TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Fast-Track Regulation

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-590).

Statutory Authority: §§ 54.1-2400 and 54.1-3423 of the Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: August 12, 2026.

Effective Date: August 27, 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 that are reasonable and necessary to effectively administer the regulatory system.

Purpose: This action is essential to protect the health, safety, and welfare of citizens because it addresses the health and safety of the incarcerated population by allowing correctional facilities to maintain floor stock of long-acting injectable medication and extended-release prescription medication, facilitating faster medical care.

Rationale for Using Fast-Track Rulemaking Process: This action is expected to be noncontroversial and is appropriate for the fast-track rulemaking process because it addresses a current gap in medical care coverage for inmates and because correctional facilities using this allowance must obtain a controlled substances registration and comply with recordkeeping and security requirements.

Substance: The amendments allow correctional facilities to maintain floor stock of long-acting injectable medication and extended-release prescription medication, provided that the correctional facility obtains a controlled substance registration and complies with security and recordkeeping requirements.

Issues: The primary advantage to the public is ensuring adequate medical care for the incarcerated population. There are no disadvantages to the public. There are no 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. In response to 2025 legislation, the Board of Pharmacy (board) proposes to amend the section on drugs in correctional facilities to allow correctional facilities to maintain a floor stock of certain long-acting or extended-release prescription drugs for the treatment of mental illness or substance use disorder. The proposed changes would (i) require the correctional facility to obtain a controlled substance registration and (ii) include inventory reconciliation and recordkeeping requirements.

Background. Chapters 278 and 283 of the 2025 Acts of Assembly allow the board to register a correctional facility to maintain a floor stock of long-acting injectable or extended-release prescription drugs for the treatment of mental illness or substance use disorder. The legislation also requires the following: (i) such drugs must be stored in an area accessible only to persons licensed to administer such drugs, regardless of whether the prescriber is on site (ii) each correctional facility must maintain an ongoing perpetual inventory of all such drugs in Schedules II through V, and (iii) the perpetual inventory must accurately indicate the physical count of each drug on hand and be reconciled at least once per month. 18VAC110-20-590 does not currently allow correctional facilities to maintain a floor stock of such drugs, leading to inmates not receiving needed prescription medication until a prescriber is on site. Thus, the board proposes to amend this to add the allowance and requirements in the legislation. The proposed amendments would specifically require the correctional facility to obtain a controlled substance registration² from the board and to comply with 18VAC110-20-690, 18VAC110-20-700, 18VAC110-20-710, and 18VAC110-20-720. The proposed amendments would also specify that the ongoing perpetual inventory required by statute be maintained for at least two years from the date of transaction.

Estimated Benefits and Costs. Neither the 2025 legislation nor the proposed regulatory changes would require correctional facilities to take any action. If correctional facilities choose to maintain a floor stock of long-acting injectables or extended-release prescription drugs, they would incur a $120 fee for the controlled substance registration, costs associated with the staff time required for inventory management, reconciliation, and recordkeeping, as well as the cost of the medications. The Department of Health Professions (DHP) reports that 37 entities with the word correctional in the name already have a controlled substance registration. Maintaining a floor stock of these drugs for administration to inmates would benefit the inmates who would receive their prescription medications in a consistent and timely manner, rather than having to wait until a prescriber is on site.

Businesses and Other Entities Affected. The proposed amendments would apply to correctional facilities in Virginia, which is defined in 18VAC110-20-10 to mean any prison, penitentiary, penal facility, jail, detention unit, or other facility in which persons are incarcerated by government officials. DHP reports that state prisons are more likely to avail of this allowance since their inmates typically stay for a longer period of time, whereas jails and detention units would be unlikely to stock long-acting injectable drugs. The Virginia Department of Corrections currently operates 31 correctional facilities, four work centers, and one treatment correctional facility.³ None of these facilities would be required to take any action, and several may already have controlled substance registrations. 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 benefit for any entity, even if the benefits exceed the costs for all entities combined.⁵ Since correctional facilities may choose whether or not to carry a floor stock of medications, any costs associated with doing so would be voluntary. Thus, an adverse impact is not indicated.

Small Businesses⁶ Affected.⁷ The proposed changes do not affect small businesses.

Localities⁸ Affected.⁹ Local governments would only incur costs if a jail, detention unit, or other facility operated by one or more localities chooses to obtain a controlled substance registration and maintain a floor stock of medications as provided by the proposed amendments. No locality would be disproportionately affected.

