TITLE 4. CONSERVATION AND NATURAL RESOURCES
VA.R. Doc. No. R19-5849; Filed February 27, 2019, 1:54 p.m.
TITLE 9. ENVIRONMENT
VA.R. Doc. No. R19-5537; Filed February 20, 2019, 8:01 a.m.
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
Title of Regulation: 18VAC110-60. Regulations
Governing Pharmaceutical Processors (adding 18VAC110-60-10 through 18VAC110-60-330).
Statutory Authority: §§ 54.1-3442.6 and 54.1-3447
of the Code of Virginia.
Public Hearing Information:
March 26, 2019 - 9:10 a.m. - Department of Health
Professions, Perimeter Center, 9960 Mayland Drive, 2nd floor, Board Room 2,
Richmond, VA 23233
Public Comment Deadline: May 17, 2019.
Agency Contact: Caroline Juran, RPh, Executive Director,
Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone
(804) 367-4456, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.
Basis: Section 54.1-3408.3 of the Code of Virginia
states that the board shall promulgate regulations to implement the
registration process for practitioners and patients. The regulations shall
include (i) a mechanism for sufficiently identifying the practitioner issuing
the written certification, the patient being treated by the practitioner, and,
if such patient is a minor or an incapacitated adult as defined in § 18.2-369
of the Code of Virginia, the patient's parent or legal guardian; (ii) a process
for ensuring that any changes in the information are reported in an appropriate
timeframe; and (iii) a prohibition for the patient to be issued a written
certification by more than one practitioner during any given time period.
Section 54.1-3442.6 A of the Code of Virginia states that the
board shall establish an application fee and other general requirements for
such application, and § 54.1-3442.6 B states that each permit shall expire
annually on a date determined by the board in regulation. Section 54.1-3442.6 C
states that the board shall adopt regulations establishing health, safety, and
security requirements for pharmaceutical processors. The regulations shall
include requirements for (i) physical standards; (ii) location restrictions;
(iii) security systems and controls; (iv) minimum equipment and resources; (v)
recordkeeping; (vi) labeling and packaging; (vii) quarterly inspections; (viii)
processes for safely and securely cultivating Cannabis plants intended for
producing cannabidiol oil and THC-A oil, for producing cannabidiol oil and THC-A
oil, and for dispensing and delivering in person cannabidiol oil and 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;
(ix) a maximum number of marijuana plants a pharmaceutical processor may
possess at any one time; (x) the secure disposal of plant remains; and (xi) a
process for registering a cannabidiol oil and THC-A oil product. Section
54.1-3442.6 E states that the board shall require an applicant for a
pharmaceutical processor permit to submit to fingerprinting and provide
personal descriptive information to be forwarded along with his 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.
Section 54.1-3442.7 A of the Code of Virginia states that the
board shall establish in regulation an amount of cannabidiol oil or THC-A oil
that constitutes a 90-day supply to treat or alleviate the symptoms of a
patient's diagnosed condition or disease.
Purpose: The purpose of the proposed regulatory action
is compliance with Chapter 577 of the 2016 Acts of Assembly and with Chapters
246 and 809 and Chapter 567 of the 2018 Acts of Assembly, which mandated the
adoption of regulations to implement the acts. The goals of the proposed
regulation are accessibility of cannabidiol oil or THC-A oil for patients with
any disease or condition diagnosed by a physician licensed in the Commonwealth
in compliance with the conditions and restraints imposed by the statute and in consideration
of the need for security of the facility and its contents and the integrity of
the dispensed product.
Section 54.1-3442.6 C of the Code of Virginia requires the
board to "adopt regulations establishing health, safety, and security
requirements for pharmaceutical processors." The safeguards put in place
in statute and regulation are essential to protect the health and safety of the
general public and, in particular, the health of the patients to whom
cannabidiol oil or THC-A oil is dispensed.
Substance: The proposed regulation sets out the
requirements for issuance of permits to pharmaceutical processors for the
cultivation, production, and dispensing of cannabidiol oil or THC-A oil.
Regulations also establish requirements for registrations of physicians for
writing certification to registered patients, parents, or legal guardians for
possession of such oils. The proposed new chapter contains six parts, as
follows:
Part I establishes definitions and fees to be charged to
applicants, registrants, and permitted processors.
Part II, as specified in the legislation, establishes
requirements for the issuance or denial of registration for certifying
physicians, patients, parents, or legal guardians.
Part III sets out the application and approval process for
issuing a permit to a pharmaceutical processor, including the information that
must be submitted, the requirements for issuing conditional and then final
approval, the rules for notification to the board of any changes or of closure
of the processor, and the causes for action against a processor.
Part IV sets out the provisions for personnel at the
pharmaceutical processor, including a requirement that a pharmacist with a
current, unrestricted Virginia license provide personal supervision on the premises
at all times during hours of operation or whenever the processor is accessed.
It includes requirements for employee training, supervision of pharmacy
technicians, and the responsibilities of the pharmacist-in-charge.
Part V sets out provisions for the operation of a
pharmaceutical processor, including requirements for inventory, security,
storage and handling, recordkeeping, and reportable events.
Part VI establishes requirements for the cultivation,
production, and dispensing of cannabidiol oil, including labeling, laboratory
and testing standards, handling dispensing errors and quality assurance, and
proper disposal.
Issues: The advantages to the public include assurance
of the safety and integrity of the product dispensed and security for the
Cannabis and oils produced; there are no disadvantages to the public.
The advantage to the agency is more clarity in the rules for a
permitted facility; there are no disadvantages to the agency.
This is a significant new program for the Board of Pharmacy and
the Department of Health Professions in an evolving environment of medical
marijuana with wide variance in the policies and models adopted across the
United States and in a situation in which marijuana remains an illegal
substance on the federal level.
Department of Planning and Budget's Economic Impact
Analysis:
Summary of the Proposed Amendments to Regulation. Pursuant to
20161 and 20182 legislation, the Board of Pharmacy
(Board) proposes to establish a permanent regulation to replace an emergency
regulation governing the cultivation of cannabis for production and sale of
cannabidiol (CBD) oil and Tetrahydrocannabinolic acid (THC-A) oil.
Result of Analysis. The benefits likely exceed the costs for
all proposed changes. A different design would likely yield improved economic
results for at least one proposed change.
Estimated Economic Impact. Legislation enacted in 2016 required
the Board to promulgate regulations addressing CBD oil and THC-A oil, including
registration by the Board of practitioners and patients, and the issuance by
the Board of permits for pharmaceutical processors to manufacture and provide
these oils for the treatment of intractable epilepsy.3 The statute
authorized only neurologists and doctors that specialize in treatment of
epilepsy to issue written certificates for obtaining these oils.
CBD and THC-A are the two primary cannabinoids that occur
naturally in the Cannabis sativa plant, most commonly known as cannabis. Both
of these substances interact with the cannabinoid receptors found in the human
body and brain, and both are minimally psychoactive, which means that they do
not have an intoxicating effect.4 While either CBD or THC-A can
provide relief from some of the same medical conditions, for some other medical
conditions one may be better suited than the other. CBD and THC-A oils are
normally administered orally, sublingually via an oral syringe, or in a
capsule, but it is possible to inhale via vaping or a nebulizer.
Pursuant to 2016 legislation, the Board established emergency
regulations that became effective August 7, 2017.5 Later, 2018
legislation required the Board to amend its emergency regulations to allow any
doctor of medicine or osteopathy to recommend the oils for any diagnosed
condition or disease that the doctor believes would benefit from their use. The
2018 legislation also made numerous other amendments to the original statute
and required the Board to promulgate additional regulations for other aspects
of CBD and THC-A oil production and sale.6
Consequently, the Board proposes to establish a permanent
comprehensive regulation governing all aspects of these oils (e.g.,
application; issuance, denial, revocation, suspension of licenses and
certifications, their duration, and fees; cultivation; production; packaging;
labeling; testing; distribution; dispensing; storage; disposal; safekeeping;
reporting; recordkeeping; training; prohibited practices; etc.) for processors,
doctors, employees involved, and patients or their legal guardians.
The enabling legislation limits the number of permits the Board
may issue to "one for each health service area [HSA] established by the
Board of Health." Currently there are five HSAs statewide; each HSA covers
nine, 26, 27, 32, and 41 localities, respectively.
Pursuant to the emergency regulations, the Board received 51
applications along with a $10,000 fee per application, and issued five permits.
These five entities will (per the regulation) pay an initial permit fee of
$60,000 and pay an annual renewal fee of $10,000 for each permit. These and
other fees would be used to cover the Board's expenses to evaluate
applications, issue permits and certificates, conduct inspections, take actions
for violations, etc.7
Currently, processors are setting up their operations, and CBD
and THC-A oils have not yet been sold; the Board expects sales to start
sometime in 2019. Statute limits each registered patient to no more than a
90-day supply of CBD or THC-A oil in a 90-day period and states that
"prior to the initial dispensing" of oil pursuant to each written
certification, the patient, parent, or legal guardian must present their
certification and a current photo identification "at the location of the
pharmaceutical processor." Pursuant to § 54.1-3408.3, each such
certification expires after one year.
The five processors will be the only entities authorized to
produce and sell CBD and THC-A oils in their assigned HSA. The news media have
reported on the locations of four of the five permitted processors, indicating
facilities will be opened in Bristol, Staunton, Richmond, and Manassas; the
location in the Hampton Roads-based HSA does not appear to be available.8
According to board staff, registered patients are not restricted to purchasing
oils only in their HSA, and may purchase from any processor in the
Commonwealth. As a result, it appears that a patient may purchase from the
closest processor, regardless of which HSA they reside in. However, the patient
must physically present their photo identification and the renewed certificate
annually at the location of each processor they choose to purchase from.
Estimated Economic Impact on Processors:
Under the proposed regulatory design, an economic benefit would
accrue to the processors. Even though they would incur costs associated with
fees, setting up initial operations, and compliance with health, safety, and
security requirements, they would apply for a permit only if they expect
benefits would exceed the costs. In fact, because there is very limited
competition and no price controls contemplated in the regulation, the permitted
processors have the flexibility to set prices to ensure a certain level of
revenues. Therefore, the proposed regulation should provide a net benefit to
processors.
Under the proposed regulatory design, the only apparent factor
that would work to keep prices under control in a given HSA is the option for
patients to buy oils from processors in other HSAs. However, depending on the
distance patients must travel to the next-closest processor, the transportation
costs (including charges associated with use of an authorized delivery agent)
may offset any potential savings available from the lower prices offered by
another processor. Any such potential savings may be further reduced given the
statutory requirements that the maximum amount that can be dispensed (and
purchased) at one time is a 90-day supply, and that a patient must present
documentation "at the location of the pharmaceutical processor" once
each year.
Within the proposed regulation, other factors that may minimize
the potential for market competition that could lead to lower prices include
the mechanism whereby the incumbent processors may renew their permits
annually, for an indefinite period of time, as long as they comply with the
regulation. In addition, under the current statutory framework no more than
five processors statewide may be permitted. In combination, these factors
impact the opportunity for prices to be lowered through competitive forces by
limiting the number of new firms that could enter the market.
Estimated Economic Impact on Patients:
The proposed regulation would benefit all patients by allowing
them to legally purchase CBD or THC-A oil in the Commonwealth. The Board has
issued registration cards to 283 patients so far, even though no CBD or THC-A
oil is available for sale, and proposes to establish certain fees for patients.9
Although the legal access to CBD or THC-A oil is the main benefit, some
patients may also have peace of mind from carrying a registration card which
may help them avoid potential legal issues that may otherwise result from
possession of these oils. Because only those patients who value the access to
these oils more than the cost of the fees would obtain a registration card, we
can reliably infer that the benefits of registration would exceed the cost of
registration for these patients.
