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September 2020 | Volume 49 | Number 8

Telehealth Utilization Grows as COVID-19 Transforms Regulatory Landscape CONTENTS

04 09 02 Policy Perspectives  State Board of 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 Utilization Grows Federal Pilot Program May Meet Pandemic Challenges as COVID-19 Transforms Help Stop Online Availability Regulatory Landscape of Unapproved

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 . 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 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 and, therefore, working with the Board? reduce risk for any 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 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 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 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 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-- 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 its owner, Navid Vahedi (collectively, plaintiffs’ arguments. The court ruled “Fusion IV”), argued that California is that California’s state law regulating prohibited from licensing outsourcing outsourcing facilities is not preempted facilities because such state licensing by the DQSA, whether by express or is preempted by the federal DQSA implied preemption. Instead, the district and also violates the Commerce court found that the DQSA contemplates Clause of the US Constitution. concurrent state regulation of federally

2 | SEPTEMBER 2020 POLICY PERSPECTIVES

Additionally, the states without licensure requirements for an FDA outsourcing facility may now consider implementing such laws. One thing is clear – state boards of pharmacy now have a federal appellate court opinion ruling that outsourcing facilities are subject to state oversight and regulation.

registered outsourcing facilities. As pervasive as to make reasonable registered outsourcing facility. But what part of its reasoning, the district court the inference that Congress left no will this mean for outsourcing facilities explained that it was possible for Fusion room for the States to supplement outside of California’s jurisdiction and IV to comply with both federal and state it’ . . . the DQSA clearly allows for other state boards of pharmacy? 1 licensure regulations and thus, there ‘complementary state regulation[s].’” Over 35 states have regulations was no conflict between the DQSA • “There is no conflict preemption, providing for a state license for facilities and California law. Lastly, the district because it is not ‘impossible for a registered with FDA as an outsourcing court determined that California’s private party to comply with both facility. And given the clear ruling by concurrent licensure requirement of state and federal [compounding] the courts in California, it would not federally registered outsourcing facilities requirements.’ Importantly, it is be surprising for these state boards of did not violate the Commerce Clause. possible to obtain authorization under pharmacy to be emboldened in their both the state and federal regulatory future dealings with FDA-registered schemes, because California does not Ninth Circuit Appeal and Decision outsourcing facilities. Additionally, the necessarily require anything more than Having lost at the district court, the states without licensure requirements for registration with the FDA before a plaintiffs appealed the court’s decision facility can acquire a state license.”1 an FDA outsourcing facility may now to the Ninth Circuit and raised the consider implementing such laws. One same two arguments: California is As to the Commerce Clause, the Ninth thing is clear – state boards of pharmacy prohibited from licensing outsourcing Circuit found that Fusion IV “failed to now have a federal appellate court opinion facilities because state licensure of establish that the requirements impose ruling that outsourcing facilities are outsourcing facilities is preempted by a ‘substantial burden’ on interstate subject to state oversight and regulation. the DQSA and the California State commerce,” and thus, there was no This article was written by Libby Baney, law violates the Commerce Clause. violation of the Commerce Clause. JD, and Jonathan A. Keller, PharmD, In a concise and clear ruling, the The Ninth Circuit’s decision was JD, RPh, with Faegre Drinker Biddle & Ninth Circuit affirmed the district clear. It unequivocally upheld the Reath LLP. Please note, the opinions and court’s decision and wholly rejected lower court’s ruling and agreed that views expressed by Faegre Drinker Biddle & the plaintiffs’ arguments. As to the California’s regulatory oversight of Reath do not necessarily reflect the official issue of preemption, the Ninth Circuit outsourcing facilities is not preempted views, opinions, or policies of NABP or any explained (emphasis added): by the DQSA, nor do such state member board unless expressly stated. • “There is no express preemption regulations violate the Commerce Clause’s because the DQSA does not protections against state laws imposing ‘explicitly manifest Congress’s intent unreasonable burdens on federal law. Hyperlinks to footnoted references are to displace state law’ dealing with available in the September 2020 Innovations mass compounding . . . express The Future of State vs Federal pdf on www.nabp.pharmacy. preemption, by its very definition, Regulation of Outsourcing Facilities 1 Fusion IV v. Sodergren, No. 19-55791, WL 3265221 cannot be implied.”1 The Fusion IV v. Sodergren case raised (2020). 2 Drug Quality and Security Act, 21 U.S.C. § 353b (2013). • “There is also no field preemption, interesting arguments regarding federal 3 California Business & Professions Code § 4129 (2016). because ‘the scheme of federal preemption of state law and the 4 Cal. Bus. & Prof. Code §§ 4129, 4129.1, 4129.2 (2016). regulation’ at issue here is not ‘so concurrent state regulation of an FDA-

SEPTEMBER 2020 | 3 Telehealth Utilization Grows as COVID-19 Transforms Regulatory Landscape

