Volume 41 Number 4 July/August 2014

An Official Publication of the American Society For Law President’s Michigan Supreme Court Holds Pharmacy Act Message Requirement to Pass on Generic Drug Cost Savings Only Applies to Transactions that Involve Generic Substitutions State ex rel. Gurganus v. CVS Caremark Corp., 2014 WL 2616577 (Mich. June 11, 2014) Laura Carpenter By Roger Morris and Christopher Dang ASPL President In June, the Michigan Supreme Court held that § 333.17755(2) of the Michigan Don’t Miss Pharmacy Practice and Drug Control Act requires to pass on generic drug ASPL’s 25th Developments in cost savings to patients or third party payors only when a pharmacist substitutes a generic in lieu of a prescribed brand-name drug. State ex rel. Gurganus v. CVS Caremark Pharmacy Law Seminar Corp., 2014 WL 2616577 (Mich. June 11, 2014). In Gurganus, the Court reinstated the trial court’s grant of summary disposition in favor of the defendant pharmacies Have you registered yet? This year’s Fall Seminar because the plaintiffs failed to allege that the defendants violated § 333.17755(2). promises to be the best yet because it has been The central issue in Gurganus was the interpretation § 333.17755. Pertinently, expanded to include pharmacy law, regulatory, and § 333.17755(1) provides that when a pharmacist receives a prescription for a brand compliance topics. name product, the pharmacist may, or upon the request of the purchaser shall, dispense I look forward to seeing you between November a lower cost generically equivalent drug if available. § 333.17755(2) requires that “[i] 6 – 9, 2014 in sunny Indian Wells, California (just f a pharmacist dispenses a generically equivalent drug product, the pharmacist shall outside of Palm Springs). ASPL’s Fall Seminar is widely pass on the savings in cost to the purchaser or to the third party payment source...” known as the best, most informative pharmacy law The term “savings in cost” is defined as the “difference between the wholesale cost to educational conference – and our 25th Fall Seminar the pharmacist of the 2 drug products.” promises to follow suit. In addition to learning, you The consolidated plaintiffs brought actions against several defendant pharmacies will also enjoy staying at a beautiful resort, swimming (including CVS, Revco, Kmart, , Perry, Target, , and Wal-Mart) in in one of 7 pools, spending time at the spa, golfing at Michigan, alleging that the defendants violated § 333.17755(2) by charging prices one of many world-class golf courses, shopping on El for generic drugs that produced a higher profit margin than equivalent brand name Paseo Drive, or dining at top-rated restaurants. drugs and by failing to pass on the cost savings to purchasers whenever they dispensed You can earn 15 hours of continuing pharmacy generic drugs, regardless of whether or not the transaction involved a generic drug education credit and 15 hours of continuing legal substitution. education credit. These will include the annual To establish violations of § 17755(2), the plaintiffs relied on data from a single Legislative and Regulatory Update (by Mary Jo West Virginia Kroger pharmacy where one of the plaintiffs had been employed. The Carden, RPh, JD, Senior Director of Regulatory Affairs data revealed the wholesale costs and sale prices of brand name and generic drugs with the Academy of Managed Care Pharmacy), Case that had been sold in 2008 at that specific West Virginia pharmacy. The plaintiffs Law Update (Bill Stilling, RPh, MS, JD, Parsons argued that since the West Virginia Kroger and the Michigan defendants operate in Behle & Latimer, and Roger Morris, RPh, JD, Quarles substantially the same manner, the court could extrapolate the wholesale costs of each & Brady), and Ethics: A Case-Based Approach (Ken of the defendants based on the West Virginia data. Baker, BS Pharm, JD, Renaud Cook Drury Mesaros, Consequently, although the plaintiffs identified more than 2,000 transactions and Bruce White, DO, JD, Alden March Bioethics involving the various defendants, the plaintiffs did not identify transactions that Institute). involved drug substitutions. Instead, the plaintiffs raised transactions that simply This year ASPL has been fortunate to also have involved generic drug sales. The transactions raised lacked detail with respect to the booked many other highly-respected speakers, all of names of drugs prescribed, the actual generic drug dispensed, their costs, and cost whom are speaking on timely and relevant topics. differentials between brand names and generics. Given the lack of particularity, the These include: trial court granted the defendants’ motion for summary disposition. • Mitigating False Claims Act and Consumer The Court of Appeals reversed the trial court, interpreting § 17755(2) to apply Protection Exposure for Retail Pharmacies. This to all transactions in which a generic drug is dispensed and finding the plaintiffs’