However, the ability of some patients to benefit from legal use
of these oils, especially patients with lower incomes, may be somewhat limited
if prices are higher than would otherwise exist if the market consisted of more
than five processors. In addition, the distance between patient's location and
the location of the nearest processor may be a limiting factor for their access
to the oils, as the patients would have to absorb travel time and costs to
purchase the oils or pay a delivery fee. Because the legislation only allows
purchases to occur in five locations, it would not be uncommon for many
patients to travel more than few hours to get to the nearest processor. Thus,
travel costs or delivery fees would add to the price of oils and may limit
patient access.
Estimated Economic Impact on Practitioners:
Similar to the patients, doctors who decide to obtain
registration to recommend CBD or THC-A oil indicate that the benefits of doing
so exceed the costs for them. The main benefits to the registered doctors are
the potential to expand their customer base through patients who would benefit
from these oils, as well as providing more effective treatment for current
patients. The proposed regulation limits the number of such patients a doctor
may treat to 600 at any given time, but allows the doctor to petition the Board
for a higher limit. The proposed regulation also establishes a $50 fee for
initial registration, a $50 fee for annual renewal, and $50 for replacement
certificate to recommend the oils. According to DHP, there are 230 registered
doctors.
Other Estimated Economic Impacts:
The issuance of certificates and permits to patients, doctors,
and processors and enforcement of the proposed rules would require additional
staff time for the Department of Health Professions (DHP). DHP has already
dedicated two employees on a part-time basis to meet the current workload
demands, and anticipates that three more full-time positions would be needed
once the oils are offered for sale. The funding source for the four positions
will be the fees collected.
The five localities where the processors will be operating
would see a positive impact from this regulation as the processors hire new
employees to grow and process the plant and get the final products ready for
sale. However, the five localities may also have to deal with attempts to steal
these oils or the cannabis plants from the processors or their delivery agents.
Finally, the proposed regulation is expected to reduce crime.
The enabling legislation made what used to be a misdemeanor crime a lawful
activity, and made the certificate from the Board an affirmative defense
against any misdemeanor charge the patient may face for possession of CBD and
THC-A oils. As a result, the number of misdemeanor charges and convictions for
possession of these oils should decline. A decline in crime would free up the
resources required for enforcement, prosecution, and incarceration of a number
of cases and reduce the burden on the criminal justice system.
Alternative Regulatory Designs:
As discussed above, the proposed regulation would produce a net
benefit to processors, patients, and doctors. However, statutory limitations on
the number of processors, plus the impact of transportation and other costs,
could limit the ability of some patients to benefit from the lower prices that
would likely exist in a more competitive market. If changes to this statutory
framework were made, alternative regulatory designs could be pursued that could
potentially allow patients to more fully realize the benefits resulting from
this regulation. These alternatives include either increasing the number of
processors, or limiting the number of annual renewals, in order to allow
additional processors to enter the market. If either course was chosen, the
Board could then request new proposals with a lowest price guarantee (e.g., per
ounce of the oils) for the duration of the permit, or with higher permit fees.
These alternatives could increase the net benefits to patients by lowering
prices or providing revenues that could be used to support compassionate need
programs.
Businesses and Entities Affected. This regulation applies to
CBD and THC-A oil processors, patients, and doctors. Currently, there are five
processors with conditional approval, 283 registered patients, and 230
registered doctors. The number of registered patients and doctors would likely
significantly increase when the processors actually start selling CBD or THC-A
oil.10
Localities Particularly Affected. The proposed regulation would
disproportionately affect the five particular localities where the processors
are operating. These affected localities would likely see an increase in
economic activity stemming from increased employment and business activity by
the processors. However, there may also be instances of theft at the processor
facilities or from the processor's delivery agents.
Projected Impact on Employment. The proposed regulation would
have a positive impact on employment, particularly in the areas where
processors operate.
Effects on the Use and Value of Private Property. The proposed
regulation would have a large positive impact on the asset value of processors
as a result of the potential perpetual price setting power they are granted.
Real Estate Development Costs. Except for potential impacts,
near the location of the five processors the proposed amendments would not
directly affect real estate development costs.
Small Businesses:
Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia,
small business is defined as "a business entity, including its affiliates,
that (i) is independently owned and operated and (ii) employs fewer than 500
full-time employees or has gross annual sales of less than $6 million."
Costs and Other Effects. The proposed amendments would not
impose costs on small businesses. Whether any of the processors would qualify
as a small business is not known. If they would qualify as small businesses,
the other effects on them would be the same as the impact on processors
described above.
Alternative Method that Minimizes Adverse Impact. The proposed
regulation does not impose adverse impacts on small businesses.
Adverse Impacts:
Businesses. The proposed regulation does not impose adverse
impacts on businesses.
Localities. The proposed regulation may adversely affect
particular localities in terms of the increased risk of theft at the processor
facilities or from the processor's delivery agents.
Other Entities. The proposed regulation does not impose adverse
impacts on other entities.
____________________________
1http://lis.virginia.gov/cgi-bin/legp604.exe?161+ful+CHAP0577
2http://lis.virginia.gov/cgi-bin/legp604.exe?181+ful+CHAP0246 & http://lis.virginia.gov/cgi-bin/legp604.exe?181+ful+CHAP0567
3In the statute, cannabidiol oil is defined as processed
Cannabis plant extract that contains at least 15 percent cannabidiol but no
more than five percent tetrahydrocannabinol, or a dilution of the resin of the
Cannabis plant that contains at least 50 milligrams of cannabidiol per milliliter
but not more than five percent tetrahydrocannabinol; and THC-A oil is defined
as processed Cannabis plant extract that contains at least 15 percent
tetrahydrocannabinol acid but not more than five percent tetrahydrocannabinol,
or a dilution of the resin of the Cannabis plant that contains at least 50
milligrams of tetrahydrocannabinol acid per milliliter but not more than five
percent tetrahydrocannabinol.
4National Academies of Sciences, Engineering, and
Medicine, The Health Effects of Cannabis and Cannabinoids: The Current State of
Evidence and Recommendations for Research. National Academies Press (US);
January 12, 2017.
5http://townhall.virginia.gov/l/ViewStage.cfm?stageid=7740
6http://lis.virginia.gov/cgi-bin/legp604.exe?181+ful+CHAP0567
7In addition to these permit and renewal fees, the
proposed regulation establishes other fees: $100 for change of a processor name
or of any other information provided on the application; $1,000 for any
acquisition, expansion, remodel, change of location; $1,000 for re-inspection;
and $25 for registration of each CBD or THC-A oil product.
8Richmond Times-Dispatch, Virginia regulators pick five
companies to open state's first medical cannabis dispensaries, September 25,
2018.
9The board proposes to establish a $50 fee for initial
registration of a patient, a $50 fee for annual renewal, a $25 fee for initial
registration of a parent or guardian (in the emergency regulation, this fee was
$50), a $25 fee for renewal of parent or guardian registration, and a $25 fee
for replacement of lost, stolen, destroyed certificates.
10According to a presentation made to the Board on July
1, 2016, 1% of the population have epilepsy and 1/3 of this population do not
respond to currently approved drug therapy, which translates to 27,000
Virginians. Source: http://townhall.virginia.gov/l/GetFile.cfm?File=meeting\30\24620
\Minutes_DHP_24620_v3.pdf
Agency's Response to Economic Impact Analysis: The Board
of Pharmacy concurs with the analysis of the Department of Planning and Budget.
Summary:
Pursuant to Chapter 577 of the 2016 Acts of Assembly,
Chapter 613 of the 2017 Acts of Assembly, and Chapters 246 and 809 and Chapter
567 of the 2018 Acts of Assembly, the Board of Pharmacy is promulgating a new
chapter, 18VAC110-60, governing the registration process for a patient who has
been issued a written certification for the use of cannabidiol oil or THC-A oil
and the issuance of a permit for a pharmaceutical processor to manufacture and
provide cannabidiol oil and THC-A oil to a registered patient. The proposed
chapter sets out the requirements for issuance of permits to pharmaceutical
processors for the cultivation, production, and dispensing of cannabidiol oil
or THC-A oil and establishes requirements for registrations of physicians for
writing certification to registered patients, parents, or legal guardians for
possession of such oils.
The proposed chapter establishes (i) definitions and fees
to be charged to applicants, registrants, and permitted processors; (ii) as
specified in the legislation, requirements for issuance or denial of
registration for certifying physicians, patients, parents, or legal guardians;
(iii) the application and approval process for issuing a permit to a
pharmaceutical processor, including the information that must be submitted, the
requirements for issuing conditional and then final approval, the rules for
notification to the board of any changes or of closure of the processor, and
the causes for action against a processor; (iv) provisions for personnel at the
pharmaceutical processor, including a requirement that a pharmacist with a
current, unrestricted Virginia license provide personal supervision on the
premises at all times during hours of operation or whenever the processor is
accessed and requirements for employee training and supervision of pharmacy
technicians and responsibilities of the pharmacist-in-charge; (v) provisions
for the operation of a pharmaceutical processor, including requirements for
inventory, security, storage and handling, recordkeeping, and reportable
events; and (vi) requirements for the cultivation, production, and dispensing
of cannabidiol oil or THC-A oil, including labeling, laboratory and testing
standards, handling dispensing errors, quality assurance, and proper disposal.
CHAPTER 60
REGULATIONS GOVERNING PHARMACEUTICAL PROCESSORS
Part I
General Provisions
18VAC110-60-10. Definitions.
In addition to words and terms defined in
§§ 54.1-3408.3 and 54.1-3442.5 of the Code of Virginia, the following
words and terms when used in this chapter shall have the following meanings,
unless the context clearly indicates otherwise:
"90-day supply" means the amount of cannabidiol
oil or THC-A oil reasonably necessary to ensure an uninterrupted availability
of supply for a 90-day period for registered patients, which cannot exceed 60
fluid ounces.
"Board" means the Board of Pharmacy.
"Certification" means a written statement,
consistent with requirements of § 54.1-3408.3 of the Code of Virginia,
issued by a practitioner for the use of cannabidiol oil or THC-A oil for
treatment of or to alleviate the symptoms of any diagnosed condition or disease
determined by the practitioner to benefit from such use.
"Dispensing error" means one or more of the
following was discovered after the final verification by the pharmacist,
regardless of whether the patient received the oil:
1. Variation from the intended oil to be dispensed,
including:
a. Incorrect oil;
b. Incorrect oil strength;
c. Incorrect dosage form;
d. Incorrect patient; or
e. Inadequate or incorrect packaging, labeling, or
directions.
2. Failure to exercise professional judgment in identifying
and managing:
a. Known therapeutic duplication;
b. Known drug-disease contraindications;
c. Known drug-drug interactions;
d. Incorrect drug dosage or duration of drug treatment;
e. Known drug-allergy interactions;
f. A clinically significant, avoidable delay in therapy; or
g. Any other significant, actual, or potential problem with
a patient's drug therapy.
3. Delivery of an oil to the incorrect patient.
4. An act or omission relating to the dispensing of
cannabidiol oil or THC-A oil that results in, or may reasonably be expected to
result in, injury to or death of a registered patient or results in any
detrimental change to the medical treatment for the patient.
"Electronic tracking system" means an electronic
radio-frequency identification (RFID) seed-to-sale tracking system that tracks
the Cannabis from either the seed or immature plant stage until the cannabidiol
oil and THC-A oil are sold to a registered patient, parent, or legal guardian
or until the Cannabis, including the seeds, parts of plants, and extracts, are
destroyed. The electronic tracking system shall include, at a minimum, a
central inventory management system and standard and ad hoc reporting functions
as required by the board and shall be capable of otherwise satisfying required
recordkeeping.
"On duty" means that a pharmacist is on the
premises at the address of the permitted pharmaceutical processor and is
available as needed.
"PIC" means the pharmacist-in-charge.
"Production" or "produce" means the
manufacture, planting, preparation, cultivation, growing, harvesting,
propagation, conversion, or processing of marijuana, (i) directly or indirectly
by extraction from substances of natural origin, (ii) independently by means of
chemical synthesis, or (iii) by a combination of extraction and chemical
synthesis. "Production" or "produce" includes any packaging
or repackaging of the substance or labeling or relabeling of its container.
