Title of Regulation: 18VAC110-21. Regulations Governing the Licensure of Pharmacists and Registration of Pharmacy Technicians (amending 18VAC110-21-120).

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

Public Hearing Information: No public hearings are currently scheduled.

Public Comment Deadline: March 3, 2021.

Effective Date: March 18, 2021.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4456, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Pharmacy the authority to promulgate regulations to administer the regulatory system. The specific statutory mandate for continuing education is found in § 54.1-3314.1 I of the Code of Virginia: "The Board shall provide for an inactive status for those pharmacists who do not wish to practice in Virginia. The Board shall require upon request for change from inactive to active status proof of continuing education hours as specified in regulations. No person shall practice in Virginia unless he holds a current active license."

Purpose: The purpose of the regulatory change is to allow pharmacists to receive credit toward fulfilling the requirement of three hours of live continuing education by volunteering. To the extent such an allowance is an incentive for a pharmacist to work without compensation in a free clinic or local health department, the proposed rule will improve the health, safety, and welfare of low income citizens who receive pharmacy services from one of those entities.

Rationale for Using Fast-Track Rulemaking Process: The amended rule will benefit pharmacists and free clinics or local health departments and will not be controversial.

Substance: 18VAC110-21-120 C is amended to allow two hours of live continuing education credit for the delivery of volunteer pharmacy services in accordance with 18VAC110-21-120 D.

Issues: The possible advantage to the public would be an increase in the amount of volunteer pharmacy services available to low-income individuals receiving health services through a local health department of a free clinic. There would also be an advantage to a pharmacist who is able to fulfill some of the three hours of live continuing education with such service. There are no disadvantages to the public. There are no advantages or disadvantages to this agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to allow up to two continuing education contact hours¹ earned through volunteer pharmacist work to count toward the required minimum of three contact hours that must be obtained in courses or programs that are live or real-time interactive.

Background. The regulation requires that pharmacists complete a minimum of 15 contact hours of continuing pharmacy education in an approved program for each annual renewal of licensure. Up to two hours of the 15 contact hours required for annual renewal may be satisfied through delivery of pharmacy services as a pharmacist, without compensation, to low-income individuals receiving health services through a local health department or a free clinic organized in whole or primarily for the delivery of those services. One contact hour of continuing education is credited for each three hours of providing such volunteer services, as documented by the health department or free clinic.

Of the 15 contact hours required for annual renewal, at least three hours must be obtained in courses or programs that are live or real-time interactive. The current regulation does not allow the contact hours obtained through volunteer pharmacist work to count toward the minimum of three contact hours that are live or real-time interactive.

Estimated Benefits and Costs. The proposal to allow up to two continuing education contact hours earned through volunteer pharmacist work to count toward the required three contact hours that are live or real-time interactive may encourage more pharmacists to provide such volunteer services. Since in order to qualify for continuing education contact hours the volunteer pharmacy services must be provided to low-income individuals receiving health services through a local health department or a free clinic, the proposal may be beneficial in that some low-income individuals may receive pharmacist services that they would not otherwise have received.

Businesses and Other Entities Affected. The proposed amendment potentially affects the 15,360 pharmacists licensed in the Commonwealth, local health departments, and free clinics. The proposal does not produce costs.

Small Businesses² Affected: The proposed amendment does not substantively affect small businesses.

Localities³ Affected.⁴ The proposed amendment applies throughout the Commonwealth, but lower-income localities may be disproportionately positively affected in that there may be greater need for volunteer pharmacist services. The proposal does not introduce costs for local governments.

Projected Impact on Employment. The proposed amendment is unlikely to substantively affect total employment.

Effects on the Use and Value of Private Property. The proposed amendment is unlikely to substantively affect the use and value of private property or real estate development costs.

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¹"Contact hour" is defined in the regulation as "the amount of credit awarded for 60 minutes of participation in and successful completion of a continuing education program."

²Pursuant to § 2.2-4007.04 of the Code of Virginia, 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."

³"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.

⁴§ 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency's Response to the Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

The amendment allows a pharmacist to satisfy two hours of the requirement for three hours of live or real-time interactive continuing education by volunteering pharmacy services for three hours.

18VAC110-21-120. Requirements for continuing education.

A. A pharmacist shall be required to have completed a minimum of 1.5 CEUs or 15 contact hours of continuing pharmacy education in an approved program for each annual renewal of licensure. CEUs or hours in excess of the number required for renewal may not be transferred or credited to another year.

B. A pharmacy education program approved for continuing pharmacy education is:

1. One that is approved by the ACPE;

2. One that is approved as a Category I continuing medical education course, the primary focus of which is pharmacy, pharmacology, or drug therapy; or

3. One that is approved by the board in accordance with the provisions of 18VAC110-21-130.

C. Of the 15 contact hours required for annual renewal, at least three hours shall be obtained in courses or programs that are live or real-time interactive. Included in the three hours, the following may be credited:

1. A maximum of one hour for attendance at a board meeting or formal hearing; or

2. A maximum of one hour for serving as a preceptor for a pharmacy student or resident in an accredited school or program or for a foreign-trained student obtaining hours of practical experience; or

3. A maximum of two hours for the delivery of volunteer pharmacy services in accordance with provisions of subsection D of this section.

D. Up to two hours of the 15 hours required for annual renewal may be satisfied through delivery of pharmacy services as a pharmacist, without compensation, to low-income individuals receiving health services through a local health department or a free clinic organized in whole or primarily for the delivery of those services. One hour of continuing education may be credited for three hours of providing such volunteer services, as documented by the health department or free clinic.

E. The board may grant an extension pursuant to § 54.1-3314.1 E of the Code of Virginia. Any subsequent extension shall be granted only for good cause shown.

F. Pharmacists are required to attest to compliance with the CE requirements in a manner approved by the board at the time of their annual license renewal. Following each renewal period, the board may conduct an audit of the immediate past two years CE documents to verify compli­ance with the requirements. Pharmacists are required to maintain for two years following renewal the original certificates documenting successful completion of CE, showing the date and title of the CE program or activity, the number of CEUs or contact hours awarded, and a certifying signature or other certification of the approved provider. Pharmacists selected for audit must provide these original documents to the board by the deadline date specified by the board in the audit notice.