Ala. Admin. Code r. 538-X-8-.05

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

Section 538-X-8-.05 - Applications And Licensing Procedures As To Dispensaries Generally

(1)Generally. Applicants for a license to operate as a Dispensary under the Act and these Rules shall be governed by the Rules for filing applications and seeking a license contained in Chapters 3 (538-X-3-.01, et seq.) and 4 (538-X-4-.01, et seq.) of these Rules, except as specifically modified below.

(2)Procedure for Filing Application -Contents of Application Specific to Dispensaries. A Dispensary's application filed with the Commission shall conform to the following requirements for all licensees set forth in 538-X-3-.05 of Chapter 3 of these Rules, except as noted below:

(a) Cover Sheet - as provided in 538-X-3-.05 of Chapter 3 of these Rules.

(b) Summary Sheet - as provided in 538-X-3-.05 of Chapter 3 of these Rules.

(c) Application Information - as provided in 538-X-3-.05 of Chapter 3 of these Rules, except as provided otherwise below:

1. The Dispensary Applicant's verification regarding each business entity that has any ownership interest in the applicant shall conform with paragraph 3.a. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

2. The Dispensary Applicant's verification regarding individuals having any ownership interest in the applicant, as to the identity, street address and responsible person of all entities with which the individual is connected, to the extent the entity is directly or indirectly involved in the cannabis industry, shall conform with paragraph 3.b. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

3. The Dispensary Applicant's verification regarding any criminal history as to any owner, director, board member, or individual with a controlling interest in the applicant shall conform with paragraph 3.c. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

4. The Dispensary Applicant's verified licensing history, cannabis industry history, and tax history regarding itself or any affiliate shall conform with paragraphs 3.d., 3.e., and 3.f. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

5. The Dispensary Applicant's verification regarding any public officials having any interest in the applicant shall conform with paragraph 3.g. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

6. The Dispensary Applicant's statement of the anticipated or actual number of employees shall conform with paragraph 3.h. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

7. The Dispensary Applicant's statement of the number of days, if awarded a license, within which it will commence operations and reach full capacity shall conform with paragraph 3.i. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

8. The Dispensary Applicant's consent to the inspections, examinations, searches and seizures contemplated by § 20-2A-52(a)(3), Code of Ala. 1975, (as amended) shall conform with paragraph 3.j. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

9. The Dispensary Applicant's verification of the permissibility of its facilities' locations and compliance with all State and local laws shall conform with paragraph 3.k. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

10. The Dispensary Applicant's Verification that it and its leadership have no economic interest in any other license or Applicant for license under the Act or this Chapter shall conform with paragraph 3.1. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

11. Self-Reporting. In the Event of an Incident Involving Injury, Loss, or Material Breach of Policies and Procedures. As provided in Chapter 3 of these Rules, any "injury," "loss," or a "material breach" of the licensee's policies and procedures shall be promptly reported to the Commission, and, as applicable, law enforcement, and in no event more than 24 hours after its occurrence or discovery, to allow for swift investigation and, as necessary, remediation.

12. Background Checks. As provided in Chapter 3 of these Rules, all board members, officers, management, staff and volunteers of prospective dispensaries shall undergo a preengagement background check, to be renewed no less often than during every third year following the date of each individual's commencement of service on behalf of the dispensary.

(3)Procedure for Filing Application - Exhibits to Dispensary's Application. Exhibits to the Dispensary Applicant's application information shall include all those as provided in subparagraphs 3.m.(1) through 3.m.(16) of Rule 538-X-3-.05 of Chapter 3 of these Rules, unless specifically provided otherwise as follows:

(a) Dispensary applicants must provide a quality control and quality assurance plan for each of their facilities, including all dispensing sites, identifying:

1. An overview of the steps to be taken in the dispensing process to provide high quality products and/or to ensure the safety, potency, stability, lifespan, and consistency among batches of the same product, whether as required by law or otherwise.

2. What tests will be conducted, if any, and at what point or points during the dispensing process.

3. Whether each test to be conducted will be performed in-house, through unofficial private testing performed by a State Testing Laboratory, or through an official test by a State Testing Laboratory.

4. A plan for return and remediation or destruction of any failed test samples, including entry of the event on the Statewide Seed-to-Sale Tracking System.

(b) Dispensary applicants must provide:

1. A curriculum vitae for the business, demonstrating the education, experience, and other credentials of the certified dispenser(s), and any other science- or engineering-based employees or employees with a business background (i.e., accounting, finance, managing, marketing, advertising, public relations, etc.) among its leadership and/or employed at each facility, including but not limited to all dispensing sites.