"Qualifying patient" means a Virginia resident
who has received from a practitioner, as defined in § 54.1-3408.3 of the
Code of Virginia, a written certification for the use of cannabidiol oil or
THC-A oil for treatment of or to alleviate the symptoms of any diagnosed condition
or disease.
"Registered patient" means a qualifying patient
who has been issued a registration by the board for the dispensing of
cannabidiol oil or THC-A oil to such patient.
"Registration" means an identification card or
other document issued by the board that identifies a person as a practitioner
or a qualifying patient, parent, or legal guardian.
"Resident" means a person whose principal place
of residence is within the Commonwealth as evidenced by a federal or state
income tax return or a current Virginia driver's license. If a person is a
minor, residency may be established by evidence of Virginia residency by a
parent or legal guardian.
"Temperature and humidity" means temperature and
humidity maintained in the following ranges:
|
Room or Phase
|
Temperature
|
Humidity
|
|
Mother room
|
65 - 75°
|
50% - 60%
|
|
Nursery phase
|
71 - 85° F
|
65% - 75%
|
|
Vegetation phase
|
71 - 85° F
|
55% - 65%
|
|
Flower/harvest phase
|
71 - 85° F
|
55% - 60%
|
|
Drying/extraction rooms
|
< 75° F
|
55% - 60%
|
18VAC110-60-20. Fees.
A. Fees are required by the board as specified in this
section. Unless otherwise provided, fees listed in this section shall not be
refundable.
B. Registration of practitioner.
|
1. Initial registration.
|
$50
|
|
2. Annual renewal of registration.
|
$50
|
|
3. Replacement of registration for a qualifying
practitioner whose information has changed or whose original registration
certificate has been lost, stolen, or destroyed.
|
$50
|
C. Registration by a qualifying patient, parent, or legal
guardian.
|
1. Initial registration of a patient.
|
$50
|
|
2. Annual renewal of registration of a patient.
3. Initial registration of a parent or legal guardian.
4. Annual renewal of registration of a parent or guardian.
|
$50
$25
$25
|
|
5. Replacement of registration for a qualifying patient,
parent, or legal guardian whose original registration certificate has been
lost, stolen, or destroyed.
|
$25
|
D. Pharmaceutical processor
permit.
|
1. Application.
|
$10,000
|
|
2. Initial permit.
|
$60,000
|
|
3. Annual renewal of permit.
|
$10,000
|
|
4. Change of name of processor.
|
$100
|
|
5. Change of PIC or any other information provided on the
permit application.
|
$100
|
|
6. Any acquisition, expansion, remodel, or change of
location requiring an inspection.
|
$1,000
|
|
7. Reinspection fee.
8. Registration of each cannabidiol oil or THC-A oil product.
|
$1,000
$25
|
Part II
Requirements for Practitioners and Patients
18VAC110-60-30. Requirements for a practitioner issuing a
certification.
A. Prior to issuing a certification for cannabidiol oil or
THC-A oil for any diagnosed condition or disease, the practitioner shall meet
the requirements of § 54.1-3408.3 of the Code of Virginia, shall submit an
application and fee as prescribed in 18VAC110-60-20, and shall be registered
with the board.
B. A practitioner issuing a certification shall:
1. Conduct an assessment and evaluation of the patient in
order to develop a treatment plan for the patient, which shall include an
examination of the patient and the patient's medical history, prescription
history, and current medical condition, including an in-person physical
examination;
2. Diagnose the patient;
3. Be of the opinion that the potential benefits of
cannabidiol oil or THC-A oil would likely outweigh the health risks of such use
to the qualifying patient;
4. Explain proper administration and the potential risks
and benefits of the cannabidiol oil or THC-A oil to the qualifying patient
and, if the qualifying patient lacks legal capacity, to a parent or legal
guardian prior to issuing the written certification;
5. Be available or ensure that another practitioner, as
defined in § 54.1-3408.3 of the Code of Virginia, is available to provide
follow-up care and treatment to the qualifying patient, including physical
examinations, to determine the efficacy of cannabidiol oil or THC-A oil for
treating the diagnosed condition or disease;
6. Comply with generally accepted standards of medical
practice, except to the extent such standards would counsel against certifying
a qualifying patient for cannabidiol oil or THC-A oil;
7. Maintain medical records in accordance with
18VAC85-20-26 for all patients for whom the practitioner has issued a
certification; and
8. Access or direct the practitioner's delegate to access
the Virginia Prescription Monitoring Program of the Department of Health
Professions for the purpose of determining which, if any, covered substances
have been dispensed to the patient.
C. Patient care and evaluation shall not occur by telemedicine
for at least the first year of certification. Thereafter, the practitioner
shall use his professional judgment to determine the manner and frequency of
patient care and evaluation.
D. A practitioner shall not delegate the responsibility of
diagnosing a patient or determining whether a patient should be issued a
certification. Employees under the direct supervision of the practitioner may
assist with preparing a certification, so long as the final certification is
approved and signed by the practitioner before it is issued to the patient.
E. The practitioner shall provide instructions for the use
of cannabidiol oil or THC-A oil to the patient, parent, or guardian, as
applicable, and shall also securely transmit such instructions to the permitted
pharmaceutical processor.
F. A practitioner shall not issue certifications for
cannabidiol oil or THC-A oil to more than 600 patients at any given time.
However, the practitioner may petition the Board of Pharmacy and Board of
Medicine for an increased number of patients for whom certifications may be
issued, upon submission of evidence that the limitation represents potential
patient harm.
G. Upon request, a practitioner shall make a copy of
medical records available to an agent of the Board of Medicine or Board of
Pharmacy for the purpose of enabling the board to ensure compliance with the
law and regulations or to investigate a possible violation.
18VAC110-60-40. Prohibited practices for practitioners.
A. A practitioner who issues certifications shall not:
1. Directly or indirectly accept, solicit, or receive
anything of value from any person associated with a pharmaceutical processor or
provider of paraphernalia, excluding information on products or educational
materials on the benefits and risks of cannabidiol oil or THC-A oil;
2. Offer a discount or any other thing of value to a
qualifying patient, parent, or guardian based on the patient's agreement or
decision to use a particular pharmaceutical processor or cannabidiol oil or
THC-A oil product;
3. Examine a qualifying patient for purposes of diagnosing
the condition or disease at a location where cannabidiol oil or THC-A oil is
dispensed or produced; or
4. Directly or indirectly benefit from a patient obtaining
a certification. Such prohibition shall not prohibit a practitioner from
charging an appropriate fee for the patient visit.
B. A practitioner who issues certifications, and such
practitioner's coworker, employee, spouse, parent, or child, shall not have a
direct or indirect financial interest in a pharmaceutical processor or any
other entity that may benefit from a qualifying patient's acquisition,
purchase, or use of cannabidiol oil or THC-A oil, including any formal or
informal agreement whereby a pharmaceutical processor or other person provides
compensation if the practitioner issues a certification for a qualifying
patient or steers a qualifying patient to a specific pharmaceutical processor
or cannabidiol oil or THC-A oil product.
C. A practitioner shall not issue a certification for
himself or for family members, employees, or coworkers.
D. A practitioner shall not provide product samples
containing cannabidiol oil or THC-A oil other than those approved by the U.S.
Food and Drug Administration.
18VAC110-60-50. Registration of a patient, parent, or legal
guardian.
A. A qualifying patient for whom a practitioner has issued
a certification shall register with the board in accordance with this section.
If the qualifying patient is a minor or an incapacitated adult, the qualifying
patient's parent or legal guardian shall register with the board in accordance
with this section. For a registration application to be considered complete,
the following items shall be submitted:
1. A copy of the certification issued by a registered
practitioner;
2. Proof of residency of the qualifying patient and proof
of residency of a parent or legal guardian, if applicable, such as a
government-issued identification card or tax receipt;
3. Proof of identity of the qualifying patient and, if the
patient is a minor, proof of identity of the parent or legal guardian in the
form of a government-issued identification card;
4. Proof of the qualifying patient's age in the form of a
birth certificate or other government-issued identification;
5. Payment of the appropriate fees; and
6. Such other information as the board may require to
determine the applicant's suitability for registration or to protect public
health and safety.
B. A qualifying patient shall not be issued a written
certification by more than one practitioner during a given time period.
C. Patients, parents, and legal guardians issued a
registration shall carry their registrations with them whenever they are in
possession of cannabidiol oil or THC-A oil.
18VAC110-60-60. Denial of a qualifying patient, parent, or
legal guardian registration application.
A. The board may deny an application or renewal of the
registration of a qualifying patient, parent, or legal guardian if the
applicant:
1. Does not meet the requirements set forth in law or
regulation or fails to provide complete information on the application form;
2. Does not provide acceptable proof of identity,
residency, or age of the patient to the board;
3. Provides false, misleading, or incorrect information to
the board;
4. Has had a qualifying registration of a qualifying
patient, parent, or legal guardian denied, suspended, or revoked by the board
in the previous six months;
5. Has a certification issued by a practitioner who is not
authorized to certify patients for cannabidiol oil or THC-A oil; or
6. Has a prior conviction of a violation of any law
pertaining to controlled substances.
B. If the board denies an application or renewal of a
qualifying patient, parent, or legal guardian applicant, the board shall
provide the applicant with notice of the grounds for the denial and shall
inform the applicant of the right to request a hearing pursuant to § 2.2-4019
of the Code of Virginia.
18VAC110-60-70. Reporting requirements for practitioners,
patients, parents, or legal guardians.
A. A practitioner shall report to the board, on a form
prescribed by the board, the death of a registered patient or a change in
status involving a registered patient for whom the practitioner has issued a
certification if such change affects the patient's continued eligibility to use
cannabidiol oil or THC-A oil or the practitioner's inability to continue
treating the patient. A practitioner shall report such death, change of status,
or inability to continue treatment not more than 15 days after the practitioner
becomes aware of such fact.
B. A patient, parent, or legal guardian who has been
issued a registration shall notify the board of any change in the information
provided to the board not later than 15 days after such change. The patient,
parent, or legal guardian shall report changes that include a change in name,
address, contact information, medical status of the patient, or change of the
certifying practitioner. The patient, parent, or legal guardian shall report
such changes on a form prescribed by the board.
C. If a patient, parent, or legal guardian notifies the
board of any change that results in information on the patient, parent, or
legal guardian's registration being inaccurate, the board shall issue a
replacement registration. Upon receipt of a new registration, the qualifying
patient, parent, or legal guardian shall destroy in a nonrecoverable manner the
registration that was replaced.
D. If a patient, parent, or legal guardian becomes aware
of the loss, theft, or destruction of the registration of such patient, parent,
or legal guardian, the patient, parent, or legal guardian shall notify the
board not later than five business days after becoming aware of the loss,
theft, or destruction, and submit the fee for a replacement registration. The
board shall inactivate the initial registration upon receiving such notice and
issue a replacement registration upon receiving the applicable fee, provided
the applicant continues to satisfy the requirements of law and regulation.
18VAC110-60-80. Proper storage and disposal of cannabidiol
oil or THC-A oil by patients, parents, or legal guardians.
A. A registered patient, parent, or legal guardian shall
exercise reasonable caution to store cannabidiol oil or THC-A oil in a manner
to prevent theft, loss, or access by unauthorized persons.
B. A registered patient, parent, or legal guardian shall
dispose of all usable cannabidiol oil or THC-A oil in the registered patient,
parent, or legal guardian's possession no later than 10 calendar days after the
expiration of the patient's registration if such registration is not renewed,
or sooner should the patient no longer wish to possess cannabidiol oil or THC-A
oil. A registered patient, parent, or legal guardian shall complete such
disposal by one of the following methods:
1. By removing the oil from the original container and
mixing it with an undesirable substance such as used coffee grounds, dirt, or
kitty litter. The mixture shall be placed in a sealable bag, empty can, or
other container to prevent the drug from leaking or breaking out of a garbage
bag.