Continued on page 7 Continued on page 7 From the States

Federal preemption of Florida drug wholesaler laws under the Drug Quality and Security Act By Martin R. Dix

After much congressional haggling and for drug wholesaling. In particular, there pharmacy warehouse if such transfers are as part of a compromise on the federal were certain federal exemptions from the intracompany sales: compounding legislation, the long awaited definition of drug wholesaling which were • is not the wholesale distribution of Federal drug track and tracing bill was enacted brought to life through the miracle of federal prescription drug; in November 2013 as “The Drug Quality preemption, including “intracompany sales” • does not require a Florida prescription and Security Act” (“DQSA”). One of the and “intracompany distribution of any drug drug wholesale distributor permit; and purposes of the law is to standardize the drug between members of an affiliate.” These • does not require prescription drug pedigree process so there is not a different federal exemptions preclude Florida from pedigrees to be provided at this time, pedigree type process as these drugs move regulating these activities as distributions. It While the declaratory statement applies across state lines. In order to standardize the is likely that the DQSA’s preemption will have to chain pharmacies such as Publix, we have process of wholesale drug distribution among a similar impact in other states. also seen Florida hospital systems that had the states, the DQSA preempts in very broad Florida allows affected persons to seek been previously required to obtain a state terms state laws governing drug wholesaling guidance on the interpretation of laws and permit to distribute drugs among the affiliated beginning on its enactment. rules through a declaratory statement process. hospital members avail themselves of the Specifically, Section 585 of the Act provides: In April 2014 the Florida Department federal preemption and begin distributing (b) WHOLESALE DISTRIBUTOR of Business and Professional Regulation drugs through the intracompany sales AND THIRD-PARTY LOGISTICS issued a declaratory statement clarifying exemption. Hospital systems should be PROVIDER STANDARDS.— the application of the exemption for the mindful of the Robinson-Pattman and intracompany sales of pharmaceuticals. (1) IN GENERAL.—Beginning on the contractual “own use” requirements if they Previously, if one retail pharmacy in Florida date of enactment of the Drug Supply engage in intracompany sales of drugs among wanted to send a bottle of prescription Chain Security Act, no State or political hospital pharmacies. Thus, sales of own use medicine to its sister pharmacy down the subdivision of a State may establish or drugs from an institutional pharmacy to street, it had to obtain a type of wholesale drug continue any standards, requirements, another and drugs sales from a community permit, as well as provide pedigree papers for or regulations with respect to wholesale pharmacy to another should be acceptable. the distribution of the drug. There was also prescription drug distributor or third- Additionally, certain of the large drug a question of whether a chain pharmacy had party logistics provider licensure that are wholesalers are taking the position that to provide a drug pedigree when it returned inconsistent with, less stringent than, they no longer need to provide a Florida a drug to its chain pharmacies warehouse. directly related to, or covered by the compliant drug pedigree and only the federal The Florida Department of Business and standards and requirements applicable pedigree is required, due to preemption. Professional Regulation, Division of Drugs, under section 503(e) (as amended by such Likewise, wholesalers are relying on the Devices and Cosmetics (“Department”) Act), in the case of a wholesale distributor, federal provisions exempting pedigree issued the declaratory statement in response or section 584, in the case of a third-party requirements for distributions from an to a request from Publix Super Markets, logistics provider. authorized distributor of record to determine Inc., a southern multi-state that Florida’s “direct purchase pedigree” is no This preemption of state laws includes chain that operates pharmacies at its grocery longer required in these instances. any state laws “directly related to” the stores. Florida requires wholesale distributors The broad federal preemption likely standards and requirements applicable under of pharmaceuticals to obtain a permit. §§ also applies to other states’ (beyond Florida) section 503(e) for wholesale drug distributors 499.01(1)(d), (2)(d), 499.003(54), Fla. Stat. wholesale prescription drug distribution and section 584 of the Act for third party The Florida law does not include the federal requirements which are inconsistent with the logistics providers and therefore is a very exemption for intracompany sales. DQSA, but potentially impacted companies broad and encompassing preemption. The Department agreed with Publix should carefully review any situations outside This preemption of state law allows that the DQSA preempts state licensing laws Florida and consult with their attorneys pharmacies and other entities to avail that are inconsistent with the federal law and to ensure their actions fall within the themselves of provisions in federal law because found: preemption. the DQSA now preempts the state laws on the Publix pharmacies’ sale of prescription 1. 21 USC 503(e)(3)(B), and 21 CFR 205.3. same subject. There are several examples of drugs from one Publix pharmacy to 2. 21 USC 503(e). This section is not effective the impact of this preemption from Florida, another, the transfer of such drugs if they until January 1, 2015. which had been widely recognized as one of are intracompany sales, and the transfer of Martin R. Dix, JD, is Partner at Akerman, the strictest state regulatory environments drugs between the pharmacy and the chain LLP, in its Tallahassee office.

