TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Fast-Track Regulation

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (adding 18VAC110-20-810).

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

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: March 25, 2026.

Effective Date: April 9, 2026.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, 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 to effectively administer the regulatory system.

Purpose: This action protects the public welfare by ensuring that the laboratories serving pharmaceutical processors maintain appropriate testing and organizational standards.

Rationale for Using Fast-Track Rulemaking Process: This action is considered noncontroversial and therefore appropriate for the fast-track rulemaking process because it adopts standards previously in existence in Regulations Governing Pharmaceutical Processors (18VAC110-60).

Substance: This action adds a new section, 18VAC110-20-810, to replace a previously repealed section regarding requirements of laboratories that test products for pharmaceutical processors. Specifically, the action sets out requirements regarding (i) organization and organizational independence, (ii) training of certain employees, (iii) obtaining a controlled substances registration from the board, (iv) laboratory accreditation, and (v) compliance with a transfer protocol for transporting cannabis.

Issues: The primary advantage to the public is ensuring safety in operation of the laboratories providing analytics and testing for cannabis products. There are no 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. To fulfil a statutory requirement, the Board of Pharmacy (board) proposes to add a section on requirements for laboratories that handle testing or analyzing cannabis products for a pharmaceutical processor. The proposed language is nearly identical to current regulatory language that falls under the Virginia Cannabis Control Authority (VCCA).

Background. Pursuant to Chapters 740 and 773 of the 2023 General Assembly, regulations of the Virginia pharmaceutical processor programs moved from this Board to the VCCA as of January 1, 2024. As a result, the board repealed all regulations relating to the pharmaceutical processor program because the board no longer had regulatory jurisdiction over the program. It was later realized, however, that § 4.1-1602 of the Code of Virginia still requires any laboratory testing products for pharmaceutical processors to obtain a controlled substances registration from the board and comply with quality standards established by the Board of Pharmacy in regulation. Accordingly, the board proposes to restore the quality standards that were previously in 18VAC110-60-300 A; these requirements would be added in 18VAC110-20-810. However, as these requirements are already in 3VAC10-60-20 A, which falls under the VCCA, the proposed addition would have no practical impact. The only difference between the proposed text and the VCCA regulation would be to direct the requirements at laboratories providing the services rather than at pharmaceutical processors.

Estimated Benefits and Costs. The proposed change would meet the requirements of § 4.1-1602 of the Code of Virginia. As these requirements are already in place under a different regulation, the proposed changes would not create any new costs or benefits.

Businesses and Other Entities Affected. The proposed change would meet the requirements of 4.1-1602 of the Code of Virginia. The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.² An adverse impact is indicated if there is any increase in net cost or reduction in net benefit for any entity, even if the benefits exceed the costs for all entities combined.³ Since the proposed changes do not change current statutory or regulatory requirements, no adverse impact is indicated.

Small Businesses⁴ Affected.⁵ The proposed amendments do not adversely affect small businesses.

Localities⁶ Affected.⁷ The proposed amendments do not disproportionately affect particular localities or affect costs for local governments.

Projected Impact on Employment. The proposed amendments do not affect total employment.

Effects on the Use and Value of Private Property. The proposed amendments affect neither the use and value of private property nor 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 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.

³ 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.

⁴ 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."

⁵ 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.

⁶ "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.

⁷ 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 § 4.1-1602 of the Code of Virginia, any laboratory testing products for pharmaceutical processors must obtain a controlled substances registration from the Board of Pharmacy and comply with quality standards established by the board. The amendments establish laboratory requirements, including (i) independence from conflict of interest, (ii) employee qualification, (iii) certification, (iv) accreditation in testing and calibration, and (v) transportation protocol.

18VAC110-20-810. Laboratory requirements for pharmaceutical processors.

A laboratory handling, testing, or analyzing cannabis products for a pharmaceutical processor shall:

1. Ensure independence from all other persons involved in the cannabis industry in Virginia, which shall mean that no person with a direct or indirect interest in the laboratory shall have a direct or indirect financial interest in a pharmacist, pharmaceutical processor, cannabis dispensing facility, certifying practitioner, or any other entity that may benefit from the production, manufacture, dispensing, sale, purchase, or use of cannabis products.

2. Employ at least one person to oversee and be responsible for the laboratory testing who has earned from a college or university accredited by a national or regional certifying authority at least (i) a master's degree in chemical or biological sciences and a minimum of two years of post-degree laboratory experience or (ii) a bachelor's degree in chemical or biological sciences and a minimum of four years of post-degree laboratory experience.

3. Obtain a controlled substances registration certificate pursuant to § 54.1-3423 of the Code of Virginia authorizing the testing of cannabis products.

4. Provide proof to the board of accreditation in testing and calibration in accordance with the most current version of the International Standard for Organization and the ISO/IEC 17025 or proof that the laboratory has applied for accreditation in testing and calibration in the most current version of ISO/IEC 17025. Any testing and calibration method utilized to perform a cannabis-related analysis for pharmaceutical processors shall be in accordance with the laboratory's ISO/IEC 17025 accreditation. The accrediting body shall be recognized by International Laboratory Accreditation Cooperation.

a. A laboratory applying for authorization to provide cannabis-related analytical tests for pharmaceutical processors shall receive ISO/IEC 17025 accreditation within two years from the date the laboratory applied for ISO/IEC 17025 accreditation. A laboratory may request and the board may grant for good cause shown additional time for the laboratory to receive ISO/IEC 17025 accreditation.

b. A laboratory shall send proof of ISO/IEC 17025 accreditation to the board for cannabis-related analytical test methods for pharmaceutical processors for which it has received ISO/IEC 17025 accreditation no later than five business days after the date on which the accreditation was received.

c. A laboratory may use nonaccredited analytical test methods as long as the laboratory has commenced an application for ISO/IEC 17025 accreditation for analytical test methods for cannabis-related analysis for pharmaceutical processors. No laboratory shall use nonaccredited analytical test methods for cannabis-related analysis for pharmaceutical processors if it has applied for and has not received ISO/IEC 17025 accreditation within two years. The laboratory may request and the board may grant for good cause shown additional time for the laboratory to utilize nonaccredited analytical test methods for cannabis-related analysis.

d. At such time that a laboratory loses its ISO/IEC 17025 accreditation for any cannabis-related analytical test methods for pharmaceutical processors, the laboratory shall inform the board within 24 hours. The laboratory shall immediately stop handling, testing, or analyzing cannabis for pharmaceutical processors.

5. Comply with a transportation protocol for transporting cannabis or cannabis products to or from the laboratory or to or from pharmaceutical processors.