2. By transferring it to law enforcement via a medication
drop-box or drug take-back event if permissible under state and federal law.
18VAC110-60-90. Revocation or suspension of a qualifying
patient, parent, or legal guardian registration.
The board may revoke or suspend the registration of a
patient, parent, or legal guardian under the following circumstances:
1. The patient's practitioner notifies the board that the
practitioner is withdrawing the written certification submitted on behalf of
the patient, and 30 days after the practitioner's withdrawal of the written
certification the patient has not obtained a valid written certification from a
different practitioner;
2. The patient, parent, or legal guardian provided false,
misleading, or incorrect information to the board;
3. The patient, parent, or legal guardian is no longer a
resident of Virginia;
4. The patient, parent, or legal guardian obtained more
than a 90-day supply of cannabidiol oil or THC-A oil in a 90-day period;
5. The patient, parent, or legal guardian provided or sold
cannabidiol oil or THC-A oil to any person, including another registered
patient, parent, or legal guardian;
6. The patient, parent, or legal guardian permitted another
person to use the registration of the patient, parent, or legal guardian;
7. The patient, parent, or legal guardian tampered,
falsified, altered, modified, or allowed another person to tamper, falsify,
alter, or modify the registration of the patient, parent, or legal guardian;
8. The registration of the patient, parent, or legal
guardian was lost, stolen, or destroyed, and the patient, parent, or legal
guardian failed to notify the board or notified the board of such incident more
than five business days after becoming aware that the registration was lost,
stolen, or destroyed;
9. The patient, parent, or legal guardian failed to notify
the board of a change in registration information or notified the board of such
change more than 14 days after the change; or
10. The patient, parent, or legal guardian violated any
federal or state law or regulation.
Part III
Application and Approval Process for Pharmaceutical Processors
18VAC110-60-100. Publication of notice for submission of
applications.
A. The board shall publish a notice of open applications
for pharmaceutical processor permits. Such notice shall include information on
how to obtain and complete an application, the required fees, the criteria for
issuance of a permit, and the deadline for receipt of applications.
B. The board shall have the right to amend the notice of
open applications prior to the deadline for submitting an application. Such
amended notice shall be published in the same manner as the original notice of
open applications.
C. The board shall have the right to cancel a notice of
open applications prior to the award of a pharmaceutical processor permit.
18VAC110-60-110. Application process for pharmaceutical
processor permits.
A. The application process for permits shall occur in
three stages: submission of initial application, award of conditional approval,
and grant of a pharmaceutical processor permit.
B. Submission of initial application.
1. A pharmaceutical processor permit applicant shall submit
the required application fee and form with the following information and
documentation:
a. The name and address of the applicant and the
applicant's owners;
b. The location within the health service area established
by the State Board of Health for the pharmaceutical processor that is to be
operated under such permit;
c. 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 pursuant to §§ 54.1-3442.6 and
54.1-3442.7 of the Code of Virginia, which may include evidence of an escrow
account, letter of credit, or performance surety bond;
d. 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;
e. Documents sufficient to establish that the applicant is
authorized to conduct business in Virginia 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 a permit;
f. Information necessary for the board to conduct a
criminal background check on the applicant;
g. Information about any previous or current involvement in
the medical cannabidiol oil or THC-A oil industry;
h. Whether the applicant has ever applied for a permit or
registration related to medical cannabidiol oil or THC-A oil in any state and,
if so, the status of that application, permit, or registration, to include any
disciplinary action taken by any state on the permit, the registration, or an
associated license;
i. Any business and marketing plans related to the
operation of the pharmaceutical processor or the sale of cannabidiol oil or
THC-A oil;
j. Text and graphic materials showing the exterior
appearance of the proposed pharmaceutical processor;
k. A blueprint of the proposed pharmaceutical processor
that shall show and identify (i) the square footage of each area of the
facility; (ii) the location of all safes or vaults used to store the Cannabis
plants and oils; (iii) the location of all areas that may contain Cannabis
plants, cannabidiol oil, or THC-A oil; (iv) the placement of walls, partitions,
and counters; and (v) all areas of ingress and egress;
l. Documents related to any compassionate need program the
pharmaceutical processor intends to offer;
m. Information about the applicant's expertise in
agriculture and other production techniques required to produce cannabidiol oil
or THC-A oil and to safely dispense such products; and
n. Such other documents and information required by the
board to determine the applicant's suitability for permitting or to protect
public health and safety.
2. In the event any information contained in the
application or accompanying documents changes after being submitted to the
board, the applicant shall immediately notify the board in writing and provide
corrected information in a timely manner so as not to disrupt the permit
selection process.
3. The board shall conduct criminal background checks on
applicants and may verify information contained in each application and
accompanying documentation in order to assess the applicant's ability to
operate a pharmaceutical processor.
C. In the event the board determines that there are no
qualified applicants to award conditional approval for a pharmaceutical
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.
D. No person who has been convicted of a felony or of any
offense in violation of Article 1 (§ 18.2-247 et seq.) or Article 1.1 (§ 18.2-265.1
et seq.) of Chapter 7 of Title 18.2 of the Code of Virginia shall have any form
of ownership, be employed by, or act as an agent of a pharmaceutical processor.
18VAC110-60-120. Conditional approval.
A. Following the deadline for receipt of applications, the
board shall evaluate each complete and timely submitted application and may
grant conditional approval on a competitive basis based on compliance with
requirements set forth in 18VAC110-60-110.
B. The board shall consider, but is not limited to, the
following criteria in evaluating pharmaceutical processor permit applications:
1. The results of the criminal background checks required
in 18VAC110-60-110 B 3 or any history of disciplinary action imposed by a state
or federal regulatory agency;
2. The location for the proposed pharmaceutical processor,
which shall not be within 1,000 feet of a school or daycare;
3. The applicant's ability to maintain adequate control
against the diversion, theft, and loss of the Cannabis, to include the seeds,
any parts or extracts of the Cannabis plants, the cannabidiol oil, or the THC-A
oil;
4. The applicant's ability to maintain the knowledge,
understanding, judgment, procedures, security controls, and ethics to ensure
optimal safety and accuracy in the dispensing and sale of cannabidiol oil or
THC-A oil;
5. The extent to which the applicant or any of the
applicant's pharmaceutical processor owners have a financial interest in
another license, permit, registrant, or applicant; and
6. Any other reason provided by state or federal statute or
state or federal regulation that is not inconsistent with the law and
regulations regarding pharmaceutical processors.
C. The board may disqualify any applicant who:
1. Submits an incomplete, false, inaccurate, or misleading
application;
2. Fails to submit an application by the published deadline;
3. Fails to pay all applicable fees; or
4. Fails to comply with all requirements for a
pharmaceutical processor.
D. Following review, the board shall notify applicants of
denial or conditional approval. The decision of the board not to grant conditional
approval to an applicant shall be final.
E. If granted conditional approval, an applicant shall
have one year from date of notification to complete all requirements for
issuance of a permit, to include employment of a PIC and other personnel necessary
for operation of a pharmaceutical processor, construction or remodeling of a
facility, installation of equipment, and securing local zoning approval.
18VAC110-60-130. Granting of a pharmaceutical processor
permit.
A. The board may issue a pharmaceutical processor permit
when all requirements of the board have been met, to include:
1. Designation of a PIC;
2. Evidence of criminal background checks for all employees
and delivery agents of the processor to ensure compliance with § 54.1-3442.6 of
the Code of Virginia;
3. Evidence of utilization of an electronic tracking
system; and
4. A satisfactory inspection of the facility conducted by
the board or its agents.
B. The permit shall not be awarded until any deficiency
identified by inspectors has been corrected and the facility has been
satisfactorily reinspected if warranted.
C. Before any permit is issued, the applicant shall attest
to compliance with all state and local laws and ordinances. A pharmaceutical
processor permit shall not be issued to any person to operate from a private
dwelling or residence.
D. If an applicant has been awarded a pharmaceutical
processor permit and has not commenced operation of such facility within 180
days of being notified of the issuance of a pharmaceutical processor permit,
the board may rescind such permit, unless such delay was caused by
circumstances beyond the control of the permit holder.
E. A pharmaceutical processor shall be deemed to have
commenced operation if Cannabis plants are under cultivation by the processor
in accordance with the approved application.
F. In the event a permit is rescinded pursuant to this
section, the board may award a pharmaceutical processor permit by
selecting among the qualified applicants who applied for the pharmaceutical
processor permit subject to rescission. If no other qualified applicant
who applied for such pharmaceutical processor permit satisfied
the criteria for awarding a permit, the board shall publish in accordance with
this section a notice of open applications for a pharmaceutical processor
permit.
G. Once the permit is issued, Cannabis may not be grown or
held in the pharmaceutical processor earlier than two weeks prior to the
opening date designated on the application. Once Cannabis has been placed in
the pharmaceutical processor, a pharmacist shall be present during hours of
operation to ensure the safety, security, and integrity of the Cannabis. If
there is a change in the designated opening date, the pharmaceutical processor
shall notify the board office, and a pharmacist shall continue to be on site on
a daily basis.
18VAC110-60-140. Notification of changes by pharmaceutical
processor.
A. Unless otherwise provided in law or regulation, the PIC
designated on the application to be in full and actual charge of the
pharmaceutical processor shall provide any notification or information that is
required from a pharmaceutical processor.
B. Prior to making any change to the pharmaceutical
processor name, the pharmaceutical processor shall submit an application for
such change to the board and pay the fee.
C. Any person wishing to engage in the acquisition of an
existing pharmaceutical processor, change the location of an existing
pharmaceutical processor, make structural changes to an existing pharmaceutical
processor, or make changes to a previously approved security system shall
submit an application to the board and pay the required fee.
1. The proposed location or structural changes shall be
inspected by an authorized agent of the board prior to issuance of a permit.
2. Cannabis shall not be moved to a new location until approval
is granted by the inspector or board staff.
18VAC110-60-150. Pharmaceutical processor closings; going
out of business; change of ownership.
A. At least 30 days prior to the date a pharmaceutical
processor closes, either temporarily or permanently, the owner shall:
1. Notify the board;
2. Send written notification to patients with current
certification; and
3. Post a notice on the window or door of the
pharmaceutical processor.
B. The proposed disposition of all Cannabis, dispensing
records, patient information records, and other required records shall be
reported to the board. If the Cannabis and records are to be transferred to
another processor located in Virginia, the owner shall inform the board and the
patients and include on the public notice the name and address of the processor
to whom the Cannabis and records are being transferred and the date of
transfer.
C. Exceptions to the public notice shall be approved by
the board and may include sudden closing due to fire, destruction, natural
disaster, death, property seizure, eviction, bankruptcy, or other emergency
circumstances. If the pharmaceutical processor is not able to meet the
notification requirements, the owner shall ensure that the board and public are
properly notified as soon as he knows of the closure and shall disclose the
emergency circumstances preventing the notification within the required
deadlines.
D. In the event of an exception to the notice, the PIC or
owner shall provide notice as far in advance of closing as allowed by the circumstances.
E. At least 14 days prior to any change in ownership of an
existing pharmaceutical processor, the owner shall notify the board of the
pending change.
1. Upon any change in ownership of an existing
pharmaceutical processor, the dispensing records for the two years immediately
preceding the date of change of ownership and other required patient
information shall be provided to the new owners on the date of change of
ownership in substantially the same format as previously used immediately prior
to the transfer to provide continuity of services.
2. The previous owner shall be held responsible for
assuring the proper and lawful transfer of records on the date of the transfer.
18VAC110-60-160. Grounds for action against a pharmaceutical
processor permit.
