TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Proposed Regulation

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-110; adding 18VAC110-20-113).

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

Public Hearing Information:

December 17, 2024 - 9:06 a.m. - Department of Health Professions, 9960 Mayland Drive, Suite 201, Board Room 4, Henrico, VA 23233.

Public Comment Deadline: January 17, 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: Regulations of the Board of Pharmacy are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which authorizes health regulatory boards to promulgate regulations that are reasonable and necessary to administer effectively the regulatory system. Section 54.1-3307 of the Code of Virginia requires the board to regulate the practice of pharmacy, including criteria for maintaining the integrity of, and public confidence in, the profession and improving the delivery of quality pharmaceutical services to the citizens of Virginia.

Purpose: The purpose of the amendments is to safeguard the health, safety, and welfare of patients by ensuring (i) safe working environments exist for pharmacists and pharmacy personnel, (ii) pharmacist authority and control over the practice of pharmacy is not usurped by the pharmacy permit holder, and (iii) proper breaks are provided for pharmacists while protecting patient safety.

Substance: In general, the substantive provisions (i) ensure that the decisions of the pharmacist are not overridden by the pharmacy permit holder, including staffing decisions and the decision of whether pharmacy staff can safely provide vaccines at a given time; (ii) ensure that pharmacy permit holders provide sufficient staffing levels to avoid interference with pharmacist ability to practice with reasonable competence and safety; (iii) ensure that a pharmacist and pharmacy personnel are provided with proper and functioning equipment; (iv) ensure pharmacists and pharmacy staff are not burdened with external factors that may inhibit the ability to provide services to the public; (v) ensure staff are properly trained to provide the services they are tasked with; (vi) ensure pharmacists are provided appropriate breaks while maintaining drug stock integrity and providing required consultation services to the public; (vii) ensure pharmacists are provided adequate time to perform professional duties; and (viii) provide a reporting mechanism for staffing concerns.

Issues: The primary advantage to the public is the provision of pharmacy services in a safe and efficient manner. 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's 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. Pursuant to Chapter 628 of the 2022 Acts of Assembly,² the Board of Pharmacy (board) proposes to make permanent an emergency regulation³ related to work environment requirements for pharmacy personnel that protect the health, safety, and welfare of patients.

Background. Chapter 628 directed the board "to adopt regulations related to work environment requirements for pharmacy personnel that protect the health, safety, and welfare of patients." The mandate further specified that "such regulations shall include provisions (i) addressing sufficient pharmacy staffing to prevent fatigue, distraction, or other conditions that interfere with a pharmacist's ability to practice with competence and safety; (ii) stating standards for uninterrupted rest periods and meal breaks for pharmacy personnel; (iii) stating standards that ensure adequate time for pharmacists to complete professional duties and responsibilities, including drug utilization reviews, immunization administration, patient counseling, and verification of prescription accuracy; and (iv) limiting external factors such as productivity or production quotas to the extent that such factors interfere with the ability to provide appropriate professional services to the public." The board promulgated emergency regulation effective September 29, 2023. This action would make the emergency regulation permanent. Relatedly, the board notes that although the General Assembly, rather than the board, determined that this legislation required emergency regulations, the emergency is likely related to concern for the safety of pharmacists, pharmacy staff, and patients given the current healthcare climate and increased workloads for pharmacists and other pharmacy personnel.

Estimated Benefits and Costs. The potential for conflict between two parties with different incentives is a common issue in various business settings. This issue is known as the "principal-agent problem" in economics. Applied to this case, the problem may arise when the principle (pharmacy owner), who seeks to maximize profit and ensure the smooth operation of the pharmacy, and the agent (pharmacist in charge or PIC), who is responsible for managing day-to-day operations may have different priorities or incentives. This understanding is consistent with the board's statement that the purpose of the proposed action in part is "ensuring pharmacist authority and control over the practice of pharmacy is not usurped by the pharmacy permit holder." Furthermore, the mandate's preferred mechanism appears to be to address such potential conflicts by clearly outlining the expectations and responsibilities of the owner and the PIC, regarding specific issues listed in items (i) through (iv), in the regulation. Generally speaking, the proposed regulatory language appears to be closely aligned with the mandate. Notably, the board proposes a form titled "Staffing Requests or Concerns"⁴ to be used by the PIC to communicate such issues to the pharmacy permit holder. The owner must maintain these forms on record for possible inspections. Thus, the proposed form is expected to help facilitate and ensure compliance and help improve working conditions for pharmacists and pharmacy technicians. The board believes that pharmacies may need to hire additional staff if pharmacies are inadequately staffed, which would add to compliance costs, although such costs would be related to complying with basic standards of care. Additionally, the board expects a small administrative cost for pharmacies to keep staffing records on board-provided forms, but expects these costs to be negligible especially if an electronic version of the form is used. Although the mandate may introduce some costs for pharmacy owners and support the provision of pharmacy services in a safe and efficient manner, given the requirements in the mandate and the presence of the emergency regulation, this action's impact mainly consists of updating the Virginia Administrative Code (VAC) permanently to reflect what has already been implemented in practice since September 29, 2023.

