Virginia Regulatory Town Hall

Proposed Text


Implementation of 2021 Periodic Review
Stage: Proposed
18VAC110-30-21 Application for facility permit

A. After June 7, 2016, any Any location at which practitioners a practitioner of the healing arts sell sells controlled substances shall have a permit issued by the board in accordance with § 54.1-3304.1 of the Code of Virginia. A licensed practitioner of the healing arts shall apply for the facility permit on a form provided by the board on which the applicant shall designate the hours of operation the location will be open to service the public.

B. For good cause shown, the board may issue a limited-use facility permit when the scope, degree, or type of services provided to the patient is of a limited nature. The permit to be issued shall be based on conditions of use requested by the applicant or imposed by the board in cases where certain requirements of this chapter may be waived.

1. The limited-use facility permit application shall list the regulatory requirements for which a waiver is requested, if any, and a brief explanation as to why each requirement should not apply to that practice.

2. A policy and procedure manual detailing the type and volume of controlled substances to be sold and safeguards against diversion shall accompany the application.

3. The issuance and continuation of a limited-use facility permit shall be subject to continuing compliance with the conditions set forth by the board.

4. A limited-use facility permit may be issued to a nonprofit facility for the purpose of dispensing Schedule VI controlled substances, excluding the combination of misoprostol and methotrexate, and hypodermic syringes and needles for the administration of prescribed controlled substances.

C. The executive director may grant a waiver of the security system when storing and selling multiple strengths and formulations of no more than five different topical Schedule VI drugs intended for cosmetic use.

18VAC110-30-55 Change of hours in a permitted facility

The practitioner designated pursuant to 18VAC110-30-70 shall be responsible for providing notice for a change in the hours of operation, which is expected to last more than one week, to the public and to the board. At least 14 days prior to the anticipated change, notice shall be posted in a conspicuous place to provide notice to the public and provided to the board in writing unless the change is necessitated by emergency circumstances beyond the control of the practitioner, or unless the change will result in an expansion of the current hours of operation. If the facility is not able to post the changes 14 days in advance, the practitioner shall ensure that the board is notified as soon as he knows of the change and disclose the emergency circumstances preventing the required notification.

18VAC110-30-80 Inspection and notice required

A. The area designated for the storage and selling of controlled substances shall be inspected by an agent of the board prior to the issuance of the first license to sell controlled substances from that site. Inspection prior to issuance of subsequent licenses at the same location shall be conducted at the discretion of the board.

B. Applications for facility permits that indicate a requested inspection date, or requests that are received after the application is filed, shall be honored provided a 14-day notice to the board is allowed prior to the requested inspection date.

C. 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.

D. At the time of the inspection, the controlled substance selling and storage area shall comply with 18VAC110-30-90, 18VAC110-30-100, 18VAC110-30-110, 18VAC110-30-120, and 18VAC110-30-130.

E. If an applicant substantially fails to meet the requirements for issuance of a facility permit 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 18VAC110-30-15 prior to a reinspection being conducted.

F. No facility permit shall be issued to sell controlled substances until adequate safeguards against diversion have been provided for the controlled substance storage and selling area and approved by the inspector or board staff.

G. No facility permit shall be issued to a private dwelling or residence for the purpose of selling controlled substances.

H. The licensee shall notify the board of any substantive changes to the approved selling and storage area including moving the location of the area, making structural changes to the area, or making changes to the alarm system for the area prior to the changes being made and pay a reinspection fee. An inspection shall be conducted prior to approval of the new or altered selling and storage area.