In addition to the bases enumerated in § 54.1-3316 of
the Code of Virginia, the board may suspend, revoke, or refuse to grant or
renew a permit issued; place such permit on probation; place conditions on such
permit; or take other actions permitted by statute or regulation on the
following grounds:
1. Any criminal conviction under federal or state statutes
or regulations or local ordinances, unless the conviction was based on a
federal statute or regulation related to the possession, purchase, or sale of
cannabidiol oil or THC-A oil that is authorized under state law and
regulations;
2. Any civil action under any federal or state statute or
regulation or local ordinance (i) relating to the applicant's, licensee's,
permit holder's, or registrant's profession or (ii) involving drugs, medical
devices, or fraudulent practices, including fraudulent billing practices;
3. Failure to maintain effective controls against
diversion, theft, or loss of Cannabis, cannabidiol oil or THC-A oil, or other
controlled substances;
4. Intentionally or through negligence obscuring, damaging,
or defacing a permit or registration card;
5. Permitting another person to use the permit of a permit
holder or registration of a qualifying patient, parent, or legal guardian;
6. Failure to cooperate or give information to the board on
any matter arising out of conduct at a pharmaceutical processor; or
7. Discontinuance of business for more than 60 days, unless
the board approves an extension of such period for good cause shown upon a
written request from a pharmaceutical processor. Good cause includes exigent
circumstances that necessitate the closing of the facility. Good cause shall
not include a voluntary closing of the pharmaceutical processor or production
facility.
Part IV
Requirements for Pharmaceutical Processor Personnel
18VAC110-60-170. Pharmaceutical processor employee licenses
and registrations.
A. A pharmacist with a current, unrestricted license
issued by the board practicing at the location of the address on the pharmaceutical
processor application shall be in full and actual charge of a pharmaceutical
processor and serve as the pharmacist-in-charge.
B. A pharmacist with a current, unrestricted license
issued by the board shall provide personal supervision on the premises of the
pharmaceutical processor at all times during hours of operation or whenever the
processor is being accessed.
C. A person who holds a current, unrestricted registration
as a pharmacy technician pursuant to § 54.1-3321 of the Code of Virginia
and who has had at least two years of experience practicing as a pharmacy
technician may perform the following duties under supervision of a pharmacist:
1. The entry of drug dispensing information and drug
history into a data system or other recordkeeping system;
2. The preparation of labels for dispensing the oils or
patient information;
3. The removal of the oil to be dispensed from inventory;
4. The measuring of the oil to be dispensed;
5. The packaging and labeling of the oil to be dispensed
and the repackaging thereof;
6. The stocking or loading of devices used in the
dispensing process;
7. The selling of the oil to the registered patient,
parent, or legal guardian; and
8. The performance of any other task restricted to pharmacy
technicians by the board's regulations.
D. A pharmacist with a current, unrestricted license; a
registered pharmacy intern who has completed the first professional year of
pharmacy school; or a pharmacy technician with a current, unrestricted
registration issued by the board may perform duties associated with the
cultivation, extraction, and dispensing of the oils as authorized by the PIC or
as otherwise authorized in law.
E. A person who does not maintain licensure as a
pharmacist or registration as a pharmacy technician but has received a degree
in horticulture or has at least two years of experience cultivating plants may
perform duties associated with the cultivation of Cannabis as authorized by the
PIC.
F. A person who does not maintain licensure as a
pharmacist or registration as a pharmacy technician, but has received a degree
in chemistry or pharmacology or has at least two years of experience extracting
chemicals from plants may perform duties associated with the extraction of
cannabidiol oil and THC-A oil as authorized by the PIC.
G. A pharmacist on duty shall directly supervise the
activities in all areas designated for cultivation, extraction, and dispensing
or have a process in place, approved by the board, that provides adequate
supervision to protect the security of the Cannabis, seeds, extracts,
cannabidiol oil, and THC-A oil and ensure quality of the dispensed oils.
H. At no time shall a pharmaceutical processor operate or
be accessed without a pharmacist on duty.
I. No person shall be employed by or serve as an agent of
a pharmaceutical processor without being at least 18 years of age.
J. No person who has had a license or registration
suspended or revoked or been denied issuance of such license or registration
shall serve as an employee or agent of the pharmaceutical processor unless such
license or registration has been reinstated and is current and unrestricted.
18VAC110-60-180. Employee training.
A. All employees of a pharmaceutical processor shall
complete training prior to the employee commencing work at the pharmaceutical
processor. At a minimum, the training shall be in the following areas:
1. The proper use of security measures and controls that
have been adopted for the prevention of diversion, theft, or loss of Cannabis,
to include the seeds, any parts or extracts of the Cannabis plants, cannabidiol
oil, and THC-A oil;
2. Procedures and instructions for responding to an
emergency;
3. Professional conduct, ethics, and state and federal statutes
and regulations regarding patient confidentiality; and
4. Developments in the field of the medical use of
cannabidiol oil or THC-A oil.
B. Prior to regular performance of assigned tasks, the
employee shall also receive on-the-job training and other related education,
which shall be commensurate with the tasks assigned to the employee.
C. The PIC shall assure the continued competency of all
employees through continuing in-service training that is provided at least
annually, is designed to supplement initial training, and includes any guidance
specified by the board.
D. The PIC shall be responsible for maintaining a written
record documenting the initial and continuing training of all employees that
shall contain:
1. The name of the person receiving the training;
2. The dates of the training;
3. A general description of the topics covered;
4. The name of the person supervising the training; and
5. The signatures of the person receiving the training and
the PIC.
E. When a change of pharmaceutical processor PIC occurs,
the new PIC shall review the training record and sign it, indicating that the
new PIC understands its contents.
F. A pharmaceutical processor shall maintain the record
documenting the employee training and make it available in accordance with
regulations.
18VAC110-60-190. Pharmacy technicians; ratio; supervision
and responsibility.
A. The ratio of pharmacy technicians to pharmacists on
duty in the areas of a pharmaceutical processor designated for production or
dispensing shall not exceed four pharmacy technicians to one pharmacist.
B. The pharmacist providing direct supervision of pharmacy
technicians may be held responsible for the pharmacy technicians' actions. Any
violations relating to the dispensing of cannabidiol oil or THC-A oil resulting
from the actions of a pharmacy technician shall constitute grounds for action
against the license of the pharmacist and the registration of the pharmacy
technician. As used in this subsection, "direct supervision" means a
supervising pharmacist who:
1. Is on duty where the pharmacy technician is performing
routine cannabidiol oil or THC-A oil production or dispensing functions; and
2. Conducts in-process and final checks on the pharmacy
technician's performance.
C. Pharmacy technicians shall not:
1. Counsel a registered patient or the patient's parent or
legal guardian regarding (i) cannabidiol oil, THC-A oil, or other drugs either
before or after cannabidiol oil or THC-A oil has been dispensed or (ii) any
medical information contained in a patient medication record;
2. Consult with the practitioner who certified the
qualifying patient, or the practitioner's agent, regarding a patient or any
medical information pertaining to the patient's cannabidiol oil or THC-A oil or
any other drug the patient may be taking;
3. Interpret the patient's clinical data or provide medical
advice;
4. Determine whether a different formulation of cannabidiol
oil or THC-A oil should be substituted for the cannabidiol oil or THC-A oil
product or formulation recommended by the practitioner or requested by the
registered patient or parent or legal guardian; or
5. Communicate with a practitioner who certified a
registered patient, or the practitioner's agent, to obtain a clarification on a
qualifying patient's written certification or instructions.
18VAC110-60-200. Responsibilities of the PIC.
A. No person shall be PIC for more than one pharmaceutical
processor or for one processor and a pharmacy at any one time. A processor
shall employ the PIC at the pharmaceutical processor for at least 35 hours per
week, except as otherwise authorized by the board.
B. The PIC or the pharmacist on duty shall control all
aspects of the practice of the pharmaceutical processor. Any decision
overriding such control of the PIC or other pharmacist on duty may be grounds
for disciplinary action against the pharmaceutical processor permit.
C. The pharmaceutical processor PIC shall be responsible
for ensuring that:
1. Pharmacy technicians are registered and all employees
are properly trained;
2. All record retention requirements are met;
3. All requirements for the physical security of the
Cannabis, to include the seeds, any parts or extracts of the Cannabis plants,
the cannabidiol oil, and the THC-A oil are met;
4. The pharmaceutical processor has appropriate
pharmaceutical reference materials to ensure that cannabidiol oil or THC-A oil
can be properly dispensed;
5. The following items are conspicuously posted in the
pharmaceutical processor in a location and in a manner so as to be clearly and
readily identifiable to registered patients, parents, or legal guardians:
a. Pharmaceutical processor permit;
b. Licenses for all pharmacists practicing at the
pharmaceutical processor; and
c. The price of all cannabidiol oil or THC-A oil products
offered by the pharmaceutical processor; and
6. Any other required filings or notifications are made on
behalf of the processor as set forth in regulation.
D. When the PIC ceases practice at a pharmaceutical
processor or no longer wishes to be designated as PIC, he shall immediately
return the pharmaceutical processor permit to the board indicating the
effective date on which he ceased to be the PIC.
E. An outgoing PIC shall have the opportunity to take a
complete and accurate inventory of all Cannabis, to include plants, extracts,
cannabidiol oil, or THC-A oil on hand on the date he ceases to be the PIC,
unless the owner submits written notice to the board showing good cause as to
why this opportunity should not be allowed.
F. A PIC who is absent from practice for more than 30
consecutive days shall be deemed to no longer be the PIC. If the PIC knows of
an upcoming absence of longer than 30 days, he shall be responsible for
notifying the board and returning the permit. For unanticipated absences by the
PIC that exceed 15 days with no known return date within the next 15 days, the
permit holder shall immediately notify the board and shall obtain a new PIC.
G. An application for a permit designating the new PIC
shall be filed with the required fee within 14 days of the original date of
resignation or termination of the PIC on a form provided by the board. It shall
be unlawful for a pharmaceutical processor to operate without a new permit past
the 14-day deadline unless the board receives a request for an extension prior
to the deadline. The executive director for the board may grant an extension
for up to an additional 14 days for good cause shown.
Part V
Operation of a Pharmaceutical Processor
18VAC110-60-210. General provisions.
A. A pharmaceutical processor shall sell cannabidiol oil
or THC-A oil only in a child-resistant, secure, and light-resistant container.
Upon a written request from the registered patient, parent, or legal guardian,
the oil may be dispensed in a non-child-resistant container so long as all
labeling is maintained with the product.
B. Only a pharmacist may dispense cannabidiol oil or THC-A
oil to registered patients or parents or legal guardians of patients who are
minors or incapacitated adults and who are registered with the board. A
pharmacy technician who meets the requirements of 18VAC110-60-170 C may assist,
under the direct supervision of a pharmacist, in the dispensing and selling of
cannabidiol oil or THC-A oil.
C. The PIC or pharmacist on duty shall restrict access to
the pharmaceutical processor to:
1. A person whose responsibilities necessitate access to
the pharmaceutical processor and then for only as long as necessary to perform
the person's job duties; or
2. A person who is a registered patient, parent, or legal
guardian, in which case such person shall not be permitted behind the service
counter or in other areas where Cannabis plants, extracts, cannabidiol oil, or
THC-A oil is stored.
D. All pharmacists and pharmacy technicians shall at all
times while at the pharmaceutical processor have their current license or
registration available for inspection by the board or the board's agent.
E. While inside the pharmaceutical processor, all
pharmaceutical processor employees shall wear name tags or similar forms of
identification that clearly identify them, including their position at the
pharmaceutical processor.
F. A pharmaceutical processor shall be open for registered
patients, parents, or legal guardians to purchase cannabidiol oil or THC-A oil
products for a minimum of 35 hours a week, except as otherwise authorized by
the board.
G. A pharmaceutical processor that closes during its
normal hours of operation shall implement procedures to notify registered
patients, parents, and legal guardians of when the pharmaceutical processor
will resume normal hours of operation. Such procedures may include telephone
system messages and conspicuously posted signs. If the pharmaceutical processor
is or will be closed during its normal hours of operation for longer than two
business days, the pharmaceutical processor shall immediately notify the board.