Businesses and Other Entities Affected. The proposed amendments would affect owners of pharmacies, including chain pharmacies, as well as pharmacists and pharmacy technicians. The board has no estimate of the number of corporations or other entities that may be affected, since many hold more than one pharmacy permit. However, as of September 30, 2023, there were 1,751 permitted pharmacies in the Commonwealth. As of the same date, there were 16,606 licensed pharmacists and 13,310 registered pharmacy technicians.⁵ No affected entity appears to be disproportionately affected. 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 benefit for any entity, even if the benefits exceed the costs for all entities combined.⁷ As noted, while the legislation may have created some costs for the pharmacy owners and benefits for the pharmacists, pharmacy technicians, and patients, the proposed action's main impact is to permanently incorporate the rules that are already in effect into VAC. Thus, an adverse impact is not indicated.

Small Businesses⁸ Affected.⁹ According to the board, there are fewer than 300 independent pharmacies in the Commonwealth that are most likely to be small businesses. However, the proposed incorporation of the existing rules permanently into VAC does not adversely affect small businesses.

Localities¹⁰ Affected.¹¹ The proposed action does not create costs or other effects for localities.

Projected Impact on Employment. The proposed action by itself does not appear to affect employment.

Effects on the Use and Value of Private Property. No effects on the use and value of private property nor on real estate costs is expected on account of this regulatory action by itself.

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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 https://lis.virginia.gov/cgi-bin/legp604.exe?221+ful+CHAP0628.

³ https://townhall.virginia.gov/l/ViewStage.cfm?stageid=9792.

⁴ https://ris.dls.virginia.gov/uploads/18VAC110/forms/Staffing Requests or Concerns Form (eff. 9-2023)-20230929153548.pdf.

⁵ Data source: Department of Health Professions.

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 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.

⁸ 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."

⁹ 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.

¹⁰ "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.

¹¹ 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 628 of the 2022 Acts of Assembly, the amendments add a new section addressing pharmacy work environments, ensuring that (i) the decisions of the pharmacist are not overridden by the pharmacy permit holder, including staffing decisions and the decision of whether pharmacy staff can safely provide vaccines at a given time; (ii) pharmacy permit holders provide sufficient staffing levels to avoid interference with a pharmacist's ability to practice with reasonable competence and safety; (iii) pharmacists and pharmacy personnel are provided with proper and functioning equipment; (iv) pharmacists and pharmacy staff are not burdened with external factors that may inhibit the ability to provide services to the public; (v) staff are properly trained to provide the services with which they are tasked; (vi) pharmacists are provided appropriate breaks while maintaining drug stock integrity and providing required consultation services to the public; (vii) pharmacists are provided adequate time to perform professional duties; and (viii) a reporting mechanism exists for staffing concerns.

18VAC110-20-110. Pharmacy permits generally.

A. A pharmacy permit shall not be issued to a pharmacist to be simultaneously in charge of more than two pharmacies.

B. Except in an emergency, a permit holder shall not require a pharmacist to work longer than 12 continuous hours in any work day and shall allow at least six hours of off-time between consecutive shifts. A pharmacist may, however, volunteer to work longer than 12 continuous hours. A pharmacist working longer than six continuous hours shall be allowed to take a 30-minute break. Breaks, including uninterrupted rest periods and meal breaks, shall be provided consistent with 18VAC110-20-113 B 5.

