Florida Pharmacy Today August 2019

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The Official Publication Of The Florida Pharmacy Association AUGUST 2019


“I’M ALWAYS WATCHING OUT FOR MY PATIENTS, BUT WHO’S WATCHING OUT FOR ME?”

WE ARE. We are the Alliance for Patient Medication Safety (APMS), a federally listed Patient Safety Organization. Our Pharmacy Quality Commitment (PQC) program: • • • •

Helps you implement and maintain a continuous quality improvement program Offers federal protection for your patient safety data and your quality improvement work Assists with quality assurance requirements found in network contracts, Medicare Part D, and state regulations Provides tools, training and support to keep your pharmacy running efficiently and your patients safe

Call toll free (866) 365-7472 or visit www.pqc.net PQC IS BROUGHT TO YOU BY YOUR STATE PHARMACY ASSOCIATION


florida PHARMACY TODAY Departments 4 Calendar 4 Advertisers 5 President’s Viewpoint

7 Executive Insight

32 Buyer's Guide

VOL. 82 | NO. 8 AUGUST 2019 THE OFFICIAL PUBLICATION OF THE FLORIDA PHARMACY ASSOCIATION

Features

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Are You at the Table Florida Pharmacy Foundation Annual Summary Regulation of Hemp Under the Federal Farm Bill and SB 1020 FPA Regional Directors Florida Pharmacy Association’s 129th Annual Meeting and Convention

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FPA Calendar 2019

Florida Pharmacy Today Journal

SEPTEMBER

NOVEMBER

2

Labor Day - FPA Office Closed

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Regulatory and Law Conference Miami

16-17 - FPA Committee, Council and Board meetings (tentative)

OCTOBER

Veterans Day - FPA Office Closed

28-29 Thanksgiving - FPA Office Closed

12-13 FPA Midyear Clinical Conference Kissimmee

DECEMBER

14-16 Florida Board of Pharmacy Meeting Fort Lauderdale

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Florida Board of Pharmacy Meeting Altamonte Springs

26-29 NCPA Annual Conference San Diego, California

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FPA Law & Regulatory Conference Sarasota

25-26 Christmas Holiday FPA Office Closed

FOR A COMPLETE CALENDAR OF EVENTS GO TO WWW.FLORIDAPHARMACY.ORG

Events calendar subject to change

CE CREDITS (CE cycle) The Florida Board of Pharmacy requires 10 hours’ LIVE Continuing Education as part of the required 30 hours’ general education needed every license renewal period. There is a new 2 hour CE requirement for pharmacists on the dispensing of controlled substances effective this biennial renewal period. Pharmacists should have satisfied all continuing education requirements for this biennial period by September 30, 2019 or prior to licensure renewal. Consultant pharmacists and technicians will need to renew their licenses and registrations by December 31, 2020. For Pharmacy Technician Certification Board Application, Exam Information and Study materials, please contact the FPA office. For more information on CE programs or events, please contact the Florida Pharmacy Association at (850) 222-2400 or visit our website at www.floridapharmacy.org CONTACTS FPA — Michael Jackson (850) 222-2400

FSHP — Tamekia Bennett (850) 906-9333 UF — Emely McKitrick (352) 273-5169

FAMU — Leola Cleveland (850) 599-3301 NSU — Carsten Evans (954) 262-1300

Mission Statements:

Note: The views of the authors do not necessarily represent the views or opinions of the Florida Pharmacy Association, Florida Pharmacy Today or any related entities.

The Florida Pharmacy Today Journal is a peer-reviewed journal which serves as a medium through which the Florida Pharmacy Association can communicate with the profession on advances in the sciences of pharmacy, socio-economic issues bearing on pharmacy and newsworthy items of interest to the profession. As a self-supported journal, it solicits and accepts advertising congruent with its expressed mission.

Florida Pharmacy Today Board of Directors The mission of the Florida Pharmacy Today Board of Directors is to serve in an advisory capacity to the managing editor and executive editor of the Florida Pharmacy Today Journal in the establishment and interpretation of the Journal’s policies and the management of the Journal’s fiscal responsibilities. The Board of Directors also serves to motivate the Florida Pharmacy Association members to secure appropriate advertising to assist the Journal in its goal of self-support.

Advertisers AMERICAN ASSOCIATED PHARMACIES...... 19 KAHAN & ASSOCIATES................................. 18 PQC........................................................................ 2 PARTNERSHIP FOR SAFE MEDICINES......... 9 PHARMACISTS MUTUAL.............................. 32

DISCLAIMER Articles in this publication are designed to provide accurate and authoritative information with respect to the subject matter covered. This information is provided with the understanding that neither Florida Pharmacy Today nor the Florida Pharmacy Association is engaged in rendering legal or other professional services through this publication. If expert assistance or legal advice is required, the services of a competent professional should be sought. The use of all medications or other pharmaceutical products should be used according to the recommendations of the manufacturers. Information provided by the maker of the product should always be consulted before use.

