(a) Processor 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.
(b) Processor 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. identify
specific plans to ensure safety of personnel and facilities based on the types
of processes proposed to be utilized, and
4. 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.
(c)
Processor 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 processing.
3. Whether the testing at each stage 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.
(d) Processor 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.
(e) Processor 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 Integrated
Facility or prospective Integrated Facility.
(f) Processor 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
another licensee's facility or another of the Processor's own facilities have
been QR coded or otherwise digitally coded to identify, at a minimum, the
Cultivator, facility, plant tag or harvest batch number, date of harvest,
expiration date (or, if no expiration date, a notation that the expiration date
does not apply), the date of the cultivator's State Laboratory testing
approval, and the Alabama Poison Control contact information as provided on the
AMCC website.
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 the Processor's
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 Processor's facility to another licensee's
facility or another of the Processor's own facilities must be QR coded or
otherwise digitally coded to identify, at a minimum, the Processor, facility,
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.
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.
(g) Processor
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
Processors' 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 Processor, 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 this Chapter.
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 this Chapter.
(h)
Processor 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 Processor 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 Processor'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; and
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.
(i) The
Processor 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, 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 Processor'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.
Processor'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 Processor'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, processed, tested, packaged,
labeled, or readied for transport. 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. The
Processor facility's perimeter and any outdoor premises 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 a Processor must be designed or
reinforced to withstand unlawful forcible entry; exterior doors shall, at all
times, remain locked against outside intruders, 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 a Processor must be reinforced to withstand unlawful forcible entry.
Windows, likewise, must be reinforced to prevent breakage by outside
intruders.
8. Processor 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, Processors must maintain, 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.
Processors 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,
a Processor 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, a
Processor shall make available to the Commission or its inspectors all
information relating to the Processor's security plan.
(j) The Processor Applicant must provide an
affidavit signed by the responsible individual and designated contact person
(or, if the Processor 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.
(k) The Processor Applicant must provide the
appropriate application fee as required by §
20-2A-22(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.
(l) In all other
respects except as expressly stated otherwise in this Rule, Processor
Applicants shall be governed by the rules for applications and licensing
generally pertaining to all applicants (Chapter 3 of these
Rules).