                                 CODE OF VIRGINIA

LICENSE TO ACT AS WHOLESALE DISTRIBUTOR; RENEWAL; FEE (§ 54.1-3435)

A. It shall be unlawful for any person to engage in the wholesale distribution
of prescription drugs in the Commonwealth without a valid unrevoked license
issued by the Board. The applicant for licensure as a wholesale distributor, as
defined in &#xA7; 54.1-3401, in the Commonwealth shall apply to the Board for a
license, using such forms as the Board may furnish; renew such license using
such forms as the Board may furnish, if granted, annually on a date determined
by the Board in regulation; notify the Board within 30 days of any substantive
change in the information reported on the application form previously submitted
to the Board; and remit a fee as determined by the Board.

B. A wholesale distributor that ceases distribution of Schedule II through V
drugs to a pharmacy, licensed physician dispenser, or licensed physician
dispensing facility located in the Commonwealth due to suspicious orders of
controlled substances shall notify the Board within five days of the cessation.
For the purposes of this section, &#8220;suspicious orders of controlled
substances&#8221; means, relative to the pharmacy&#8217;s, licensed physician
dispenser&#8217;s, or licensed physician dispensing facility&#8217;s order
history and the order history of similarly situated pharmacies, licensed
physician dispensers, or licensed physician dispensing facilities, (i) orders of
unusual size, (ii) orders deviating substantially from a normal pattern, and
(iii) orders of unusual frequency.

C. A wholesale distributor shall be immune from civil liability for giving
notice in accordance with subsection B unless the notice was given in bad faith
or with malicious intent.

D. The Board shall not impose any disciplinary or enforcement action against any
licensee or permit holder solely on the basis of a notice received from a
wholesale distributor pursuant to subsection B.

E. The Board may promulgate such regulations relating to the storage, handling,
and distribution of prescription drugs by wholesale distributors as it deems
necessary to implement this section, to prevent diversion of prescription drugs,
and to protect the public.

F. Every wholesale distributor shall comply with federal requirements for an
electronic, interoperable system to identify, trace, and verify prescription
drugs as they are distributed.

HISTORY: 1970, c. 650, § 54-524.44; 1976, c. 614; 1980, c. 288; 1988, c. 765;
1992, c. 737; 2008, c. 320; 2015, c. 299; 2016, c. 221.