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E-MAIL YOUR SUGGESTIONS/IDEAS TO dave@fiorecommunications.com


The President’s Viewpoint DAVID "CHACHI" MACKERAY, RPH

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I’ll Give You a Piece of My Mind

s I begin my term as FPA president, my mind is filled with so many thoughts and ideas resulting from so many people offering me suggestions and recommendations. They’ve shared what FPA needs to do, as well as what we might consider changing for this upcoming year, and I am greatly appreciative of it all. I’ve received other comments that can be considered a litttle intimidating. “Do you know what you’re getting yourself into?” “Are you sure you’re ready for this?” “Do you really think FPA is going to make a difference for pharmacy?” “I will say lots of prayers for you, as you’re going to need them.” I truly believe that these comments were said with good, heartfelt intentions. However abrasive some were, it only tells me that people feel the desperation and urgency that the pharmacy profession has reached. That’s a good thing. As they say, “One must first recognize that there’s a problem before one can ask for help and begin to fix it.” In my acceptance speech, I mentioned how wonderful it was that so many people had offered their help and assistance if I needed it. Well, guess what? I’m going to need it – lots of it! My leadership team and I can’t do it alone. We need everyone’s involvement, no matter how big or small, as your involvement at any level is so greatly needed and appreciated. Everyone has something to offer. So, don’t be surprised if the next time I see you I ask for help. Membership My first and foremost priority – one that I honestly believe is vital to the success and sustainability of FPA – is membership. I mentioned this phrase in my speech, as many people com-

mented on it: “More members equal more voices, more voices make more noise, more noise makes people listen, and when people listen then change can occur.” It’s very basic but very realistic. A simple request I will ask each of you is to get just one new member to join FPA,

In my acceptance speech, I mentioned how wonderful it was that so many people had offered their help and assistance if I needed it. Well, guess what? I’m going to need it – lots of it! which would then double our numbers. Sounds great right? It’s also pretty easy to do, so why can’t we accomplish this simple little task? That major increase of membership would allow us to create many powerful results for FPA. Other ideas I’ll ask the Membership Affairs Committee to discuss are a “group discount” program, “dual

David Mackeray, RPh

membership” with the local unit affiliates to help lower the cost to those members who belong to both associations and possibly discounts to those members who pay for multiple years at once. We also desperately need to revitalize and induct more members into the prestigious FPA #1 Club, which is open to members who sponsor 10 new active regular members and participate in one retention program. This distinct honor has some valuable perks, which unfortunately have only benefitted one person in each of the past few years, where previous years had multiple members to become inductees. We need to bring this program back to that level again. Thus, you can see that we are always working hard to create ways to increase membership while also giving members the best bang for their buck. Communication Another concern that I’ve heard so many times before is the communicaSee President’s Viewpoint, continued on page 6 AUGUST 2019

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2018-19 FPA Board of Directors The Florida Pharmacy Association gratefully acknowledges the hard work and dedication of the following members of the FPA leadership who work diligently all year long on behalf of our members.

Angela Garcia.....................................................................................................Board Chair David Mackarey..........................................................................................FPA President Kimberly Jones.......................................................................................... FPA Treasurer Joseph Scuro............................................................................................ President Elect Gary Koesten..............................................................................Speaker of the House Eric Larson.......................................................................Vice Speaker of the House Bill Kernan................................................................................................... FSHP President Preston McDonald............................................................................. Region 1 Director Neil Barnett............................................................................................Region 2 Director Larry Alaimo..........................................................................................Region 3 Director Cheryl Rouse.........................................................................................Region 4 Director James Alcorn.......................................................................................Region 5 Director Barbara Beadle...................................................................................Region 6 Director Paul Delisser.......................................................................................... Region 7 Director Ramy Gabriel.........................................................................................Region 8 Director Mitchell Levinson...............................................................................Region 9 Director Julie Burger.......................................................................................Technician Director

Florida Pharmacy Today Journal Board Chair.............................................................. Carol Motycka, motycka@cop.ufl.edu Vice Chair....................................................Cristina Medina, cmmedina@cvs.com Treasurer.........................................................Eric Jakab, ericjakab@hotmail.com Secretary............................................. Julie Burger, julieburger133@gmail.com Member.................................................. Michael Finnick, michaelfinnick@ufl.edu Member.....................................................David Mackarey, dmackarey@aol.com Member.......................................................Matt Schneller, schnem18@gmail.com Member..........................................Teresa Tomerlin, teresapharmd@cfl.rr.com Member............................................Greta Pelegrin, gretapelegrin@yahoo.com Technician Member........................Julie Burger, julieburger133@gmail.com Executive Editor................Michael Jackson, mjackson@pharmview.com Managing Editor...................Dave Fiore, dave@fiorecommunications.com Journal Reviewer....................... Dr. Melissa Ruble, mruble@health.usf.edu Journal Reviewer....................................Dr. Angela Hill, ahill2@health.usf.edu