2. A detailed explanation of the role each leader, certified dispenser, scientist, businessperson, or engineer is to have in the operation of the dispensary at each facility.

3. A 5-year hiring plan for its employees, identifying the types, positions, required education, required experience, and expected roles of such personnel.

(c) Dispensary Applicants must provide a plan for receiving and coordinating information and certifications from registered certifying physicians recommending medical cannabis products for patient and caregiver customers.

(d) Dispensary Applicants must provide a plan for point-of-sale education, consultation, provision of information, responses to patient and caregiver questions, and instructions for use regarding all medical cannabis products, to be conducted by the certified dispenser.

(e) Dispensary applicants must create and maintain at all times a plan pursuant to 538-X-3-.05 -3.m.(16)(i) and 538-X-4-.07 -12.o.(9), for maintaining confidential information and providing cyber security for sensitive information with respect to patients and caregivers, but the dispensary shall include within that plan a set of protocols for maintaining the confidentiality of patient information in accordance with HIPAA arising from or related to the dispensary's access to the Patient Registry and/or from any other source.

(f) Dispensary applicants must provide a Community Engagement Plan describing all efforts that have been or will be made to foster the dispensary's relationship with, involvement in, and commitment to any community (including municipality or county) in which the dispensary intends to locate a facility within the next three years.

(g) Dispensary applicants must provide an Environmental Impact Statement outlining the anticipated impact of each of the dispensary's proposed operations, per facility, on the local environment; the applicant's efforts or plans, if any, to build a relationship to foster cooperation and compliance with federal, state and local agencies providing environmental oversight; and any steps the applicant has taken or will take to reduce or eliminate its carbon footprint and/or to achieve and maintain a positive environmental profile in each community where the applicant intends to locate and operate a facility within the next three years.

(h) Dispensary applicants must provide a detailed plan for handling money and allocating and remitting taxes as required by any local, state or federal agency.

(i) Dispensary applicants must provide copies of all contracts, contingent contracts, memoranda of understanding (or, if none of the foregoing are available, exemplars) between themselves and:

1. Any Cultivator or prospective Cultivator.

2. Any Secure Transporter or prospective Secure Transporter.

3. Any State Testing Laboratory or prospective State Testing Laboratory.

4. Any Processor or prospective Processor.

5. Any Integrated Facility or prospective Integrated Facility.

(j) Dispensary applicants must create a receiving and shipping plan that, at a minimum, ensures the following, in coordination with the contracted Secure Transporter or State Testing Laboratory, as applicable:

1. Individual batches of medical cannabis being received for storage and/or dispensing were appropriately prepared, packaged, and labeled at the time of receipt, having been QR coded or otherwise digitally coded to identify, at a minimum, the Processor or Integrated Facility, the facility of origin, date of processing, packaging, and labeling, and the date of the Processor's or Integrated Facility's State Laboratory testing approval.

2. Incoming medical cannabis is accompanied by the Secure Transporter's manifest and other appropriate documentation; the information thereon is accurate, and the manifest has been duly executed by all appropriate parties.

3. All information from the QR code relating to the incoming medical cannabis, as well as the date and time of arrival, has been logged into the Statewide-Seed-to-Sale Tracking System.

4. Medical cannabis products being received by the Dispensary by means of a Secure Transporter must be appropriately packaged, labeled, and inserted in containers prior to transport.

5. Batches and containers being shipped by the Dispensary to or from another licensee's facility or to or from another of the Dispensary's own facilities must be QR coded or otherwise digitally coded to identify, at a minimum, the Cultivator, Processor or Integrated Facility from which the medical cannabis was sourced, the facility or facilities of origin, type of product, date of processing and packaging, expiration date (or, if no expiration date, a notation that the expiration date does not apply), the date of the Processor's State Laboratory testing approval, and the Alabama Poison Control contact information as provided on the AMCC website.

6. Outgoing medical cannabis being sent for testing is accompanied by the Secure Transporter's or State Testing Laboratory's manifest and other appropriate documentation; the information thereon is accurate and has been duly executed by all appropriate parties.

7. All information from the QR code relating to the outgoing medical cannabis, as well as the date and time of shipment, has been logged into the Statewide-Seed-to-Sale Tracking System.