H. A pharmacist shall counsel registered patients,
parents, and legal guardians regarding the use of cannabidiol oil or THC-A oil.
Such counseling shall include information related to safe techniques for proper
use and storage of cannabidiol oil or THC-A oil and for disposal of the oils in
a manner that renders them nonrecoverable.
I. The pharmaceutical processor shall establish,
implement, and adhere to a written alcohol-free, drug-free, and smoke-free work
place policy that shall be available to the board or the board's agent upon
request.
18VAC110-60-220. Pharmaceutical processor prohibitions.
A. No pharmaceutical processor shall:
1. Cultivate Cannabis plants or produce or dispense
cannabidiol oil or THC-A oil in any place except the approved facility at the
address of record on the application for the pharmaceutical processor permit;
2. Sell, deliver, transport, or distribute Cannabis,
including cannabidiol oil or THC-A oil, to any other facility;
3. Produce or manufacture cannabidiol oil or THC-A oil for
use outside of Virginia; or
4. Provide cannabidiol oil or THC-A oil samples.
B. No pharmaceutical processor shall be open or in
operation, and no person shall be in the pharmaceutical processor, unless a
pharmacist is on the premises and directly supervising the activity within the
pharmaceutical processor. At all other times, the pharmaceutical processor
shall be closed and properly secured.
C. No pharmaceutical processor shall sell anything other
than cannabidiol oil or THC-A oil products from the pharmaceutical processor.
D. A pharmaceutical processor shall not advertise
cannabidiol oil or THC-A oil products, except it may post the following
information on websites:
1. Name and location of the processor;
2. Contact information for the processor;
3. Hours and days the pharmaceutical processor is open for
dispensing cannabidiol oil or THC-A oil products;
4. Laboratory results;
5. Product information and pricing; and
6. Directions to the processor facility.
E. No cannabidiol oil or THC-A oil shall be consumed on
the premises of a pharmaceutical processor, except for emergency administration
to a registered patient.
F. No person except a pharmaceutical processor employee or
a registered patient, parent, or legal guardian shall be allowed on the
premises of a processor with the following exceptions: laboratory staff may
enter a processor for the sole purpose of identifying and collecting Cannabis,
cannabidiol oil, or THC-A oil samples for purposes of conducting laboratory
tests; the board or the board's authorized representative may waive the
prohibition upon prior written request.
G. All persons who have been authorized in writing to
enter the facility by the board or the board's authorized representative shall
obtain a visitor identification badge from a pharmaceutical processor employee
prior to entering the pharmaceutical processor.
1. An employee shall escort and monitor an authorized
visitor at all times the visitor is in the pharmaceutical processor.
2. A visitor shall visibly display the visitor
identification badge at all times the visitor is in the pharmaceutical
processor and shall return the visitor identification badge to a pharmaceutical
processor employee upon exiting the pharmaceutical processor.
3. All visitors shall log in and out. The pharmaceutical
processor shall maintain the visitor log that shall include the date, time, and
purpose of the visit and that shall be available to the board.
4. If an emergency requires the presence of a visitor and makes
it impractical for the pharmaceutical processor to obtain a waiver from the
board, the processor shall provide written notice to the board as soon as
practicable after the onset of the emergency. Such notice shall include the
name and company affiliation of the visitor, the purpose of the visit, and the
date and time of the visit. A pharmaceutical processor shall monitor the
visitor and maintain a log of such visit as required by this subsection.
H. No cannabidiol oil or THC-A oil shall be sold, dispensed,
or distributed via a delivery service or any other manner outside of a
pharmaceutical processor, except that a registered parent or legal guardian may
deliver cannabidiol oil or THC-A oil to the registered patient or in accordance
with 18VAC110-60-310 A.
I. Notwithstanding the requirements of subsection F of
this section, an agent of the board or local law enforcement or other federal,
state, or local government officials may enter any area of a pharmaceutical
processor if necessary to perform their governmental duties.
18VAC110-60-230. Inventory requirements.
A. Each pharmaceutical processor prior to commencing
business shall:
1. Conduct an initial comprehensive inventory of all
Cannabis plants, including the seeds, parts of plants, extracts, cannabidiol
oil, and THC-A oil, at the facility. The inventory shall include, at a minimum,
the date of the inventory, a summary of the inventory findings, and the name,
signature, and title of the pharmacist or pharmacy technician who conducted the
inventory. If a facility commences business with no Cannabis on hand, the
pharmacist shall record this fact as the initial inventory; and
2. Establish ongoing inventory controls and procedures for
the conduct of inventory reviews and comprehensive inventories of all Cannabis
plants, including the seeds, parts of plants, extracts, cannabidiol oil, and
THC-A oil, that shall enable the facility to detect any diversion, theft, or
loss in a timely manner.
B. Upon commencing business, each pharmaceutical processor
and production facility shall conduct a weekly inventory of all Cannabis
plants, including the seeds, parts of plants, cannabidiol oil, and THC-A oil in
stock, that shall include, at a minimum, the date of the inventory, a summary
of the inventory findings, and the name, signature, and title of the pharmacist
or pharmacy technician who conducted the inventory. The record of all
cannabidiol oil and THC-A oil sold, dispensed, or otherwise disposed of shall
show the date of sale; the name of the pharmaceutical processor; the registered
patient, parent, or legal guardian to whom the cannabidiol oil or THC-A oil was
sold; the address of such person; and the kind and quantity of cannabidiol oil
or THC-A oil sold.
C. The record of all cannabidiol oil and THC-A oil sold,
dispensed, or otherwise disposed of shall show the date of sale or disposition;
the name of the pharmaceutical processor; the name and address of the
registered patient, parent, or legal guardian to whom the cannabidiol oil or
THC-A oil was sold; the kind and quantity of cannabidiol oil or THC-A oil sold
or disposed of; and the method of disposal.
D. A complete and accurate record of all Cannabis plants,
including the seeds, parts of plants, cannabidiol oil, and THC-A oil on hand
shall be prepared annually on the anniversary of the initial inventory or such
other date that the PIC may choose, so long as it is not more than one year
following the prior year's inventory.
E. All inventories, procedures, and other documents
required by this section shall be maintained on the premises and made available
to the board or its agent.
F. Inventory records shall be maintained for three years
from the date the inventory was taken.
G. Whenever any sample or record is removed by a person
authorized to enforce state or federal law for the purpose of investigation or
as evidence, such person shall tender a receipt in lieu thereof and the receipt
shall be kept for a period of at least three years.
18VAC110-60-240. Security requirements.
A. A pharmaceutical processor shall initially cultivate
only the number of Cannabis plants necessary to produce cannabidiol oil or
THC-A oil for the number of patients anticipated within the first nine months
of operation. Thereafter, the processor shall:
1. Not maintain more than 12 Cannabis plants per patient at
any given time based on dispensing data from the previous 90 days;
2. Not maintain cannabidiol oil or THC-A oil in excess of
the quantity required for normal, efficient operation;
3. Maintain all Cannabis plants, seeds, parts of plants,
extracts, cannabidiol oil, and THC-A oil in a secure area or location
accessible only by the minimum number of authorized employees essential for
efficient operation;
4. Store all cut parts of Cannabis plants, extracts,
cannabidiol oil, or THC-A oil in an approved safe or approved vault within the
pharmaceutical processor and not sell cannabidiol oil or THC-A oil products
when the pharmaceutical processor is closed;
5. Keep all approved safes, approved vaults, or any other
approved equipment or areas used for the production, cultivation, harvesting,
processing, manufacturing, or storage of cannabidiol oil or THC-A oil securely
locked or protected from entry, except for the actual time required to remove
or replace the Cannabis, seeds, parts of plants, extracts, cannabidiol oil, or
THC-A oil;
6. Keep all locks and security equipment in good working
order;
7. Restrict access to keys or codes to all safes, approved
vaults, or other approved equipment or areas to pharmacists practicing at the
pharmaceutical processor; and
8. Not allow keys to be left in the locks or accessible to
non-pharmacists.
B. The pharmaceutical processor shall have an adequate
security system to prevent and detect diversion, theft, or loss of Cannabis
seeds, plants, extracts, cannabidiol oil, or THC-A oil. A device for the
detection of breaking and a back-up alarm system with an ability to remain
operational during a power outage shall be installed in each pharmaceutical
processor. The installation and the device shall be based on accepted alarm
industry standards and subject to the following conditions:
1. The device shall be a sound, microwave, photoelectric,
ultrasonic, or other generally accepted and suitable device;
2. The device shall be monitored in accordance with
accepted industry standards, be maintained in operating order, have an
auxiliary source of power, and be capable of sending an alarm signal to the
monitoring entity when breached if the communication line is not operational;
3. The device shall fully protect the entire processor
facility and shall be capable of detecting breaking by any means when
activated;
4. The device shall include a duress alarm, a panic alarm,
and an automatic voice dialer; and
5. Access to the alarm system for the pharmaceutical
processor shall be restricted to the pharmacists working at the pharmaceutical
processor, and the system shall be activated whenever the pharmaceutical
processor is closed for business.
C. A pharmaceutical processor shall keep the outside
perimeter of the premises well-lit. A processor shall have video cameras in all
areas that may contain Cannabis plants, seeds, parts of plants, extracts,
cannabidiol oil, or THC-A oil and at all points of entry and exit, which shall
be appropriate for the normal lighting conditions of the area under
surveillance.
1. The processor shall direct cameras at all approved
safes, approved vaults, dispensing areas, cannabidiol oil or THC-A oil sales
areas, and any other area where Cannabis plants, seeds, extracts, cannabidiol
oil, or THC-A oil are being produced, harvested, manufactured, stored, or
handled. At entry and exit points, the processor shall angle cameras so as to
allow for the capture of clear and certain identification of any person
entering or exiting the facility;
2. The video system shall have:
a. A failure notification system that provides an audible,
text, or visual notification of any failure in the surveillance system. The
failure notification system shall provide an alert to the processor within five
minutes of the failure, either by telephone, email, or text message;
b. The ability to immediately produce a clear color still
photo that is a minimum of 9600 dpi from any camera image, live or recorded;
c. A date and time stamp embedded on all recordings. The
date and time shall be synchronized and set correctly and shall not
significantly obscure the picture; and
d. The ability to remain operational during a power outage;
3. All video recordings shall allow for the exporting of
still images in an industry standard image format. Exported video shall have
the ability to be archived in a proprietary format that ensures authentication
of the video and guarantees that no alteration of the recorded image has taken
place. Exported video shall also have the ability to be saved in an industry
standard file format that can be played on a standard computer operating
system. A pharmaceutical processor shall erase all recordings prior to disposal
or sale of the facility; and
4. The processor shall make 24-hour recordings from all
video cameras available for immediate viewing by the board or the board's agent
upon request and shall retain the recordings for at least 30 days. If a
processor is aware of a pending criminal, civil, or administrative
investigation or legal proceeding for which a recording may contain relevant
information, the processor shall retain an unaltered copy of the recording
until the investigation or proceeding is closed or the entity conducting the
investigation or proceeding notifies the pharmaceutical processor PIC that it
is not necessary to retain the recording.
D. The processor shall maintain all security system
equipment and recordings in a secure location so as to prevent theft, loss,
destruction, or alterations. All security equipment shall be maintained in good
working order and shall be tested at least every six months.
E. A pharmaceutical processor shall limit access to
surveillance areas to persons who are essential to surveillance operations,
law-enforcement agencies, security system service employees, the board or
the board's agent, and others when approved by the board. A processor shall
make available a current list of authorized employees and security system
service employees who have access to the surveillance room to the processor.
The pharmaceutical processor shall keep all onsite surveillance rooms locked
and shall not use such rooms for any other function.
F. If diversion, theft, or loss of Cannabis plants, seeds,
parts of plants, extracts, cannabidiol oil, or THC-A oil has occurred from a
pharmaceutical processor, the board may require additional safeguards to ensure
the security of the products.
