TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Fast-Track Regulation

Title of Regulation: 18VAC110-15. Regulations for Delegation to an Agency Subordinate (amending 18VAC110-15-10).

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

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: September 24, 2025.

Effective Date: October 9, 2025.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive Suite 300, Henrico, VA 23233, telephone (804) 367-4456, fax (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia authorizes the Board of Pharmacy to promulgate regulations that are reasonable and necessary to effectively administer the regulatory system.

Purpose: This action allows agency subordinates to hear credentials cases, which benefits public health by expediting the review process and getting practitioners into the workforce faster.

Rationale for Using Fast-Track Rulemaking Process: This action is noncontroversial and appropriate for the fast-track rulemaking process because it conforms the regulation to statute and will lead to faster adjudication of applicant cases.

Substance: Pursuant to Chapter 191 of the 2023 Acts of Assembly, the amendment removes a limitation that agency subordinates be used only for disciplinary matters, which will allow the board to employ agency subordinates to hear credentials cases as well as disciplinary cases.

Issues: There are no primary advantages or disadvantages to the public. There are no primary advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget Economic Impact Analysis:

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 Code of Virginia and Executive Order 19. The analysis presented represents DPB's best estimate of the potential economic impacts as of the date of this analysis.¹

Summary of the Proposed Amendments to Regulation. The current Regulations for Delegation to an Agency Subordinate (regulation) allows the Board of Pharmacy (board) to delegate an informal fact-finding proceeding to an agency subordinate² only upon a determination that probable cause exists that a practitioner or an entity may be subject to a disciplinary action. Following changes made by Chapter 191 of the 2023 Acts of Assembly (legislation), the board proposes to remove this restriction from the regulation.

Background. Section 54.1-2400 of the Code of Virginia authorizes the board to appoint a special conference committee to ascertain the fact basis for their decisions of cases through informal conference or consultation proceedings. The statute provides that this may occur upon receipt of information that a practitioner or permit holder of the appropriate board may be subject to disciplinary action or to consider an application for a license, certification, registration, or permit. Prior to the 2023 legislation, the same statute indicated that the board may delegate to an appropriately qualified agency subordinate the authority to conduct informal fact-finding proceedings, but only upon receipt of information that a practitioner may be subject to a disciplinary action. This effectively prevented delegation from occurring to consider nonroutine³ applications for a license, certification, registration, or permit. The legislation removed the requirement that a practitioner must be subject to a disciplinary action in order for the board to make such delegation. Accordingly, the board is now proposing to remove that same restriction from the regulation as it is no longer mandated by statute.

Estimated Benefits and Costs. By removing the restriction, the legislation newly permitted the delegation of an informal fact-finding proceeding to occur for nonroutine applications for licensure, certification, registration, or a permit. However, the current regulation only allows such delegation to occur when there is information that a practitioner or an entity may be subject to a disciplinary action. When statute and regulation conflict, the statute prevails. Thus, amending the regulation to reflect the legislation would not affect what is permitted, but would be beneficial in accurately informing readers of the regulation concerning what is permitted.

Businesses and Other Entities Affected. According to the Department of Health Professions, there are about five to 10 nonroutine applications per year for board licensure, certification, registration, or permit that require evidentiary hearings. Such applicants, as well as potential delegated agency subordinates, would be particularly affected. The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.⁴ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined.⁵ As there is no increase in net cost nor reduction in net revenue, an adverse impact is not indicated.

Small Businesses⁶ Affected.⁷ The proposed amendment does not adversely affect small businesses.

Localities⁸ Affected.⁹ The proposed amendment neither disproportionately affects any particular locality, nor introduces costs for local governments.

Projected Impact on Employment. The proposed amendment does not appear to affect total employment.

Effects on the Use and Value of Private Property. The legislation may quicken the licensing of pharmacists and wholesale distributors, the permitting of pharmacies, manufacturers and third-party logistics providers, and the registration of pharmacy technicians with nonroutine applications for licensure. Such individuals may start practicing and operating in Virginia sooner. The proposed amendment does not affect real estate development costs.

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¹ Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

² The current and proposed regulations state that an agency subordinate authorized by the board to conduct an informal fact-finding proceeding may include board members and professional staff or other persons deemed knowledgeable by virtue of their training and experience in administrative proceedings involving the regulation and discipline of health professionals.

³ Nonroutine applications may require evidentiary hearings. In contrast, routine applications for licensure do not require such proceedings.

⁴ Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

⁵ Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation. As a result, DPB has adopted a definition of adverse impact that assesses changes in net costs and benefits for each affected Virginia entity that directly results from discretionary changes to the regulation.

⁶ Pursuant to § 2.2-4007.04, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

⁷ If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation. Additionally, pursuant to § 2.2-4007.1 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

⁸ "Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

⁹ Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency Response to Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis prepared by the Department of Planning
and Budget.

Summary:

Pursuant to Chapter 191 of the 2023 Acts of Assembly, the amendment removes a limitation that agency subordinates be used only for disciplinary matters, which will allow the Board of Pharmacy to employ agency subordinates to hear credentials cases as well as disciplinary cases.

18VAC110-15-10. Criteria for delegation of informal fact-finding proceeding to an agency subordinate.

A. Decision to delegate. In accordance with subdivision 10 of § 54.1-2400 of the Code of Virginia, the board may delegate an informal fact-finding proceeding to an agency subordinate upon determination that probable cause exists that a practitioner or an entity may be subject to a disciplinary action.

B. Criteria for delegation. Cases that may not be delegated to an agency subordinate, except as may be approved by a committee of the board, include those that involve:

1. Intentional or negligent conduct that causes or is likely to cause injury to a patient;

2. Drug diversion;

3. Impairment with an inability to practice with skill and safety;

4. Indiscriminate dispensing; and

5. Medication error in administration or dispensing.

C. Criteria for an agency subordinate.

1. An agency subordinate authorized by the board to conduct an informal fact-finding proceeding may include board members and professional staff or other persons deemed knowledgeable by virtue of their training and experience in administrative proceedings involving the regulation and discipline of health professionals.

2. The executive director shall maintain a list of appropriately qualified persons to whom an informal fact-finding proceeding may be delegated.

3. The board may delegate to the executive director the selection of the agency subordinate who is deemed appropriately qualified to conduct a proceeding based on the qualifications of the subordinate and the type of case being heard.