The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise.

"Board" means the Virginia Board of Pharmacy.

"Controlled substance" means a drug, substance, or immediate precursor in Schedules I through VI of the Drug Control Act.

"Licensee" means a practitioner who is licensed by the Board of Pharmacy to sell controlled substances.

"Personal supervision" means the licensee must be physically present and render direct, personal control over the entire service being rendered or acts being performed. Neither prior nor future instructions shall be sufficient nor shall supervision be rendered by telephone, written instructions, or by any mechanical or electronic methods.

"Practitioner" or "practitioner of the healing arts" means a doctor of medicine, osteopathic medicine, or podiatry, or physician assistant who possesses a current active license issued by the Board of Medicine, or an advanced practice registered nurse who possesses a current active license issued by the Boards of Nursing and Medicine, or a TPA-certified optometrist who possesses a current active license issued by the Board of Optometry. For the purpose of a limited-use permit for a nonprofit facility, a "practitioner" or "practitioner of the healing arts" may also mean a physician assistant with a current active license issued by the Board of Medicine or an advanced practice registered nurse with a current active license issued by the Joint Boards of Nursing and Medicine.

"Practitioner of the healing arts" means a doctor of medicine, osteopathic medicine, or podiatry who possesses a current active license issued by the Board of Medicine. For the purpose of a limited-use permit for a nonprofit facility, a "practitioner of the healing arts" may also mean a physician assistant with a current active license issued by the Board of Medicine or an advanced practice registered nurse with a current active license issued by the Boards of Nursing and Medicine.

"Sale" means barter, exchange, or gift, or offer thereof, and each such transaction made by any person, whether as an individual, proprietor, agent, servant, or employee. It does not include the gift of manufacturer's samples to a patient.

"Special packaging" means packaging that is designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the controlled substance within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging that all such children cannot open or obtain a toxic or harmful amount within a reasonable time.

"TPA-certified optometrist" means an optometrist licensed by the Virginia Board of Optometry and authorized by the Board of Optometry to treat diseases and abnormal conditions of the human eye and its adnexa and to prescribe and administer certain therapeutic pharmaceutical agents.

"U.S.P.-N.F." means the United States Pharmacopeia-National Formulary.

A. Unless otherwise provided, fees listed in this section shall not be refundable.

B. Initial application fees.

1. License for practitioner of the healing arts to sell controlled substances: $300.

2. Permit for facility in which practitioners of the healing arts sell controlled substances: $700.

C. Annual renewal fees.

1. License for practitioner of the healing arts to sell controlled substances: $175.

2. Permit for facility in which practitioners of the healing arts sell controlled substances: $490.

D. Late fees. The following late fees shall be paid in addition to the current renewal fee to renew an expired license within one year of the expiration date.

1. License for practitioner of the healing arts to sell controlled substances: $40.

2. Permit for facility in which practitioners of the healing arts sell controlled substances: $120.

E. Reinstatement fees. Any person or entity attempting to renew a license or permit more than one year after the expiration date shall submit an application for reinstatement with any required fees.

1. License for practitioner of the healing arts to sell controlled substances: $300.

2. Permit for facility in which practitioners of the healing arts sell controlled substances: $415.

3. Application fee for reinstatement of a license or permit that has been revoked or suspended indefinitely: $750.

F. Facilities in which only one practitioner of the healing arts is licensed by the board to sell controlled substances shall be exempt from fees associated with obtaining and renewing a facility permit. Facilities that change from only one practitioner to more than one shall notify the board within 30 days of such change.

G. The fee for reinspection of any facility shall be $435.

H. The handling fee for returned check or a dishonored credit card or debit card shall be $50.

A. Unless otherwise provided, fees listed in this section shall not be refundable.

B. Initial application fees.

1. License for a practitioner of the healing arts to sell controlled substances: $300.

2. Permit for facility in which practitioners of the healing arts sell controlled substances: $700.

C. Annual renewal fees.

1. License for a practitioner of the healing arts to sell controlled substances: $175.

2. Permit for facility in which practitioners of the healing arts sell controlled substances: $490.

D. Late fees. The following late fees shall be paid in addition to the current renewal fee to renew an expired license within one year of the expiration date.