18VAC110-60-250. Requirements for the storage and handling
of Cannabis, cannabidiol oil, or THC-A oil.
A. A pharmaceutical processor shall:
1. Have storage areas that provide adequate lighting,
ventilation, sanitation, temperature, and humidity as defined in 18VAC110-60-10
and space, equipment, and security conditions for the cultivation of Cannabis
and the production and dispensing of cannabidiol oil or THC-A oil;
2. Separate for storage in a quarantined area Cannabis
plants, seeds, parts of plants, extracts, including cannabidiol oil or THC-A
oil, that is outdated, damaged, deteriorated, misbranded, or adulterated, or
whose containers or packaging have been opened or breached, until such Cannabis
plants, seeds, parts of plants, extracts, cannabidiol oil, or THC-A oil are
destroyed;
3. Be maintained in a clean, sanitary, and orderly
condition; and
4. Be free from infestation by insects, rodents, birds, or
vermin of any kind.
B. A processor shall compartmentalize all areas in the
facility based on function and shall restrict access between compartments. The
processor shall establish, maintain, and comply with written policies and
procedures regarding best practices for the secure and proper cultivation of
Cannabis and production of cannabidiol oil or THC-A oil. These shall include
policies and procedures that:
1. Restrict movement between compartments;
2. Provide for different colored identification cards for
facility employees based on the compartment to which they are assigned at a
given time so as to ensure that only employees necessary for a particular
function have access to that compartment of the facility;
3. Require pocketless clothing for all production facility
employees working in an area containing Cannabis plants, seeds, and extracts,
including cannabidiol oil or THC-A oil; and
4. Document the chain of custody of all Cannabis plants,
parts of plants, seeds, extracts, cannabidiol oil, and THC-A oil products.
C. The PIC shall establish, maintain, and comply with
written policies and procedures for the cultivation, production, security,
storage, and inventory of Cannabis, including seeds, parts of plants, extracts,
cannabidiol oil, and THC-A oil. Such policies and procedures shall include
methods for identifying, recording, and reporting diversion, theft, or loss,
and for correcting all errors and inaccuracies in inventories. Pharmaceutical
processors shall include in their written policies and procedures a process for
the following:
1. Handling mandatory and voluntary recalls of cannabidiol
oil or THC-A oil. The process shall be adequate to deal with recalls due to any
action initiated at the request of the board and any voluntary action by the
pharmaceutical processor to (i) remove defective or potentially defective
cannabidiol oil or THC-A oil from the market or (ii) promote public health and
safety by replacing existing cannabidiol oil or THC-A oil with improved
products or packaging;
2. Preparing for, protecting against, and handling any
crises that affect the security or operation of any facility in the event of
strike, fire, flood, or other natural disaster, or other situations of local,
state, or national emergency;
3. Ensuring that any outdated, damaged, deteriorated,
misbranded, or adulterated Cannabis, including seeds, parts of plants,
extracts, cannabidiol oil, and THC-A oil, is segregated from all other
Cannabis, seeds, parts of plants, extracts, cannabidiol oil, and THC-A oil and
destroyed. This procedure shall provide for written documentation of the
Cannabis, including seeds, parts of plants, extracts, cannabidiol oil, and
THC-A oil disposition; and
4. Ensuring the oldest stock of Cannabis, including seeds,
parts of plants, extracts, cannabidiol oil, and THC-A oil product is used
first. The procedure may permit deviation from this requirement if such
deviation is temporary and appropriate.
D. The processor shall store all Cannabis, including
seeds, parts of plants, extracts, cannabidiol oil, and THC-A oil, in the
process of production, transfer, or analysis in such a manner as to prevent
diversion, theft, or loss; shall make Cannabis, including the seeds, parts of
plants, extracts, cannabidiol oil, and THC-A oil accessible only to the minimum
number of specifically authorized employees essential for efficient operation;
and shall return the aforementioned items to their secure location immediately
after completion of the production, transfer, or analysis process or at the end
of the scheduled business day. If a production process cannot be completed at
the end of a working day, the pharmacist shall securely lock the processing
area or tanks, vessels, bins, or bulk containers containing Cannabis, including
the seeds, parts of plants, extracts, cannabidiol oil, and THC-A oil, inside an
area or building that affords adequate security.
18VAC110-60-260. Recordkeeping requirements.
A. If a pharmaceutical processor uses an electronic system
for the storage and retrieval of patient information or other records related
to cultivating, producing, and dispensing cannabidiol oil or THC-A oil, the
pharmaceutical processor shall use a system that:
1. Guarantees the confidentiality of the information
contained in the system;
2. Is capable of providing safeguards against erasures and
unauthorized changes in data after the information has been entered and
verified by the pharmacist; and
3. Is capable of being reconstructed in the event of a
computer malfunction or accident resulting in the destruction of the data bank.
B. All records relating to the inventory, laboratory
results, and dispensing shall be maintained for a period of three years and
shall be made available to the board upon request.
18VAC110-60-270. Reportable events; security.
A. Upon becoming aware of (i) diversion, theft, loss, or
discrepancies identified during inventory; (ii) unauthorized destruction of any
cannabidiol oil or THC-A oil; or (iii) any loss or unauthorized alteration of
records related to cannabidiol oil or THC-A oil or qualifying patients, a
pharmacist or pharmaceutical processor shall immediately notify appropriate
law-enforcement authorities and the board.
B. A pharmacist or processor shall provide the notice
required by subsection A of this section to the board by way of a signed
statement that details the circumstances of the event, including an accurate
inventory of the quantity and brand names of cannabidiol oil or THC-A oil
diverted, stolen, lost, destroyed, or damaged and confirmation that the local
law-enforcement authorities were notified. A pharmacist or processor shall make
such notice no later than 24 hours after discovery of the event.
C. A pharmacist or pharmaceutical processor shall notify
the board no later than the next business day, followed by written notification
no later than 10 business days, of any of the following:
1. An alarm activation or other event that requires a
response by public safety personnel;
2. A breach of security;
3. The failure of the security alarm system due to a loss
of electrical support or mechanical malfunction that is expected to last longer
than eight hours; and
4. Corrective measures taken if any.
D. A pharmacist or pharmaceutical processor shall
immediately notify the board of an employee convicted of a felony or any
offense referenced in § 54.1-3442.6 of the Code of Virginia.
Part VI
Cultivation, Production, and Dispensing of Cannabidiol Oil or THC-A Oil
18VAC110-60-280. Cultivation and production of cannabidiol
oil or THC-A oil.
A. No cannabidiol oil or THC-A oil shall have had
pesticide chemicals or petroleum-based solvents used during the cultivation,
extraction, production, or manufacturing process, except that the board may
authorize the use of pesticide chemicals for purposes of addressing an
infestation that could result in a catastrophic loss of Cannabis crops.
B. Cultivation methods for Cannabis plants and extraction
methods used to produce the cannabidiol oil and THC-A shall be performed in a
manner deemed safe and effective based on current standards or scientific
literature.
C. Any Cannabis plant, seed, parts of plant, extract,
cannabidiol oil, or THC-A oil not in compliance with this section shall be
deemed adulterated.
18VAC110-60-285. Registration of products.
A. A pharmaceutical processor shall assign a brand name to
each product of cannabidiol oil or THC-A oil. The pharmaceutical processor
shall register each brand name with the board on a form prescribed by the board
prior to any dispensing and shall associate each brand name with a specific
laboratory test that includes a terpenes profile and a list of all active
ingredients, including:
1. Tetrahydrocannabinol (THC);
2. Tetrahydrocannabinol acid (THC-A);
3. Cannabidiols (CBD);
4. Cannabidiolic acid (CBDA); and
5. Any other active ingredient that constitutes at least
1.0% of the batch used in the product.
B. A pharmaceutical processor shall not label two products
with the same brand name unless the laboratory test results for each product
indicate that they contain the same level of each active ingredient listed in
subsection A of this section within a range of 97% to 103%.
C. The board shall not register any brand name that:
1. Is identical to or confusingly similar to the name of an
existing commercially available product;
2. Is identical to or confusingly similar to the name of an
unlawful product or substance;
3. Is confusingly similar to the name of a previously
approved cannabidiol oil or THC-A oil product brand name;
4. Is obscene or indecent;
5. May encourage the use of marijuana, cannabidiol oil, or
THC-A oil for recreational purposes;
6. May encourage the use of cannabidiol oil or THC-A oil
for a disease or condition other than the disease or condition the practitioner
intended to treat;
7. Is customarily associated with persons younger than the
age of 18; or
8. Is related to the benefits, safety, or efficacy of the
cannabidiol oil or THC-A oil product unless supported by substantial evidence
or substantial clinical data.
18VAC110-60-290. Labeling of batch of cannabidiol oil or
THC-A oil products.
A. Cannabidiol oil or THC-A oil produced as a batch shall
not be adulterated.
B. Cannabidiol oil or THC-A oil produced as a batch shall
be:
1. Processed, packaged, and labeled according to the U.S.
Food and Drug Administration's Current Good Manufacturing Practice in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, 21 CFR Part 111; and
2. Labeled with:
a. The name and address of the pharmaceutical processor;
b. The brand name of the cannabidiol oil or THC-A oil
product that was registered with the board pursuant to 18VAC110-20-285;
c. A unique serial number that matches the product with the
pharmaceutical processor batch and lot number so as to facilitate any warnings
or recalls the board or pharmaceutical processor deem appropriate;
d. The date of testing and packaging;
e. The expiration date;
f. The quantity of cannabidiol oil or THC-A oil contained
in the batch;
g. A terpenes profile and a list of all active ingredients,
including:
(1) Tetrahydrocannabinol (THC);
(2) Tetrahydrocannabinol acid (THC-A);
(3) Cannabidiol (CBD);
(4) Cannabidiolic acid (CBDA); and
(5) Any other active ingredient that constitutes at least
1.0% of the batch used in the product; and
h. A pass or fail rating based on the laboratory's
microbiological, mycotoxins, and heavy metals and pesticide chemical residue
analysis.
18VAC110-60-295. Labeling of dispensed cannabidiol oil or
THC-A oil.
A. A pharmaceutical processor shall label each cannabidiol
oil or THC-A oil product prior to dispensing by a pharmacist and shall securely
affix to the package a label that states in legible English:
1. The brand name of the cannabidiol oil or THC-A oil that
was registered with the board pursuant to 18VAC110-20-285;
2. A serial number as assigned by the pharmaceutical
processor;
3. The date of dispensing the cannabidiol oil or THC-A oil;
4. An appropriate expiration date, not to exceed six
months;
5. The quantity of cannabidiol oil or THC-A oil contained
in the package;
6. A terpenes profile and a list of all active ingredients,
including:
a. Tetrahydrocannabinol (THC);
b. Tetrahydrocannabinol acid (THC-A); and
c. Cannabidiol (CBD);
7. A pass or fail rating based on the laboratory's
microbiological, mycotoxins, heavy metals, and chemical residue analysis;
8. The name and registration number of the qualifying
patient;
9. The name of the certifying practitioner;
10. Directions for use as may be included in the
practitioner's written certification or otherwise provided by the practitioner;
11. Name and address of the pharmaceutical processor; and
12. Any cautionary statement required by statute or
regulation.
B. No person except a pharmacist or pharmacist technician
under the direct supervision of a pharmacist at the pharmaceutical processor
shall alter, deface, or remove any label so affixed.
C. A pharmaceutical processor shall not label cannabidiol
oil or THC-A oil products as "organic" unless the Cannabis plants
have been organically grown and the cannabidiol oil or THC-A oil products have
been produced, processed, manufactured, and certified to be consistent with
organic standards in compliance with 7 CFR Part 205.
18VAC110-60-300. Laboratory requirements; testing.