C. The PIC or the pharmacist on duty shall control all aspects of the practice of pharmacy. Any decision overriding such control of the PIC or other pharmacist on duty shall be deemed the practice of pharmacy and may be grounds for disciplinary action against the pharmacy permit.

D. A pharmacist shall not be eligible to serve as PIC until after having obtained a minimum of two years of experience practicing as a pharmacist in Virginia or another jurisdiction in the United States. The board may grant an exception to the minimum number of years of experience for good cause shown.

E. When the PIC ceases practice at a pharmacy or no longer wishes to be designated as PIC, he the pharmacist shall immediately return the pharmacy permit to the board indicating the effective date on which he the pharmacist ceased to be the PIC.

F. Although not required by law or regulation, an outgoing PIC shall have the opportunity to take a complete and accurate inventory of all Schedules II through V controlled substances on hand on the date he the pharmacist ceases to be the PIC, unless the owner submits written notice to the board showing good cause as to why this opportunity should not be allowed.

G. A PIC who is absent from practice for more than 30 consecutive days shall be deemed to no longer be the PIC. Pharmacists-in-charge having knowledge of upcoming absences for longer than 30 days shall be responsible for notifying the board and returning the permit. For unanticipated absences by the PIC, which that exceed 15 days with no known return date within the next 15 days, the owner shall immediately notify the board and shall obtain a new PIC.

H. An application for a permit designating the new PIC shall be filed with the required fee within 14 days of the original date of resignation or termination of the PIC on a form provided by the board. It shall be unlawful for a pharmacy to operate without a new permit past the 14-day deadline unless the board receives a request for an extension prior to the deadline. The executive director for the board may grant an extension for up to an additional 14 days for good cause shown.

I. Only one pharmacy permit shall be issued to conduct a pharmacy occupying the same designated prescription department space. A pharmacy shall not engage in any other activity requiring a license or permit from the board, such as manufacturing or wholesale-distributing, out of the same designated prescription department space.

J. Before any permit is issued, the applicant shall attest to compliance with all federal, state, and local laws and ordinances. A pharmacy permit shall not be issued to any person to operate from a private dwelling or residence after September 2, 2009.

18VAC110-20-113. Pharmacy working conditions.

A. A pharmacy permit holder shall protect the health, safety, and welfare of patients by consulting with the PIC or pharmacist on duty and other pharmacy staff to ensure patient care services are safely provided in compliance with applicable standards of patient care. A permit holder's decisions shall not override the control of the PIC or other pharmacist on duty regarding appropriate working environments for all pharmacy personnel necessary to protect the health, safety, and welfare of patients.

B. To provide a safe working environment in a pharmacy, a permit holder shall, at a minimum:

1. Ensure sufficient personnel are scheduled to work at all times in order to prevent fatigue, distraction, or other conditions that interfere with a pharmacist's ability to practice with reasonable competence and safety. Staffing levels shall not be solely based on prescription volume, but shall consider any other requirements of pharmacy staff during working hours;

2. Provide sufficient tools and equipment in good repair and minimize excessive distractions to support a safe workflow for a pharmacist to practice with reasonable competence and safety to address patient needs in a timely manner;

3. Avoid the introduction of external factors, such as productivity or production quotas or other programs, to the extent that they interfere with the pharmacist's ability to provide appropriate professional services to the public;

4. Ensure staff are sufficiently trained to safely and adequately perform assigned duties, ensure staff demonstrate competency, and ensure that pharmacy technician trainees work closely with pharmacists and pharmacy technicians with sufficient experience as determined by the PIC;

5. Provide appropriate opportunities for uninterrupted rest periods and meal breaks consistent with 18VAC110-20-110 and the following:

a. A pharmacy may close when a pharmacist is on break based on the professional judgment of the pharmacist on duty, provided that the pharmacy has complied with the 14-day notice to the public pursuant to § 54.1-3434 of the Code of Virginia and 18VAC110-20-135;

b. If a pharmacy does not close while the pharmacist is on break, the pharmacist must ensure adequate security of drugs by taking a break within the prescription department or on the premises. The pharmacist on duty must determine whether pharmacy technicians or pharmacy interns may continue to perform duties and whether the pharmacist is able to provide adequate supervision; and

c. If the pharmacy remains open, only prescriptions verified by a pharmacist pursuant to 18VAC110-20-270 may be dispensed when the pharmacist is on break. An offer to counsel any person filling a new prescription must be offered pursuant to § 54.1-3319 of the Code of Virginia. Persons who request to speak to the pharmacist shall be told that the pharmacist is on break and that they may wait to speak with the pharmacist or provide a telephone number for the pharmacist to contact them upon return from break. Pharmacists returning from break shall immediately attempt to contact persons who requested counseling and document when such counseling is provided;