2 American Society for Pharmacy Law American Society for Pharmacy Law Developments in Pharmacy Law Seminar XXV November 6 - 9, 2014 Hyatt Regency Indian Wells Resort & Spa Indian Wells, California

We invite you to join us to attend 12 informative educational sessions and earn 15 hours of legal and pharmacy continuing education credits while networking with your colleagues and friends.

ACPE Continuing Education Credits Participants may earn up to 15 contact hours (1.5 continuing education units) of Accreditation Council for Pharmacy Education (ACPE)-accredited continuing pharmacy education (CPE) credit. Sessions approved for CPE credit are listed with an ACPE universal activity number and number of continuing education units. To receive credit for successful completion for any activity, the participant must complete an attendance form and an activity evaluation form at the conclusion of the program. Verification of participation will be reported to the CPE tracking service, CPE Monitor, within 4 weeks after the program, and will then be accessible to participants at MyCPEMonitor.net. You will need your NABP e-profile ID to note on your CE form so that it may be reported to CPE Monitor. If you have not yet obtained your NABP e-Profile ID, you may do so by visiting MyCPEMonitor.net, creating an e-Profile, and registering for CPE Monitor. Be sure to register for CPE Monitor to ensure that your e-Profile ID is fully activated. The Washington State University College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. CPE now requires that all pharmacy continuing education (CE) credits must be processed and claimed no later than 60 days from the date of the live activity. Continuing Legal Education Credits If you intend to apply for continuing legal education credits, please be sure to indicate the state (or states) in which you are licensed and the corresponding license number(s) on the conference registration form. Quarles & Brady, LLP will process the CLE credits for the Developments in Pharmacy Law Seminar. Continuing Legal Education credit will be applied for based on attendee return of the “Continuing Legal Education Credit Certificate of Attendance Form” at the conclusion of the seminar.