(k) Dispensary applicants must provide a marketing and advertising plan, if any, including:

1. Any proposed logos, branding, messaging, or other marketing or advertising communications, either in-house (e.g., in displays or on video monitors installed in the dispensing site) or providing exemplars of any specific advertisements.

2. Any specific media outlets or platforms where the marketing or advertising campaigns or programs will be utilized.

3. The identity of any media outlet, social media platform, or third-party individual or entity which is projected to play any role in the Dispensary's marketing or advertising efforts, and copies of all contracts or contract forms proposed for use, if any, between itself and such media outlet or third-party individual or entity.

(l) Dispensary applicants must provide a detailed recall plan that will be followed in the event one or more of the products offered for sale at its dispensing sites, including any lots or batches thereof, is determined to require recall. The plan must include, but is not limited to, the following:

1. Provisions for notifying the originating Processor or Integrated Facility and any other licensee in the chain of custody of an adverse event;

2. Factors about an adverse event that would likely necessitate a recall, and any potential for retesting or remediation;

3. Responsible individuals or positions within the Dispensary's organization who will oversee the recall process;

4. Notification protocols to other licensees and the Commission through the Statewide Seed-to-Sale Tracking System;

5. Processes to ensure that the recalled product is returned, remediated (and ultimately approved as safe), or destroyed; processes to report to the Commission and any other appropriate regulatory body regarding crisis response and steps taken to mitigate or avoid danger to the public;

6. Steps to be taken to avoid further contamination, to preserve and protect uncontaminated cannabis or medical cannabis products, and to ensure access to said products by those who depend on it; and

7. Investigation and analysis of the factors that led to the unsafe condition requiring the recall, and any adjustments to internal protocols and processes to avoid recurrence.

(m) The Dispensary Applicant's Security Plan must include a plan for security at each facility, including but not limited to the following:

1. Twenty-four-hour alarm systems must be installed in all facilities where cannabis or medical cannabis products are present. Such alarms shall be provided and installed by experts in industry-standard commercial-grade alarm systems. Alarm systems must be fully operational, securing all entry points and perimeter windows, be equipped with motion detectors and pressure switches, and must cover all areas where cannabis or medical cannabis products are delivered, received, handled, stored, prepared, dispensed or sold.

2. Reception areas and personnel adjacent to ingress and egress points shall have ready access to duress panic and hold-up alarms that may be activated in the event of access by unauthorized personnel or intruders.

3. Broadcast communication devices (cell phones, intercom equipment or the like) must be:

(i) Carried by each employee or installed in all areas of each Dispensary's facility designed for regular access by humans.

(ii) Accessible for communication by all personnel at all times, and particularly at perimeter ingress/egress stations, facility reception areas, and the security office.

(iii) Capable of providing information with sufficient clarity to be heard and understood by all personnel and visitors within earshot of the employee receiving the communication.

4. Dispensary's facilities shall maintain an audio/video surveillance system that shall be in continuous operation 24 hours per day. Cameras shall be fixed in place covering both the interior and exterior of the Dispensary's facility, in such quantity, with such lighting, and at such resolution as shall allow for the clear identification of individuals and activities in all reasonably accessible areas of the premises, including but not limited to all entrances, exits, parking lots, and any area where cannabis or medical cannabis is delivered, received, handled, stored, prepared, dispensed, or sold. Audio/Video surveillance recordings must clearly and accurately display the time and date. Audio recordings shall clearly and accurately capture sound within camera range at a level of 20 decibels or greater.

5. As to any facility owned by a dispensary at which medical cannabis is maintained, except a dispensary site, the dispensary must surround the perimeter of such facility with a sufficient fence or barrier to prevent access by unauthorized persons and must have sufficient lighting to allow for the proper functioning of video surveillance equipment at all times between dusk and dawn or at any other time when ambient lighting requires enhancement to permit identification of individuals and activities upon or immediately adjacent to the premises. Indoor premises must likewise be sufficiently lit to allow for the identification of individuals and activities.

6. Exterior doors of each facility operated by a Dispensary must be designed or reinforced to withstand unlawful forcible entry; exterior doors shall remain locked against outside intruders at all times, while allowing free egress by the facility's occupants in the event of an emergency; doors must permit ingress to employees and other appropriate persons (other than Patients and Caregivers) only by means of a keycard or other similar electronic access device. Patients and caregivers may be granted access by Dispensary personnel only upon showing a valid, unexpired and unrevoked medical cannabis card.

