Part II
Licensure Requirements

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 60 40 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, provided 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:

1. 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.