“Social distancing,” “shelter in,” and “” relaxed certain Health Portability and Accountability quickly became household phrases when the coronavirus disease Act (HIPAA) requirements, intended to protect patient , 2019 (COVID-19) swept through the United States. The global by issuing waivers that allowed greater utilization of available pandemic strained and threatened to overflow the capacity of to provide telehealth services during the pandemic. the health care system, making it urgent to contain the volume These regulatory changes have helped to drive a massive increase of of COVID-19 cases. At the same time, health care systems – be telemedicine use, at least in some areas. Illustrating the effect this has it , community , or pharmacies – needed a means had, one study found that virtual urgent care visits at NYU Langone to safely provide care and treatments to patients for health issues Health increased by nearly seven times, and non-urgent virtual care other than COVID-19. Telehealth and practice were visits increased by more than 43 times the previous daily averages expanded to meet some of this need. Advances in communication between March 2 and April 14, 2020. Of those telemedicine visits, and access to a regulatory framework already in 56.2% of urgent care and 17.6% of non-urgent visits were COVID- place for telehealth and telepharmacy gave patients continued 19-related. Additionally, data showed that telemedicine use was highest access to care needed for both routine and urgent issues while among patients aged 20 to 44 years old, particularly for urgent care. allowing them to follow state and local orders to stay home. However, patients of all ages demonstrated use of the technology. “Beyond the clinical benefits and more effective utilization of Regulation Changes Increase Utilization providers in very atypical circumstances, the changes instigated When the virus first began to spread in the US, patients and health initially by the COVID-19 pandemic have likely irreversibly care providers began utilizing telemedicine to limit in-person altered the position of telemedicine in the US health care interactions. As part of a wave of regulatory changes spurred by the system,” noted the investigators of the study, published in the public health emergency, Centers for & Services Journal of the American Medical Informatics Association. (CMS) directed an expansion of telehealth services that would allow This exponential growth does not appear to be limited to NYU. doctors, pharmacists, and other health care providers to deliver a According to US News and World Report, an analysis of insurance wider range of care to Medicare beneficiaries in their homes. Among claims in March 2020 showed that telehealth claims increased 4,347%. other provisions, CMS waived limitations on the types of clinical In the Northeastern US, the area hit hardest by the pandemic during practitioners that can furnish Medicare telehealth services. Before this that month, claims rose from 0.1% to 11.1%, an increase of 15,503%. change, only doctors, nurse practitioners, assistants, and Telehealth and telepharmacy have enabled patients to access certain others could deliver telehealth services for Medicare patients. needed health care services while maintaining a lower risk of With the adoption of the new rule, pharmacists were authorized to exposure to or inadvertent transmission of COVID-19. In fact, deliver these services to Medicare beneficiaries. In addition, CMS according to guidelines published by the Centers for Disease

4 | SEPTEMBER 2020 Control and Prevention, expanding access to telehealth may clinics hire pharmacy technicians to compound and mix chemotherapy have reduced the strain on health care systems and helped offices under the supervision of a remote pharmacist via telepharmacy. This conserve personal protective equipment, which has been in supervision is not under the purview of boards of pharmacy, which short supply in many facilities since the pandemic began. may indicate there are insufficient regulations and public protections Although there are still questions about any long-term effect in place. As a result of this discussion, the task force recommended these temporary increases will have on the practice of pharmacy that NABP collaborate with its member boards to better regulate beyond the scope of the pandemic, there are benefits and telepharmacy practice between pharmacies and medical clinics or other conveniences associated with telepharmacy that some patients may facilities that are not currently regulated by the board of pharmacy. be eager to continue. For example, patients with mobility issues or limited access to transportation may find that telepharmacy Potential Limitations visits make the process of getting their much easier. Despite the benefits of telepharmacy and other telehealth Similarly, patients with chronic conditions may be able to practices, there are some known limitations that may present simplify routine pharmacy visits via telehealth technology, with obstacles to pharmacies that wish to utilize these technologies. medications being mailed or delivered directly to their homes. These include situations in which in-person visits are more appropriate due to urgency, underlying health conditions, or Is This the New Normal? the need to perform certain tasks. There are also concerns that This unprecedented growth in telemedicine is expected to have remote health care may make it harder to address sensitive a long-lasting effect on pharmacy, and on health care as a whole. topics, especially in situations when patients are experiencing However, there is some disagreement among industry professionals discomfort, or where privacy may be a concern. In addition, regarding what that transformation – the new normal – will look like. both health care providers and patients are sometimes limited Operation of the technology used to provide telepharmacy by their access and comfort level with telehealth technologies. involves training patients, troubleshooting technological issues, and Another major concern, particularly for pharmacies, involves other skills. Placing the burden of these interstate licensure. Because telehealth allows providers to tasks on existing pharmacy staff can lead to burnout and reduced work with patients who may be hundreds or even thousands patient satisfaction. These issues are explored in an April 2020 article of miles away, demand for licensure in multiple states may published in Pharmacy Times in which the authors suggest that “hybrid increase. In fact, during the COVID-19 pandemic, NABP pharmacy-telemedicine technicians” would be needed to sustain such issued over 51,000 NABP Passports to pharmacists seeking services on a permanent basis. Such technicians would be technically emergency licensure in multiple states to better serve patients trained workers who could act as care extenders by optimizing technical during the crisis. Additional information on that service is aspects of delivering a telepharmacy service while also providing available in the article “NABP’s Experience Enabled Swift patients with IT training and ongoing support, assisting in billing, Development of Passport to Support Member Boards’ COVID-19 and ultimately improving patients’ ability to use the communication Response” in the August 2020 issue of Innovations. technology necessary for effective delivery of telepharmacy services. At the state level, at least 33 jurisdictions allow the practice of Another barrier to pharmacies and other health care providers telepharmacy under varying conditions, according to the 2020 delivering telehealth services comes in the form of privacy regulations, NABP Survey of Pharmacy Law. These policy differences include: particularly the rigorous requirements of HIPAA. The protections of • Geographic restrictions, such as telepharmacy sites not HIPAA are intended to help safeguard patients’ personal information, being allowed within a certain radius of existing pharmacies but since it became law in 1996, some communication technologies • Facility limitations, such as only allowing telepharmacy that could be used for telehealth do not meet all the security services in remote rural clinics, health centers, or health requirements. To provide more flexibility, the US Department of care facilities located in medically underserved areas Health and Human Services and Office for Civil Rights announced • Staffing and education requirements, such as allowing in March 2020 that they would not impose penalties for HIPAA pharmacy technicians to work under the supervision of a violations against providers working in good faith to provide telehealth licensed pharmacist connected via telepharmacy technology using technologies such as Zoom, FaceTime, and Skype. Experts believe that this flexibility will be removed as the pandemic subsides, Through the Model State Pharmacy Act and Model Rules of but see the potential benefit of permanently revising the law to allow the National Association of Boards of Pharmacy, NABP offers greater access to telehealth services. The balance of patient demand for model language to its member boards that may be used to help these services may encourage government agencies to consider allowing establish and clarify telepharmacy-related regulations, including more permanent relaxation of regulations to meet that demand. definitions of telepharmacy technologies and practice, and a section Telepharmacy is not always defined as communication between detailing the practice of telepharmacy and all that it entails. This provider and patient. In the case of practicing pharmacy, telepharmacy language was last updated according to recommendations from technologies have been used to supervise pharmacy technicians. During the Task Force on the Regulation of Telepharmacy Practice. the 2017 Task Force on the Regulation of Telepharmacy Practice, NABP will continue to monitor the effect of the members expressed concern that compounding and drug dispensing COVID-19 pandemic on the practice of telepharmacy that occurs in medical clinics and other facilities is not generally and provide up-to-date information to its members. regulated by the boards of pharmacy. For example, some

