                                 CODE OF VIRGINIA

PERMIT TO OPERATE PHARMACEUTICAL PROCESSOR OR CANNABIS DISPENSING FACILITY (§
4.1-1602)

A. No person shall operate a pharmaceutical processor or a cannabis dispensing
facility without first obtaining a permit from the Board. The application for
such permit shall be made on a form provided by the Authority and signed by a
pharmacist who will be in full and actual charge of the pharmaceutical
processor&#8217;s dispensing area or cannabis dispensing facility. The Board
shall establish an application fee and other general requirements for such
application.

B. Each permit shall expire annually on a date determined by the Board in
regulation. The number of permits that the Board may issue or renew in any year
is limited to one pharmaceutical processor and up to five cannabis dispensing
facilities for each health service area established by the Board of Health.
Permits shall be displayed in a conspicuous place on the premises of the
pharmaceutical processor and cannabis dispensing facility.

C. The Board shall adopt regulations establishing health, safety, and security
requirements for pharmaceutical processors and cannabis dispensing facilities.
Such 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)
routine inspections no more frequently than once annually; (viii) processes for
safely and securely dispensing and delivering in person cannabis products to a
patient, his registered agent, or, if such patient is a minor or a vulnerable
adult as defined in &#xA7; 18.2-369, such patient&#8217;s parent or legal
guardian; (ix) dosage limitations for cannabis products that provide that each
dispensed dose of a cannabis product not exceed 10 milligrams of total
tetrahydrocannabinol, except as permitted under &#xA7; 4.1-1603.2; (x) a process
for the wholesale distribution of and the transfer of usable cannabis, botanical
cannabis, cannabis oil, and cannabis products between pharmaceutical processors,
between a pharmaceutical processor and a cannabis dispensing facility, and
between cannabis dispensing facilities; (xi) an allowance for the sale of
devices for administration of dispensed cannabis products and hemp-based CBD
products that meet the applicable standards set forth in state and federal law,
including the laboratory testing standards set forth in subsection N; (xii) an
allowance for the use and distribution of inert product samples containing no
cannabinoids for patient demonstration exclusively at the pharmaceutical
processor or cannabis dispensing facility, and not for further distribution or
sale, without the need for a written certification; (xiii) a process for
acquiring industrial hemp extracts and formulating such extracts into cannabis
products; and (xiv) an allowance for the advertising and promotion of the
pharmaceutical processor&#8217;s products and operations, which shall not limit
the pharmaceutical processor from the provision of educational material to
practitioners who issue written certifications and patients. The Board shall
also adopt regulations for pharmaceutical processors that include requirements
for (a) processes for safely and securely cultivating cannabis plants intended
for producing cannabis products, (b) the disposal of agricultural waste, and (c)
a process for registering cannabis products.

D. The Board shall require pharmaceutical processors, after processing and
before dispensing any cannabis products, to make a sample available from each
batch of cannabis product for testing by an independent laboratory that is
located in Commonwealth and meets Board requirements. A valid sample size for
testing shall be determined by each laboratory and may vary due to sample
matrix, analytical method, and laboratory-specific procedures. A minimum sample
size of 0.5 percent of individual units for dispensing or distribution from each
homogenized batch of cannabis oil is required to achieve a representative
cannabis oil sample for analysis. A minimum sample size, to be determined by the
certified testing laboratory, from each batch of botanical cannabis is required
to achieve a representative botanical cannabis sample for analysis. Botanical
cannabis products shall only be tested for the following: total cannabidiol
(CBD), total tetrahydrocannabinol (THC), terpenes, pesticide chemical residue,
heavy metals, mycotoxins, moisture, and microbiological contaminants. Testing
thresholds shall be consistent with generally accepted cannabis industry
thresholds. The pharmaceutical processor may remediate botanical cannabis or
cannabis oil that fails any quality testing standard except pesticides.
Following remediation, all remediated botanical cannabis or cannabis oil shall
be subject to laboratory testing, which shall not be more stringent than initial
testing prior to remediation. Remediated botanical cannabis or cannabis oil that
passes such quality testing may be packaged and labeled. If a batch of botanical
cannabis fails retesting after remediation, it shall be considered usable
cannabis and may be processed into cannabis oil. Stability testing shall not be
required for any cannabis product with an expiration date assigned by the
pharmaceutical processor of 12 months or less from the date of the cannabis
product registration approval. Stability testing required for assignment of an
expiration date longer than 12 months shall be limited to microbial testing, on
a pass/fail basis, and potency testing, on a 15 percent deviation basis, of
total THC and total CBD. No cannabis product shall have an expiration date
longer than 12 months from the date of the cannabis product registration
approval unless supported by stability testing.

E. A laboratory testing samples for a pharmaceutical processor shall obtain a
controlled substances registration certificate pursuant to &#xA7; 54.1-3423 and
shall comply with quality standards established by the Board of Pharmacy in
regulation.

F. Every pharmaceutical processor&#8217;s dispensing area or cannabis dispensing
facility shall be under the personal supervision of a licensed pharmacist on the
premises of the pharmaceutical processor or cannabis dispensing facility unless
all cannabis products are contained in a vault or other similar container to
which only the pharmacist has access controls. The pharmaceutical processor
shall ensure that security measures are adequate to protect the cannabis from
diversion at all times, and the pharmacist-in-charge shall have concurrent
responsibility for preventing diversion from the dispensing area.
			Every pharmaceutical processor shall designate a person who shall have
oversight of the cultivation and production areas of the pharmaceutical
processor and shall provide such information to the Board. The Board shall
direct all communications related to enforcement of requirements related to
cultivation and production of cannabis and cannabis products by the
pharmaceutical processor to such designated person.