President’s Viewpoint, from Page 5

tion, or lack thereof, between FPA and its members, students, local unit affiliates, our own committee/councils and, yes, even our own FPA Board of Directors. Being an FPA Board member myself for the past six years, I know that this issue comes up frequently. I’m happy to say that this past year with Dr. Angela Garcia as president and myself as president-elect, we promised each other that this would be a top priority to resolve quickly. Now, I admit it’s far from perfect, but it’s much better than it previously was and it will continue to improve as the current president-elect, Joe Scuro, vowed to maintain its advancement. One fine example of our success was the much needed and overdue remodeling of the outdated FPA website, Pharmview.com. Because of the hard work and dedication of the Public Affairs Committee and so many others, this challenging task was successfully completed. Please check it out if you haven’t already – it looks awesome and will greatly increase the communication among FPA members. Legislation, Advocacy and Policy This next topic is probably the most controversial, costly and least predictable area that causes the most conflicts within FPA. It doesn’t have to be, but usually ends up being such. We can’t ignore it, hide from it or pray that it will go away. It happens to be the foundation of our great country and how the wonderful USA still works today, whether we like it or not. Yes, I’m referring to our legislative, advocacy and policy-making decisions, which affect each of us daily, both personally and professionally. Making decisions within these areas is the way this great country gets things done – or fails to do so – and the pharmacy profession is no different. We first must recognized this fact and join together as one, with a common goal of protecting the pharmacy profession. I know that many pharmacy organizations exist, however. I truly and sincerely believe that if we unite as one large powerful group with simiSee President’s Viewpoint, continued on page 8

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Executive Insight BY MICHAEL JACKSON, RPH MICHAEL JACKSON, BPHARM, EVP & CEO, FLORIDA PHARMACY ASSOCIATION

Would You Fly in a Commercial Airliner Across the Pacific with Only One Pilot?

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ow that is an unusual title for an article in a pharmacy journal. What does this have to do with our profession and why does it matter? Well, it may matter more than one might think. Let’s give this some thought. It takes a large passenger jet a little over nine hours to make the trip from Atlanta, Georgia, to Barcelona, Spain. That’s nine hours of non-stop transit time to the U.S. coast, across the Atlantic Ocean with feet dry over Portugal and finally into eastern Spain, landing in Barcelona near the southern French border. Add in time for preflight planning, cockpit check lists and post-landing procedures and you could easily be looking at a 12-hour work day. Here is where the similarities begin with the profession of pharmacy. We do 12-hour work days as well. However, in many pharmacies the day may begin and end with only a single pharmacist on duty and no other personnel support. Airliners rarely if ever leave the ground with only one pilot in the cockpit. Pilots are responsible for the lives of well over 200 passengers. In many pharmacies, we may be responsible for the lives of hundreds of patients, each with unique medical needs. It is common knowledge that reimbursement for pharmacy services has declined significantly over the years. This includes onerous clawbacks that the PBMs have been executing against paid pharmacy claims. The only way our industry seems to be reacting to this reduction in revenue is to roll back payroll costs by either salary reductions, cutting support staff or both. This means in many cases a pharmacist

could be left alone in a busy pharmacy when there really should be additional personnel on hand to manage the work flow. Pharmacists have to make a lot of critical decisions on the fly (no pun intended with this article) during a typi-

Airliners rarely if ever leave the ground with only one pilot in the cockpit. Pilots are responsible for the lives of well over 200 passengers. In many pharmacies, we may be responsible for the lives of hundreds of patients, each with unique medical needs. cal work day. Pilots do as well, though once altitude is achieved, most of the work is monitoring automated systems to make sure that everything on the aircraft is working properly. Still there are always at least two pilots in the cockpit. We run pharmacies with only one phar-

Michael Jackson, B.Pharm

macist whose tasks include a lot of decision-making that affect patient safety. This summer at convention, the members participating in the House of Delegates adopted an important policy related to the need to ensure support staff in a pharmacy during normal operating hours. That policy was driven by growing member concerns with anemic staffing levels implemented in many pharmacies today. The 2019 House of Delegates endorsed the following statements by resolution: The Florida Pharmacy Association adopts a policy that states that pharmacies are required to have at least one pharmacist and one technician present during operating hours in a pharmacy owned by a company that owns more than two locations. The Florida Pharmacy Association will work to pursue legislative or regulatory changes that require pharmacies See Executive Insight, continued on page 8 AUGUST 2019 |

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FPA STAFF Executive Vice President/CEO Michael Jackson (850) 222-2400, ext. 200

Director of Continuing Education Tian Merren-Owens, ext. 120

Continuing Education Coordinator Stacey Brooks, ext. 210 Coordinator of Membership Christopher Heil, ext. 110 Accounting Coordinator Ashley Gandy ext. 211

