HomeMy WebLinkAboutLOD201800007 Review Comments Appeal to BOS 2018-04-16Virginia Department of
Health Professions
Commonwealth of Virginia
REQUEST FOR APPLICATIONS (RFA)
Issue Date: April 16, 2018
Title: Pharmaceutical Processors
Issuing Agency: Department of Health Professions
Virginia Board of Pharmacy
Perimeter Center
9960 Mayland Drive, Ste. 300
Henrico, VA 23233
Contact Information: Caroline D. Juran, RPh, DPh
Executive Director
Virginia Board of Pharmacy
Phone: (804) 367-4456
Fax: (804) 527-4472
Email: pharmbd(c_,dhp.vireinia.gov
Application Due Date: June 8, 2018 at 2:00 P.M.
RFA No. PHR-2018-01
All inquiries for information should be directed to Caroline D. Juran.
Purpose
The purpose of this Request for Application (RFA) is to solicit applications for a permit to operate
a pharmaceutical processor. As required by law, the Virginia Board of Pharmacy (Board) will
award conditional approval for no more than one pharmaceutical processor for each health service
area established by the Board of Health. There are five (5) defined health service areas.
(Attachment 1) A pharmaceutical processor is a facility that is authorized to: cultivate Cannabis
plants intended only for the production and dispensing of cannabidiol (CBD) oil or THC-A oil;
produce cannabidiol oil or THC-A oil; and, dispense cannabidiol oil or THC-A oil to patients for
treatment or to alleviate the symptoms of any diagnosed condition or disease determined by a
practitioner to benefit from such use. With the exception of delivering dispensed oils under certain
conditions, the cultivation, production, and dispensing will occur on -site at the address of record
of the facility.
The application process for pharmaceutical processor permits will occur in three stages:
submission of initial application, awarding of conditional approval, and granting of a
pharmaceutical processor permit. The review and scoring of the applications will be performed
by an ad hoc committee appointed by the Board which will recommend to the Board the awarding
of conditional approval or the need to re -issue the RFA should the committee determine there is
an insufficient number of qualified applications. Persons interested in being considered for
obtaining conditional approval must submit, in accordance with this RFA, the Code of Virginia,
and the Regulations Governing Pharmaceutical Processors, an initial application and the non-
refundable application fee of$10,000, as listed in 18VAC110-60-20.
If granted conditional approval, an applicant will have one year from date of notification to
complete all requirements for issuance of a permit to include the construction or remodeling of a
facility, installation of equipment and security, local zoning approval, and employment of a
pharmacist -in -charge and other personnel necessary for operation. Upon completion of all
requirements, an agent of the Board will perform an inspection of the facility to assess compliance
with the granted conditional approval and the relevant laws and regulations. Written corrective
action will be submitted to the Board for any deficiencies identified during the inspection and a
reinspection will be performed, if necessary. An application for initial permit, along with any
required documentation, the initial permit fee of $60,000 and any reinspection fees, if required,
will be submitted to the Board prior to issuance of the pharmaceutical processor permit. Once the
pharmaceutical processor permit is issued, the facility may obtain Cannabis seeds and begin
operation. Barring suspension, revocation, or refusal to grant or renew such permit as outlined in
18VAC110-60-160, the permit will be valid for one year from the date of issuance and may be
renewed annually pursuant to Board regulations for continued operation.
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Background
The Virginia Board of Pharmacy is one of 13 health regulatory boards within the Department of
Health Professions, a state agency that licenses and regulates over 350,000 health care
professionals across 62 health professions. The Department is also composed of the Board of
Health Professions, the Health Practitioners Monitoring Program, the Healthcare Workforce Data
Center, and the Prescription Monitoring Program. The mission of the Department is to ensure safe
and competent patient care by licensing health professionals, enforcing standards of practice, and
providing information to health care practitioners and the public. Information on these health
regulatory boards and programs may be accessed on the Department's Web site,
hqp://www.dhp.virginia.gov/.