G. The Board shall require the material owners of an applicant for a
pharmaceutical processor or cannabis dispensing facility 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&#8217;s material owners. The cost of
fingerprinting and the criminal history record search shall be paid by the
applicant. The Central Criminal Records Exchange shall forward the results of
the criminal history background check to the Board or its designee, which shall
be a governmental entity.

H. A pharmaceutical processor shall maintain evidence of criminal background
checks for all employees and delivery agents of the pharmaceutical processor.
Criminal background checks of employees and delivery agents may be conducted by
any service sufficient to disclose any federal and state criminal convictions.

I. In addition to other employees authorized by the Board, a pharmaceutical
processor may employ individuals who may have less than one year of experience
(i) to perform cultivation-related duties under the supervision of an individual
who has received a degree in a field related to the cultivation of plants or a
certification recognized by the Board or who has at least one year of experience
cultivating plants, (ii) to perform extraction-related duties under the
supervision of an individual who has a degree in chemistry or pharmacology or at
least one year of experience extracting chemicals from plants, (iii) to perform
duties at the pharmaceutical processor and cannabis dispensing facility upon
certification as a pharmacy technician, and (iv) to serve as pharmacy technician
trainees.

J. A pharmaceutical processor to whom a permit has been issued by the Board may
(i) establish up to five cannabis dispensing facilities, subject to the permit
requirement set forth in subsection B, for the dispensing of cannabis products
that have been cultivated and produced on the premises of a pharmaceutical
processor permitted by the Board and (ii) establish, if authorized by the Board,
one additional location at which the pharmaceutical processor may cultivate
cannabis plants. Each cannabis dispensing facility and the additional
cultivation location shall be located within the same health service area as the
pharmaceutical processor.

K. No person who has been convicted of a felony under the laws of the
Commonwealth or another jurisdiction within the last five years shall be
employed by or act as an agent of a pharmaceutical processor or cannabis
dispensing facility.

L. Every pharmaceutical processor or cannabis dispensing facility shall adopt
policies for pre-employment drug screening and regular, ongoing, random drug
screening of employees.

M. A pharmacist at the pharmaceutical processor&#8217;s dispensing area and the
cannabis dispensing facility shall determine the number of pharmacy interns,
pharmacy technicians, and pharmacy technician trainees who can be safely and
competently supervised at one time; however, no pharmacist shall supervise more
than six persons performing the duties of a pharmacy technician at one time in
the pharmaceutical processor&#8217;s dispensing area or cannabis dispensing
facility.

N. A pharmaceutical processor may acquire from a registered industrial hemp
handler or processor industrial hemp extracts that (i) are grown and processed
in Virginia in compliance with state or federal law, and (ii) notwithstanding
the tetrahydrocannabinol limits set forth in the definition of &#8220;industrial
hemp extract&#8221; in &#xA7; 3.2-5145.1, contain a total tetrahydrocannabinol
concentration of no greater than 0.3 percent. A pharmaceutical processor may
process and formulate such extracts into an allowable dosage of cannabis
product. Industrial hemp extracts acquired and formulated by a pharmaceutical
processor are subject to the same third-party testing requirements that may
apply to cannabis plant extract. Testing shall be performed by a laboratory
located in Virginia and in compliance with state law governing the testing of
cannabis products. The industrial hemp handler or processor shall provide such
third-party testing results to the pharmaceutical processor before industrial
hemp extracts may be acquired.

O. Product labels for all cannabis products and botanical cannabis shall be
complete, accurate, easily discernable, and uniform among different products and
brands. Pharmaceutical processors shall affix to all cannabis products and
botanical cannabis a label, which shall also be accessible on the pharmaceutical
processor&#8217;s website, that includes:

   1. The product name;

   2. All active and inactive ingredients, including cannabinoids, terpenes,
   additives, preservatives, flavorings, sweeteners, and carrier oils;

   3. The total percentage and milligrams of tetrahydrocannabinol and cannabidiol
   included in the product and the number of milligrams of tetrahydrocannabinol
   and cannabidiol in each serving;

   4. The amount of product that constitutes a single serving and the amount
   recommended for use by the practitioner or dispensing pharmacist;

   5. Information regarding the product&#8217;s purpose and detailed usage
   directions;

   6. Child and safety warnings in a conspicuous font; and

   7. Such other information required by the Board.

P. A pharmaceutical processor or cannabis dispensing facility shall maintain an
adequate supply of cannabis products that (i) contain cannabidiol as their
primary cannabinoid and (ii) have low levels of or no tetrahydrocannabinol.

Q. With the exception of &#xA7; 2.2-4031, neither the provisions of the
Administrative Process Act (&#xA7; 2.2-4000 et seq.) nor public participation
guidelines adopted pursuant thereto shall apply to the adoption of any
regulation pursuant to this section. Prior to adopting any regulation pursuant
to this section, the Board shall publish a notice of opportunity to comment in
the Virginia Register of Regulations and post the action on the Virginia
Regulatory Town Hall. Such notice of opportunity to comment shall contain (i) a
summary of the proposed regulation; (ii) the text of the proposed regulation;
and (iii) the name, address, and telephone number of the agency contact person
responsible for receiving public comments. Such notice shall be made at least 60
days in advance of the last date prescribed in such notice for submittals of
public comment. The legislative review provisions of subsections A and B of
&#xA7; 2.2-4014 shall apply to the promulgation or final adoption process for
regulations pursuant to this section. The Board shall consider and keep on file
all public comments received for any regulation adopted pursuant to this
section.

HISTORY: 2023, cc. 740, 744, 760, 773, 780, 794, 799, 812; 2024, c. 732.