FLORIDA PHARMACY TODAY BOARD Chair............................... Carol Motycka, St. Augustine Vice Chair.........................Cristina Medina, Hollywood Treasurer.................................... Eric Jakab, Gainesville Secretary............................. Julie Burger, Pensacola Member.........................Michael Finnick, Jacksonville Member.............David Mackarey, Boynton Beach Member....................................... Matt Schneller, Tampa Member............................Teresa Tomerlin, Rockledge Member...................................... Greta Pelegrin, Hialeah Technician Member..........Julie Burger, Pensacola Executive Editor.......Michael Jackson, Tallahassee Managing Editor...................Dave Fiore, Tallahassee Journal Reviewer........................... Dr. Melissa Ruble Journal Reviewer....................................Dr. Angela Hill This is a peer-reviewed publication. ©2019 FLORIDA PHARMACY JOURNAL, INC. ARTICLE ACCEPTANCE: The Florida Pharmacy Today is a publication that welcomes articles that have a direct pertinence to the current practice of pharmacy. All articles are subject to review by the Publication Review Committee, editors and other outside referees. Submitted articles are received with the understanding that they are not being considered by another publication. All articles become the property of the Florida Pharmacy Today and may not be published without written permission from both the author and the Florida Pharmacy Today. The Florida Pharmacy Association assumes no responsibility for the statements and opinions made by the authors to the Florida Pharmacy Today. The Journal of the Florida Pharmacy Association does not accept for publication articles or letters concerning religion, politics or any other subject the editors/publishers deem unsuitable for the readership of this journal. In addition, The Journal does not accept advertising material from persons who are running for office in the association. The editors reserve the right to edit all materials submitted for publication. Letters and materials submitted for consideration for publication may be subject to review by the Editorial Review Board. FLORIDA PHARMACY TODAY, Annual subscription - United States and foreign, Individual $36; Institution $70/year; $5.00 single copies. Florida residents add 7% sales tax. FLORIDA PHARMACY ASSOCIATION

610 N. Adams St. • Tallahassee, FL 32301 850/222-2400 • FAX 850/561-6758 Web address: www.floridapharmacy.org

President’s Viewpoint, from Page 6

Executive Insight, from Page 7

lar concerns, our chances of success will increase greatly. Why do so many other professions seem to get so much accomplished, while we in pharmacy keep struggling so much constantly? We need to become one strong, powerful, incredible force in order to succeed, not multiple small groups that are easily defeated. Similar to team sports, pharmacy needs to find a way to work together, as does the offense, defense and special players on winning teams. One part alone will not work well nor win championships – I believe this is part of our problem. As you probably know, FPA has a specific group, the Governmental Affairs Committee (GAC), that works tirelessly all year long, nights and weekends, traveling to Tallahassee, fighting for the cause. Committee members work with legislators to educate them on issues that directly affect the health care, well-being and safety of the patients of Florida. This past year, the GAC team, chaired by Eric Larson, in conjunction with the FPA advocacy team from Adams Street Advocacy, did an awesome job at the Capitol and throughout the state. This past year was, in my opinion, the most recognizable that FPA has had in many years. FPA had attendance at so many political events that many legislators are finally beginning to know who we are and understand the importance of pharmacy in health care. We must continue our involvement, with major increases annually to successfully obtain our goals and objectives. I can assure you as FPA president that this years’ GAC, led by Sarah Steinhardt, will continue this fight to have the legislators be more supportive to the needs and concerns of the pharmacy profession. This is certainly an area of our profession that isn’t enjoyable or pleasant, but realistically speaking, it’s vital in advancing and protecting our profession. We can’t ignore, lose sight of or disregard the amount of influence this area has on all of us. For those interested in any of our past or current advocacy and/or legislative issues, please refer to our new and very informative FPA website, Pharmview.com. n

to have at least one pharmacist and one technician present during operating hours in a pharmacy owned by a company that owns more than two locations. These two policy statements are very bold and ask the Association to consider taking action on a matter of significant concern to its members. The Brevard County Pharmacy Association facilitated a survey of its member stakeholders recently that revealed some very interesting results. Over 81 percent of the respondents to the survey reported that there was a reduction in support staffing in their practices and nearly 79 percent felt that the reduction in support staffing affected patient safety. Another question on the survey asked if the intake of fluids was limited during a work shift to avoid needing to use the restroom. Nearly 57 percent of those who responded said “yes.” Clearly these responses to this survey are signs that the above policy is worthy of consideration. How many of us would be willing to travel on an airplane for over nine hours if it was flown by only one person? How many of us would be willing to accept a prescription medication from a pharmacist who was the sole health care provider on duty for over 12 hours? The economics behind staffing is well understood. However, the negative economics of safety-related issues with inadequate staffing cannot be overlooked or ignored. n



Are You at the Table?

By: Larry C. Alaimo, PharmD, FPA Region 3 Director The pharmacy industry is under siege with regulatory hurdles, declining reimbursement and crippling loophole fees known as Direct and/or Indirect Remunerations (DIR). DIR fees are fees that pull back dollars retroactively from pharmacies leaving inflated drug prices at point of sale, lack of transparency of actual reimbursement and many times rendering an underwater claim. Whether you are an independent pharmacy owner, employed by one of the major chains and/or a hospital pharmacist, you are seeing the impacts of DIR fee pressures and the general state of reimbursement. Recently, you’ve seen headlines such as 200 Walgreen store closures, staff reductions at Walmart pharmacies, and numerous independent store closures. The impact of DIR fees is not restricted to community/ retail as the impact extents to specialty pharmacy and hospital systems. (1). So, what can you do. It’s been said that if you are not at the table you are on the menu. Pharmacy needs to be at the table and advocating for pharmacy as a value driver and not a cost center. DIR fees are a symptom of a bigger issue around the continued focus on pharmacy as an opportunity to reduce cost. But the reality is that services you provide and the potential services we can provide drive value that ultimately reduce health care cost, even with increasing script count. The Congressional Budget Office, surveying the literature, assumes that a 1% increase in drug consumption reduces nondrug medical consumption by 0.2% (2). Adherence and appropriate pharmacy care improves health care outcomes and costs. There needs to be a shift in the perception of pharmacy. First, we need to address pressing issues like DIR fees. There