Legislation was passed during the 2016 Virginia General Assembly Session and reenacted in 2017
(http://legl.state.va.us/egi-bin/legj2504.exe? 171 +ful+SB I 027ER) which authorized the permitting
of pharmaceutical processors. The Virginia Board of Pharmacy subsequently adopted emergency
regulations governing pharmaceutical processors, effective August 7, 2017 through February 6,
2019. (18VAC110-60-10 et sec., found at
http://register.dls.virginia.gov/details.aSDX?id=6508 This created a regulatory framework for
"pharmaceutical processors", a term that was defined in Code to mean "a facility that (i) has
obtained a permit from the Board pursuant to § 54.1-3408.3 and (ii) cultivates Cannabis plants
intended only for the production of cannabidiol oil or THC-A oil, produces cannabidiol oil or THC-
A oil, and dispenses cannabidiol oil or THC-A oil to a registered patient or, if such patient is a
minor or an incapacitated adult as defined in § 18.2-369, such patient's parent or legal guardian for
the treatment of intractable epilepsy." Additionally, the Code was amended to authorize a
"practitioner" to issue a written certification for the use of cannabidiol oil or THC-A oil for the
treatment or to alleviate the symptoms of a patient's intractable epilepsy. The term "practitioner"
was defined in Code to mean "a practitioner of medicine or osteopathy licensed by the Board of
Medicine who is a neurologist or who specializes in the treatment of epilepsy."
During the 2018 General Assembly Session, several bills were passed that amended the laws
associated with pharmaceutical processors:
http://leg1.state.va.us/cei-bin/legp504.exe?181+ful+HB1251ER (2018 Va. Acts of Assembly ch.
246)
http://legl.state.va.us/cgi-biii/legp5O4.exc?181+ftil+SB330ER (2018 Va. Acts of Assembly ch.
567)
http://legl.state.va.us/cgi-bin/]egp5O4.exe?181+ful+SB726ER (2018 Va. Acts of Assembly ch.
809)
Such amendments included expanding the use of cannabidiol oil and THC-A oil to any diagnosed
condition or disease determined by the practitioner to benefit from such use, authorizing any
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practitioner of medicine or osteopathy licensed by the Virginia Board of Medicine (and registered
by the Virginia Board of Pharmacy) to issue written certifications, and further elaborating on
allowances and requirements for pharmaceutical processors.
Anticipated Timeline
April 16, 2018
Issue RFA
June 8, 2018, 2:OOp.m.
Applications due
June 25, 2018
Applications and submitted documentation to ad hoc committee
July 30-31, 2018
In -person meeting of ad hoc committee to discuss scoring of
applicants
August 14, 2018
Board reviews scoring and identifies which Applicants will be
awarded conditional approval
August 24, 2018
Deadline for fingerprinting and submission of information for
criminal background checks
September 25, 2018
Board reviews results of criminal background check and finalizes
the awarding of the conditional approvals
Application Submission and Instructions
In order to be considered for selection, an Applicant must submit a complete Application for a
Pharmaceutical Processor Permit (Attachment 2) with required documentation and application fee
in accordance with this RFA no later than June 8, 2018 at 2:OOp.m. EST. Note: Applications
submitted without the required fee or information or in a manner that is significantly
inconsistent with the RFA will be deemed incomplete and will not be considered for selection,
nor will applications received after the submission due date.
Application Submission: The application and all required attachments must be provided as
follows:
Twelve (12) hard copies (printed), one marked Original, for a total of twelve (12) copies;
and twelve (12) soft copies (CD or thumb drive) with a searchable PDF copy of the
complete submission labeled with the RFA number, name and address of the
pharmaceutical processor as indicated on the application, and the health service area in
which the proposed entity would be located.
2. All copies of applications and documentation must be mailed or hand -delivered to the
address below. Mail sent using the United States Postal Service, including those requesting
a certified mail receipt, is received in approximately one week. Mail sent using private
mail carriers, e.g., UPS and FedEx, is more efficient as it arrives directly to the Board's
3
address. It is strongly recommended that Applicants track delivery to ensure timely receipt
of their mailing.
Department of Health Professions
Board of Pharmacy
Perimeter Center
9960 Mayland Drive, Suite 300
Henrico, VA 23233
If hand -delivered, deliver to the 151 floor receptionist.
In order to be considered for selection, Applicants must submit a complete response to this
RFA.
In the event state business operations are suspended (office is closed) on the date set for
receipt of applications, applications will be due at the same time on the next regular
business day.
