Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-80, 18VAC110-20-105; adding 18VAC110-20-22).

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

Public Hearing Information:

September 25, 2018 - 9:10 a.m. - Perimeter Center, 9960 Mayland Drive, Suite 201, Board Room 2, Richmond, VA 23233

Public Comment Deadline: November 16, 2018.

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 are promulgated under the general authority of Chapter 24 of Title 54.1 of the Code of Virginia. Section 54.1-2400, which provides the Board of Pharmacy the authority to promulgate regulations to administer the regulatory system that are reasonable and necessary to administer effectively the regulatory system.

Purpose: The purpose of the proposed regulatory action is to streamline the licensure process and expedite National Association of Boards of Pharmacy (NABP) reporting of demographic information, examination scores, licensure status in all states, disciplinary history, and continuing education. By having real-time information, the board will have greater assurance that there are no grounds for denial of an initial or reinstatement application for a pharmacist, a pharmacy intern, or a pharmacy technician. The e-profile information available to the board will enhance its ability to protect the public health and safety.

Substance: Sections relating to initial application for licensure or registration as a pharmacist, pharmacy intern, or pharmacy technician or for renewal of any of such license or registration are amended to include a requirement for each such person to report an e-profile identification number obtained from NABP.

Issues: There are no advantages or disadvantages to the public. The advantage to the agency is the ability to expedite applications by accessing data in a centralized location with NABP. There are no disadvantages to the agency.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to require individuals applying for initial pharmacist licensure, pharmacist license renewal, pharmacist license reinstatement, pharmacy intern registration, initial pharmacy technician registration, pharmacy technician registration renewal, or pharmacy technician registration reinstatement, to provide their e-profile identification number (e-profile ID) from the National Association of Boards of Pharmacy (NABP) in their application.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact.

Background. NABP is a 501(c)(3) nonprofit association that protects public health by assisting its member boards of pharmacy and offers programs that promote safe pharmacy practices for the benefit of consumers. The e-profile ID is provided through the CPE Monitor Service, a collaborative effort of NABP, the Accreditation Council for Pharmacy Education (ACPE), and ACPE-accredited providers. The CPE Monitor Service allows electronic tracking of continuing pharmacy education (CPE) credits from ACPE-accredited providers. The NABP assigns an e-profile ID through the CPE Monitor Service to applicants so they can track credits, apply to sit for an exam, monitor continuing education, verify licensure, etc.

Analysis. Most pharmacists, technicians, and interns already possess an e-profile ID since it is assigned anytime an NABP service is first used, e.g., examination, CPE monitoring, licensure by endorsement, etc.¹ There is no charge to acquire an e-profile ID, and it is already required to be approved to sit for the licensure examination or to receive NABP-approved CPE.

The Department of Health Professions (DHP) indicates that requiring the e-profile ID may decrease its administrative burden when communicating with the NABP, and may reduce the possible chance of error when using the applicant's name or a breach of confidentiality occurring as a result of using other methods of identifying applicants such as the social security number. The applicant's name is currently used to obtain exam scores, but the e-profile ID is used to verify CPE credits when it is available. According to DHP, there have been instances in other states where personal information, such as the social security number, has been released as the result of a data breach; this situation could have been avoided if the e-profile ID had been used in its place. Given the potential reduction in administrative costs, errors, or breach of confidentiality, and the lack of cost acquiring an e-profile ID, the proposed amendment should produce a net benefit.

Businesses and Entities Affected. The proposed amendments would apply to the 14,714 licensed pharmacists, 14,662 registered pharmacy technicians, and 1,848 registered pharmacy interns in the Commonwealth, as well as future applicants. In 2017, 854 pharmacists were newly licensed, 2,017 pharmacy technicians were newly registered, and 591 pharmacy interns were newly registered.²

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

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

Effects on the Use and Value of Private Property. The proposed amendments do not significantly affect the use and value of private property.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

Small Businesses:

Definition. Pursuant 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."

Costs and Other Effects. The proposed amendments would not significantly affect costs for small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendments would not adversely affect small businesses.

Adverse Impacts:

Businesses. The proposed amendments would not adversely affect businesses.

Localities. The proposed amendments would not adversely affect localities.