A. No pharmaceutical processor shall utilize a laboratory
to handle, test, or analyze cannabidiol oil or THC-A oil unless such
laboratory:
1. Is independent from all other persons involved in the
cannabidiol oil or THC-A oil industry in Virginia, which shall mean that no
person with a direct or indirect interest in the laboratory shall have a direct
or indirect financial interest in a pharmacist, pharmaceutical processor,
certifying practitioner, or any other entity that may benefit from the
production, manufacture, dispensing, sale, purchase, or use of cannabidiol oil
or THC-A oil; and
2. Has employed at least one person to oversee and be
responsible for the laboratory testing who has earned from a college or
university accredited by a national or regional certifying authority at least
(i) a master's level degree in chemical or biological sciences and a minimum of
two years of post-degree laboratory experience or (ii) a bachelor's degree in
chemical or biological sciences and a minimum of four years of post-degree
laboratory experience.
B. Immediately prior to
producing any cannabidiol oil or THC-A oil product, a pharmaceutical processor
shall segregate all harvested Cannabis into homogenized batches. A
pharmaceutical processor shall make a sample available from each batch for a
laboratory to (i) test for microbiological contaminants, mycotoxins, heavy
metals, and pesticide chemical residue and (ii) conduct an active ingredient
analysis.
C. From the time that a
batch of Cannabis has been homogenized for sample testing and eventual
packaging, until the laboratory provides the results from its tests and
analysis, the pharmaceutical processor shall segregate and withhold from use
the entire batch of Cannabis, except the samples that have been removed by the
laboratory for testing. During this period of segregation, the pharmaceutical
processor shall maintain the Cannabis in a secure, cool, and dry location so as
to prevent the Cannabis from becoming contaminated or losing its efficacy.
D. Under no circumstances shall a pharmaceutical processor
include Cannabis in a cannabidiol oil or THC-A oil product or sell it prior to
the time that the laboratory has completed its testing and analysis and
provided a certificate of analysis to the pharmaceutical processor or other
designated facility employee.
E. The processor shall require the laboratory to
immediately return or properly dispose of any Cannabis products and materials
upon the completion of any testing, use, or research.
F. If a sample of Cannabis does not pass the
microbiological, mycotoxin, heavy metal, or pesticide chemical residue test
based on the standards set forth in this subsection, the pharmaceutical
processor shall dispose of the entire batch from which the sample was taken.
1. For purposes of the microbiological test, a cannabidiol
oil or THC-A oil sample shall be deemed to have passed if it satisfies the standards
set forth in Section 1111 of the United States Pharmacopeia.
2. For purposes of the mycotoxin test, a Cannabis sample
shall be deemed to have passed if it meets the following standards:
|
Test Specification
|
|
|
Aflatoxin B1
|
<20 ug/kg of Substance
|
|
Aflatoxin B2
|
<20 ug/kg of Substance
|
|
Aflatoxin G1
|
<20 ug/kg of Substance
|
|
Aflatoxin G2
|
<20 ug/kg of Substance
|
|
Ochratoxin A
|
<20 ug/kg of Substance
|
3. For purposes of the heavy metal test, a Cannabis sample
shall be deemed to have passed if it meets the following standards:
|
Metal
|
Natural Health Products Acceptable Limits ug/kg body
weight/Day
|
|
Arsenic
|
<0.14
|
|
Cadmium
|
<0.09
|
|
Lead
|
<0.29
|
|
Mercury
|
<0.29
|
4. For purposes of the pesticide chemical residue test, a
Cannabis sample shall be deemed to have passed if it satisfies the most
stringent acceptable standard for a pesticide chemical residue in any food item
as set forth in Subpart C of the federal Environmental Protection Agency's
regulations for Tolerances and Exemptions for Pesticide Chemical Residues in Food,
40 CFR Part 180.
G. If a sample of Cannabis passes the microbiological,
mycotoxin, heavy metal, and pesticide chemical residue test, the entire batch
may be utilized by the processor for immediate manufacturing, packaging, and
labeling for sale.
H. The processor shall require the laboratory to file with
the board an electronic copy of each laboratory test result for any batch that
does not pass the microbiological, mycotoxin, heavy metal, or pesticide
chemical residue test at the same time that it transmits those results to the
pharmaceutical processor. In addition, the laboratory shall maintain the
laboratory test results and make them available to the board or an agent of the
board.
I. Each pharmaceutical processor shall have such
laboratory results available upon request to registered patients, parents, or
legal guardians and registered practitioners who have certified qualifying
patients.
18VAC110-60-310. Dispensing of cannabidiol oil or THC-A oil.
A. A pharmacist in good faith may dispense cannabidiol oil
or THC-A oil to any registered patient, parent, or legal guardian as indicated
on the written certification.
1. Prior to the initial dispensing of oil pursuant to each
written certification, the pharmacist or pharmacy technician at the location of
the pharmaceutical processor shall view a current photo identification of the
patient, parent, or legal guardian. The pharmacist or pharmacy technician shall
verify in the Virginia Prescription Monitoring Program of the Department of
Health Professions or other program recognized by the board that the
registrations are current, the written certification has not expired, and the
date and quantity of the last dispensing of cannabidiol oil or THC-A oil to the
registered patient.
2. The pharmacist or pharmacy technician shall make and
maintain for two years a paper or electronic copy of the current written
certification that provides an exact image of the document that is clearly
legible.
3. Prior to any subsequent dispensing, the pharmacist,
pharmacy technician, or delivery agent shall view the current written
certification and a current photo identification and current registration of
the patient, parent, or legal guardian and shall maintain record of such viewing
in accordance with policies and procedures of the processor.
B. A pharmacist may dispense a portion of a registered
patient's 90-day supply of cannabidiol oil or THC-A oil. The pharmacist may
dispense the remaining portion of the 90-day supply of cannabidiol oil or THC-A
oil at any time except that no registered patient, parent, or legal guardian
shall receive more than a 90-day supply of cannabidiol oil or THC-A oil in a
90-day period from any pharmaceutical processor.
C. A dispensing record shall be maintained for three years
from the date of dispensing, and the pharmacist or pharmacy technician under
the direct supervision of the pharmacist shall affix a label to the container
of oil that contains:
1. A serial number assigned to the dispensing of the oil;
2. The name or kind of cannabidiol oil or THC-A oil and its
strength;
3. The serial number assigned to the oil during production;
4. The date of dispensing the cannabidiol oil or THC-A oil;
5. The quantity of cannabidiol oil or THC-A oil dispensed,
which cannot exceed 60 fluid ounces;
6. The name and registration number of the registered
patient;
7. The name and registration number of the certifying
practitioner;
8. Directions for use as may be included in the
practitioner's written certification or otherwise provided by the practitioner;
9. The name or initials of the dispensing pharmacist;
10. Name, address, and telephone number of the
pharmaceutical processor;
11. Any necessary cautionary statement; and
12. A prominently printed expiration date based on the
pharmaceutical processor's recommended conditions of use and storage that can
be read and understood by the ordinary individual.
D. The cannabidiol oil or THC-A oil shall be dispensed in
child-resistant packaging, except as provided in 18VAC110-60-210 A. A package
shall be deemed child-resistant if it satisfies the standard for "special
packaging" as set forth in the Poison Prevention Packaging Act of 1970
Regulations, 16 CFR 1700.1(b)(4).
E. No person except a pharmacist or a pharmacy technician
operating under the direct supervision of a pharmacist shall alter, deface, or
remove any label so affixed.
F. A pharmacist shall be responsible for verifying the
accuracy of the dispensed oil in all respects prior to dispensing and shall
document that each verification has been performed.
G. A pharmacist shall document a registered patient's
self-assessment of the effects of cannabidiol oil or THC-A oil in treating the
registered patient's diagnosed condition or disease or the symptoms thereof. A
pharmaceutical processor shall maintain such documentation in writing or
electronically for two years from the date of dispensing and such documentation
shall be made available in accordance with regulation.
H. A pharmacist shall exercise professional judgment to
determine whether to dispense cannabidiol oil or THC-A oil to a registered
patient, parent, or legal guardian if the pharmacist suspects that dispensing
cannabidiol oil or THC-A oil to the registered patient, parent, or legal
guardian may have negative health or safety consequences for the registered
patient or the public.
18VAC110-60-320. Dispensing error review and reporting;
quality assurance program.
A. A pharmaceutical processor shall implement and comply
with a quality assurance program that describes, in writing, policies and
procedures to detect, identify, and prevent dispensing errors. A pharmaceutical
processor shall distribute the written policies and procedures to all
pharmaceutical processor employees and shall make the written policies and procedures
readily available on the premises of the pharmaceutical processor. The policies
and procedures shall include:
1. Directions for communicating the details of a dispensing
error to the practitioner who certified a qualifying patient and to the qualifying
patient, the patient's parent or legal guardian or appropriate family member if
the patient is deceased or is unable to fully comprehend the communication. The
communication shall describe methods of correcting the dispensing error or
reducing the negative impact of the error on the qualifying patient; and
2. A process to document and assess dispensing errors to
determine the cause of the error and an appropriate response.
B. A pharmaceutical processor shall use the findings of
its quality assurance program to develop systems and workflow processes
designed to prevent dispensing errors. A pharmaceutical processor PIC shall:
1. Inform pharmaceutical processor employees of changes to
policy, procedure, systems, or processes made as a result of recommendations
generated by the quality assurance program;
2. Notify all processor employees that the discovery or
reporting of a dispensing error shall be relayed immediately to a pharmacist on
duty;
3. Ensure that a pharmacist performs a quality assurance
review for each dispensing error. A pharmacist shall commence such review as
soon as is reasonably possible, but no later than two business days from the
date the dispensing error is discovered; and
4. Create a record of every quality assurance review. This
record shall contain at least the following:
a. The date of the quality assurance review and the names
and titles of the persons performing the review;
b. The pertinent data and other information relating to the
dispensing error reviewed;
c. Documentation of contact with the registered patient,
parent, or legal guardian where applicable, and the practitioner who certified
the patient;
d. The findings and determinations generated by the quality
assurance review; and
e. Recommended changes to pharmaceutical processor policy,
procedure, systems, or processes if any.
C. A pharmaceutical processor shall maintain for three
years a copy of the pharmaceutical processor's quality assurance program and
records of all reported dispensing errors and quality assurance reviews in an
orderly manner and filed by date.
18VAC110-60-330. Disposal of cannabidiol oil or THC-A oil.
A. To mitigate the risk of diversion, a pharmaceutical
processor shall routinely and promptly dispose of undesired, excess,
unauthorized, obsolete, adulterated, misbranded, or deteriorated Cannabis
plants, including seeds, parts of plants, extracts, cannabidiol oil, or THC-A
oil by disposal in accordance with a plan approved by the board and in a manner
as to render the cannabidiol oil or THC-A oil nonrecoverable.
B. The destruction shall be witnessed by the PIC and an
agent of the board or another pharmacist not employed by the pharmaceutical
processor. The persons disposing of the cannabidiol oil or THC-A oil shall
maintain and make available a separate record of each such disposal indicating:
1. The date and time of disposal;
2. The manner of disposal;
3. The name and quantity of cannabidiol oil or THC-A oil
disposed of; and
4. The signatures of the persons disposing of the
cannabidiol oil or THC-A oil.
C. The record of disposal shall be maintained at the
pharmaceutical processor for three years from the date of disposal.
NOTICE: The following
forms used in administering the regulation are not being published. The forms
are available in electronic form only online at the listed website. Questions
regarding the agency forms should be directed to the agency contact.
FORMS (18VAC110-60)
Application for registration of a patient, online form
available at https://www.license.dhp.virginia.gov/apply
Application for registration of a parent or legal
guardian, online form available at https://www.license.dhp.virginia.gov/apply
Application for registration of a practitioner to issue
certifications, online form available at
https://www.license.dhp.virginia.gov/apply
Application for a pharmaceutical processor
VA.R. Doc. No. R17-4878; Filed February 27, 2019, 9:24 a.m.