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.

Effective Dates: September 29, 2023, through March 28, 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.

Preamble:

Section 2.2-4011 of the Code of Virginia states that agencies may adopt emergency regulations in situations in which Virginia statutory law or the appropriation act requires that a regulation be effective in 280 days or less from its enactment, and the regulation is not exempt under the provisions of § 2.2-4006 A 4 of the Code of Virginia.

Pursuant to Chapter 628 of the 2022 Acts of Assembly, the amendments add a new section addressing pharmacy work environments, including to ensure (i) 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) that pharmacy permit holders provide sufficient staffing levels to avoid interference with a pharmacist's ability to practice with reasonable competence and safety; (iii) that a pharmacist 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) the existence of a reporting mechanism 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 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 their 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 Chapter 33 (§ 54.1-3300 et seq.) and Chapter 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 all 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 shall be communicated by the PIC or pharmacist on duty to the permit holder using a form developed by the board.

1. Executed staffing forms 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.

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 or pharmacist on duty result in workplace discipline against the reporting staff member.

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

1. Respond to 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. 10/2020)

Application for a Non-resident Pharmacy Registration (rev. 10/2020)

Application for a Non-Resident Wholesale Distributor Registration (rev. 10/2020)

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

Application for a Non-Resident Third Party Logistics Provider Registration (rev. 10/2020)

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

Application for a Non-resident 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 Non-Restricted Manufacturer (rev. 10/2020)

Application for a License as a Wholesale Distributor (rev. 10/2020)

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

Application for a Permit as a Third-Party Logistics Provider (rev. 10/2020)

Application for Registration as a Non-resident Medical Equipment Supplier (rev. 10/2020)

Application for a Controlled Substances Registration Certificate (rev. 10/2020)

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 Re-inspection 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)