All packages must be sealed. The following information must be included in the return
address and identified as follows:
From:
Name of Applicant RFA Number: PHR-2018-01
Street or Box Number Designated Health Service Area
City, State, Zip Code
Pursuant to §54.1-3442.6 of the Code of Virginia, the number of permits that the Board of
Pharmacy may issue or renew in any year is limited to one for each health service area established
by the Board of Health. There are five health service areas in the Commonwealth. Applicants
MAY submit separate applications for proposed locations in different health service areas,
however, each application must be submitted as a complete application. Incomplete applications
will not be considered. In the event the Board determines that there are no qualified applicants to
award conditional approval for a phannaceutical processor permit in a health service area, the
Board may republish, in accordance with 18VAC110-60-100, a notice of open applications for
pharmaceutical processor permits.
The Board may disqualify any applicant:
Who submits an incomplete, false, inaccurate or misleading application;
Who fails to submit an application by the published deadline;
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3. Who fails to pay all applicable fees;
4. Who fails to comply with all requirements for a pharmaceutical processor; or,
5. For whom there is evidence of a criminal conviction that would disqualify the applicant under
18VAC110-60-110(D).
The Board, and the ad hoc committee acting on its behalf, reserves the right to waive minor
irregularities or to request clarifications, modifications, or amendments to an application, provided
such application substantially complies with the RFA. The board also reserves the right to amend
the notice of open applications prior to the deadline for submitting an application. Such amended
notice will be published in the same manner as the original notice of open applications. The Board
may cancel a notice of open applications prior to an award of a pharmaceutical processor permit.
Evaluation Criteria
The evaluation of applications will involve the scoring of each application by the ad hoc committee
of the Board. While a maximum of 275 points is possible, proposals must achieve a minimum
score of 160 points to be awarded conditional approval for a pharmaceutical processor permit. If
an insufficient number of applications obtain a score of at least 160 to award a conditional approval
in each health service area, the ad hoc committee may request modifications from those applicants
whose scores are closest to 160 so as to render the applications acceptable. Alternatively, if the ad
hoc committee determines that sufficient modifications cannot be made to render the applications
in one or more health service area acceptable, the ad hoc committee may recommend to the Board
that it re -issue the RFA or proceed with the RFA and issue conditional approval for the health
service area(s) for which there is an otherwise qualified applicant.
In conducting its evaluation of each of the criteria listed below, the Board, and the ad hoc
committee acting on its behalf, may conduct interviews, contact references, contact state or local
officials in any other state(s) where the applicant, applicant's backers or others associated with the
applicant have engaged, or sought to be engaged in, similar activities and visit the location of the
proposed facility or other related businesses associated with the applicant or applicant's backers
or key personnel.
The number of points after each component listed below is the maximum number of points that
may be awarded for each of the corresponding components of the RFA. For each component, the
applicant's score will be based on the totality of the response to the corresponding component.
The description listed within each component is not intended to be an exhaustive list of all relevant
factors, but rather is intended to provide guidance as to the focus of the Board's analysis.
❑ Financial Position (25 points): An analysis will be performed of the submitted
information detailing the applicant's financial position, indicating all assets, liabilities,
income and net worth, to demonstrate the financial capacity of the applicant to build and
operate a facility to cultivate Cannabis plants intended only for the production and
dispensing of cannabidiol oil and THC-A oil. This will include an evaluation of financial
soundness, funding sources, any evidence of an escrow account, letter of credit, or
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performance surety bond, and a determination of the applicant's ability to remain a long-
term, stable, and sustained source of CBD and THC-A oils for patients.
❑ Location within the Health Service Area (25 points): An analysis will be performed
of the submitted description of the facility's proposed location within the health service
area as established by the Board of Health, which cannot be within 1,000 feet of a school
or daycare. This will include an evaluation of the accessibility to patients, compatibility
with other commercial and residential structures in the immediate neighborhood, any
evidence of support from the immediate neighborhood or locality, and ability to safely
dispose of unwanted product.
❑ Security Plans (25 points): An analysis will be performed of the submitted plans
detailing the proposed security to maintain adequate control against the diversion, theft,
or loss of the Cannabis plants and the cannabidiol oil or THC-A oil. This will include
an analysis of any proposed training opportunities for employees and processes to be
implemented to protect against diversion, theft, or loss. Additionally, the analysis will
include how the pharmaceutical processor will comply with security requirements
pursuant set forth in 18VAC110-60-240 through 18VAC110-60-270 and the
requirement for an electronic tracking system pursuant to 18VAC110-60-130 and as
defined in 18VAC110-60-10.
