Part III. Inspection Requirements, Standards, and Security for Storage Areas; Disposal of Controlled Substances
18VAC110-30-70. Practitioner in charge in a permitted facility.
A facility with a permit for practitioners of the healing arts to sell controlled substances shall:
1. Designate a practitioner with a license to sell controlled substances who shall be the primary person responsible for the stock, the required inventory, the records of receipt and destruction, safeguards against diversion and compliance with this chapter;
2. Report to the board the name of the licensee and the location of the controlled substance stock on a form provided by the board;
3. Upon a change in the licensee so designated, an inventory of all Schedules II through V controlled substances shall be conducted in the manner set forth in § 54.1-3404 of the Drug Control Act of the Code of Virginia and such change shall immediately be reported to the board; and
4. Nothing shall relieve the other individual licensees who sell controlled substances at the location of the responsibility for the requirements set forth in this chapter.
Statutory Authority
§§ 54.1-2400 and 54.1-3304.1, and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 3.1, eff. May 9, 1990; amended, Virginia Register Volume 8, Issue 13, eff. April 22, 1992; Volume 10, Issue 1, eff. November 3, 1993; Volume 33, Issue 20, eff. June 28, 2017.
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. 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.
Statutory Authority
§§ 54.1-2400, 54.1-3304.1, and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 3.2, eff. May 9, 1990; amended, Virginia Register Volume 8, Issue 13, eff. April 22, 1992; Volume 10, Issue 1, eff. November 3, 1993; Volume 17, Issue 7, eff. January 17, 2001; Volume 22, Issue 10, eff. February 22, 2006; Volume 33, Issue 20, eff. June 28, 2017.
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 40 square feet that is designated as the controlled substances selling and storage area, which shall be used exclusively for storage, preparation, and dispensing. 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 20 feet of the selling and storage area and not located within an examination room or restroom; 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.
Statutory Authority
§§ 54.1-2400, 54.1-3304.1, and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 3.3, eff. May 9, 1990; amended, Virginia Register Volume 8, Issue 13, eff. April 22, 1992; Volume 10, Issue 1, eff. November 3, 1993; Volume 17, Issue 7, eff. January 17, 2001; Volume 29, Issue 21, eff. August 2, 2013; Volume 33, Issue 20, eff. June 28, 2017.
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 office is at least 40 square feet in area; provided the drugs are stored in a cabinet, closet, or other lockable area 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.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 3.4, eff. May 9, 1990; amended, Virginia Register Volume 17, Issue 7, eff. January 17, 2001; Volume 29, Issue 21, eff. August 2, 2013.
18VAC110-30-110. Minimum equipment.
The licensee shall be responsible for maintaining the following equipment in the designated area:
1. A current dispensing information reference source, either hard copy or electronic;
2. A refrigerator with a monitoring thermometer, located in the selling area, if any controlled substances requiring refrigeration are maintained;
3. Equipment consistent with requirements of § 54.1-3410.2 of the Code of Virginia and USP-NF standards, if sterile products are to be prepared;
4. Prescription balances, sensitive to 15 milligrams, and weights or an electronic scale, if the licensee is engaged in dispensing activities that require the weighing of components; and
5. Other equipment, supplies, and references consistent with the practitioner's scope of practice and with the public safety.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 3.5, eff. May 9, 1990; amended, Virginia Register Volume 17, Issue 7, eff. January 17, 2001; Volume 22, Issue 10, eff. February 22, 2006.
18VAC110-30-120. Safeguards against diversion of controlled substances.
A device for the detection of breaking shall be installed in the controlled substances selling and storage area. The installation and the device shall be based on accepted burglar alarm industry standards, and shall be subject to the following conditions:
1. The device shall be a sound, microwave, photoelectric, ultrasonic, or any other generally accepted and suitable device;
2. The device shall be maintained in operating order;
3. The device shall fully protect the immediate controlled substance selling and storage areas and shall be capable of detecting breaking by any means whatsoever in the area when the area is closed;
4. The alarm system must have an auxiliary source of power;
5. The alarm system shall be capable of being activated and operated separately from any other alarm system in the area or the business in which the controlled substance selling and storage area is located;
6. The alarm system is controlled only by the licensee; and
7. An emergency key or access code to the system may be maintained as set forth in 18VAC110-30-130 B of this chapter.
Statutory Authority
§§ 54.1-113, 54.1-2400 and 54.1-3304.1 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 3.6, eff. May 9, 1990; amended, Virginia Register Volume 10, Issue 1, eff. November 3, 1993.
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 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 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 restricted to the licensee with the following exceptions:
1. 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 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.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 3.7, eff. May 9, 1990; amended, Virginia Register Volume 10, Issue 1, eff. November 3, 1993; Volume 22, Issue 10, eff. February 22, 2006; Volume 29, Issue 21, eff. August 2, 2013.
18VAC110-30-140. Prescriptions awaiting delivery.
Prescriptions prepared for delivery to the patient may be placed in a secure place outside of the controlled substance selling area and access to the prescriptions restricted by the licensee to designated assistants. The prepared prescriptions may be transferred to the patient whether or not the licensee is on duty with prior approval of the licensee.
Statutory Authority
§§ 54.1-113, 54.1-2400 and 54.1-3304.1 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 3.8, eff. May 9, 1990; amended, Virginia Register Volume 10, Issue 1, eff. November 3, 1993.
18VAC110-30-150. Expired controlled substances; security.
Any controlled substance which has exceeded the expiration date shall not be dispensed or sold and shall be separated from the stock used for selling but shall be maintained in the selling and storage area prior to the disposal of the expired controlled substances.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 3.9, eff. May 9, 1990; amended, Virginia Register Volume 22, Issue 10, eff. February 22, 2006.
18VAC110-30-160. Disposal of Schedule II through VI controlled substances.
A. If a licensee wishes to dispose of unwanted Schedule II through VI controlled substances, he shall use one of the following procedures:
1. Transfer the drugs to another person or entity authorized to possess Schedule II through VI drugs; or
2. Destroy the drugs by burning in an incinerator in compliance with all applicable local, state, and federal laws and regulations.
B. If Schedule II through V drugs are to be destroyed, the following additional procedures shall apply:
1. At least 14 days prior to the destruction date, the licensee shall provide a written notice to the board office. The notice shall state the following:
a. Date, time, manner, and place of destruction;
b. The names of the licensees who will witness the destruction process.
2. If the destruction date is to be changed or the destruction does not occur, a new notice stating the information required in subdivision 1 of this subsection shall be provided to the board;
3. The actual destruction shall be witnessed by the licensee conducting the destruction and another licensee of the board who is not employed by the licensee conducting the destruction;
4. At the conclusion of the destruction of the controlled substance stock, the DEA drug destruction form shall be fully completed and used as the record of all drugs to be destroyed. A copy of the destruction form shall be retained at the practitioner's office with other inventory records.
Statutory Authority
§§ 54.1-2400 and 54.1-3304 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 3.10, eff. May 9, 1990; amended, Virginia Register Volume 10, Issue 1, eff. November 3, 1993; Volume 17, Issue 7, eff. January 17, 2001.