                                 CODE OF VIRGINIA

REGISTRATION OF NONRESIDENT WHOLESALE DISTRIBUTORS; RENEWAL; FEE (§
54.1-3435.01)

A. Any person located outside the Commonwealth who engages in the wholesale
distribution of prescription drugs into the Commonwealth shall be registered
with the Board. The applicant for registration as a nonresident wholesale
distributor shall apply to the Board using such forms as the Board may furnish;
renew such registration, if granted, using such forms as the Board may furnish,
annually on a date determined by the Board in regulation; notify the Board
within 30 days of any substantive change in the information previously submitted
to the Board; and remit a fee, which shall be the fee specified for wholesale
distributors located within the Commonwealth.

B. The nonresident wholesale distributor shall at all times maintain a valid,
unexpired license, permit, or registration in the state in which it is located
and shall furnish proof of such upon application and at each renewal.

C. Records of prescription drugs distributed into the Commonwealth shall be
maintained in such a manner that they are readily retrievable from records of
distributions into other jurisdictions and shall be provided to the Board, its
authorized agent, or any agent designated by the Superintendent of State Police
upon request within seven days of receipt of such request.

D. A nonresident 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.

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

F. 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
nonresident wholesale distributor pursuant to subsection D.

G. This section shall not apply to persons who distribute prescription drugs
directly to a licensed wholesale distributor located within the Commonwealth.

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

HISTORY: 1994, c. 300; 2008, c. 320; 2015, c. 299; 2016, c. 221.