18VAC110-30-20. Application for licensure.
A. Prior to engaging in the sale of controlled substances, a practitioner shall make application on a form provided by the board and be issued a license.
B. In order to be eligible for a license to sell controlled
substances, a practitioner shall possess a current, active license to practice
medicine, osteopathic medicine, or podiatry issued by the Virginia Board
of Medicine. Any disciplinary action taken by the Board of Medicine against the
practitioner's license to practice
medicine shall constitute grounds for
the board to deny, restrict, or place terms on the license to sell.
C. For good cause shown, the board may issue a limited-use license, when the scope, degree or type of services provided to the patient is of a limited nature. The license 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 regulations may be waived. The following conditions shall apply:
1. A policy and procedure manual detailing the type and volume of controlled substances to be sold and safeguards against diversion must accompany the application. The application shall list the regulatory requirements for which a waiver is requested and a brief explanation as to why each requirement should not apply to that practice; and
2. The issuance and continuation of such license shall be subject to continuing compliance with the conditions set forth by the board.
18VAC110-30-90. Physical standards.
Physical standards for the controlled substance selling and storage area:
1. The building in which the controlled substances selling and storage area is located shall be constructed of permanent and secure materials. Trailers and other movable facilities shall not be permitted;
2. There shall be an enclosed area of not less than
square feet that is designated as the controlled substances selling and storage
area, which shall be used exclusively for the storage, preparation, and
dispensing , and record-keeping. Records related to the sale of
controlled substances may be maintained outside the selling and storage area
with access limited to the licensee and those persons authorized to assist in
the area. The work space used in preparation of the drugs shall be
contained within the enclosed area. A controlled substance selling and storage
area inspected and approved prior to November 3, 1993, shall not be required to
meet the size requirement of this chapter;
3. Controlled substances maintained for ultimate sale shall be maintained separately from any other controlled substances maintained for other purposes. Controlled substances maintained for other purposes such as administration or samples may be stored within the selling and storage area provided they are clearly separated from the stock maintained for sale;
4. The selling and storage area, work counter space and equipment in the area shall be maintained in a clean and orderly manner;
5. A sink with hot and cold running water shall be available within the immediate vicinity of the selling and storage area; and
6. The entire area described in this chapter shall be well lighted and ventilated; the proper storage temperature shall be maintained to meet official specifications for controlled substance storage.
18VAC110-30-100. Access to selling area.
Access to stock rooms, rest rooms, and other areas other than
an office that is exclusively used by the licensee shall not be through the
selling and storage area. The selling and storage area may be in an office that
is exclusively used by the licensee and to which only the licensee has access,
the portion of the office used exclusively for controlled
substances storage and preparation is at least 60 40 square
feet in area; provided the drugs are stored in a cabinet, closet,
or other lockable area which that can be locked when the
practitioner is using the office for purposes other than dispensing; and
provided the office meets all other requirements of 18VAC110-30-90,
18VAC110-30-120, and 18VAC110-30-130.
18VAC110-30-130. Selling area enclosures.
A. The controlled substance selling and storage area of the licensee shall be provided with enclosures subject to the following conditions:
1. The enclosure shall be
construed constructed in
such a manner that it protects the controlled substance stock from unauthorized
entry and from pilferage at all times whether or not the licensee is on duty; 2. The enclosure shall be of sufficient height as to prevent
anyone from reaching over to gain access to the controlled substances; 3. Entrances to the enclosed area must have a door which
extends from the floor and which is at least as high as the adjacent counters
or adjoining partitions; and 4. Doors to the area must have locking devices which will
prevent entry in the absence of the licensee.
2. The enclosure shall be locked and alarmed at all times when the licensee is not on duty.
3. The enclosure shall be capable of being locked in a secure manner at any time the licensee on duty is not present in the storage and selling area.
B. The door keys or other means of entry and alarm access code
to the selling and storage area shall be
subject to the following
requirements restricted to the licensee with the following exceptions:
Only the licensee shall be in possession of the alarm
access code and any keys or other means of entry to the locking device on the
door to such enclosure Other persons authorized to assist the licensee
in the selling and storage area may possess a key or other means of entry into
a locked area only when the licensee is on duty. Such key or other means of
entry shall not allow entry when the licensee is not on duty; and 2. The selling and storage area must be locked when the
licensee is not present and engaged in preparation or selling of drugs; and 3. 2. The licensee may place a key or other means
of opening the locking device and the alarm access code in a sealed envelope or
other sealed container with the licensee's signature across the seal in a safe
or vault within the office or other secured place for use by another licensee for
emergency access. In lieu of the licensee's signature across a seal, the
executive director for the board may approve other methods of securing the
emergency keys or access codes to the enclosed area.
C. The controlled substance selling and storage area is restricted to the licensee and one person designated by the licensee. The designated person may be present in the selling and storage area only during the hours when the licensee is on duty to render personal supervision.