SEPTEMBER 2020 | 5 ASSOCIATION NEWS

New Benefit Available to Boards Using the .Pharmacy Domain – NABP Can Handle Annual Renewals

domain name can also simply be configured to direct users to the board’s official website safely and easily. Boards interested in registering a .pharmacy domain name for the first time, or reregistering an expired domain name, may contact NABP at [email protected]. More information about .pharmacy is available in the Programs section of the NABP website.

Why .Pharmacy Verification?

• Displays a “seal” of safety in a website address that cannot be faked by bad actors Boards of pharmacy that utilize a .pharmacy boards are helping to educate patients and • Raises consumer awareness domain name as a path to their board’s pharmacists alike about the dangers of about illegal online drug sellers website address now have an option to illegal online drug sellers. Nearly six years that dispense unsafe products eliminate the administrative task of annual since its inception, the program is growing over the , endangering renewals. NABP can now handle .pharmacy strong, and the .pharmacy domain is gaining the public health domain name renewals on behalf of the recognition as a cyber “seal of approval.” • Cements a board’s reputation boards of pharmacy, if they so choose. Boards that do not currently have a as a leader contributing to the Launched in 2014, the .Pharmacy Verified .pharmacy domain name are encouraged protection of public health Websites Program is dedicated to patient to register one to set themselves out as an safety and protecting the public health example for their licensees and a leader .Pharmacy Annual online by making it easier to recognize in patient safety online. Through the Renewal Form a verified and safe site by simply having .Pharmacy Program, NABP can provide “.pharmacy” at the end of the web address. boards with a short, simple domain name Boards interested in having NABP To date, 34 boards of pharmacy, including that represents their jurisdiction at no cost, handle their annual .pharmacy domain those representing 10 Canadian provinces, while allowing them to keep their current name renewals may indicate their preference on the form found at nabp have joined NABP in creating a safe online website address. While boards have the .pharmacy/dotpharmacy-renewal/. environment through the .Pharmacy option to use the .pharmacy domain name Program. By taking part in this initiative, as their primary web address, the .pharmacy

NABP Accreditations and Verifications NABP awarded a total of 53 accreditations and verifications from April 1 to May 31, 2020. The breakdown by program is as follows:

Drug Distributor Accreditation: Digital Pharmacy Accreditation: .Pharmacy 19 4 Verified Websites: formerly known as Verified-Accredited formerly known as Verified Internet 30 Wholesale Distributors® Pharmacy Practice Sites®

To see the names of businesses accredited and verified by NABP, visit the Programs section of the Association’s website at www.nabp.pharmacy.