❑ Authorization to Conduct Business (20 points): An analysis will be performed of the
submitted documents sufficient to establish that the applicant is authorized to conduct
business in Virginia in good standing, such as through the State Corporation
Commission, and that all applicable state and local building, fire, and zoning
requirements and local ordinances are met or will be met prior to issuance of the permit.
This will include the review of any proof of the Applicant's right to occupy the proposed
premises.
❑ Industry Involvement and Disciplinary Action (25 Points): An analysis will be
performed of the information submitted regarding previous or current applications for
permits, licenses, or registrations related to the cultivation, production, or dispensing of
cannabidiol oil or THC-A oil in any state and the status of that application, permit,
license, or registration. This will include the review of any disciplinary action taken by
any state or federal entity on the permit, license, or registration.
❑ Agriculture, Production, and Dispensing Expertise (50 points): An analysis will be
performed of the information submitted that describes the collective expertise of the
applicant and employees in: agricultural techniques required to cultivate Cannabis for
the production of CBD and THC-A oil; production techniques for accurately producing
unadulterated CBD and THC-A oil that satisfies concentrations defined by law and
quality assurance testing; and dispensing techniques for safely dispensing CBD oil and
N.
THC-A oil to patients, to include counseling patients to ensure appropriate dosing.
Consideration will be given to any education obtained and any proposed training
opportunities for staff to safely cultivate, and accurately produce and dispense
unadulterated CBD and THC-A oil.
❑ Marketing Plans (20 points): An analysis will be performed of the submitted marketing
plan based on its ability to effectively educate patients and others on the medical use of
CBD and THC-A oils, how to safely secure the oils, and how to properly dispose of
unwanted oils. The analysis will include the care that is taken to not promote the use of
marijuana or the oils for recreational purposes or by persons not authorized to possess
and administer CBD and THC-A oils.
❑ Facility Exterior and Blueprint (25 points): An analysis will be performed of the
submitted text or graphic material showing the exterior appearance of the proposed
pharmaceutical processor. The analysis will include a review of the blueprint of the
proposed pharmaceutical processor which shows and identifies square footage of each
area of the facility, to include the location of all safes or vaults used to store the Cannabis
plants and oils and the location of all areas that may contain Cannabis plants, CBD or
THC-A oil, showing the placement of walls, partitions, counters and all areas of ingress
and egress. The information submitted should also support the Applicant's ability to
comply with 18VACI10-60-250. Consideration will be given to any systems that will
be used to reduce or prevent off -site odors.
❑ Product and Site Safety (20 points): An analysis will be performed of the list of oils
anticipated to be produced and dispensed at the proposed location. It will include an
evaluation of the robustness of the Applicant's submitted plan to cultivate Cannabis and
produce oils that are safe, unadulterated, comply with the legal definitions for
cannabidiol oil and THC-A oil, and satisfy quality assurance testing. The analysis will
also review the Applicant's submitted plan to produce a safe work environment for its
employees.
❑ Expected Hours of Operation (15 points): A analysis will be performed of the
Applicant's proposed hours of operation which will be at least 35 hours per week for
eligible persons to purchase oil, except as otherwise authorized by the Board.
❑ Additional Points (25 points): An evaluation will be performed of each plan listed
below and its ability to meet the objectives of the category.
o Compassionate need plan, e.g., discounted pricing for qualifying patients (5
points)
o Delivery service plan that mitigates risk of diversion, theft, or loss (15 points)
o Research plan (5 points)
iFA
Maximum Total of Eligible Points = 275
Awarding of Conditional Approval
After completing the review and scoring, the ad hoc committee will rank each application
according to its score. The committee will recommend to the Board the issuance of conditional
approval to an Applicant in each health service area with the highest ranked score and may
recommend an otherwise qualifying alternate Applicant for consideration, should the top
Applicant choose to withdraw or otherwise not accept the conditional approval upon awarding,
provided: the recommended Applicant's or alternate Applicant's total scores exceed the minimum
established score and no reasons exist to deny issuance of conditional approval. Selection will be
made of applicants deemed to be fully qualified and best suited among those submitting
applications based on the evaluation criteria and results of the criminal background check. The
Board will grant conditional approval to the Applicant(s) which, in its opinion, have made the best
application. The Board will notify applicants of denial or conditional approval. The decision of
the Board not to grant conditional approval to an applicant will be final.