Register Today at www.aspl.org

American Society for Pharmacy Law 3 American Society for Pharmacy Law November 6 - 9, 2014 Hyatt Regency Indian Wells Resort & Spa - Indian Wells, California Thursday, November 6, 2014 requirements, and increased patient-related demands. John S. Linehan, Ober/Kaler (1 credit hour) 8:30 am – 5:00 pm ASPL Board Meeting 12:00 pm – 1:00 pm Lunch 3:00 pm – 5:00 pm Registration Open 1:00 pm – 3:00 pm Case Law Update 5:30 pm – 7:00 pm ASPL Opening Reception Once again, there have been significant court decisions affecting many areas of pharmacy and the pharmaceutical industry. This presentation will summarize cases involving pharmacy board Friday, November 7, 2014 decisions, pharmacists’ liability, product liability, drug product 7:00 am – 5:00 pm Registration Open labeling, the Federal False Claims Act, anti-kickback claims, and more. 7:00 am – 8:00 am Breakfast Roger Morris, RPh, JD, Quarles & Brady, LLP; William Stilling, RPh, MS, 8:00 am – 8:15 am Welcome JD, Parsons Behle & Latimer (2 credit hours) 8:15 am – 9:45 am Legislative and Regulatory Update 3:00 pm – 3:15 pm Break Federal and state legislative and regulatory activity that impact 3:15 pm – 4:15 pm What’s Next?: The Ever Changing payment for medications, professional services, and government Landscape of Pharmacy Compounding initiatives that impact the quality and safety of medications This presentation will shed light on the expected impact on constantly evolve and legal professionals in pharmacy must pharmacy compounding from the Drug Quality and Security Act understand the impact of these changes to pharmacists and on pharmacies and pharmacists. Attendees will gain insight on the pharmacies. This session will provide an update on the latest history and foundation of pharmacy compounding, highlighting developments in federal and state regulations impacting past case law and FDA guidance and focusing on recent legislative pharmacy and pharmacists including compounding, Medicare and FDA actions. The presentation will focus on both the expected Part D, health care reform, controlled substances, and provider challenges and the likely opportunities for pharmacists presented status. by the DQSA as it is implemented. Mary Jo Carden, RPh, JD, Academy of Managed Care Pharmacy Frank Palumbo, PhD, Esq, University of Maryland School of Pharmacy (1.5 credit hours) Center on Drugs & Public Policy; Lee Rosebush, PharmD, RPh, JD, MBA, MS, BakerHostetler (1 credit hour) 9:45 am – 10:00 am Break 4:15 pm – 5:15 pm Maintaining an Effective Controlled 10:00 am – 11:00 am Update: Mitigating False Claims Act and Substance Compliance Program Consumer Protection Exposure for Retail Pharmacies This session will provide strategies and tools for companies to Retail pharmacies’ vulnerability to whistleblower cases under use in maintaining an effective program to comply with federal federal and state False Claims Acts has grown as government and state requirements on the receipt, storing, distribution and reimbursement expands and costs to government payors dispensing of controlled substances. It also will emphasize areas increase. At the same time, state consumer protection agencies such as where investigators/inspectors are known to focus their are becoming more active in investigating pharmacies and inspections, how to be prepared for these inquiries, when and if threatening injunctions and penalties to enforce their regulations. to authorize employee interviews, the importance of developing This interactive session will review recent enforcement trends for techniques to “audit the investigator” and how to “own your data” retail, mail order and specialty pharmacies. to ensure ongoing compliance and successful audits. Barbara Rowland, Principal; John Joseph, Principal, Post & Schell, PC John A. Gilbert, Jr, JD, Hyman, Phelps & McNamara, PC (1 credit hour) (1 credit hour) 11:00 am – 12:00 pm The Legal Implications of Pharmacist 6:30 pm – 8:30 pm Reception Provider Status: the Past, Present, and Future of a Transformative Movement Afternoon of Golf This presentation will explore the quest for pharmacist provider Are you interested in playing a round of golf on Saturday? We status by outlining the history of the movement, current legislative would play at the hotel golf course (if available) or at a local golf and lobbying efforts, and the potential industry-wide impact and course starting at 12:00 noon. Format (e.g., scramble) and cost will significance of provider designation. In addition to providing up- be dependent upon the number of players, but a fair estimate is to-date information on federal and state legal reforms, this session $130. Please respond to Aaron Moore by Sept. 5, 2014 if you intend will explore how the practice of pharmacy may be transformed to play and/or have any questions at [email protected] or 410- through greater regulatory scrutiny, expanded credentialing

