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’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’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 with controlled
substances in Schedules II through VI. Practitioners registered under federal
law to conduct research with Schedule I substances may conduct research with
Schedule I substances within this 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’s regulations. The Board shall consider, at a minimum, the
factors listed in subsection A of this section in determining whether the
registration shall be issued. Notwithstanding the exceptions listed in §
54.1-3422 A, 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.

E. The Board may register a public or private animal shelter as defined in §
3.2-6500 to purchase, possess, and administer certain Schedule II-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 controlled substances 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. The drugs 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 used for treatment and prevention of communicable
diseases within the shelter shall be determined by the supervising veterinarian
of the shelter and the drugs 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, written protocols for
administering, and training records of those persons administering drugs on the
premises of the shelter.

F. The Board may register a crisis stabilization unit established pursuant to §
37.2-500 or 37.2-601 and licensed by the Department of Behavioral Health and
Developmental Services to maintain a stock of Schedule VI controlled substances
necessary for immediate treatment of patients admitted to the crisis
stabilization unit, which may be accessed and administered by a nurse pursuant
to a written or oral order of a prescriber in the absence of a prescriber.
Schedule II through Schedule V controlled substances shall only be maintained if
so authorized by federal law and Board regulations.

G. 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.

H. 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.