CODE OF VIRGINIA

NONRESIDENT OUTSOURCING FACILITIES TO REGISTER WITH THE BOARD (§ 54.1-3434.5)

A. Any outsourcing facility located outside the Commonwealth that ships, mails,
or delivers in any manner Schedule II through VI drugs or devices into the
Commonwealth shall be considered a nonresident outsourcing facility and shall be
registered with the Board.

B. Applications for registration to act as a non-resident outsourcing facility
shall be made on a form provided by the Board and signed by a pharmacist who is
licensed as a pharmacist in Virginia and who is in full and actual charge of the
outsourcing facility, is fully engaged in the compounding performed at the
location stated on the application, and is fully responsible for the outsourcing
facility’s compliance with state and federal law and regulations. Such
application shall be accompanied by a fee determined by the Board in regulation.
All registrations shall expire annually on a date determined by the Board in
regulation.

C. As a prerequisite to registering or renewing a registration with the Board,
the outsourcing facility shall (i) register as an outsourcing facility with the
U.S. Secretary of Health and Human Services in accordance with 21 U.S.C. § 353b
and (ii) submit a copy of a current inspection report resulting from an
inspection conducted by the U.S. Food and Drug Administration that indicates
compliance with the requirements of state and federal law and regulations,
including all applicable guidance documents and Current Good Manufacturing
Practices published by the U.S. Food and Drug Administration.The inspection
report required pursuant to clause (ii) shall be deemed current for the purposes
of this section if the inspection was conducted (a) no more than one year prior
to the date of submission of an application for registration with the Board or
(b) no more than two years prior to the date of submission of an application for
renewal of a registration with the Board. However, if the outsourcing facility
has not been inspected by the U.S. Food and Drug Administration within the
required period, the Board may accept an inspection report or other
documentation from another entity that is satisfactory to the Board, or the
Board may cause an inspection to be conducted by its duly authorized agent and
may charge an inspection fee in an amount sufficient to cover the costs of the
inspection.

D. A nonresident outsourcing facility shall not engage in compounding of drug
products to be dispensed pursuant to a valid prescription for a specific patient
without first obtaining a registration to operate a nonresident pharmacy. The
nonresident pharmacy shall comply with all state and federal laws, regulations,
and requirements except § 54.1-3410.2.

HISTORY: 2015, c. 300.