is legislation in Congress that is starting to address DIR fees under the Phair Pricing Act (S. 640/HR. 1034). This bill directs all pharmacy DIR fees, excluding positive incentives, to point of sale, which revises the definition of “negotiated price.” In addition, it requires PBMs/plans to provide pharmacies with claim-level data on DIR fees applied which ensures pharmacy is not reimbursed less than pharmacy’s cost to purchase/ dispense. It also works to establish quality measures that are standardized and pharmacy specific. Does your legislator support this bill? Who is advising your legislators how they should approach this bill? Get a seat at the table. Connect with your legislators, educate them on what pharmacy is and is not. It’s not about complaining, but more about educating. Whether it be a letter, email, call and/or visit, start somewhere. Invite your legislator to see your pharmacy, experience the great services and passion you have for your patients and profession. Educate them on challenges and opportunities and that pharmacy is a value generator and not a cost center. Get involved with your state and/or local associations. Someone’s sitting in the shade today because someone planted a tree a long time ago. ~ Warren Buffett Plant the tree for your future and the future of pharmacy. Take action now, let your voice be heard and let’s get off the menu. https://www.ashp.org/Advocacy-and-Issues/Key-Issues/ Drug-Pricing/ASHP-Issue-Brief-Direct-and-Indirect-Remuneration-Fees https://www.cbo.gov/sites/default/files/112th-congress-2011-2012/reports/43741-MedicalOffsets-11-29-12.pdf

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ANNUAL SUMMARY

Congratulations to all of our 2019 Award Winners. Your commitment to the profession of pharmacy continues to inspire those around you.

After Black Friday and Cyber Monday is‌.

Thanks to our donors, colleagues and friends for attending the 1st Foundation Celebration at the NOVA Oceanographic Center. It was a success and we had a great time. Next year it will be even better. The Foundation supports the profession of pharmacy with student scholarships and awards that recognize our colleagues who are doing great work. Our website is currently undergoing maintenance but please register with your email at the link below to receive notifications when the site returns live. Your Privacy is Guaranteed.

https://www.flpharmfound.org/ AUGUST 2019 |

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Regulation of Hemp Under the Federal Farm Bill and SB 1020 By T.J. Morton, The Lockwood Law Firm

On May 3, 2019, the Florida Legislature passed SB 1020 which paved the way for the legal cultivation, distribution, and sale of hemp and hemp extract in Florida, effective July 1, 2019. The passage of SB 1020 mirrors a recent shift in attitude toward hemp and hemp-derived products. The prohibition on hemp cultivation and production has been steadily relaxing in recent years. Last year, Congress passed the 2018 Farm Bill (the “Farm Bill”), legalizing industrial hemp as an agricultural product. A notable change resulting from the Farm Bill is that hemp is no longer a part of the federal definition of “marijuana” and as such, no longer considered a federal controlled substance. SB 1020 takes advantage of changes brought by the Farm Bill and legalizes the cultivation of hemp and the retail sale of hemp and hemp extract under certain conditions. This article examines federal regulation of hemp under the Farm Bill and state regulation of hemp under SB 1020. Federal Regulation of Hemp under the Farm Bill The Farm Bill made two significant changes to federal law relating to hemp. First, it removed hemp from the Federal Controlled Substances Act (“Federal CSA”) by amending the definition of “marihuana” to specifically exclude hemp and by excluding tetrahydrocannabinols (“THC”) in hemp from Schedule I. Next, the Farm Bill authorized states to create hemp production programs beyond the university research setting. Prior to the passage of the Farm Bill, only universities or state departments of agriculture could cultivate hemp for research purposes. Under the Farm Bill, once a state has created a hemp production program which has been approved by the United States Department of Agriculture, states can begin issuing licenses for the production of hemp for commercial purposes to private entities. Just as important as what the Farm Bill changed, is what the Farm Bill did not change. The Farm Bill did not address the retail sale of hemp and hemp-derived products, such as cannabidiol (“CBD”) oil, or the legality of hemp under state law. The Farm Bill also did not change the Food and Drug Administration’s (“FDA”) authority to regulate products containing hemp and hemp-derived products under the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”). This means that even if a product meets the definition of hemp under the Farm Bill, it still must comply with all other applicable laws, including the FD&C Act. Whether hemp-derived products are legal under the FD&C 12