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

Effects on the Use and Value of Private Property. The proposed amendments would not affect the use or value of private property. Real estate development costs would not be affected.

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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 See https://ris.dls.virginia.gov/uploads/18VAC110/forms/0220 Controlled Substance Registration Application 8-2024-20240819122354.pdf.

³ https://vadoc.virginia.gov/facilities-and-offices/.

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:

The amendments allow registered correctional facilities to possess long-acting injectables or extended-release prescription drugs for administration to inmates.

18VAC110-20-590. Drugs in correctional facilities.

A. All prescription drugs at any correctional facility shall be subject to the following conditions:

1. Notwithstanding the allowances in subsections B, C, and D, and E of this section, prescription drugs shall be obtained only on an individual prescription basis.

2. All prepared drugs shall be maintained in a suitable locked storage area with only the person responsible for administering the drugs having access.

3. Complete and accurate records shall be maintained of all drugs received, administered, and discontinued. The administration record shall show the:

a. Patient name;

b. Drug name and strength;

c. Number of dosage units received;

d. Prescriber's name; and

e. Date, time, and signature of the person administering the individual dose of drug.

4. All unused or discontinued drugs shall be sealed and the amount in the container at the time of the sealing shall be recorded on the drug administration record. Schedule VI drugs shall be returned to the provider pharmacy or to a secondary pharmacy along with the drug administration record, a copy of the drug administration record, or other form showing substantially the same information, within 30 days of discontinuance.

a. The provider or secondary pharmacy shall conduct random audits of returned drug administration records for accountability.

b. The drug administration records shall be filed in chronological order by the provider or secondary pharmacy and maintained for a period of one year or, at the option of the facility, the records may be returned by the pharmacy to the facility.

c. Drugs may be returned to pharmacy stock in compliance with the provisions of 18VAC110-20-400.

d. Other drugs shall be disposed of or destroyed by the provider pharmacy in accordance with local, state, and federal regulations.

5. After performing the audit required by subdivision 4 a of this subsection and ensuring the proper maintenance of the administration records, drugs in Schedules II through V shall be destroyed at the site of the correctional facility using a method of destruction that renders the drug unrecoverable.

a. The destruction shall be performed by a nurse, pharmacist, or physician and witnessed by the nurse supervisor, a pharmacist, or a physician.

b. Destruction of drugs shall occur within 30 days of discontinuance.

c. A complete and accurate record of the drugs destroyed shall be made. The original of the record of destruction shall be signed and dated by the persons witnessing the destruction and maintained at the correctional facility for a period of two years. A copy of the destruction record shall be maintained at the provider pharmacy for a period of two years.

B. Emergency and stat-drug box. An emergency box and a stat-drug box may be prepared for a correctional facility served by the pharmacy pursuant to 18VAC110-20-540 and 18VAC110-20-550 provided that the facility employs one or more full-time physicians, registered nurses, licensed practical nurses, or physician assistants.

C. A correctional facility may maintain a stock of intravenous fluids, irrigation fluids, sterile water, and sterile saline to be accessed only by those persons licensed to administer drugs and shall be administered only by such persons pursuant to a valid prescription or lawful order of a prescriber. Such stock shall be limited to a listing to be determined by the provider pharmacist in consultation with the medical and nursing staff of the institution.

D. Except for drugs in an emergency box, stat-drug box, or a stock of intravenous fluids, irrigation fluids, sterile water, and sterile saline, and the drugs referenced in subsection E of this section, prescription drugs, including vaccines, may be floor-stocked only at a medical clinic or surgery center that is part of a correctional facility and that is staffed by one or more prescribers during the hours of operation, provided the clinic first obtains a controlled substances registration and complies with the requirements of 18VAC110-20-690, 18VAC110-20-700, 18VAC110-20-710, and through 18VAC110-20-720.

E. A floor stock of long-acting injectable or extended-release prescription drugs for the treatment of mental illness or substance use disorder may be maintained and stored in an area accessible only to persons who are licensed to administer such prescription drugs, regardless of whether the prescriber is on site, provided the correctional facility first obtains a controlled substances registration and complies with the requirements of 18VAC110-20-690 through 18VAC110-20-720. A perpetual inventory and reconciliation shall be performed on an ongoing basis in accordance with § 54.1-3423 of the Code of Virginia. Inventory and reconciliation records shall be maintained for a period of not less than two years from the date of transaction.