Part II. Licensure and Permit 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. After June 7, 2016, the practitioner 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, a nurse practitioner, or a physician assistant shall make application on a form provided by the board and be issued a limited-use license.
C. Any disciplinary action taken by the Board of Medicine, or in the case of a nurse practitioner, 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.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 2.1, eff. May 9, 1990; amended, Virginia Register Volume 8, Issue 13, eff. April 22, 1992; Volume 10, Issue 1, eff. November 3, 1993; Volume 17, Issue 7, eff. January 17, 2001; Volume 22, Issue 10, eff. February 22, 2006; Volume 29, Issue 21, eff. August 2, 2013; Volume 33, Issue 20, eff. June 28, 2017; Volume 38, Issue 12, eff. March 3, 2022.
18VAC110-30-21. Application for facility permit.
A. After June 7, 2016, any location at which practitioners of the healing arts sell 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.
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.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 33, Issue 20, eff. June 28, 2017; amended, Virginia Register Volume 38, Issue 12, eff. March 3, 2022.
18VAC110-30-30. Renewal of license or permit.
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 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 seeking reinstatement of a facility permit shall not stock drugs until approved by the board or its authorized agent.
E. The selling of controlled substances without a current, active license or facility permit is unlawful and shall constitute grounds for disciplinary action by the board.
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 § 2.2, 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.
18VAC110-30-35. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 17, Issue 7, eff. January 17, 2001; repealed, Virginia Register Volume 22, Issue 10, eff. February 22, 2006.
18VAC110-30-40. Acts to be performed by the licensee.
A. The selection of the controlled substance from the stock, any preparation or packaging of a controlled substance or the preparation of a label for a controlled substance to be transferred to a patient shall be the personal responsibility of the licensee.
1. Any compounding of a controlled substance shall be personally performed by the licensee or a registered pharmacy technician under the supervision of the licensee.
2. A licensee may supervise one person who may be present in the storage and selling area to assist in performance of pharmacy technician tasks, as set forth in § 54.1-3321 of the Code of Virginia, provided such person is not licensed to sell controlled substances and is either:
a. A pharmacy technician registered with the board; or
b. A licensed nurse or physician assistant who has received training in technician tasks consistent with training required for pharmacy technicians.
3. Unless using one of the board-approved training courses for pharmacy technicians, a licensee who uses a nurse or physician assistant to perform pharmacy technician tasks shall develop and maintain a training manual and shall document that such licensee has successfully completed general training in the following areas:
a. The entry of prescription information and drug history into a data system or other recordkeeping system;
b. The preparation of prescription labels or patient information;
c. The removal of the drug to be dispensed from inventory;
d. The counting or measuring of the drug to be dispensed to include pharmacy calculations;
e. The packaging and labeling of the drug to be dispensed and the repackaging thereof;
f. The stocking or loading of automated dispensing devices or other devices used in the dispensing process, if applicable; and
g. Applicable laws and regulations related to dispensing.
4. A licensee who employs or uses pharmacy technicians, licensed nurses or physician assistants to assist in the storage and selling area shall develop and maintain a site-specific training program and manual for training to work in that practice. The program shall include training consistent with that specific practice to include training in proper use of site-specific computer programs and equipment, proper use of other equipment used in the practice in performing technician duties, and pharmacy calculations consistent with the duties in that practice.
5. A licensee shall maintain documentation of successful completion of the site-specific training program for each pharmacy technician, nurse or physician assistant for the duration of the employment and for a period of two years from date of termination of employment. Documentation for currently employed persons shall be maintained on site or at another location where the records are readily retrievable upon request for inspection. After employment is terminated, such documentation may be maintained at an off-site location where it is retrievable upon request.
B. Prior to the dispensing, the licensee shall:
1. Conduct a prospective drug review and offer to counsel a patient in accordance with provisions of § 54.1-3319 of the Code of Virginia; and
2. Inspect the prescription product to verify its accuracy in all respects, and place his initials on the record of sale as certification of the accuracy of, and the responsibility for, the entire transaction.
C. If the record of sale is maintained in an automated data processing system as provided in 18VAC110-30-200, the licensee shall personally place his initials with each entry of a sale as a certification of the accuracy of, and the responsibility for, the entire transaction.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 2.3, eff. May 9, 1990; amended, Virginia Register Volume 10, Issue 1, eff. November 3, 1993; Volume 22, Issue 10, eff. February 22, 2006; Volume 38, Issue 12, eff. March 3, 2022.
18VAC110-30-50. Licensees ceasing to sell controlled substances; inventory required prior to disposal.
A. Any licensee who intends to cease selling controlled substances shall notify the board 10 days prior to cessation and surrender his license, and his license will be placed on expired status. If no other practitioner of the healing arts licensed to sell controlled substances intends to sell controlled substances from the same location, the practitioner shall also surrender the facility permit, and the permit will be placed on expired status.
B. Any Schedules II through V controlled substances shall be inventoried and may be disposed of by transferring the controlled substance stock to another licensee or other person authorized by law to possess such drugs or by destruction as set forth in this chapter.
C. The licensee or other responsible person shall inform the board of the name and address of the licensee to whom the controlled substances are transferred.
D. A licensee who has surrendered his license or facility permit pursuant to this section may request that it be made current again at any time within the same renewal year without having to pay an additional fee, provided the licensee is selling from the same location or from another location that has been inspected and approved by the board.
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 § 2.4, 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.
18VAC110-30-60. (Repealed.)
Historical Notes
Derived from VR530-01-2 § 2.5, eff. May 9, 1990; amended, Virginia Register Volume 10, Issue 1, eff. November 3, 1993; repealed, Virginia Register Volume 17, Issue 7, eff. January 17, 2001.