                                 CODE OF VIRGINIA

PERMIT TO ACT AS AN OUTSOURCING FACILITY (§ 54.1-3434.05)

A. No person shall act as an outsourcing facility without first obtaining a
permit from the Board.

B. Applications for a permit to act as an outsourcing facility shall be made on
a form provided by the Board and signed by a pharmacist who will be in full and
actual charge of the outsourcing facility and who will be fully engaged in the
compounding performed at the location designated on the application. Such
application shall be accompanied by a fee determined by the Board in regulation.
All permits shall expire annually on a date determined by the Board in
regulation. No permit shall be issued or renewed for an outsourcing facility
unless the facility can demonstrate compliance with all applicable federal and
state laws and regulations governing outsourcing facilities.

C. As a prerequisite to obtaining or renewing a permit from 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. &#xA7; 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 a
permit to the Board or (b) no more than two years prior to the date of
submission of an application for renewal of a permit to 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. Every outsourcing facility shall compound in compliance with the requirements
of state and federal law and regulations except &#xA7; 54.1-3410.2, to include
all applicable guidance documents and Current Good Manufacturing Practices
published by the U.S. Food and Drug Administration.

E. An 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 permit to operate a pharmacy.

HISTORY: 2015, c. 300.