6 | SEPTEMBER 2020 ASSOCIATION NEWS

Compounding Pharmacy Information Sharing Network Begins With Pilot Project

Through an expansion of its information licensees and state boards will both be able The MOU does not require boards to sharing network, NABP’s e-Profile systems to enter compounding data and related enter data into the information sharing will soon accommodate the collection, documentation into the system. Licensees network. It does, however, allow boards to management, and sharing of information will do so through their business e-Profile. rely exclusively on the data that has been related to compounding pharmacies in the Boards will be able to enter or annotate data reported to the system by their licensees. Using United States. As announced in October 2019, in a pharmacy’s facility e-Profile page, as well that data, boards will be required to identify the Association was awarded funding from as enter complaints related to drug products for FDA, on an annual basis, pharmacies Food and Drug Administration (FDA) compounded at the facility. These revisions that distribute inordinate amounts of to create a network with the goal of sharing will align with the reporting requirements compounded human drug products interstate. critical information that will help reduce of the FDA final standard memorandum of State boards that do not sign the FDA the risk of injury to patients from understanding (MOU) titled “Memorandum MOU will still have access to the information improperly compounded drug products. of Understanding Addressing Certain sharing network. The information will be Distributions of Compounded Human Drug part of each pharmacy’s facility e-Profile, Pilot Project Kicks Off With Products Between the [Insert State Board of which boards can currently access. Three Main Goals Pharmacy or Other Appropriate State Agency] Development of the network began in June and the U.S. Food and Drug Administration.” Pharmacies Encouraged 2020 as part of a three-year pilot project On May 14, 2020, FDA published a version to Self-Report that will extend into 2022. Implementation of the final MOU for submission to the US NABP will encourage pharmacies to voluntarily of the network is expected to begin in early Office of Management and Budget for review self-report information and will incorporate 2021 with the collection of information from and clearance under the Paperwork Reduction the requirement to input this data into compounding pharmacies. Boards of pharmacy Act of 1995. Once the version intended for the Verified Pharmacy Program® (VPP®) will have access to this information and the use by FDA and the states is published, FDA application and certain other accreditation ability to supplement it. Subsequently, NABP will provide a one-year period for states to program applications. To further incentivize will evaluate the usability of the network and make any necessary legislative or regulatory pharmacies to enter their information into the the accuracy of the information collected changes so that they may sign the MOU. system, NABP will offer each pharmacy the during the pilot and present a final analysis After that time, FDA has indicated that it chance to receive a VPP inspection at no cost to FDA. The pilot focuses on three goals: will begin enforcing the 5% limitation on if they supply the requested information. The • establish a novel information sharing interstate distribution. Section 503A of the inspection will be adapted to serve the dual network capable of collecting, managing, Federal Food, Drug, and Cosmetic Act limits purpose of a traditional blueprint inspection and exchanging data pertaining to distribution of compounded drugs outside the and an audit for the pilot project. state-licensed pharmacies engaged state by a pharmacist, pharmacy, or physician in human drug compounding; located in a state that has not entered into the Benefits for Member Boards • improve upon and increase the amount MOU to 5% of its total prescription orders The expanded information sharing network of information that will be made available dispensed or distributed. States that sign will provide state boards of pharmacy with to the state boards of pharmacy and the MOU agree to identify for FDA those several benefits. It will give them a tool to FDA about compounding pharmacies pharmacies that are compounding human drug report interstate compounding pharmacy that distribute interstate; and products and distributing inordinate amounts information to other state boards of pharmacy • foster better and more targeted regulation of such products interstate. The amount is and FDA. This tool will also organize and and oversight of compounding pharmacies considered inordinate if it is greater than 50% make available information and data needed for the purpose of reducing risk to patients. of the total number of prescription orders for to make informed oversight determinations. To expand the current information sharing compounded human drug products that were The system will also enable boards to network, NABP is revising its existing e-Profile sent out of or dispensed from the facility in prioritize their limited resources to address system for licensees and NABP e-Profile which the drug products were compounded the compounding pharmacies that pose the Connect for boards of pharmacy by adding during the identified calendar year. The greatest risks to patients. Upon completion, new fields and uploading capabilities (see boards will identify these pharmacies by the project will provide a tool to reduce the chart titled “NABP e-Profile System using surveys or reviews of inspection records, risksto patients by fostering better and Changes for Licensees and Boards of data submitted to the information sharing more targeted oversight of compounding Pharmacy” on page 8). Upon implementation, network, or other available mechanisms. pharmacies.

SEPTEMBER 2020 | 7 ASSOCIATION NEWS

In addition, the system improves upon products and compounding pharmacies. For Develop Data-Sharing System for Improved the information currently available to the example, upon a board’s directive, the system Oversight of Compounding Pharmacies,” state boards of pharmacy and FDA about will provide FDA with information about in the Newsroom section of the NABP compounding pharmacies, allowing the complaints of adverse drug experiences and website. In addition, information about boards of pharmacy and FDA to gain a better product quality issues relating to human drug recent compounding pharmacy safety efforts understanding of the interstate distribution products compounded at a pharmacy and by the boards of pharmacy is available in of compounded drugs. Boards will be able distributed interstate. It will also inform FDA the article “Sharing Compounding Data, to uniformly track pharmacies that ship if a board receives any complaints relating Regulators Strive to Increase Patient Safety,” inordinate amounts of compounded drug to human drug products compounded by a in the January 2020 issue of Innovations. products out of state and the kinds of physician or regarding the distribution of any For more information about compounded drug products that they are amount of human drug products compounded NABP’s expanded information sharing shipping and flag these pharmacies for FDA. by a physician and distributed interstate. network for compounding pharmacies, Further, the system will enable state boards For more information about the FDA email the NABP Executive Office at to collect and share information about grant, see the October 2, 2019 news [email protected]. complaints concerning compounded drug release “NABP Receives FDA Funding to

NABP e-Profile System Changes for Licensees and Boards of Pharmacy

For Licensees For Boards of Pharmacy

In their business e-Profile, pharmacies will enter the Through NABP e-Profile Connect, boards of pharmacy will be following information: able to enter information regarding, and upload documents relating to, complaints of the following:

• the number of prescription orders for compounded human • adverse drug experiences and product quality issues relating drug products that the pharmacy sent out (or caused to to human drug products compounded at a pharmacy and be sent out) of the facility in which the drug products were distributed outside the state. Such information includes: compounded during that same calendar year | name and contact information of complainant, if available • the number of prescription orders for compounded human | name and address of the pharmacy that is the subject drug products that were dispensed (eg, picked up by a of the complaint patient) at the facility in which the drug products were | description of the complaint, including a description compounded during that same calendar year of any compounded human drug product that is the With this information, the system will calculate the total number subject of the complaint of prescription orders for compounded human drug products | board’s or state agency’s assessment of whether the that were sent out of or dispensed from the facility in which the complaint was substantiated, if available drug products were compounded during that same calendar year | description and date of any actions the board or state • the total number of prescription orders for compounded agency has taken to address the complaint human drug products distributed interstate during that same • adverse drug experiences and product quality issues relating calendar year to human drug products compounded by a physician and With this information, the system will calculate the percentage of distributed outside the state. Such information includes: compounded human drug products distributed interstate | name and contact information of complainant/notifier, •  the number of prescription orders for sterile compounded if available human drug products distributed interstate during that same | name and address of the physician who is the subject of calendar year the complaint/notification • names of states in which the pharmacy is licensed | description of the complaint/notification, including a • names of states into which the pharmacy distributed description of any compounded human drug product that compounded human drug products is the subject of the complaint • whether or not the compounded human drug products are being distributed without patient-specific prescriptions

8 | SEPTEMBER 2020 ASSOCIATION NEWS

NABP Quickly Shifted Gears to Meet Pandemic Challenges

When state governments across the them the flexibility to help respond to the country began ordering residents to stay pandemic where they were needed most. at home and shelter in place during the Additional details on the NABP Passport early stages of the coronavirus disease 2019 service and its development are available (COVID-19) pandemic, NABP, like many in the August 2020 issue of Innovations. other organizations, met an unprecedented NABP also held weekly phone calls with challenge head on. The Association quickly boards of pharmacy executive directors, staff, mobilized to support member boards of and members to provide updates, gather input pharmacy responding to the public health on board challenges, and create an online crisis by modifying and expanding certain forum for boards to share information and NABP services and creating new channels guidance. NABP Passport, Pearson VUE test of communication about the pandemic. To site availability, pharmacy closures, pharmacy support these responses, NABP was able to staff protocols, and COVID-19 testing were quickly transition staff to a work-from-home among the many topics discussed during in a condensed format, and staff is working to model across all program and service areas. these weekly calls. In addition, guest speakers create virtual ways for attendees to network from Food and Drug Administration, and interact. In addition, NABP has begun NABP Staff Goes Remote Drug Enforcement Administration, offering webinars on topics that would have Illinois began to close in mid-March 2020, and other partner organizations were been included in the Annual Meeting agenda. therefore the Association’s headquarters, invited to provide updates on federal located in Mount Prospect, IL, became guidelines and other related information. Providing Examination subject to state orders limiting gatherings Seats in a Pandemic and eventually requiring schools and NABP Meetings Went Virtual NABP’s examination programs met several businesses to close. Although NABP is For the first time in the Association’s history, challenges, particularly in the early months qualified as an “essential business” under the NABP Annual Meeting was held online. of the pandemic, when shelter-in-place the governor’s orders, the majority of Plans for the traditional 116th NABP Annual orders were the most strict and widespread. employees were transitioned from working Meeting originally scheduled to take place NABP utilizes Pearson VUE testing centers at NABP Headquarters to working in Baltimore, MD, were quickly shifted due to administer all of its examination programs exclusively from home by the end of March to travel bans, shelter-in-place orders, and and due to state-mandated closures, candidate to better protect themselves and their other COVID-19 safety measures. In less scheduling was initially closed. The testing families from the virus. Because there was than three months, NABP transitioned the centers slowly reopened across the country, but already a basic infrastructure in place, the meeting’s three-day, in-person format to a with limited capacity and prioritizing those transition went very well. There were only one-day, virtual meeting format focused on taking examinations for licensure in fields minor disruptions as staff adjusted, and conducting the Association’s annual business deemed essential. NABP worked with Pearson minor tweaks were made to workflows of electing officers and discussing and voting VUE and state governments to ensure that and electronic communication tools. on proposed Constitution and Bylaws pharmacist candidates were among those amendments and proposed resolutions. deemed essential. As a result, candidates New Services Supported The online meeting also featured an address slowly began to have more access to schedule COVID-19-Related Regulation from outgoing Executive Director/Secretary a test at a Pearson VUE site. As states opened That success was instrumental as it enabled Carmen Catizone, the NABP treasurer’s up, and more Pearson VUE sites became NABP to continue to act as a valuable report, the annual award ceremony, and the available, this meant that pharmacy students resource for its member boards with little to report of the executive director delivered and other candidates were positioned to no disruption. In fact, during this transition, by incoming Executive Director/Secretary schedule their tests. NABP worked with NABP was able to successfully develop and Lemrey “Al” Carter. In addition, the Pearson VUE to open additional testing sites. launch the NABP Passport service, which scheduled continuing pharmacy education Simultaneous to these efforts, NABP provided boards of pharmacy with an efficient sessions transitioned to webinars held at a later considered the feasibility of nontraditional means to grant temporary or emergency date. Though attendees certainly missed the alternate testing strategies, including offering licensure to nonresident pharmacists, pharmacy networking opportunities, participants overall a remote testing option for the Multistate technicians, interns, and pharmacies. As an found the meeting engaging and valuable. Pharmacy Jurisprudence Examination® added benefit, those seeking a Passport could The Interactive Executive Officer Forum on (MPJE®). After careful consideration, NABP apply for multiple states, thereby giving September 30, 2020, will also be held online chose not to pursue the remote option, and