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Act primarily depends on the intended use of the product and how it is marketed. The FD&C Act regulates, among other things, food, drugs, cosmetics, and dietary supplements. According to the FDA, other than Epidiolex, no products that contain CBD may be sold as a drug. The FDA also takes the position that CBD products may not be sold as dietary supplements. Similarly, the FDA does not allow for the sale in interstate commerce of food to which CBD has been added. On the other hand, the FDA generally allows for CBD products to be sold as cosmetics as long as the products are not adulterated, misbranded, or make any claims that would cause the product to be treated as a drug. The FDA’s regulation of CBD products underscores the complex federal regulation of hemp-derived CBD that continues to exist despite the passage of the Farm Bill. State Regulation of Hemp under SB 1020 During the 2019 legislative session, and in response to the passage of the Farm Bill, the Florida Legislature passed SB 1020. SB 1020 made three significant changes to Florida law regarding hemp and hemp extract. First, SB 1020 amends the definition of “cannabis” in the Florida Controlled Substances Act (“Florida CSA”) to exclude hemp. Previously, “cannabis”, a Schedule I controlled substances, was defined as: [A]ll parts of any plant of the genus Cannabis, whether growing or not; the seeds thereof; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant or its seeds or resin. The term does not include “marijuana,” as defined in s. 381.986, if manufactured, possessed, sold, purchased, delivered, distributed, or dispensed, in conformance with s. 381.986. Hemp and hemp-derived products fell within this broad definition of “cannabis”. SB 1020 changes hemp’s status un-

THE RECENT PASSAGE OF THE FARM BILL AND SB 1020 MARK A MONUMENTAL SHIFT IN THE LEGALITY OF HEMP AND HEMPDERIVED PRODUCTS.


qualify as an independent testing laboratory. First, the laboratory may not have any interest in the entity whose product is being tested. Second, it may not have any interest in a facility that is involved in the cultivation, processing, distribution, or sale of hemp in this state or any other jurisdiction, or in a medical marijuana treatment center licensed under section 381.986, Florida Statutes. Third, it must be accredited by a third-party accrediting body as a competent testing lab pursuant to ISO/IEC 17025 of the International Organization for Standardization. Currently, independent testing laboratories are not required to be licensed by DACS. It is unclear whether independent testing laboratories will be subject to state regulatory authority in the future.

der Florida’s CSA by amending the definition of “cannabis” to specifically exclude hemp and industrial hemp. Thus, effective July 1, 2019, hemp and hemp-derived products, such as CBD, are no longer controlled substances under either the Federal CSA or the Florida CSA. The second major change effectuated by SB 1020 is the creation of a state hemp program. The bill directs the Department of Agriculture and Consumer Services (“DACS”) to regulate the cultivation of hemp in Florida by issuing licenses, upon approval of the state program by the United States Secretary of Agriculture, to persons and entities that meet certain requirements. In addition, the bill makes it unlawful to cultivate hemp in Florida without a license issued by DACS. The third significant change to Florida law brought about by SB 1020 is the authorization of the distribution and retail sale of hemp extract, such as CBD, under certain circumstances. The bill defines “hemp extract” as “a substance or compound intended for ingestion that is derived from or contains hemp and that does not contain other controlled substances.” Under the bill, hemp extract may only be distributed and sold in Florida if it has a certificate of analysis prepared by an independent testing laboratory that states the hemp was batch tested by the laboratory, the batch’s total delta-9-THC concentration does not exceed 0.3 percent, and the batch does not contain contaminants unsafe for human consumption. The packaging of the hemp extract must include a scannable barcode or quick response code linked to the certificate of analysis from the independent testing laboratory, the batch number, the internet address of a website where batch information may be obtained, the expiration date, the number of milligrams of hemp extract, and a statement that the product contains a total delta-9-THC concentration that does not exceed 0.3 percent. Notably, SB 1020 does not require hemp extract distributed or sold at retail to be obtained from a Florida licensed hemp cultivator; however, it must comply with the laboratory testing and packaging requirements. SB 1020 establishes three requirements for a laboratory to

Conclusion The recent passage of the Farm Bill and SB 1020 mark a monumental shift in the legality of hemp and hemp-derived products. No longer a controlled substance, hemp can now be lawfully grown and possessed in Florida. SB 1020 clears the path for the lawful retail sale of hemp extract, including CBD, under certain circumstances and will likely accelerate the growth of an already burgeoning industry. Despite these recent changes that clarify the legal status of hemp and hemp extract, there are still some uncertainties regarding the lawful sale of the products, particularly under federal law. State and federal legislation and agency regulations regarding hemp should be monitored closely as the regulation of hemp will continue to come into sharper focus in the near future. Disclaimer This article does not, and is not intended to, constitute legal advice. Instead, the article is for general information purposes only. Readers should contact their attorney to obtain advice as to any specific matter, including whether a particular product may be lawfully sold. REFERENCES 1. 2. 3. 4. 5.

Governor DeSantis signed SB 1020 into law on June 25, 2019. Section 12608 of the 2018 Farm Bill. Section 10113 of the 2018 Farm Bill. Id. https://www.fda.gov/news-events/public-health-focus/ fda-regulation-cannabis-and-cannabis-derived-productsquestions-and-answers#legaltosell 6. Id. 7. Id. 8. Id. 9. Section 893.02, F.S. (2018) 10. Lines 267-279 of CS for CS for SB 1020 available at: https:// www.flsenate.gov/Session/Bill/2019/1020/BillText/er/PDF 11. Lines 65-67 of CS for CS for SB 1020 12. Lines 128-140 of CS for CS for SB 1020 13. Lines 141-152 of CS for CS for SB 1020 14. Lines 68-79 of CS for CS for SB 1020

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FPA Regional Directors Do you know your Regional Director? Take a look at the map below and follow this link to reach out. www.floridapharmacy.org/page/FPAlRegionalDiectors

Regional directors have the most up-to-date information related to pharmacy issues and legislation affecting your areas. What issues do you see at your practice site? Reach out to work with others facing similar issues in your community.

