Virginia Board of Pharmacy Update
The Virginia Board of Pharmacy convened a virtual meeting on May 18, 2020 (virtual meetings of government bodies during the COVID-19 public health emergency have been allowed by the Governor and General Assembly). The agenda packet can be found
here.
Public Hearings and Adoption of Minutes
All Board members were present. There was no public comment for the Public Hearing on Placement of Chemicals into Schedule I and Conforming Drug Schedules to Actions Taken by DEA.
All minutes from the previous Board of Pharmacy meetings listed on the agenda were approved.
Christina Barille, VPhA, stated that pharmacists are prepared to offer COVID-19 testing and vaccinations. She mentioned HB 1506 (Sickles) from the 2020 General Assembly Session regarding pharmacist scope of practice as a positive initial step (more on HB 1506 below).
Three representatives spoke on behalf of Covetrus Maine, an internet and mail delivery pharmacy that provides pharmacy services to veterinarians and is licensed in Virginia as a non-resident pharmacy. See p. 150 in the agenda packet and the New Business section below for more information.
Department of Health Professions (DHP) Director's Report
Dr. David Brown mentioned that the Board of Pharmacy has issued various waivers to address COVID-19. DHP's various other regulatory boards have also issued waivers to address licensure and continuing education, and the Governor issued an executive order to increase the healthcare workforce during the COVID-19 public health emergency.
DHP is working on electronic participation for regulatory board members and members of the public when in-person meetings resume, provided that an in-person quorum of the Board will be required.
Some teleworking among DHP staff will likely continue after the public health emergency.
Legislative/Regulatory/Guidance
Elaine Yeatts, DHP Senior Policy Analyst, reviewed the list of General Assembly Post Session Studies/Reports on p. 43 of the agenda packet, particularly the extensive "rewrite of pharmacist scope" required by HB 1506. Board member Kristofer Ratcliffe stated that he wants to make sure frontline pharmacists are involved in the pharmacist scope study. VSHP is sending a letter to the Board regarding the various stakeholder groups we will engage in.
At the Reconvened Session on April 22, 2020, the General Assembly accepted the Governor's amendments to SB 976 (Marsden) pertaining to pharmaceutical processors and cannabis dispensing facilities. The major change was to replace the two definitions of CBD and THC-A oils with a single definition of cannabis oil.
As a result of COVID-19, study reporting deadlines may be extended if requested by DHP. No activity has been conducted on the various studies, and staff will likely ask for an extension on the 2020 deadlines.
The Virginia Joint Commission on Health Care request on statewide standing protocols is similar to the stakeholder group created by HB 1506. Staff will determine if both studies can be addressed in the same work group, which is expected to begin this summer.
Chart of Regulatory Actions (p. 60). Ms. Yeatts stated that the adopted fee increase was approved by the Secretary of Health and Human Resources and is now awaiting action at the Governor's office. The fee increase needs to go into effect by this fall in order to avoid a possible budget deficit at the Board of Pharmacy.
Adoption of Exempt Regulation to Schedule Certain Chemicals into Schedule I (pp. 61-70) - Adopted.
Adoption of Exempt Regulation to Conform Drug Schedules to Actions Taken by DEA (pp. 71-83) - Adopted.
Adoption of Final Regulations for Delivery of Prescription Devices (pp. 84-88) - Adopted.
Adoption of Final Regulations for Delivery of Dispensed Prescriptions, Labeling (pp. 89-93).Chair Cynthia Warriner stated that she remains concerned about the lack of certain contact information on the label for the pharmacy where the prescription is picked up that could lead to confusion, especially for senior citizens. She also stated that the public comment period for the proposed regulations was during the height of the COVID-19 emergency, which may have deterred public input.
Ms. Juran stated that she received a message from a lobbyist requesting that the public comment period be extended. Ms. Yeatts stated that the Board can vote to extend the public comment period, and that notice is required. The public hearing for this matter was canceled as part of the March Board meeting that was canceled due to the public health emergency.
The Board voted to extend the public comment period to, and schedule a public hearing at, the June Board meeting for this item.
Adoption of Proposed Regulations for Pharmaceutical Processors (pp. 94-125) - Adopted.
Adoption of Final Regulations for White Bagging and Brown Bagging (pp. 126-135) - Adopted.
Adoption of Regulatory Amendments for Handling Fee for Returned Check (pp. 137-149) - Adopted. Raises the fee to $50 from $35 consistent with other regulatory boards.
New Business
Consideration of certification from a substantially similar program approved by the Board for nonresident pharmacies (§ 54.1-3434.1(A)(4)) (pp. 150-156) - The Board voted to waive the VIPPS certification but require an approved credential. Staff will draft a Guidance Document on acceptable credentials for consideration at the June Board meeting.
Chairman's Report
Chairman Warriner stated that the 2 years of experience requirement for PIC eligibility went into effect on December 11, 2019 and has created some confusion and questions to the Board. The Board can grant an exemption for good cause shown. Staff will draft guidance for the June meeting formalizing the process for exemption requests, including for when a PIC moves to a new store vs. staying at the same store when the PIC has less than 2 years of experience.
Board of Health Professions Report
Board member Ryan Logan reported that there were 50% more bills related to healthcare this General Assembly session. He highlighted the pharmaceutical processor program and licensing of dispensaries, Art Therapists which will now be licensed under the Board of Counseling, and Music Therapists which will now be licensed under the Board of Social Work.
Other items
There were no presentations on the remaining agenda items. Please refer to the agenda packet for any written documentation provided.
NOTE: This virtual Board of Pharmacy meeting was not eligible for live CE credit.
The next Board meeting is scheduled for June 16, 2020 at 9:00 AM.