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Telehealth Utilization Grows As COVID-19 Transforms Regulatory Landscape CONTENTS September 2020 | Volume 49 | Number 8 Telehealth Utilization Grows as COVID-19 Transforms Regulatory Landscape CONTENTS 04 09 02 Policy Perspectives California State Board of Pharmacy Wins Ninth Circuit Appeal: Outsourcing Facilities Subject to State Regulation 06 Association News 06 New Benefit Available to Boards Using the .Pharmacy Domain – NABP Can Handle Annual Renewals 07 Compounding Pharmacy Information Sharing Network Begins With Pilot Project 10 New Online CPE Series Will Keep You Up to Date 11 Interview With a Board Member Donna S. Wall, PharmD, RPh 12 State Board News Idaho Requires Mandatory PDMP Checks, Launches Data Dashboard Association News Feature News 13 Professional Affairs Update NABP Quickly Shifted Gears to Telehealth Utilization Grows Federal Pilot Program May Meet Pandemic Challenges as COVID-19 Transforms Help Stop Online Availability Regulatory Landscape of Unapproved Opioids NABP Executive Committee (ISSN 2472-6850 — print; ISSN 2472-6958 — Amy Sanchez Jack W. “Jay” Fred M. Weaver online) is published 10 times a year by the National Communications Manager Campbell IV Member, District 4 Association of Boards of Pharmacy® (NABP®) Chairperson ©2020 National Association of Boards of Pharmacy. Shane R. Wendel to educate, to inform, and to communicate the All rights reserved. No part of this publication may Timothy D. Fensky Member, District 5 objectives and programs of the Association and its be reproduced in any manner without the written President 65 member boards of pharmacy. Lenora S. Newsome permission of the executive director/secretary of the Caroline D. Juran Member, District 6 National Association of Boards of Pharmacy. The opinions and views expressed in this President-elect publication do not necessarily reflect the official Nicole L. Chopski NABP Mission Statement views, opinions, or policies of NABP or any board Reginald B. “Reggie” Member, District 7 NABP is the independent, international, and unless expressly so stated. The subscription rate is Dilliard impartial association that assists its member boards Kamlesh “Kam” $70 per year. Treasurer and jurisdictions for the purpose of protecting the Gandhi Member, District 8 National Association of Boards of Pharmacy public health. Bradley S. Hamilton Member, District 1 1600 Feehanville Drive, Mount Prospect, IL 60056 NABP Executive 847/391-4406 | www.nabp.pharmacy Tejal J. Patel Committee elections [email protected] Member, District 2 are held each year at the Association’s Lemrey “Al” Carter Jeffrey J. Mesaros Annual Meeting. Executive Director/Secretary Member, District 3 2 | APRIL 2020 INTERVIEW WITH A BOARD EXECUTIVE OFFICER Traci Collier, PharmD, RPh Administrator/Chief Drug Inspector, South Carolina Department of Labor, Licensing, and Regulation – Board of Pharmacy How long have you served unpermitted site. The Board recognized as administrator/chief drug that COVID-19 is a risk to health care inspector of the South workers and that allowing the use of Carolina Board of Pharmacy? remote order entry would reduce the What was your role prior to risk for the pharmacists and, therefore, working with the Board? reduce risk for any patients they may come I began employment with the Board into contact with. Other actions taken in April 2016. I initially served as the by the Board included the temporary assistant administrator and have been allowance of pickup kiosks, extended the administrator/chief drug inspector renewal timelines for all licensees, and since August 2018. Prior to joining a safe harbor for pharmacists regarding South Carolina Board the Board, I was employed by Kaiser compounding in light of potential of Pharmacy Permanente of Georgia and the Mid- personal protective equipment shortages. Atlantic states in various roles, ranging As testing evolved and became more from ambulatory care to pharmacy urgent, the Board released guidance on Number of Board Members systems and workflow optimization. authorizing licensed pharmacists to order 8 pharmacist and administer COVID-19 tests that Food members and 1 What is one of the most and Drug Administration authorized. public member significant challenges or The Board is closely monitoring the issues your Board addressed pandemic as it continues to present new in the past year or so? Number of challenges and will swiftly address these Compliance As is most likely the case with all boards, challenges as they present themselves. Officers/Inspectors the most significant challenge for the 4 South Carolina Board of Pharmacy has What other key issues has been regulating while supporting the the Board been focusing on? profession during the unprecedented The Board continues to study Rules & Regulations and ongoing coronavirus disease pharmacy