Criminal Background Check:
Those Applicants who are notified of the Board's willingness to grant them conditional approval
must, as a condition of the awarding, submit to fingerprinting and provide personal descriptive
information to be forwarded along with their fingerprints through the Central Criminal Records
Exchange to the Federal Bureau of Investigation for the purpose of obtaining criminal history
record information regarding the applicant. The cost of fingerprinting and the criminal history
record search must be paid by the applicant. The Central Criminal Records Exchange will forward
the results of the criminal history background check to the Board or its designee, which will be a
governmental entity. An analysis will be performed of the results of the criminal history record
information, to include a review of any identified irregularities or falsified information submitted
on the application.
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Attachment 1
HEALTH
SERVICE
COUNTY
CITY
AREA
EQUIVALENT
COUNTY
I
Augusta
County
I
Bath
County
I
Buena Vista
(city)
I
Harrisonburg
(city)
I
Highland
County
I
Lexington
(city)
I
Rockbridge
County
I
Rockingham
County
I
Staunton
(city)
I
Waynesboro
(city)
I
Clarke
County
I
Frederick
County
I
Page
County
I
Shenandoah
County
I
Warren
County
I
Winchester
(city)
I
Culpeper
County
I
Fauquier
County
I
Madison
County
I
Orange
County
I
Rappahannock
County
I
Albemarle
County
I
Charlottesville
(city)
I
Fluvanna
County
I
Greene
County
I
Louisa
County
I
Nelson
County
I
Caroline
County
I
Fredericksburg
(city)
I
King George
County
I
Spotsylvania
County
I
Stafford
County
11
Alexandria
(city)
II
Arlington
County
11
Fairfax
(city)
11
Fairfax
County
II
Falls Church
(city)
1I
Loudoun
County
11
Manassas
(city)
II
Manassas Park
(city)
II
Prince William
County
III
Lee
County
III
Norton
(city)
III
Scott
County
III
Wise
County
III
Buchanan
County
III
Dickenson
County
III
Russell
County
III
Tazewell
County
III
Bland
County
III
Bristol
(city)
III
Carroll
County
III
Galax
(city)
III
Grayson
County
III
Smyth
County
III
Washington
County
III
Wythe
County
III
Floyd
County
III
Giles
County
III
Montgomery
County
III
Pulaski
County
III
Radford
(city)
III
Alleghany
County
III
Botetourt
County
III
Clifton Forge
(city)
III
Covington
(city)
III
Craig
County
III
Roanoke
(city)
III
Roanoke
County
III
Salem
(city)
III
Amherst
County
III
Appomattox
County
III
Bedford
(city)
III
Bedford
County
III
Campbell
County
III
Lynchburg
(city)
III
Danville
(city)
III
Franklin
County
III
Henry
County
III
Martinsville
(city)
III
Patrick
County
III
Pittsylvania
County
IV
Brunswick
County
IV
Halifax
County
IV
Mecklenburg
County
IV
Amelia
County
10
IV
Buckingham
County
IV
Charlotte
County
IV
Cumberland
County
IV
Lunenburg
County
IV
Nottoway
County
IV
Prince Edward
County
IV
Charles City
County
IV
Chesterfield
County
IV
Goochland
County
IV
Hanover
County
IV
Henrico
County
IV
New Kent
County
IV
Powhatan
County
IV
Richmond
(city)
IV
Colonial Heights
(city)
IV
Dinwiddie
County
IV
Emporia
(city)
IV
Greensville
County
IV
Hopewell
(city)
IV
Petersburg
(city)
IV
Prince George
County
IV
Surry
County
IV
Sussex
County
V
Lancaster
County
V
Northumberland
County
V
Richmond
County
V
Westmoreland
County
V
Essex
County
V
Gloucester
County
V
King And Queen
County
V
King William
County
V
Mathews
County
V
Middlesex
County
V
Chesapeake
(city)
V
Franklin
(city)
V
Isle Of Wight
County
V
Norfolk
(city)
V
Portsmouth
(city)
V
Southampton
County
V
Suffolk
(city)
V
Virginia Beach
(city)
V
Hampton
(city)
V
James City
County
V
Newport News
(city)
V
Poquoson
(city)
11
V Williamsburg (city)
V York County
V Accomack County
V Northampton County
12
Attachment 2
e COMMONWEALTH OF VIRGINIA
Board of Pharmacy
9960 Mayland Drive, Suite 300 (804) 367-4456 (Tel)
Henrico, Virginia 23233 (804) 527-4472 (Fax)
www.dhp.virllinia.gov/pharmacy pharmbd@dhp.virginia.gov (email)
APPLICATION FOR A PHARMACEUTICAL PROCESSOR PERMIT
Check Appropriate Box(es):
[-]Initial Application $10,000.00 ❑Initial Permit 2 $60,000.00
❑Change of Ownership $1,000.00 [-]Change of Location 4 $1,000.00
❑Change of Name $100.00 ❑Remodel, Expansion, Acquisitions $1,000.00
❑Change of Pharmacist -In -Charge t $100.00 ❑Re -Inspection 6 $1,000.00
❑Change in Hours of Operation 3 No Fee
Application fees are not refundable. Applications are valid for one year from the date of receipt.