Other Entities. The proposed amendments would not adversely affect other entities.

_______________________________________

¹Source: Department of Health Professions

²Data source: Department of Health Professions

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

Summary:

The proposed amendments require a pharmacist, pharmacy intern, or pharmacy technician applicant to provide an e-profile identification number from the National Association of Boards of Pharmacy in an application for a license, registration, and renewal or reinstatement of license or registration.

18VAC110-20-22. Application to include e-profile number.

An application for licensure as a pharmacist by examination or endorsement or for registration as a pharmacy intern or pharmacy technician shall include an e-profile number issued by NABP.

18VAC110-20-80. Renewal and reinstatement of license.

A. Pharmacist licenses expire on December 31 and shall be renewed annually prior to that date by the submission of a renewal fee, renewal form, an e-profile number issued by NABP, and statement of compliance with continuing education requirements.

B. A pharmacist newly licensed on or after October 1 shall not be required to renew that license until December 31 of the following year.

C. A pharmacist who fails to renew his license by the expiration date may renew his license at any time within one year of its expiration by submission of the renewal fee and late fee, renewal form, and statement of compliance with continuing education requirements.

D. A pharmacist who fails to renew his license for more than one year following expiration and who wishes to reinstate such license shall submit an application for reinstatement, pay the current renewal fee and a reinstatement fee, and submit documentation showing compliance with continuing education requirements. Reinstatement is at the discretion of the board and may be granted by the executive director of the board provided no grounds exist to deny said reinstatement.

E. A pharmacist who has been registered as inactive for more than one year must apply for reinstatement, submit documentation showing compliance with continuing education requirements, and pay the current year active renewal fee in order to resume active licensure.

F. In order to reactivate or reinstate a license to active status, a pharmacist who holds an inactive license, who has allowed his license to lapse, or who has had his license suspended or revoked must submit evidence of completion of CEU's or hours equal to the requirements for the number of years in which his license has not been active, not to exceed a total of 60 hours of CE.

G. A pharmacist whose license has been lapsed, in inactive status, or suspended or revoked for more than five years shall, as a condition of reinstatement in addition to 60 hours CE, take and receive a passing score on the board-approved law examination and furnish acceptable documentation of one of the following:

1. Active pharmacy practice within the past five years as a properly licensed pharmacist in another state; or

2. Practical experience as a pharmacy intern registered with the board of at least 160 hours within six months immediately prior to being reinstated.

H. The practice of pharmacy without a current, active pharmacist license is unlawful and shall constitute grounds for disciplinary action by the board.

I. It shall be the duty and responsibility of each licensee to inform the board of his current address. A licensee shall notify the board within 14 days in writing or electronically of any change of an address of record. Properly updating address of record directly through the board's web-based application or other approved means shall constitute lawful notification. All notices required by law or by these rules and regulations are deemed to be legally given when mailed to the address of record and shall not relieve the licensee of the obligation to comply.

18VAC110-20-105. Renewal and reinstatement of registration.

A. Pharmacy technician registrations expire on December 31 and shall be renewed annually prior to that date by the submission of a renewal fee, and renewal form, and an e-profile number issued by NABP. A pharmacy technician newly registered on or after July 1 shall not be required to renew that registration until December 31 of the following year. Failure to receive the application for renewal shall not relieve the pharmacy technician of the responsibility for renewing the registration by the expiration date.

B. A pharmacy technician who fails to renew his registration by the expiration date may renew his registration at any time within one year of its expiration by submission of the renewal fee and late fee, renewal form, and attestation of having obtained required continuing education.

C. A pharmacy technician who fails to renew his registration for more than one year following expiration and who wishes to reinstate such registration shall submit an application for reinstatement, pay the current renewal fee and a reinstatement fee, and submit documentation showing compliance with continuing education requirements. Reinstatement is at the discretion of the board and may be granted by the executive director of the board provided no grounds exist to deny said reinstatement. Conducting tasks associated with a pharmacy technician with a lapsed registration shall be illegal and may subject the registrant to disciplinary action by the board.

D. A person who fails to reinstate a pharmacy technician registration within five years of expiration, shall not be eligible for reinstatement and shall repeat an approved training program and repeat and pass the examination, or hold current PTCB certification, before applying to be reregistered.