workplace conditions and Established by 2019 (COVID-19) pandemic. The any potential effect on public safety. Board of Pharmacy nature of the pandemic itself forced In addition, the Board has been and approved by the us as a Board to act quickly to support working on regulations that will General Assembly our licensees on the front lines. clarify the permitting requirements and processes for the state’s licenses. Number of What actions were taken by the Pharmacist Licensees Board to address the issue? What insights do you have 9,003 The Board immediately took steps for other states that may to address the issues presented by be facing similar challenges? COVID-19. Numerous emergency As the practice of pharmacy has changed, Number of orders were put into place by the Board, so have the regulatory challenges. In Pharmacies including allowing temporary 90- South Carolina, we have found that solid 1,324 day permits for nonresident facilities relationships with the regulatory boards actively involved in activities related to from other states have been instrumental fighting the pandemic. This allows South in the work we do. If you do not have Number of Carolina pharmacies broader access to this already, I would encourage a strong Wholesale medication supply chains in the event of avenue of information sharing with Distributors drug shortages. In addition, during the sister boards, which will be invaluable in 96 declared state of emergency, the Board has protecting the citizens of your state. allowed for remote order entry from an SEPTEMBER 2020 | 1 POLICY PERSPECTIVES California State Board of Pharmacy Wins Ninth Circuit Appeal: Outsourcing Facilities Subject to State Regulation On June 17, 2020, the United States Fusion IV was an FDA-registered Court of Appeals for the Ninth Circuit outsourcing facility located in California issued its ruling in the case, Fusion IV that, pursuant to such registration, Pharmaceuticals, Inc. v. Anne Sodergren sought to compound and distribute its and California State Board of Pharmacy; drug products in interstate commerce. et al.1 This case has been closely watched Under the DQSA, an outsourcing by boards of pharmacy as it addresses facility is not required to be a licensed a state board’s ability to concurrently pharmacy.2 However, California law regulate federally registered outsourcing required FDA-registered outsourcing facilities. The June decision affirmed a facilities to be concurrently licensed by lower court decision that California’s state the Board as outsourcing facilities if law regulating outsourcing facilities is not such facilities compound non-patient- Libby Baney, JD preempted by federal law. specific drug products for distribution Faegre Drinker Biddle & Reath LLP within or into California.4 Fusion IV’s Federal Regulation of activities clearly fell within this category. Outsourcing Facilities In 2017, Fusion IV obtained its In 2013, Congress enacted the Drug outsourcing facility registration from Quality and Security Act (DQSA), which, FDA and then applied for state licensure among other things, established a new with the Board. The Board, however, category of pharmaceutical entities known denied Fusion IV’s state licensure as “outsourcing facilities.” Outsourcing application for its outsourcing facility facilities are required to register with Food because there was a pending Board and Drug Administration (FDA) and disciplinary action against Vahedi and comply with relevant federal regulations, another pharmacy facility he owned. including current Good Manufacturing Unwilling to issue Fusion IV a state Practices, as such entities are permitted outsourcing facility license, the Board to engage in large-scale compounding of subsequently ordered Fusion IV to Jonathan A. Keller, PharmD, JD, RPh 2 Faegre Drinker Biddle & Reath LLP drug products for interstate commerce. cease all operations as an outsourcing Subsequently, in 2017, California facility in California. In response, passed a state law, which, among other Fusion IV filed a lawsuit in early 2019 things, requires a facility registered as in federal district court challenging an outsourcing facility with FDA to be the Board’s authority to require it – as concurrently licensed by the California an FDA-registered outsourcing facility State Board of Pharmacy.3 These two – to also be concurrently licensed by laws set the stage for the dispute in the Board. The plaintiffs argued that Fusion IV v. Sodergren and the resulting California’s regulation of outsourcing decision by the Ninth Circuit. facilities was preempted by the DQSA and that such regulation was an Fusion IV v. Sodergren impediment to interstate commerce, Fusion IV Pharmaceuticals, Inc, also violating the Commerce Clause. known as Axia Pharmaceutical, and The district court rejected both of the
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