SEPTEMBER 2020 | 9 ASSOCIATION NEWS

instead upheld the requirement that the practice. For boards of pharmacy, the web resources on key topics such as controlled MPJE be administered at a Pearson VUE page included a state-by-state compiled chart substances, emergency use authorizations, testing center. One factor in this decision of emergency and temporary orders, policies, and personal protective equipment. In was the result of test center openings and all board statements, and results from a board of addition, NABP e-News was temporarily the previous groundwork between NABP pharmacy survey related to remote processing. expanded to twice a week distribution to and Pearson VUE on making more seats In addition, NABP provided boards with allow for more timely reporting on vital available for those needing to take NABP information regarding preemption of state COVID-19-related information during the examinations. In fact, at least 420 testing and local legal requirements related to the US pandemic. NABP continues to utilize its sites – 138 more sites than last year – are now Department of Health and Human Services Twitter, Facebook, and LinkedIn accounts available to candidates across the country. Advisory Opinion 20-02 on the Public for timely COVID-19 pandemic updates. Readiness and Emergency Preparedness Through close collaboration with its Increased Member Communication Act and the Secretary’s Declaration Under member boards and partner organizations, NABP also broadened its communication the Act. For NABP customers, information the Association has navigated the challenges avenues in an ongoing effort to support was posted on testing center availability and obstacles posed by the COVID-19 its member boards during the COVID-19 and updated requirements, changes to pandemic thus far. As we are all well pandemic. Most visibly, NABP launched exam and accreditation processes, and a aware, more pandemic-related challenges a Coronavirus Updates section on its list of states allowing inspections during lie ahead, and the Association remains website, to relay important updates about the pandemic. Also housed in this section ready and able to continue assisting its NABP programs as well as vital information is the web page “What Pharmacists member boards during this crisis. pertaining to pharmacy and pharmacy Should Know,” which provided a list of

New Online CPE Series Will Keep You Up to Date

and school and college of pharmacy NABP conflict of interest webinar that was representatives presented nine poster displays held in March, are now available related to working together to educate on demand in the Publications section on pharmacy practices to further protect of the NABP website under Educational the public health. Presentations included Programs. All of the 2020 CPE live webinars “Preventative Measures for HIV Vulnerable will also be offered as home study activities Patients in the LGBTQ+ Community,” that are eligible for ACPE-accredited “Maximizing HPV Vaccination Rates CPE credit. The home study versions Through Community Pharmacist will be released about three weeks after Utilization,” “Standard of Care: A National the live versions. Recordings of the live Live and recorded webinars on topics ranging Three-Profession Survey of Health Care webinars are not eligible for CPE credit. from technician roles to cannabidiol (CBD) State Agencies,” and “Expanding the Tentative topics for the live and home now offer more educational opportunities for Roles of Pharmacy Technicians: Why study webinars slated for fall 2020 are a NABP members. These complimentary online Not North Dakota?,” among others. discussion of legal cases and decisions relevant courses are eligible for Accreditation Council The webinar “The CBD Explosion ‒ to board attorneys in September and a for Pharmacy Education (ACPE)-accredited Keeping Out of Harm’s Way,” presented look at pharmacist-provided, medication- continuing pharmacy education (CPE) credit. on July 15, described the pharmacological assisted treatment for patients diagnosed The live webinar series kicked off on June effects of CBD on various human with use disorder in October. 16 with a two-part series titled “Virtual physiological systems; discussed how Promotional emails will be sent to board Educational Poster Session: Uniting to CBD may interact with other drugs; and members and other stakeholders prior to Protect the Public Health.” Each part featured explained the regulatory framework of live webinars with information about the educational posters that were originally CBD. The August webinar (the only 2020 topic, scheduled speakers, and CPE credit intended to be presented during the 116th webinar not eligible for CPE), presented information (if applicable). Links to a NABP Annual Meeting in Baltimore, MD, on August 19, focused on cybersecurity. registration form and an ACPE Activity before the meeting was moved to a virtual The educational poster sessions, CBD, Information Guide will also be provided. format. Seventeen board of pharmacy and cybersecurity webinars, in addition to an

