TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Fast-Track Regulation

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-735).

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

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: July 16, 2025.

Effective Date: July 31, 2025.

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: The Board of Pharmacy is authorized by § 54.1-2400 of the Code of Virginia to promulgate regulations in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) that are reasonable and necessary to effectively administer the regulatory system.

Purpose: This action protects the health, safety, and welfare of citizens because individuals who do not dispense injectable naloxone gain clarity regarding which regulatory requirements apply to them, which may prevent delays in naloxone availability to the public.

Rationale for Using Fast-Track Rulemaking Process: This action is appropriate for the fast-track rulemaking process because the amendment merely clarifies the application of the regulation.

Substance: The amendment clarifies that the requirements for dispensing of naloxone by trained individuals in 18VAC110-20-735 only apply to the injectable formulation with a hypodermic needle or syringe.

Issues: The primary advantage to the public is clarification of which provisions apply to individuals dispensing noninjectable naloxone formulations. 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. The Board of Pharmacy (board) proposes to clarify that the requirements for dispensing of naloxone by trained individuals in 18VAC110-20-735 only apply to the injectable formulation with a hypodermic needle or syringe.

Background. Naloxone is a medication approved by the Food and Drug Administration designed to rapidly reverse opioid overdose.² There are two types of injectables for naloxone. One requires a hypodermic needle or syringe to draw up naloxone from a vial; the other form of injectable is an auto-injector with a built-in needle (like an Epi-Pen).³ There is also non-injectable naloxone (nasal spray). This action serves to clarify that the regulatory requirements in 18VAC110-20-735 only apply to the injectable formulation of naloxone using a hypodermic needle or syringe. Specifically, the board proposes to add "in an injectable formulation with a hypodermic needle or syringe" to make this clarification. The requirements for the dispensing of naloxone by auto-injector or nasal spray can be found in a board guidance document called Naloxone Protocols.⁴ The requirements in Naloxone Protocols also apply to the injectable formulation of naloxone using a hypodermic needle or syringe.

Estimated Benefits and Costs. The proposed amendment does not change any requirements. By clarifying that dispensers of naloxone via auto-injector or nasal spray are not subject to the requirements of 18VAC110-20-735, it is possible that more people would be willing to dispense naloxone. To the extent that this is the case, the proposed clarification could be beneficial in that it may increase the likelihood that naloxone would be available for someone experiencing an opioid overdose.

Businesses and Other Entities Affected. Section 54.1-3408 Y of the Code of Virginia⁵ states "Notwithstanding any other law or regulation to the contrary, a person who is acting on behalf of an organization that provides services to individuals at risk of experiencing an opioid overdose or training in the administration of naloxone for overdose reversal may dispense naloxone, provided that such dispensing is (i) pursuant to a standing order issued by a prescriber and (ii) in accordance with protocols developed by the Board of Pharmacy in consultation with the Board of Medicine and the Department of Health." Thus, organizations that provide services to individuals at risk of experiencing an opioid overdose are particularly affected. The Naloxone Protocols are the protocols developed by the board.

Section 54.1-3408 Y goes on to state "If the person acting on behalf of an organization dispenses naloxone in an injectable formulation with a hypodermic needle or syringe, he shall first obtain authorization from the Department of Behavioral Health and Developmental Services to train individuals on the proper administration of naloxone by and proper disposal of a hypodermic needle or syringe, and he shall obtain a controlled substance registration from the Board of Pharmacy." The requirements of 18VAC110-20-735 concern the controlled substance registration. The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.⁶ 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. As the proposed amendment neither increases costs nor reduces net revenue for any entity, no adverse impact is indicated.

Small Businesses⁷ Affected.⁸ The proposed amendment does not adversely affect small businesses.

Localities⁹ Affected.¹⁰ The proposed amendment does not disproportionally affect any particular localities, nor introduce 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 proposed amendment does not appear to affect the use and value of private property or 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 Source: https://www.samhsa.gov/medications-substance-use-disorders/medications-counseling-related-conditions/naloxone.

³ Source: Department of Health Professions.

⁴ See https://townhall.virginia.gov/L/GetFile.cfm?File=C:\TownHall\docroot\GuidanceDocs\223\GDoc_DHP_6099_v12.pdf.

⁵ See https://law.lis.virginia.gov/vacode/title54.1/chapter34/section54.1-3408/.

⁶ 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.

⁷ 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."

⁸ 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.

⁹ "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.

¹⁰ 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:

The amendments clarify that the requirements for dispensing of naloxone by trained individuals in 18VAC110-20-735 apply only to the injectable formulation with a hypodermic needle or syringe.

18VAC110-20-735. Requirements for dispensing of naloxone by trained individuals.

A. Persons authorized by the Department of Behavioral Health and Developmental Services to train individuals on the administration of naloxone in an injectable formulation with a hypodermic needle or syringe and dispense the naloxone for opioid overdose reversal pursuant to subsection Y of § 54.1-3408 of the Code of Virginia shall maintain the following records:

1. The prescriber's standing order issued in accordance with subsection Y of § 54.1-3408 of the Code of Virginia authorizing the trained individual to dispense naloxone.

2. Invoices or other records showing receipts of naloxone shall be maintained but may be stored in an electronic database or record as an electronic image that provides an exact, clearly legible image of the document or in secured storage either on site or off site. All records in off-site storage or database shall be retrieved and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

3. A manual or electronic log indicating the name, strength, lot, expiration date, and quantity of naloxone transferred to and from the controlled substances registration location to the off-site training location, along with date of transfer and the name of the trained individual approved by the Department of Behavioral Health and Developmental Services.

4. Record of dispensing indicating the name of the person receiving naloxone, address or contact information if available, date of dispensing, drug name, strength, quantity, lot number, expiration date, and the name of the trained individual approved by the Department of Behavioral Health and Developmental Services to dispense naloxone.

B. The naloxone shall be labeled with directions for use in accordance with the prescriber's standing order, date of dispensing, name of person receiving the drug, drug name and strength, and the name and the telephone number for the entity associated with the controlled substances registration.

C. The naloxone shall be stored and transported under appropriate storage conditions in accordance with the manufacturer's directions to protect it from adulteration.

D. In the event of a manufacturer recall, the supervising practitioner or responsible party associated with the controlled substances registration certificate shall ensure compliance with recall procedures as issued by the manufacturer, the U.S. Food and Drug Administration, or the board to ensure an affected drug is transferred to a person or entity authorized to possess the drug for return or destruction.

E. Except for a prescriber's standing order, which shall be maintained on site for a period of not less than two years from the date of the last dispensing, records shall be filed chronologically and maintained for a period of not less than two years from the date of transaction.