The required fees must accompany the application. Make check payable to "Treasurer of Virginia".
Applicant —Please provide the information
Name of Pharmaceutical Processor
Address
City
below. (Print or Type) Use full name not initials.
Area Code and Telephone Number
Area Code and Fax Number
State I Zip Code I Designated Health Service Area
If a current pharmaceutical processor permit is held, indicate the permit number
02
Area Code and Telephone Number (currently working number)
(Print) Name of the Pharmacist -In -Charge (PIC) (if change of PIC, list incoming) 1,2
License Number of the PIC 1,2
0202-
Effective Date of Change (if change of PIC, date assuming role as PIC)
Email Address of PIC 1,2
Hours of Operation t, 2.3
Anticipated Opening Date 2
Name of Owner Applicant
Telephone Number of Owner Applicant
Email Address of Owner Applicant
Expected Completion Date of
Remodel or Expansion or Date for
Change of Location 4,5
Requested Inspection Date 2,4,5,E
FOR OFFICE USE ONLY:
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OWNERSHIP TYPE — Corporation
check one: p ❑
Partnership ❑
Individual ❑
Other ❑
Name of ownership entity if different
from name of application:
Street Address:
Phone No.
City:
State:
Zip Code:
State(s) of incorporation:
List all other trade or business names used by this facility
Name: Name:
Name: Name:
LIST OF OWNERS/OFFICERS AND RESIDENCE ADDRESSES, OR LIST IS ATTACHED ❑
Name: Title:
Residence Address:
Name: Title:
Residence Address:
Pharmaceutical Processor Permit Application, April 2018
14
Please respond to all of the following questions:
1. Have you, any owner, employee, or agent of this business entity ever been convicted of,
pled nolo contendere to, or currently have charges pending for 1) any felony, 2) any
misdemeanor involving moral turpitude, or 3) violation of any federal or state law relating to
controlled substances? If yes, provide name of owner, employee, or agent, name of
jurisdiction and date of charges or convictions, explain, and attach copies of any official
documents such as warrants and court orders showing the nature and disposition of such
charges or convictions.
❑Yes ❑No
2. Have you, any owner, employee, or agent of this business ever had any civil action under
any federal or state statute or regulation or local ordinance relating to the applicant's,
licensee's, permit holder's or registrant's profession, or involving drugs, medical devices or
fraudulent practices, including, but not limited to, fraudulent billing practices? If yes,
provide name of owner, employee, or agent, name of jurisdiction and date of charges or
convictions, explain, and attach copies of any official documents such as warrants and
court orders showing the nature and disposition of such charges or convictions.
❑Yes ❑No
3. Has any owner, employee, or agent of this business had a license or registration suspended
or revoked or denied issuance of such license or registration? If yes, provide name of
employee or agent, name of jurisdiction, date of action, and attach copies of any official
documents related to the issue.
❑Yes ❑No
4. Does a practitioner of medicine or osteopathy licensed by the Board of Medicine and who
issues written certifications, or such practitioner's co-worker, employee, spouse, parent or
child, have a direct or indirect financial interest in this business?
❑Yes ❑No
NOTE:
In accordance with the RFA, qualifying applicants will be informed of the need to submit to fingerprinting and providing
personal descriptive information to be forwarded along with their fingerprints through the Central Criminal Records Exchange
to the Federal Bureau of Investigation for the purpose of obtaining criminal history record information regarding the applicant.