10 | SEPTEMBER 2020 INTERVIEW WITH A BOARD MEMBER

Donna S. Wall, PharmD, RPh Member, Indiana Board of Pharmacy

When were you appointed to the it does has to go back to the governor’s Indiana Board of Pharmacy? Are office. Anything that the Board would like you a pharmacist, technician, to create a regulation on must undergo public member, or other member? an 18-month approval process. At the I was appointed to the Board in 1994 end of the process, the governor’s office as a pharmacist representative. will review the proposed regulation My term on the Board will end at the and determine if it will go into law. end of August 2020, but I will continue to serve on the Board until replaced. What advice would you give to a new board member? What steps should a board My advice is to never forget that you member take to be successful in are accountable to the public for patient his or her role? safety. Learn as much as you can about safe Ask questions of everybody involved with practice and make educating yourself a Indiana Board of Pharmacy the board. Get an idea of what is expected lifelong, ongoing commitment. Knowing of a board member and what you can what is going on in the practice of and cannot do. Arm yourself with that pharmacy – good and bad – makes Number of Board information. Also, spend time researching you a better board member. It is also Members and reading the laws in your state. The important to ask questions and develop 6 pharmacist language that the laws are written in is a confidence in yourself to express your members and 1 little different, so it may take you a while opinions. That is the only way the Board public member to understand them. Discuss the laws with has really good, solid conversations. other board members. Everything you do as Number of a board member must be based on the law. Have you served as a member Compliance of any NABP task forces or Officers/Inspectors What are some recent policies, committees, or attended 7 legislation, or regulations NABP or district meetings? your Board has implemented I was NABP president from 2003–2004 or is currently working on? and have also served on many task forces Rules & Regulations After the March 2020 meeting, the and committees. Since 1994, I have missed Established by Board minimized its activities due to the one annual meeting and a few district Board of Pharmacy coronavirus disease 2019. The Board has meetings. Important issues – many of continued to have virtual meetings for which go beyond the normal work emergency items or functions required environment – are discussed at these by law (licensure and hearings). All meetings. I have had so much exposure to Number of other Board work, like committees people and information that I feel made Pharmacist Licensees and discussion items, was halted. The me a better board member and a more 11,497 August meeting was the first time that knowledgeable and contributing pharmacist the Board had an opportunity to discuss to my employer. I have also met lots of other topics and to start addressing issues new people who I would never have had Number of surrounding technicians, white bagging, the opportunity to meet and to learn what Pharmacies and issues confronting current practices. is happening in their lives, in their states, 1,370 and at the national level. To me, these Has the Board encountered any meetings are very enriching opportunities challenges to developing and/ Number of that not only helped me grow and become Wholesale or implementing new policies, a better pharmacist and a better board Distributors legislation, or regulations? member, but, hopefully, a better person. 409 Because the Board is under the Indiana Professional Licensing Agency, everything

SEPTEMBER 2020 | 11 STATE BOARD NEWS

done for non-controlled prescriptions An amount not to exceed a 72-hour by pharmacy interns. Controlled supply of a Schedule III, IV, or V medication prescription transfers prescription may be provided to the must still be completed between two patient as demonstrated by records pharmacists, as required by DEA. maintained by the pharmacy. A • All records in West Virginia pharmacies pharmacist shall not dispense a particular are required to be kept on site for drug to a patient as an emergency supply one year, then may be kept off site in more than once in any 12-month period. a Portability and • The daily required “printout” of all Accountability Act-compliant manner refills completed and signed within for years two through five. Depending 72 hours has been deleted from on the type of records, the pharmacy the regulations. A verified record would have had a varying time frame must now be retrievable within to produce the necessary records. These 72 hours of when the refill was time frames have all been standardized dispensed when it was requested. to 72 hours for record production, Idaho Requires Mandatory  Additional rule changes that went into regardless of the record type. effect on March 6, 2020, are available PDMP Checks, Launches • The white lab coat is no longer a legal in the Board’s June 2020 Newsletter, Data Dashboard requirement in West Virginia. Wearing which can be accessed via the Boards of Beginning October 1, 2020, Idaho a name tag identifying the individual Pharmacy section of the NABP website. will require all prescribers to check the and showing his or her job designation monitoring program remains a requirement for all pharmacy Wyoming Updates (PDMP) and review the previous 12 months employees. The only individuals who Prescription Tracking of data regarding a patient’s prescription may wear a white coat in the pharmacy Program Rules history prior to issuing the patient a are the pharmacists or pharmacy interns. The Wyoming Legislature passed and prescription for an opioid or • Emergency dispensing rules have been Governor Mark Gordon signed House Bill benzodiazepine listed in Schedules II, updated. If a pharmacist is unable to (HB) 0085, which amends the requirements III, or IV. Exceptions to this requirement obtain a refill authorization from a for using the prescription tracking program include patients receiving treatment health care professional who issued the by requiring a practitioner to search the in an inpatient setting, patients being prescription and the pharmacy at which prescription tracking program as needed when treated at the site of an emergency or in the pharmacist works has a record of the issuing non-opioid prescriptions based on an ambulance, patients in skilled prescription for the drug in the name best practices for CS other than opioids, and facilities or under care, or if the of the patient who is requesting it, a every three months for prescribed opioids pharmacist may dispense an emergency prescription is for three days or less. for as long as the opioids remain a part of supply of a prescription drug of The Idaho State Board of Pharmacy is the patient’s treatment. The act provides life-sustaining medication or continue also implementing a new Tableau reporting for a chronic condition of the Wyoming State Board of Pharmacy program that will allow prescribers to the patient, when, in the professional with rulemaking authority related to the monitor their use of the PDMP. The judgment of the pharmacist, failure to prescription tracking program and specifies report will be generated based on the user’s dispense could result in harm to the that the rules may apply to practitioners, personal Drug Enforcement Administration health of the patient. An amount not to pharmacists, and others who are authorized (DEA) number. If the user has more than exceed a 30-day supply or the standard to use the tracking program. HB 0085 also one DEA number, there will be a report unit of dispensing of a non-controlled authorizes the Board to survey the use of the for each number. This report will allow substance (CS) may be provided to prescription tracking program and report each prescriber to ensure that they follow the patient as demonstrated by records inappropriate use to the professional licensing the mandatory checking PDMP statute. maintained by the pharmacy. board of any offending practitioner. West Virginia Rule Changes Impact Pharmacy Practice State Board News articles are selected from the The West Virginia Board of Pharmacy newsletters of state boards that participate in implemented a number of rules that impact the NABP State Newsletter Program. Five years’ the practice of pharmacy. Such changes worth of issues are posted on the NABP website include the following: on each participating state’s page. • Transfers of prescriptions from one pharmacy to another can now be legally