7. A dispensary site must be housed (A) in a stand-alone building or (B) within a multi-use structure, strip mall or other such retail facility; the area occupied by the dispensary site is not to be accessible to or used by neighboring businesses, other tenants or others not employed by the dispensary. To the extent that the dispensary site is housed within a multi-use structure, strip mall or other such retail facility, the dispensary site must be self-contained, or at a minimum, segregated from other businesses and activities being conducted in the multi-use structure, strip mall or other such retail facility by separate points of ingress and egress or, at a minimum, separately keyed and electronically protected entryways accessible only to employees of the dispensary; patients and caregivers; AMCC representatives and their guests; representatives of other licensees; vendors, cleaning crew personnel, and repair workers carrying out business-related functions on the premises; representatives of the lessor during routine inspections or similar circumstances warranting a physical visit to the premises; or other appropriate individuals.

8. Dispensary Facilities must maintain sufficient staffing of security guards at each facility where cannabis and medical cannabis is present to reasonably ensure the safety of the products stored therein; however, the dispensary must provide, at a minimum, one (1) security guard per facility during the facility's business/operating hours.

9. Strict access controls shall protect areas where cannabis or medical cannabis and daily monetary receipts are handled or stored - in a secured, locked room or vault.

10. Protocols for beginning-of-day and end-of-day movement of medical cannabis and cash between secure areas and sales areas, as well as a plan for maintaining security of daily cash on hand at all times.

11. Members of the public, other than patients and caregivers holding a valid, unexpired, unrevoked medical cannabis card, are not allowed inside a dispensing site. Records, whether electronic or manual, must be kept of all persons on the premises at a facility at all times, including employees, vendors, transporters or other licensees, and all official visitors, recording the individuals' name, date, time of ingress and egress, and (as to non-employees) the reason for their presence; such records shall be kept for a minimum of two years, and longer at the request of the Commission or law enforcement.

12. Audio/Video surveillance records must be kept for at least 60 days, and longer upon the request of the Commission, its inspectors, or any law enforcement personnel. Audio/Video recordings potentially reflecting an incident of actual or attempted diversion must be kept for the longer of a period of two years, or until resolution of the incident and apprehension and discipline or prosecution of the individuals involved in the actual or attempted diversion.

13. Employees, while on duty, shall wear identification badges that clearly identify them as employees.

14. Visitors, including vendors, other licensees, Commission members, inspection personnel, or other representatives must wear a "visitor pass" or "AMCC Official" pass, as applicable, at all times while on the premises.

15. Dispensaries shall maintain, review and update policies to report theft, diversion, or other loss of cannabis products to the Commission and to law enforcement as early as practicable and not more than 24 hours from the event or its discovery.

16. Upon request, a Dispensary shall make available to the Commission or its inspectors all information relating to security alarm systems, monitoring, alarm activity, maps of camera locations and camera coverage, audio/video footage, surveillance equipment maintenance logs, authorized use lists, operation instructions, and any other security-related information deemed relevant by the Commission or its inspectors.

17. Upon request, a Dispensary shall make available to the Commission or its inspectors all information relating to the Dispensary's security plan.

18. Signage. The dispensary shall prominently display at each entrance point to a dispensing site and in at least one location in the sales area of the dispensing site signs stating as follows:

"WARNING: This facility is monitored at all times using audio and video surveillance. Entry to this business and purchases within are strictly prohibited except as to registered patients and caregivers presenting valid identification as required by law."

(n) The number of patients, caregivers and others on the premises at a dispensing site at any given time may not be more than can be reasonably monitored by the employees present in the retail area, and in no event shall the total number of individuals on the premises exceed that permitted by the applicable fire code.

(o) The Dispensary Applicant must provide an affidavit signed by the responsible individual and designated contact person (or, if the Dispensary is an entity, the duly authorized officer, owner or interest holder and the designated contact person) that the information provided in the Application is true and correct, to the best of the Affiants' knowledge upon a diligent investigation thereof.

(p) The Dispensary Applicant must provide the application fee required by § 20-2A-55(f), Code of Ala. 1975, (as amended). The application fee is nonrefundable and must be submitted electronically per instructions in the Application Form received in response to the applicant's Request for Application.

(4) In all other respects except as expressly stated otherwise in this Rule, Dispensary Applicants shall be governed by the rules for applications (Chapter 3 of these Rules) and licensing (Chapter 4 of these Rules) generally pertaining to all applicants.

Ala. Admin. Code r. 538-X-8-.05

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.