reason for the difference and a specific period of time (no longer than six (6) months, renewable once for good cause shown for an additional six (6) months) during which operations must return to compliance with documentation previously provided. The Commission shall rule on a requested waiver within 14 days of its submission.

(5)Amendment. The licensee may request an Amendment to previously provided documentation where the identified change is expected to be permanent; if not in contravention of the Act or these Rules, Amendments should be quickly and routinely granted.

(6)Temporary Variance. A licensee may request a temporary variance pursuant to the procedures of 538-X-1-.08 -1. When seeking a temporary variance under these Rules, Licensees should also, when applicable, notify the Commission of a material change in circumstances as defined herein.

(7)Permanent Variance. A licensee may request a permanent variance pursuant to the procedures of 538-X-1-.08 -2. When seeking a permanent variance under these Rules, Licensees should also, when applicable, notify the Commission of a material change in circumstances as defined herein.

(8)Consequences. Except in the case of self-reporting as delineated above, a licensee's timely discharge of this duty, by filing amended documentation, seeking a waiver or variance, should not result in sanctions:

(a) in the absence of clear and convincing evidence that the licensee's request was fraudulent, frivolous or a subterfuge for willful non-compliance, or

(b) where the circumstances necessitating the self-report or giving rise to a material change were accompanied by a substantial risk of harm to individuals or property and occurred due to the negligent, reckless, willful or deliberate conduct (whether an act or omission) of the licensee or its representatives.

Ala. Admin. Code r. 538-X-4-.08

Adopted by Alabama Administrative Monthly Volume XL, Issue No. 11, August 31, 2022, eff. 10/15/2022.

Author: William H. Webster

Statutory Authority:Code of Ala. 1975, §§ 20-2A-22, as amended.