1. License for a practitioner of the healing arts to sell controlled substances: $40.

2. Permit for facility in which practitioners of the healing arts sell controlled substances: $120.

E. Reinstatement fees. Any person or entity attempting to renew a license or permit more than one year after the expiration date shall submit an application for reinstatement with any required fees.

1. License for a practitioner of the healing arts to sell controlled substances: $300.

2. Permit for facility in which practitioners of the healing arts sell controlled substances: $415.

3. Application fee for reinstatement of a license or permit that has been revoked or suspended indefinitely: $750.

F. Facilities in which only one practitioner of the healing arts is licensed by the board to sell controlled substances shall be exempt from fees associated with obtaining and renewing a facility permit. Facilities that change from only one practitioner to more than one shall notify the board within 30 days of such change.

G. The fee for reinspection of any facility shall be $435.

H. The handling fee for returned check or a dishonored credit card or debit card shall be $50.

A. Prior to engaging in the sale of controlled substances, a practitioner of the healing arts shall make application on a form provided by the board and be issued a license. After June 7, 2016, the practitioner Practitioners of the healing arts shall engage in such sale from a location that has been issued a facility permit.

B. Prior to engaging in the sale of Schedule VI controlled substances, excluding the combination of misoprostol and methotrexate, and hypodermic syringes and needles for the administration of prescribed controlled substances from a nonprofit facility, a doctor of medicine, osteopathic medicine, or podiatry, an advanced practice registered nurse, or a physician assistant shall make application on a form provided by the board and be issued a limited-use license.

C. A TPA-certified optometrist shall be issued a limited-use license from the board prior to engaging in the sale of Schedule VI controlled substances.

C. D. Any disciplinary action taken by the Board of Medicine, the Board of Optometry, or in the case of an advanced practice registered nurse, by the Joint Boards of Nursing and Medicine, against the practitioner's license to practice shall constitute grounds for the board to deny, restrict, or place terms on the license to sell.

A. A license or facility permit so issued shall be valid until December 31 of the year of issue. Renewal of the license shall be made on or before December 31 of each year.

B. If a practitioner or practitioner of the healing arts fails to renew his license or facility permit to sell within the Commonwealth by the renewal date, he must pay the renewal fee plus the late fee. He may renew his license or facility permit by payment of these fees for one year from the date of expiration.

C. Failure to renew the license or facility permit to sell within one year following expiration shall cause the license or permit to lapse. The selling of controlled substances with a lapsed license or permit shall be illegal and may subject the practitioner to disciplinary action by the board. To reinstate a lapsed license or permit, a practitioner shall submit an application for reinstatement and pay the reinstatement fee, plus the reinspection fee if a reinspection is required as set forth in subsection D of this section. Reinstatement is at the discretion of the board and may be granted by the executive director on the board's behalf provided no grounds exist to deny said reinstatement.

D. Prior to reinstatement of a facility permit that has been lapsed for more than one year, a reinspection of the storage and selling area shall be conducted. A practitioner of the healing arts seeking reinstatement of a facility permit shall not stock drugs until approved by the board or its authorized agent.

E. Prior to reinstatement of a license issued to a TPA-certified optometrist that has been lapsed for more than one year, reinspection of the storage and selling area shall be conducted. A TPA-certified optometrist seeking reinstatement of a license shall not stock drugs until approved by the board or its authorized agent.

E. F. The selling of controlled substances without a current, active license for practitioners or a current, active license and facility permit for practitioners of the healing arts is unlawful and shall constitute grounds for disciplinary action by the board.

A. 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.

B. A TPA-certified optometrist with a license to sell controlled substances in a non-permitted facility shall:

1. Assume primary responsibility for the stock, the required inventory, the records of receipt and destruction, safeguards against diversion and compliance with this chapter; and

2. Report to the board the location of the controlled substance stock on a form provided by the board.

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 or limited-use license for TPA-certified optometrists 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.

In addition to those grounds listed in § 54.1-3316 of the Code of Virginia, the board may revoke, suspend, or refuse to issue or renew a license to sell controlled substances or may deny any application if it finds that the licensee or applicant has had his license to practice medicine, osteopathic medicine, or podiatry or, license as a physician assistant or, license as an advanced practice registered nurse, or license as a TPA-certified optometrist suspended or revoked in Virginia or in any other state or no longer holds a current active license to practice in the Commonwealth of Virginia.