2014 Developments in Pharmacy Law Seminar XXV SEMINAR AGENDA 783-4994.

4 American Society for Pharmacy Law Saturday, November 8, 2014 clinical origins; (2) key jurisprudential cases; (3) supply chain disruption; and (4) fundamental ethical principles involved. Dilemmas in supply chain 7:00 am – 12:00 pm Registration Open disruption are an opportunity for the professions of pharmacy and law 7:00 am – 8:00 am Breakfast to reflect on the objectives of lethal injection in civilized society. James Ruble, PharmD, JD, University of Utah College of Pharmacy 8:00 am – 10:00 am Ethics: A Case-Based Approach (1 credit hour) This session will study legal and pharmacy ethics as they relate to ethical decision-making both for the pharmacist and the 9:00 am – 10:00 am Use of Technology for Telepharmacy and lawyer. The program will explore legal and pharmacy ethics by Remote Dispensing interacting with the lawyers and pharmacists in the audience This interactive session will provide a comprehensive overview of remote while examining decisions and incidents, real and hypothetical, dispensing and telepharmacy regulations from a patient, pharmacy, in both professions. physician, healthcare facility perspective as well as an overview of Ken Baker, BS Pharm JD, Renaud Cook Drury Mesaros, PA; Bruce D. technology advancements in the field of remote pharmacy services. The White, DO, JD, Alden March Bioethics Institute (2 credit hours) session also will focus on a variety of related federal and state regulations 10:00 am – 10:15 am Break as well as operational issues associated with the technology. Practical 10:15 am – 11:15 am Implications of the Drug Quality and operational and regulatory considerations applicable when developing Security Act on Track and Trace Requirements remote dispensing/telepharmacy regulation, particularly concerning On November 27, 2013, President Obama signed into law the the integration of the technology into an existing IT infrastructure will Drug Quality and Security Act (H.R. 3204). Title II of the Act, the be discussed. Drug Supply Chain Security Act, establishes a national system Loreto Grimaldi, JD, Medavail Technologies; Michael Simko, RPh, Walgreens for tracing pharmaceutical products through the supply chain (1 credit hour) and sets national licensing standards for wholesale distributors and third-party logistics providers. This Act will change the way 10:00 am – 10:15 am Break prescription drugs are distributed in the United States over the next 10 years. This session will discuss these changes and their 10:15 am – 11:45 am Marijuana: The Evolving Issues impact on stakeholders. This program will summarize the state of state marijuana laws, legal Martha Russell, Cardinal Health; Susan Pilch, JD, National implications of real-life clinical and business issues that arise in all states Community Pharmacists Association (1 credit hour) as a result of the conflict between federal and state laws, and ethical considerations for attorneys who advise clients and pharmacists who 11:15 am – 12:15 pm What Should CIA’s Be Telling Me? Using participate in a marijuana business. Recent Corporate Integrity Agreements to Inform and Laura Carpenter, RPh, JD, LLM, Carpenter Law Firm PC; William Stilling, RPh, Assess Your Compliance Program’s Effectiveness MS, JD, Parsons Behle & Latimer (1 credit hour) Corporate integrity agreements (“CIAs”) are a common feature of health care fraud settlements and they offer important lessons about expectations for effective compliance programs for health Accommodations: care providers. CIAs shed light on the government’s thinking on A block of rooms has been reserved for the ASPL Seminar at the Hyatt industry best practices, and help organizations to identify risk Regency Indian Wells Resort & Spa, Indian Wells, California. The resort is areas and to benchmark their own compliance practices. This located at 44600 Indian Wells Lane, Indian Wells, California 92210. presentation will discuss trends in recent CIAs and what they Room Rate is $169 plus 11.25% tax. Call 1-888-421-1442 to make your mean for pharmacies and related organizations not under a CIA reservation. Be sure to identify yourself with the ASPL meeting to receive themselves. this special rate. The hotel reservation cut-off date is October 14, 2014. Deborah Gersh, Partner; Brett Friedman, Partner, Ropes & Gray When you make your room reservation, you will need to guarantee (1 credit hour) the room with a credit card. The cancellation of a guaranteed reservation must be received 72 hours prior to arrival to avoid a charge of one night’s 2:00 pm– 4:30 pm Pharmacy Law Educators room and tax. Space is limited so make your reservations today! Join other pharmacy law educators to share information and materials to assist with course development and student Travel: assessment. Air Transportation: The Hyatt Regency Indian Hills Resort and Spa is conveniently located 15 miles from Palm Springs International Airport. Sunday, November 9, 2014 Ground Transportation: 7:00 am – 12:00 pm Registration Open Rental Car: Eight (8) National chains service the Palm Springs International Airport: Alamo, Avis, Budget, Dollar, Enterprise, Hertz, National 7:00 am – 8:00 am Breakfast and Thrifty. 8:00 am – 9:00 am Pharmacy and the Continuum of Lethal Taxi: Taxis are available curbside, outside baggage claim. Approximate Injection cost is $60 (plus gratuity) each way. Lethal injection drug shortages in the US are disrupting the capital Shuttle: Service First Transportation, 760-272-0960. Vehicles punishment process. This program reviews clinical, legal, and accommodate 1-6 passengers in courteous and clean comfort. Fee from ethical implications of lethal injections, including: (1) scientific/ Palm Springs International Airport is $80 (plus gratuity) each way.