A 14-day notice is required for scheduling an opening or change of location inspection. Cannabis seeds and drugs may not be
stocked prior to inspection and approval. An inspector will call prior to the requested date to confirm readiness for inspection
or the applicant or PIC may call the Enforcement Division at 804-3674691 to verify the inspection date with the inspector.
Signature of Owner Applicant
Date
Signature of PIC (required except for initial application if PIC not known) Date
Pharmaceutical Processor Permit Application, April 2018
15
Information Required for Initial Application
To be considered for issuance of a conditional approval, the following information must be submitted, in accordance with
the current Request for Application (RFA), along with the application form and initial application fee. Refer to the Evaluation
Criteria found within the RFA for how the submitted information will be evaluated.
❑ Financial Position: Detailed information regarding the applicant's financial position, indicating all assets,
liabilities, income and net worth to demonstrate the financial capacity of the applicant to build and operate a
facility to cultivate Cannabis plants intended only for the production and dispensing of cannabidiol oil and THC-A
oil. This may include evidence of an escrow account, letter of credit, or performance surety bond.
❑ Location within the Health Service Area: Description of the facility's proposed location within the health service
area as established by the Board of Health.
❑ Security Plans: Details regarding the applicant's plans for security to maintain adequate control against the
diversion, theft, or loss of the Cannabis plants and the cannabidiol oil or THC-A oil.
❑ Authorization to Conduct Business: Documents sufficient to establish that the applicant is authorized to
conduct business in Virginia in good standing, such as through the State Corporation Commission, and that all
applicable state and local building, fire, and zoning requirements and local ordinances are met or will be met prior
to issuance of the permit.
❑ Industry Involvement and Disciplinary Action: Information about current or previous involvement in the
medical cannabidiol oil or THC-A oil industry. Information about previous applications for permits or registration
related to medical cannabidiol oil or THC-A oil in any state and if so, the status of that application, permit,
registration including any disciplinary action taken by any state on the permit, registration, or an associated
license.
❑ Agriculture Production and Dispensing Expertise: Information regarding expertise in agriculture and other
production techniques required to produce cannabidiol oil or THC-A oil and to safely dispense such products.
❑ Marketing Plans: Information regarding the business and marketing plans related to the operation of the
pharmaceutical processor or the sale of cannabidiol oil or THC-A oil.
❑ Facility Exterior and Blueprint: Any text or graphic material showing the exterior appearance of the proposed
pharmaceutical processor. Include a blueprint of the proposed pharmaceutical processor which shall show and
identify square footage of each area of the facility, to include the location of all safes or vaults used to store the
Cannabis plants and oils and the location of all areas that may contain Cannabis plants, cannabidiol oil, or THC-
A oil, showing the placement of walls, partitions, counters and all areas of ingress and egress.
❑ Product and Site Safety: Plan to safely cultivate Cannabis and produce oils that are safe, unadulterated,
comply with the legal definitions for cannabidiol oil and THC-A oil, and satisfy quality assurance testing. Plan to
produce a safe work environment for employees.
❑ Expected Hours of Operation: A facility shall be open a minimum of 35 hours a week for eligible persons to
purchase oil, except as otherwise authorized by the Board.
❑ Compassionate Need Plan: Documents related to any compassionate need program, e.g., discounted pricing
for qualifying patients the pharmaceutical processor intends to offer.
❑ Delivery Service Plan: A plan detailing any delivery service the pharmaceutical processor intends to offer that
mitigates any risk of diversion, theft, or loss.
❑ Research Plan: A plan detailing any research the pharmaceutical processor intends to perform or in which it
may participate.
Pharmaceutical Processor Permit Application, April 2018
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Information Required for Initial Permit
In addition to satisfactory inspection of the facility conducted by the Board or its agent, an applicant that has
received conditional approval shall complete the following steps and provide the required information prior to
issuance of an initial permit:
❑ Application: Submission of an Application for a Pharmaceutical Processor Permit. Check the box
indicating "Initial Permit", designate the pharmacist -in -charge (PIC), indicate the requested inspection
date, and submit the required fee for "Initial Permit".
❑ Criminal Background Checks: Evidence of criminal background checks of all employees or agents
of the processor to ensure compliance with §54.1-3442.6 of the Code.
❑ Electronic Tracking System: Evidence of utilization of an electronic tracking system.
❑ Attestation: Submission of an attestation indicating full compliance with all state and local laws and
ordinances for the operation of a pharmaceutical processor.
Pharmaceutical Processor Permit Application, April 2018
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