                                 CODE OF VIRGINIA

BOARD TO ISSUE REGISTRATION UNLESS INCONSISTENT WITH PUBLIC INTEREST;
AUTHORIZATION TO CONDUCT RESEARCH; APPLICATION AND FEES (§ 54.1-3423)

A. The Board shall register an applicant to manufacture or distribute controlled
substances included in Schedules I through V unless it determines that the
issuance of that registration would be inconsistent with the public interest. In
determining the public interest, the Board shall consider the following factors:

   1. Maintenance of effective controls against diversion of controlled
   substances into other than legitimate medical, scientific, or industrial
   channels;

   2. Compliance with applicable state and local law;

   3. Any convictions of the applicant under any federal and state laws relating
   to any controlled substance;

   4. Past experience in the manufacture or distribution of controlled
   substances, and the existence in the applicant&#8217;s establishment of
   effective controls against diversion;

   5. Furnishing by the applicant of false or fraudulent material in any
   application filed under this chapter;

   6. Suspension or revocation of the applicant&#8217;s federal registration to
   manufacture, distribute, or dispense controlled substances as authorized by
   federal law; and

   7. Any other factors relevant to and consistent with the public health and
   safety.

B. Registration under subsection A does not entitle a registrant to manufacture
and distribute controlled substances in Schedule I or II other than those
specified in the registration.

C. Practitioners must be registered to conduct research or laboratory analysis
with controlled substances in Schedules II through VI or marijuana.
Practitioners registered under federal law to conduct research with Schedule I
substances, other than marijuana, may conduct research with Schedule I
controlled substances within the Commonwealth upon furnishing the evidence of
that federal registration.

D. The Board may register other persons or entities to possess controlled
substances listed on Schedules II through VI upon a determination that (i) there
is a documented need, (ii) the issuance of the registration is consistent with
the public interest, (iii) the possession and subsequent use of the controlled
substances complies with applicable state and federal laws and regulations, and
(iv) the subsequent storage, use, and recordkeeping of the controlled substances
will be under the general supervision of a licensed pharmacist, practitioner of
medicine, osteopathy, podiatry, dentistry, or veterinary medicine as specified
in the Board&#8217;s regulations. The Board shall consider, at a minimum, the
factors listed in subsection A in determining whether the registration shall be
issued. Notwithstanding the exceptions listed in subsection A of &#xA7;
54.1-3422, the Board may mandate a controlled substances registration for sites
maintaining certain types and quantities of Schedules II through VI controlled
substances as it may specify in its regulations. The Board shall promulgate
regulations related to requirements or criteria for the issuance of such
controlled substances registration, storage, security, supervision, and
recordkeeping. Notwithstanding the provisions of this subsection or Board
regulations, the Board may register a correctional facility to maintain a floor
stock of long-acting injectable or extended-release prescription drugs for the
treatment of mental illness or substance use disorder. Such long-acting
injectable or extended-release prescription drugs shall be stored in an area
accessible only to persons who are licensed to administer such prescription
drugs, regardless of whether the prescriber is on site. Each correctional
facility shall maintain an ongoing perpetual inventory of all such drugs in
Schedules II through V. Such perpetual inventory shall (a) accurately indicate
the physical count of each drug on hand at the time the inventory is performed
and (b) no less than once per month, include a reconciliation of each drug with
a written explanation for any difference between the physical count and the
theoretical count.

E. The Board may register a public or private animal shelter as defined in
&#xA7; 3.2-6500 to purchase, possess, and administer certain Schedules II
through VI controlled substances approved by the State Veterinarian for the
purpose of euthanizing injured, sick, homeless, and unwanted domestic pets and
animals and to purchase, possess, and administer certain Schedule VI drugs and
biological products for the purpose of preventing, controlling, and treating
certain communicable diseases that failure to control would result in
transmission to the animal population in the shelter. Controlled substances used
for euthanasia shall be administered only in accordance with protocols
established by the State Veterinarian and only by persons trained in accordance
with instructions by the State Veterinarian. The list of Schedule VI drugs and
biological products used for treatment and prevention of communicable diseases
within the shelter shall be determined by the supervising veterinarian of the
shelter and the drugs and biological products shall be administered only
pursuant to written protocols established or approved by the supervising
veterinarian of the shelter and only by persons who have been trained in
accordance with instructions established or approved by the supervising
veterinarian. The shelter shall maintain a copy of the approved list of drugs
and biological products, written protocols for administering, and training
records of those persons administering drugs and biological products on the
premises of the shelter.

F. The Board may register a facility, as defined in &#xA7; 37.2-100, that
provides crisis stabilization services and is licensed by the Department of
Behavioral Health and Developmental Services. Such facility may maintain a stock
of Schedules II through VI controlled substances necessary for immediate
treatment of patients admitted to such facility, which may be accessed and
administered by a person licensed to administer drugs pursuant to a written or
oral order of a prescriber in the absence of a prescriber.

G. The Board may register an entity at which a patient is treated by the use of
instrumentation and diagnostic equipment through which images and medical
records may be transmitted electronically for the purpose of establishing a bona
fide practitioner-patient relationship and is prescribed Schedules II through VI
controlled substances when such prescribing is in compliance with federal
requirements for the practice of telemedicine and the patient is not in the
physical presence of a practitioner registered with the U.S. Drug Enforcement
Administration. In determining whether the registration shall be issued, the
Board shall consider (i) the factors listed in subsection A, (ii) whether there
is a documented need for such registration, and (iii) whether the issuance of
the registration is consistent with the public interest.

H. Applications for controlled substances registration certificates and renewals
thereof shall be made on a form prescribed by the Board and such applications
shall be accompanied by a fee in an amount to be determined by the Board.

I. Upon (i) any change in ownership or control of a business, (ii) any change of
location of the controlled substances stock, (iii) the termination of authority
by or of the person named as the responsible party on a controlled substances
registration, or (iv) a change in the supervising practitioner, if applicable,
the registrant or responsible party shall immediately surrender the
registration. The registrant shall, within 14 days following surrender of a
registration, file a new application and, if applicable, name the new
responsible party or supervising practitioner.

HISTORY: 1972, c. 798, § 54-524.47:3; 1978, c. 833; 1980, c. 288; 1988, c. 765;
1996, cc. 468, 496; 1998, c. 490; 2009, cc. 149, 169; 2010, c. 28; 2014, c. 148;
2017, cc. 58, 110; 2018, c. 774; 2020, c. 941; 2023, cc. 744, 794; 2024, cc. 63,
513; 2025, cc. 278, 283.