12 | SEPTEMBER 2020 PROFESSIONAL AFFAIRS UPDATE

Federal Pilot Program May to continue supporting robust investments and Research,” said Patrizia Cavazzoni, MD, Help Stop Online Availability in federal programs to combat both the acting director of FDA’s Center for Drug of Unapproved Opioids ongoing opioid epidemic and COVID-19 Evaluation. “We remain committed to using Food and Drug Administration (FDA) pandemic. Signed by NABP Executive every tool at our disposal in collaboration and the National and Director/Secretary Lemrey “Al” Carter, with innovators and researchers to provide Information Administration (NTIA) have PharmD, MS, RPh, the letter expresses sick patients timely access to appropriate launched a 120-day pilot program to help specific concern about reports that opioid new . Our decisions will always be reduce the availability of unapproved opioids overdoses and abuse may be increasing based on objective and rigorous evaluation of illegally offered for sale online. Under the during the pandemic. the scientific data. This will never change.” program, FDA will notify internet registries “Early data has demonstrated that the that are participating in the pilot when economic downturn, prolonged periods of a company does not adequately respond social distancing, and overall uncertainty of to a warning letter within the required COVID-19 have caused an increase in opioid- Early data has time. These registries will review FDA’s related mortality in at least 30 states,” stated demonstrated that the notifications and assess whether to take Carter. “Congress must continue to consider voluntary action against the company, which the damage caused by the opioid epidemic economic downturn, may include domain name suspensions or and proactively invest in countermeasures to prolonged periods of social blocks. NTIA will work with the registries to ensure this crisis is not further exacerbated assess the impact of the program. by the COVID-19 pandemic.” distancing, and overall On June 17, 2020, NABP responded to The letter also reviews some of the uncertainty of COVID-19 the launch of the pilot program in a letter to Association’s efforts to help its member boards FDA Commissioner Stephen Hahn, MD. respond to the crisis, including expanding have caused an increase in The letter describes the program as being pharmacists’ access to prescription monitoring opioid-related mortality “consistent with NABP’s longstanding effort programs across state lines through NABP to urge internet intermediaries, registries and PMP InterConnect®. NABP also asks Congress in at least 30 states. registrars, to implement policies that could to consider NABP as a potential resource when significantly protect patient safety upon considering legislation and other public health notification from authoritative sources.” policies impacting the practice of pharmacy. The letter also refers to NABP’s most recent The full letter can be accessed in the Role of Pharmacists Emphasized Rogue Rx Activity Report, published in May Newsroom section of the NABP website in Surgeon General’s Report 2020, which details how rogue online under News. on Smoking Cessation pharmacies use crises such as the coronavirus Pharmacists can play an important role disease 2019 (COVID-19) pandemic to FDA Revokes EUA for Chloroquine in helping patients quit smoking, as market potentially dangerous products. and Hydroxychloroquine for highlighted in the Surgeon General’s 2020 The NABP report is available in the Treatment of COVID-19 report on smoking cessation. The report Publications and Reports section of FDA has revoked the emergency use advises pharmacists to recommend the the NABP website under Program and authorization (EUA) for the anti-malaria use of both prescription and over-the- Committee Reports. More information drugs chloroquine and hydroxychloroquine counter medications, when appropriate. In about the pilot program is available in to be used for treatment of COVID-19 under addition, the report notes that authorizing an FDA news release at www.fda.gov/ certain conditions. Citing ongoing analysis pharmacists to prescribe cessation therapies news-events/press-announcements/ and results of recent clinical trials, FDA has and allowing them to bill for interventions federal-government-announces- determined that the drugs are unlikely to be could increase the number of successes. new-pilot-program-help-stop-illegal- effective in treating COVID-19, and that the According to the American Pharmacists availability-unapproved-opioids. risk of serious adverse events outweigh the Association, pharmacists in Colorado, potential benefits of using the drugs to treat Idaho, Indiana, and New Mexico are NABP Urges Congressional the disease. currently authorized to prescribe all Leaders to Continue Supporting “While additional clinical trials continue to cessation medications. Pharmacists can also Federal Programs to Combat Both evaluate the potential benefit of these drugs provide behavior counseling resources, and Opioid Epidemic and COVID-19 in treating or preventing COVID-19, we should continually support and follow up Emphasizing the role that pharmacists and determined the emergency use authorization with patients to help prevent relapses. state boards of pharmacy play in protecting was no longer appropriate. This action was The Surgeon General’s report can be the public health, NABP has sent a letter to taken following a rigorous assessment by accessed at www.hhs.gov/sites/default/files/2020- congressional leadership urging Congress scientists in our Center for Drug Evaluation cessation-sgr-full-report.pdf.

SEPTEMBER 2020 | 13 Presorted First Class U.S. Postage PAID Permit #583 Schaumburg, IL 60173 1600 Feehanville Dr Mount Prospect, IL 60056

UPCOMING EVENTS

NABP Interactive Executive Officer Forum September 30, 2020 | Virtual Meeting NABP/AACP District 4 Meeting October 8, 2020 | Virtual Meeting NABP/AACP Districts 6, 7, and 8 Meeting October 13, 2020 | Virtual Meeting

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