(a) Minimum Performance
Bond Requirements.
1. At the time of
application, an Integrated Facility Applicant must provide a letter of
commitment or other form of acknowledgement approved by the Commission (i.e.,
executed bond documents, proof of capital in the required amount, or other
similar verifying documentation), of the ability to secure a performance bond
issued by a surety insurance company acceptable to the Commission, possessing
at minimum an A rating, in the amount of at least two million dollars
($2,000,000).
2. Said performance
bond must have been secured by the Integrated Licensee at the time a license is
issued.
(b) Minimum
Liquid Assets Requirement. Proof of at least two hundred fifty thousand dollars
($250,000) in liquid assets, available at the time the license is
issued.
(c) Minimum Operating
Capital Requirement. Proof that the applicant has the financial ability to
maintain operations for not less than two years following the date the
application is accepted by the Commission.
(d) Plan for Segregation of Processes Within
and Transportation Between Facilities. An Integrated Facility applicant must
provide a plan for keeping strictly separated all aspects of production,
including cultivation of cannabis, the processing of medical cannabis, the
dispensing of medical cannabis, and the secure transport of medical cannabis to
and from its facilities.
(e)
Integrated Facility applicants must provide, as available, sales contracts and
receipts, lease agreements or other documentation demonstrating possessory
interest in all machinery and equipment to be used in the processing of medical
cannabis, as well as specifications and operations manuals of such
machinery.
(f) Integrated Facility
applicants must:
1. identify which of the
approved types of medical cannabis will be produced at each facility where
cannabis is to be processed,
2.
provide a summary of the manufacturing processes and methods to be utilized to
produce each product, including the machinery, equipment, materials, and
personnel necessary to produce each product,
3. provide a professionally-rendered
blueprint (or if not available, professionally rendered floorplans or
schematics) showing which portions of each of its facilities are ascribed to a
particular phase or department of integrated production - cultivation,
processing, transporting, and dispensing (or, as applicable, none of the
foregoing).
4. identify specific
plans to ensure safety of personnel and facilities based on the types of
processes proposed to be utilized, and
5. provide a detailed list of formulae and
ingredients for each medical cannabis product, including a list of all
excipients to be utilized in the manufacture of each product, and the purpose
served by each.
(g)
Integrated Facility applicants must provide a quality control and quality
assurance plan for each of their proposed medical cannabis products
identifying:
1. An overview of the steps to be
taken in the manufacturing 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, at
each stage or stages of production.
3. Whether the testing at each stage will be
in house, unofficially by private testing through a State Testing Laboratory,
or solely by official testing through 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.
(h) Integrated Facility applicants must
provide:
1. A curriculum vitae for the
business, demonstrating the education, experience, and other credentials of its
leadership, including but not limited to all scientists and engineers employed
at each facility.
2. A detailed
explanation of the role each leader, scientist or engineer is to have in the
processing of medical cannabis at each facility.
3. A 5-year hiring plan for its leaders,
scientists, and engineers, identifying the types, positions, required
education, required experience, and expected roles of such personnel.
(i) Integrated Facility 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 Dispensary or prospective
Dispensary.
5. Any Processor or
prospective Processor.
6. Any other
Integrated Facility or prospective Integrated Facility.
(j) Integrated Facility 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 cannabis being received for storage and/or processing were
appropriately prepared, tagged or otherwise identified, and inserted in
containers at the time of receipt.
2. Batches and containers arriving from the
cultivator have been QR coded or otherwise digitally coded to identify, at a
minimum, the Cultivator, facility, plant tag identification number, date of
harvest, and the date of the cultivator's State Laboratory testing
approval.
3. Incoming cannabis is
accompanied by the Secure Transporter's manifest and other appropriate
documentation; the information thereon is accurate and has been duly executed
by all appropriate parties.
4. All
information from the QR code relating to the incoming cannabis, as well as the
date and time of arrival, has been logged into the Statewide-Seed-to-Sale
Tracking System.
5. Individual
batches of medical cannabis products being shipped from a facility operated by
an Integrated Facility to a Dispensary or Cultivator by means of a Secure
Transporter must be appropriately packaged, labeled, and inserted in containers
prior to transport.
6. Batches and
containers being shipped from the Integrated Facility's facility must be QR
coded or otherwise digitally coded to identify, at a minimum, the Integrated
Facility, facility, type of product, date of processing and packaging, and the
date of the Integrated Facility's State Laboratory testing
approval(s).
7. Outgoing medical
cannabis is accompanied by the Secure Transporter's manifest and other
appropriate documentation; the information thereon is accurate and has been
duly executed by all appropriate parties.
8. 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) Integrated Facility applicants
must provide a marketing and advertising plan, if any, including:
1. Any proposed logos, branding, messaging,
or other marketing or advertising communications, 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 or
third-party individual or entity who is projected to play any role in the
Integrated Facilities' 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.
4. Virtual renderings of all packaging to be
provided by the Integrated Facility, demonstrating the size, color, logo,
artwork, or statements appearing on the packaging, as well as all
child-resistant, tamper-evident, or other safety features, demonstrating
conformity with the Act and these Rules.
5. Exemplars of all proposed labeling,
including labels on packaging, on containers and any inserts to be included in
any packages, demonstrating conformity with the Act and these Rules.
(l) Integrated Facility applicants
must provide a detailed recall plan that will be followed in the event one or
more of its products, including any lots or batches thereof, is determined to
require recall. The plan must include, but should not be limited to, the
following:
1. Provisions for notifying the
Integrated Facility 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 Integrated Facility'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 approved as safe), or destroyed;
6. 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;
7. 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;
8. 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 Integrated Facility
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 commercialgrade 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, processed, tested, packaged, labeled, or
readied for transport.
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 Integrated Facility'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.
Integrated Facility licensee'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
facility operated by the Integrated 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, processed, tested, packaged, labeled, or readied for transport.
Audio/Video surveillance recordings must clearly and accurately display the
time and date, and audio recordings must clearly and accurately capture
conversations and activities within camera range to a level of 20
decibels.
5. The perimeter and any
outdoor premises of a facility operated by an Integrated Facility must be
surrounded by 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 or 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 an Integrated Facility 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 only by means of a keycard or other similar electronic access
device.
7. Exterior walls of each
facility operated by an Integrated Facility must be reinforced to withstand
unlawful forcible entry. Windows, likewise, must be reinforced to prevent
breakage by outside intruders.
8.
Integrated Facilities applicants and licensees must provide and maintain a plan
for 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 integrated facility 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 is handled or stored -
in a secured, locked room or vault.
10. 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 others,
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.
11. 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.
12. Employees, while on duty, shall wear
identification badges that clearly identify them as employees.
13. 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.
14.
Integrated Facilities 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.
15. Upon
request, an Integrated Facility 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.
16. Upon request, an Integrated Facility
shall make available to the Commission or its inspectors all information
relating to the Integrated Facility's security plan.
(n) The Integrated Facility Applicant must
provide an affidavit signed by the responsible individual and designated
contact person (or, if the Integrated Facility 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.
(o) The Integrated
Facility Applicant must provide the appropriate application fee as required by
§20-2A-SS(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.