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FROM THE 129TH FPA CONVENTION

Launch Your Profession Forward Florida Pharmacy Association’s 129th Annual Meeting and Convention July 11-14, 2019

Top Row: FPA Past Presidents and president Angela Garcia Bottom Left: EVP Michael Jackson and Senator Gary Farmer Bottom Right: FAMU Dean Johnnie Early and FAMU Graduates

AUGUST 2019

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FROM THE 129TH FPA CONVENTION

Thank You

The FPA recognizes the importance of the support of all the Sponsors and Contributors to the 129th Annual Meeting & Convention. We would like to offer them a sincere thank you for helping to make our program a wonderful success.

2019 Convention Sponsors & Contributors

GOLD

AbbVie Women’s Health

Pharmacists Mutual Insurance Company

SPONSORS Cardinal Health Empire Pharmacy Consultants

EPIC Pharmacies

PharmEd by Pocket Nurse

Partnership for Safe Medicine, Inc

Wolters Kluwer Health / Lexi Comp

Exhibitors AbbVie Women’s Health

QS/1

Marina del Palma Yacht Club

Real Value RX

Aspen RxHealth

APCI

Medicare’s Limited Income NET Program (LINET)

Sunstate Nootropics, LLC

BIOLYTE

Micro Merchant Systems

CVS Health

Persona

American Associated Pharmacies

BestRx Pharmacy Software

McKesson Corp

Merck & Co., Inc.

Smart-Fill

Smith Drug Company

Sushoo/AL Cloud Care Therapeutics MD

Cardinal Health

Omnis Health

E-FORCSE Florida’s Prescription Drug Monitoring Program and Foundation

Pharmacists Mutual Insurance Company

University of Florida College of Pharmacy

ExeGi Pharma

Pharmacy Cure All

Westshore Financial Group

EPIC Pharmacies, Inc. FastFingerprints

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Pharmacists United for Truth & Transparency Pharmacy-Lite Packaging

Florajen Probiotics

PharmEd by Pocket Nurse

Integral Rx

Pure Science Remedies

Gulf Coast Pharmaceuticals Plus

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Liberty Software

Air Force Recruiting Service

FLORIDA PHARMACY TODAY

PioneerRx

Tobacco Free Florida AHEC Cessation Program Veltek Associates, Inc.

Washburn & Associates


FROM THE 129TH FPA CONVENTION Top Left: Past FPA presidents (from back left) Joy Marcus and Betty Harris (seated) Suzy Wise, Angela Garcia, Kathy Petsos and Theresa Tolle Top Right: Angela Garcia & Sarah Steinhardt Middle: Past FPA presidents (from back left) Eric Alvarez, Humberto Martinez, Goar Alvarez, Terry Gubbins, Tim Rogers, Scott Tomerlin (seated) Allen Nichol, Ed Hamilton, Mark Hobbs, Paul Ackerman Bottom Left: Dancing to the music at the Awards event Bottom Right: Angela Garcia, Peter Won and Alyson Lozicky

AUGUST 2019

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FROM THE 129TH FPA CONVENTION

Keeping a Pulse

2019 Award Recipients Each year the Florida Pharmacy Association recognizes individuals who have shown their commitment to pharmacy in many exceptional ways. These award recipients continue to strive for excellence in their profession, meeting

The following awards were presented during the 129th Annual Meeting and Convention at the Marriott Resort Harbor Beach Resort and Spa.

challenges and opportunities while demonstrating their commitment to their respective communities.

Frank Toback/AZO Consultant Pharmacist Award presented to Tim Rogers. DCPA Sidney Simkowitz Pharmacy Involvement Award presented to Angela Garcia NASPA/APhA Bowl of Hygeia presented to Carmen Aceves Gordon NASPA-Upsher Smith Excellence in Innovation Award presented to Timothy Edminister Interamerican Pharmacist Association’s (IPA) Roman Maximo Corrons Inspiration & Motivation Award presented to Kathy Petsos

Kathy Petsos presents the #1 Club plaque and jacket to Angela Garcia

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FLORIDA PHARMACY TODAY

Jean Lamberti Mentorship Award presented to Erin Dorval R.Q. Richards Pharmacy Public Relations Award presented to William Garst Pharmacists Mutual Companies Distinguished Young Pharmacist Award presented to Sarah G Haley #1 Club New Member Plaque presented to Angela Garcia


FROM THE 129TH FPA CONVENTION

on Pharmacy Photography courtesy of Peter Won

Steven Shafor and FPA member Bob Renna receive their 50 year license pharmacist certificate from the Board of Pharmacy

Jean Lambertu Mentorship presented to Erin Dorval

Tim Rogers receives the Consultant Pharmacist Award from Angela Garcia

Technician of the Year Award presented to Julie Burger James H. Beal “Pharmacist of the Year” Award presented to Suzy Wise

National Alliance of State Pharmacy Association Nonprescription Medicines Academy Game Show 1st Place: Larkin (Scott Arrighi, Jessica Bruno and Taylor Harris)