American Society for Pharmacy Law 5 2014 Developments in Pharmacy Law Seminar XXV November 6-9, 2014 Hyatt Regency Indian Wells Resort & Spa Indian Wells, California

Last Day to PRE-Register for seminar - OCTOBER 24, 2014 To Register Online Now! Please indicate: Please print or type participant information exactly as you would like it to appear on your badge. Please use a separate form for each registrant.  Pharmacist  Attorney Name: ______ Pharmacist/Attorney Credentials: (i.e. RPh, JD, PharmD, etc.) ______ Student  Technician For CLE Credit, please provide:  Paralegal Licensure State(s): ______License #(s) ______ Other ______Company: ______Address: ______Please indicate which meals you/guests plan to attend: City: ______State: ______Zip: ______Thursday q Reception Phone: ______E-mail: ______Friday q Breakfast q Lunch Medically necessary dietary needs: ______q Reception In case of emergency contact: ______Saturday q Breakfast Sunday q Breakfast Phone: ______Registered guest(s): ______You have a choice between receiving your conference materials electronically on a thumb drive or in a conference  I am a first time ASPL Conference attendee binder. Please select one option.  I plan to attend the Saturday afternoon Pharmacy Law  I want my materials electronically on a Thumb Drive Educators Session  I want my materials in print via a Conference Binder

Register by October 17 For Early Bird Discount FULL CONFERENCE: By 10/17 After 10/17 Registration fee for Seminar includes attendance at all seminar sessions,  ASPL Member $570.00 $645.00 breakfast, refreshment breaks, Thursday and Friday receptions, Friday  Nonmember $700.00 $800.00 lunch and all seminar materials.  Spouse/Guest $225.00 $225.00  Student  Tech.  Paralegal $300.00 $375.00 Cancellation policy: Cancellations must be received in writing. You can email to [email protected] or fax to 217-529-9120. Your cancellation is null One Day Registration: and void unless you receive confirmation of cancellation from the ASPL office.  ASPL Member  Fri $300.00 $350.00 Refund of registration (less a $50 administrative fee) will be granted for cancellations  Sat  Sun $175.00 $225.00 received in writing on or before October 1, 2014. Refund of registration (less a $150 administrative fee) will be granted for cancellations received in writing after  Nonmember  Fri $370.00 $420.00 October 1, 2014 but on or before October 31, 2014. Refunds will not be granted for  Sat  Sun $200.00 $250.00 no-shows or cancellations received after October, 31, 2014 regardless of cause. In  Student  Tech.  Paralegal the event of a no-show or cancellation after October 31, 2014, meeting materials  Fri $175.00 $205.00 will be forwarded to the address provided on your registration form.  Sat  Sun $100.00 $130.00 Total Fees: ______Register on-line at www.aspl.org ASPL is accepting on-line registrations at www.aspl.org Payment Method: or, you can mail registration form to:  Check enclosed for full payment. American Society for Pharmacy Law 3085 Stevenson Drive - Suite 200 - Springfield, IL 62703 Please charge my:  MasterCard  Visa or fax to: 217-529-9120. Card Number: ______Payment must accompany registration. Direct registration questions to Exp. Date: ______CVV#______Janet Bascom at [email protected] or 217-529-6948 Name on Card: ______ASPL is a 501(c)(3) non-profit, voluntary professional association and all contributions Signature: ______are fully tax deductible. The ASPL Federal Tax ID Number is: 52-1250852.

