Alabama Administrative Code › Title 538 - ALABAMA MEDICAL CANNABIS COMMISSION › Chapter 538-X-4 - Licensee Requirements - Generally › Section 538-X-4-.08 - Duty To Notify Or Seek Permission Regarding Material Change In Licensing Information

Current through Register Vol. 42, No. 9, June 28, 2024
(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.