6. Provide adequate time for a pharmacist to complete professional duties and responsibilities, including:

a. Drug utilization review;

b. Immunization;

c. Counseling;

d. Verification of prescriptions;

e. Patient testing; and

f. All other duties required by Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia and this chapter; and

7. Ensure that pharmacy technicians shall never perform duties otherwise restricted to a pharmacist.

C. A pharmacy permit holder shall not override the control of the pharmacist on duty regarding any aspects of the practice of pharmacy, including a pharmacist's decision not to administer vaccines when one pharmacist is on duty and, in the pharmacist's professional judgment, vaccines cannot be administered safely.

D. Staffing requests or concerns as described in this section shall be communicated by the PIC or pharmacist on duty to the permit holder using the Staffing Requests or Concerns Form developed by the board or a form containing information identical to the form developed by the board, which may be electronic.

1. Such forms, once completed, shall be provided to the immediate supervisor of the PIC or pharmacist on duty, with one copy maintained in the pharmacy for three years, and produced for inspection by the board within 48 hours of request.

2. The PIC or pharmacist on duty may report any staffing issues directly to the board if the PIC or pharmacist on duty believes the situation warrants immediate board review.

3. Under no circumstances shall a good faith report of staffing concerns by the PIC, pharmacist on duty, or notification of such issues by pharmacy personnel to the PIC, pharmacist on duty, or board result in workplace discipline against the reporting staff member.

E. Permit holders shall review completed staffing reports and shall:

1. Respond to the reporting staff member to acknowledge receipt of the staffing request or concern;

2. Resolve any issues listed in a timely manner to ensure a safe working environment for pharmacy staff and appropriate medication access for patients;

3. Document any corrective action taken, steps taken toward corrective action as of the time of inspection, or justification for inaction, which documentation shall be maintained on site or produced for inspection by the board within 48 hours of request; and

4. Communicate corrective action taken or justification for inaction to the PIC or reporting pharmacist on duty.

FORMS (18VAC110-20)

Application for a Pharmacy Permit (rev. 1/2024)

Application for a Nonresident Pharmacy Registration (rev. 1/2024)

Application for a Nonresident Wholesale Distributor Registration (rev. 4/2024)

Application for Registration as Nonresident Manufacturer (rev. 10/2020)

Application for a Nonresident Third-Party Logistics Provider Registration (rev. 4/2024)

Application for Registration as a Nonresident Warehouser (rev. 10/2020)

Application for a Nonresident Outsourcing Facility Registration (rev. 10/2020)

Application for an Outsourcing Facility Permit (rev. 10/2020)

Application for a Medical Equipment Supplier Permit (rev. 10/2020)

Application for a Permit as a Restricted Manufacturer (rev. 10/2020)

Application for a Permit as a Nonrestricted Manufacturer (rev. 10/2020)

Application for a Wholesale Distributor Permit (rev. 4/2024)

Application for a Permit as a Warehouser (rev. 10/2020)

Application for a Permit as a Third-Party Logistics Provider (rev. 4/2024)

Application for Registration as a Nonresident Medical Equipment Supplier (rev. 10/2020)

Application for a Controlled Substances Registration Certificate (rev. 8/2024)

Closing of a Pharmacy (rev. 5/2018)

Application for Approval of an Innovative (Pilot) Program (rev. 8/2023)

Registration for a Pharmacy to be a Collection Site for Donated Drugs (rev. 5/2018)

Application for Approval of a Repackaging Training Program (rev. 10/2020)

Registration for a Facility to be an Authorized Collector for Drug Disposal (rev. 5/2018)

Application for Reinspection of a Facility (rev. 3/2023)

Notification of Distribution Cessation due to Suspicious Orders (rev. 5/2018)

Staffing Requests or Concerns Form (eff. 9/2023)