18VAC110-30 Regulations for Practitioners of the Healing Arts to Sell Controlled Substances

REGULATIONS

Vol. 32 Iss. 9 - December 28, 2015

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Chapter 30

Emergency Regulation

Title of Regulation: 18VAC110-30. Regulations for Practitioners of the Healing Arts to Sell Controlled Substances (amending 18VAC110-30-15, 18VAC110-30-20, 18VAC110-30-30, 18VAC110-30-50 through 18VAC110-30-90; adding 18VAC110-30-21).

Statutory Authority: §§ 54.1-2400 and 54.1-3304.1 of the Code of Virginia.

Effective Dates: December 7, 2015, through June 6, 2017.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone [phone], FAX [phone], or email [e-mail].

Preamble:

Section 2.2-4011 of the Code of Virginia states that agencies may adopt emergency regulations in situations in which Virginia statutory law requires that a regulation be effective in 280 days or less from its enactment. Chapter 117 of the 2015 Acts of the Assembly, which requires practitioners of the healing arts to dispense controlled substances in permitted facilities, contains such a clause.

The Board of Pharmacy currently licenses individual physicians to sell controlled substances to their own patients and already has regulations for security, recordkeeping, storage, and other requirements relating to the facility from which physicians licensed to sell drugs dispense. Oversight of physicians selling drugs was relatively simple when the number of physicians was approximately 100, but the total is now over 550 and continues to increase. The increase is due to an increasingly larger supply of drugs on the market repackaged specifically for physicians to sell, an increase in the number of urgent care centers that dispense drugs when treating patients, and an increase in drugs available to treat popular dermatological issues.

The practice of physicians selling drugs is analogous to pharmacies dispensing drugs. In regulating the practice of pharmacy, the board licenses both pharmacists and pharmacies. This level of oversight for both the individuals and the facility works well, and this emergency action seeks to mirror this level of oversight for physicians selling drugs. With a facility permit, which is similar to a pharmacy permit, the board can hold the permit holder responsible and accountable for the stock of drugs. Clearer regulation and accountability will foster public protection in assuring the safety and integrity of prescription drugs. Additionally, during inspections of facilities where multiple licensed physicians sell drugs, it is reasonable to hold the facility responsible for possible violations and not an individual physician. This proposed process is also analogous to the inspection process currently used for pharmacies.

This emergency regulation implements Chapter 117 and includes (i) setting fees for approval of applications, renewal of permits, and reinstatement of lapsed permits; (ii) establishing requirements for inspections and physical standards for the facility; and (iii) requiring notification to the board through the facility permit rather than the individual licensee. The only change in physical requirements is specificity about the availability of hot and cold water, which must be within 20 feet of the selling and storage area and not located within an examination room or restroom.

18VAC110-30-15. Fees.

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

B. Fee for initial license for a practitioner of the healing arts to sell controlled substances Initial application fees.

1. The application fee for initial licensure shall be $240 License for practitioner of the healing arts to sell controlled substance: $180.

2. The application fee for reinstatement of a license that has been revoked or suspended indefinitely shall be $500 Permit for facility in which practitioners of the healing arts sell controlled substance: $240.

C. Renewal of license for a practitioner of the healing arts to sell controlled substances Annual renewal fees.

1. The annual fee for renewal of an active license shall be $90. For the annual renewal due on December 31, 2009, the fee shall be $50 License for practitioner of the healing arts to sell controlled substance: $90.

2. The late fee for renewal of a license within one year after the expiration date is $30 in addition to the annual renewal fee Permit for facility in which practitioners of the healing arts sell controlled substance: $240.

3. The fee for reinstatement of a license expired for more than one year shall be $210.

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 substance: $30.

2. Permit for facility in which practitioners of the healing arts sell controlled substance: $40.

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: $150.

2. Permit for facility in which practitioner of the healing arts to sell controlled substances: $240.

3. Application fee for reinstatement of a license or permit that has been revoked or suspended indefinitely: $500.

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.

D. G. The fee for reinspection of any facility shall be $150.

E. H. The fee for a returned check shall be $35.

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. After (insert six months from effective date of the regulation), the practitioner shall engage in such sale from a location that has been issued a facility permit.

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 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.

18VAC110-30-21. Application for facility permit.

A. After (insert six months from effective date of the regulation), 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 shall make application 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.

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.

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 license facility permit that has been lapsed for more than one year, a reinspection of the storage and selling area shall be conducted unless another practitioner at the same location has held an active license to sell controlled substances during that period. 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.

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 Schedule 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.

Part III
Inspection Requirements, Standards, and Security for Storage Areas; Disposal of Controlled Substances

18VAC110-30-70. Maintenance of a common stock of controlled substances Practitioner in charge in a permitted facility.

Any two or more licensees who elect to maintain a common stock of A facility with a permit for practitioners of the healing arts to sell controlled substances for dispensing shall:

1. Designate a licensee 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 Schedule 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.

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 licenses which facility permits that indicate a requested inspection date, or requests which 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 which 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 license 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 license 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 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.

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 the immediate vicinity 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.

NOTICE: The following forms used in administering the regulation were filed by the agency. The forms are not being published; however, online users of this issue of the Virginia Register of Regulations may click on the name of a form with a hyperlink to access it. The forms are also available from the agency contact or may be viewed at the Office of the Registrar of Regulations, General Assembly Building, 2nd Floor, Richmond, Virginia 23219.

FORMS (18VAC110-30)

Application for a License to Sell Controlled Substances by a Practitioner of the Healing Arts (rev. 8/07).

Application for a License to Sell Controlled Substances by a Practitioner of the Healing Arts (rev. 12/2015)

Application for a Facility Permit for Practitioner(s) of the Healing Arts to Sell Controlled Substances (rev. 12/2015)

VA.R. Doc. No. R16-4532; Filed December 7, 2015, 11:22 a.m.