Title of Regulation: 18VAC110-30. Regulations for Practitioners of the Healing Arts to Sell Controlled Substances (amending 18VAC110-30-20, 18VAC110-30-90, 18VAC110-30-100, 18VAC110-30-130).

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: July 17, 2013.

Effective Date: August 2, 2013.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 527-4416, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: The action is the result of a periodic review conducted pursuant to the Governor's Regulatory Reform Project. 18VAC110-30, Regulations for Practitioners of the Healing Arts to Sell Controlled Substances, is promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which establishes the general powers and duties of health regulatory boards, including the responsibility to promulgate regulations in accordance with the Administrative Process Act.

The specific statutory authority for the Board of Pharmacy to regulate the practice of pharmacy, including the dispensing of controlled substances, is found in § 54.1-3307 of the Code of Virginia.

Purpose: The purpose of the amended regulation is to reduce the requirements for the enclosure used by practitioners for the storage and selling of controlled substances. The amendments to the regulation eliminate requirements that are not necessary to protect the health of patients or safety of prescription medications. While security of patient records and of stock of drugs is essential, the amendments make reasonable allowances for access while the licensee is on duty or for emergency access by another licensed physician.

Rationale for Using Fast-Track Process: The board has opted to use the fast-track process for two reasons: the action is consistent with the Governor's project to reform regulations that are unnecessarily burdensome, and the board does not anticipate any objection to the amendments to the regulation.

Substance: The substantive changes are (i) reduction in the square footage for the selling and storage area from 60 to 40 square feet; (ii) allowance for maintenance of prescription records outside of the area if access is limited to authorized persons; (iii) elimination of specific height requirements for the enclosure; and (iv) security access to the area by other persons authorized to assist the practitioner while the practitioner is on duty.

Issues: The primary advantage of the regulatory action is less burdensome and costly regulation for practitioners who sell controlled substances to their patients. There are no disadvantages to the public. By reducing the square foot requirement for the selling and storage area, fewer requests for a limited use permit or a waiver from the 60-foot requirement will occur. There are no disadvantages to the Commonwealth.

Small Business Impact Report of Findings: This regulatory action serves as the report of findings of the regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. As a result of a periodic review, the Board of Pharmacy (Board) proposes to amend its regulations for controlled substances sold by practitioners of the healing arts. Specifically, the Board proposes to add practitioners of osteopathic medicine and podiatry to the list in these regulations of those that are eligible to sell controlled substances, decrease the amount of space that licensed entities must allot for storage of controlled substances and eliminate other requirements for storage areas that the Board deems unnecessary.

Result of Analysis. Benefits likely outweigh costs for implementing these proposed changes.

Estimated Economic Impact. Current regulations specify that individuals who possess a current active license to practice medicine are eligible to be licensed to sell controlled substances. The Code of Virginia and other relevant regulations, however, also allow individuals licensed in osteopathic medicine and as podiatrists to be licensed to sell controlled substances. The Board now proposes to add these groups so that these regulations conform to the Code of Virginia and current practice. No entity is likely to incur costs on account of this regulatory change. Interested individuals will benefit from having a seeming contradiction between these regulations and the Code of Virginia fixed.

Current regulations require individuals licensed under these regulations to have an area or not less than 60 square feet. Currently, the Board can grant a waiver to this requirement but now proposes to change it so that licensees will just have to have 40 square feet to hold the prescription drugs that they are licensed to sell. This change will benefit licensees as they can choose to use the space that would otherwise be used to store drugs more efficiently and for some other purpose.

Current regulations also contain a list of other requirements that selling or storage area must conform to. The Board proposes to amend these provisions to eliminate any that do not contribute directly to the security of the storage/selling area. For instance the Board proposes to eliminate provisions that prescribe the type of doors that these enclosures must have but keep requirements that enclosures be locked and alarmed when the licensee is not on duty. No entity is likely to incur costs on account of these changes nor is the security of controlled substances likely to be affected. Licensed entities will likely benefit from additional flexibility to structure their storage areas in a more efficient manner that the proposed regulations will afford them.

Businesses and Entities Affected. The Department of Health Professions (DHP) reports that there are 591 licensed practitioners of the healing arts (physicians, individuals licensed in osteopathic medicine and podiatrists) who are licensed to sell prescription drugs in the Commonwealth. All of these entities will be affected by these proposed regulations.

Localities Particularly Affected. No locality will be particularly affected by the proposed regulations.

Projected Impact on Employment. This proposed regulatory action is unlikely to have any effect on employment in the Commonwealth.

Effects on the Use and Value of Private Property. These proposed regulatory changes are unlikely to have any impact on the use or value of private property in the Commonwealth.

Small Businesses: Costs and Other Effects. No small business is likely to incur any costs on account of this regulatory action.

Small Businesses: Alternative Method that Minimizes Adverse Impact. No small business is likely to incur any costs on account of this regulatory action.

Real Estate Development Costs. This regulatory action will likely have no effect on real estate development costs in the Commonwealth.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis of the Department of Planning and Budget for amendments to 18VAC110-30, relating to regulatory reform changes.

Summary:

The regulatory action amends requirements for the selling and storage area used by practitioners who sell controlled substances to their patients for consistency with amended regulations governing the practice of pharmacy and in response to the Governor's Regulatory Reform Initiative. The amendments (i) reduce in square footage the selling and storage area enclosure from 60 to 40 square feet; (ii) allow for maintenance of prescription records outside of the area if access is limited to authorized persons; (iii) eliminate the specific height requirements for the enclosure; and (iv) stipulate access to the area by other persons authorized to assist the practitioner while he is on duty.

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.