Poster Awards 1st Place - Divya Desai, Javier Herrera, PBAU 2nd Place - Malak Hasan, PBAU 3rd Place - Lizette Taveras, PBAU

Most Outstanding Exhibit Award 1st Place – Aspen Rx Health 2nd Place – Integral Rx 3rd Place – BIOLYTE

Student Patient Counseling Competition 1st – Jaimie Myers, USF 2nd- Morgan Everson, FAMU 3rd – Angela Mathany, USF

Board of Pharmacy 50 Year Certificate presented to Robert Renna and Steven Shafor

AUGUST 2019

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FROM THE 129TH FPA CONVENTION

129th Annual Meeting and Convention

Betsy Petsos presents the Roman Maximo Corrons Inspriation and Motivation Award to Karen Whalen

Rosamond Pappy.(L) amd friend.

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FLORIDA PHARMACY TODAY

NASPA-Upsher Smith Excellence in Innovation preented to Timothy Edminster

APhA-NASPA Bowl of Hygeia presented to Carmen Aceves Gordon

Bill Eley from APCI presents Mark Hobbs a contribution for the FPA Political Action Committee


FROM THE 129TH FPA CONVENTION Florida Pharmacy Association Award presented to Marjorie Diaz

Technician of the Year presented to Julie Burger

The James H. Beal Award presented to Susan Wise

AUGUST 2019

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FROM THE 129TH FPA CONVENTION

129th Annual Meeting and Convention

NASPA game show

Jeanette Connelly presenting appreciation award to Raul Correa

Adopt-A-Student The Florida Pharmacy Association would like to thank the 2019 Mentor Sponsors of the Adopt-AStudent program:

Paul Ackerman – Bronze Sponsor Alachua County Pharmacy Association – Platinum Sponsor Brevard County Pharmacy Association – Silver Sponsor Betty Harris – Gold Sponsor Angela Hill - Bronze Sponsor Howard Kichler – Bronze Sponsor Recognition awards to Raul Correa and Alyson Lozicky for their work on the Public Affairs Council

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FLORIDA PHARMACY TODAY

Rosamond Pappy - Bronze Sponsor Kathy Petsos - Bronze Sponsor


FROM THE 129TH FPA CONVENTION The Pino family having a good time at convention

50 Year Pharmacist Steven Shafor addresses FPA House of Delegates

AUGUST 2019

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FROM THE 129TH FPA CONVENTION

2 0 1 9 F PA 5 0 -Y E A R P H A R M A C I S T S 50-Year Pharmacists Honored

Those who have served our profession as pharmacists for a half-century were honored at the 129th Annual Meeting and Convention. We are grateful for these pioneers who have seen our profession evolve over five decades and have played such an important role in making pharmacy what it is today. William Andrews** (FPA Member since August 1990) IN ATTENDANCE Kamel Batteh** (FPA Member since May 1982) Roger Berman James Bryant

Franklin Page Fred Phifer

Emanuel Donati

Thomas Sawdon

Gerald Dubois

Daniel Seckler** (FPA Member since December 1985) IN ATTENDANCE

William Everett** (FPA Member since August 1984) Rose Ferlita** (FPA Member since June 1984) Theodore Frederickson Walter Griffin Donnie Hicks TOP EVP Michael Jackson and FPA General Counsel TJ Morton working the House of Delegates

Hubert Holcombe

ABOVE Organizational Affairs Council Chair Humberto Martinez presents governing documents to the House of Delegates

Leonard Longo

Donna Jordan James Lumbard Stanley Majewski Charles McArthur** (FPA Member since January 1972)

FLORIDA PHARMACY TODAY

James Norris

Eugene Coulter

Ethel Evans

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Melvin Norfleet

Robert Renna** (FPA Member since January 1972) IN ATTENDANCE

Michael Christian

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Courtney C. Moore** (FPA Member since November 2003)

Steven Shafor James Singletary Michael Stamitoles** (FPA Member since January 1972) James Syfrett Roger Tateishi Vincent Trunzo Shirley Wilkie Gerd Zeiler** (FPA Member since September 2002) IN ATTENDANCE

** denotes FPA lifetime member


FROM THE 129TH FPA CONVENTION

FPA RECOGNIZES THOSE WE LOST IN 2018-19 During the 129th Annual Meeting and Convention in Ft. Lauderdale, the Florida Pharmacy Association recognized the passing of the following FPA members. We are grateful for their contributions and remember them with fondness and respect.

IN MEMORIAM* Ken Bauer- Palmetto Salvatore Gaetano Venetia, Pennsylvania John Hawes – Tampa Raymond E. Johns - Winter Haven Attendees enjoy the student mentor social

Hoke Stephens Johnson Jr. – Ormond Beach Cordy Massy – Port St. Joe Cecil R. Phillips– Jay (FPA Life Member) Malcom (Ken) Pfeiffer – Pensacola (FPA Life Member) Gene (Edgar) Sego – Titusville (FPA Life Member) Stu Ulrich- Boynton Beach Arthur Wharton – Gainesville

Board Chair Suzy Wise addresses House of Delegates

*This list is believed to be accurate as of the convention. If any names were omitted, please contact the FPA office.

AUGUST 2019

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