Virginia Administrative Code › Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING › Agency 110 - BOARD OF PHARMACY › Chapter 50 - Regulations Governing Wholesale Distributors, Manufacturers, Third-Party Logistics Providers, and Warehousers › Part I - General Provisions › Section 18VAC110-50-30 - Application; location of business; inspection required

Current through Register Vol. 40, No. 24, July 15, 2024
A. Any person or entity desiring to obtain a
				  license as a wholesale distributor; registration as a nonresident wholesale
				  distributor , nonresident manufacturer, nonresident warehouser, or nonresident
				  third-party logistics provider; or permit as a manufacturer, warehouser, or
				  third-party logistics provider shall file an application with the board on a
				  form approved by the board. An application shall be filed for a new license,
				  registration, or permit, or for acquisition of an existing wholesale
				  distributor, manufacturer, warehouser, nonresident wholesale distributor,
				  nonresident manufacturer, third-party logistics provider, nonresident
				  warehouser, or nonresident third-party logistics provider.
B. A licensee or permit holder proposing to
				  change the location of an existing license or permit, or make structural or
				  security system changes to an existing location, shall file an application for
				  approval of the changes following an inspection conducted by an authorized
				  agent of the board.
C. A license,
				  permit, or registration shall not be issued to any wholesale distributor,
				  manufacturer, warehouser, nonresident warehouser, nonresident wholesale
				  distributor, nonresident manufacturer, third-party logistics provider, or
				  nonresident third-party logistics provider to operate from a private dwelling
				  or residence or to operate without meeting the applicable facility requirements
				  for proper storage and distribution of drugs or devices. Before any license,
				  permit, or registration is issued, the applicant shall demonstrate compliance
				  with all federal, state, and local laws and ordinances.
D. If a wholesale distributor, manufacturer,
				  warehouser, or third-party logistics provider engages in receiving, possessing,
				  storing, using, manufacturing, distributing, or otherwise disposing of any
				  Schedules II through V controlled substances, it shall also obtain a controlled
				  substances registration from the board in accordance with §
										54.1-3422
				  of the Code of Virginia and shall also be duly registered with the DEA and in
				  compliance with all applicable laws and rules for the storage, distribution,
				  shipping, handling, and transporting of controlled substances.
E. The proposed location, structural changes,
				  or security system changes shall be inspected by an authorized agent of the
				  board prior to issuance of a license or permit.
1. Applications that indicate a requested
				  inspection date, or requests that are received after the application is filed,
				  shall be honored provided a 14-day notice is allowed prior to the requested
				  inspection date.
2. Requested
				  inspection dates that do not allow a 14-day notice to the board may be adjusted
				  by the board to provide 14 days for the scheduling of the inspection.
3. At the time of the inspection, the
				  proposed prescription drug storage area shall comply with
				  18VAC110-50-40
				  and
				  18VAC110-50-50, and
				  wholesale distributors shall meet the requirements of
				  18VAC110-50-90.
4. If an applicant substantially fails to
				  meet the requirements for issuance of a permit or license and a reinspection is
				  required, or if the applicant is not ready for the inspection on the
				  established date and fails to notify the inspector or the board at least 24
				  hours prior to the inspection, the applicant shall pay a reinspection fee as
				  specified in
				  18VAC110-50-20
				  prior to a reinspection being conducted.