6 American Society for Pharmacy Law Michigan Supreme Court President’s Message Continued from page 1 Continued from page 1 pleadings sufficient for the pleading stage. The session, by Barbara Rowland and John Joseph of Post & Schell, PC, will review recent defendants then appealed to the Michigan federal and state False Claims Acts cases and provide attendees with ideas for how to avoid Supreme Court. and defend such claims. The Michigan Supreme Court vacated • The Legal Implications of Pharmacist Provider Status: The Past, Present, and Future of a the Court of Appeals’ judgment finding that Transformative Movement. John Linehan of Ober/Kaler will explore federal and state legal § 17755(2) only applied when the pharmacist reforms and how pharmacy may be impacted by greater regulatory scrutiny, expanding substituted a generically equivalent drug credentialing requirements, and increased patient-related demands. product in lieu of a prescribed brand-name • What’s Next: The Ever Changing Landscape of Pharmacy Compounding. This session will drug. In arriving at this interpretation, be taught by Frank Palumbo, PhD, Esq., University of Maryland School of Pharmacy the Court pointed to § 17755(1) which Center on Drugs & Public Policy and Lee Rosebush, PharmD, RPh, JD, MBA, MS, states that “[w]hen a pharmacist receives a BakerHostetler. The presentation wsill focus on expected challenges and likely opportunities prescription for a brand name drug product, for pharmacists presented by the Drug Quality and Security Act. the pharmacist may [or, upon request, shall] • Maintaining an Effective Controlled Substance Compliance Program. This session will dispense a lower cost [generic drug].” This address common areas that investigators/ inspectors focus their efforts. John Gilbert, Jr, language, in turn, limits the context of § JD, Hyman, Phelps & McNamara, PC will present his insight gained from responding to 17755(2) to situations where the pharmacist compliance investigations. dispenses a generic equivalent as a substitute • Implications of the Drug Quality and Security Act on Track and Trace Requirements. for a brand name drug. The court also noted Martha Russell, JD of Cardinal Health, and Susan Pilch, JD of National Community that a substitution transaction is inherently Pharmacists Association will explain how the federal pedigree requirements will change required since § 17755(2) states that cost how prescription drugs are distributed in the U.S. over the next 10 years. savings are to be calculated by comparing the • What Should CIA’s be Telling Me? This session, by Deborah Gersh and Brett Friedman of difference between “2 drug products” (i.e. the Ropes & Gray, will discuss trends in corporate integrity agreements and what they mean difference between the cost of the brand name for all pharmacies, even those that are not under a CIA. prescribed versus the generic dispensed). • Pharmacy and the Continuum of Lethal Injection. James Ruble, PharmD, JD, University Turning to the plaintiff’s claims, the of Utah College of Pharmacy, will discuss the dilemmas in supply chain disruption for Court found that the plaintiffs’ reliance the lethal injection drugs. West Virginia Kroger pharmacy data to charge • Use of Technology for Telepharmacy and Remote Dispensing. Loreto Grimaldi, JD, MedAvail various Michigan defendants with systematic Technologies and Michael Simko, RPh, JD, Walgreens will focus on the regulatory and fraud was too tenuous and conclusory to state operational issues with the constantly changing new technologies allowing for telepharmacy a claim upon which relief could be granted. and remote dispensing. Additionally, because the Court found that § • Marijuana: The Evolving Issues. Laura Carpenter, RPh, JD, LLM, BulaLaw, and 17755(2) does not impose a duty to pass on William Stilling, RPh, MS, JD, Parsons Behle & Latimer will discuss the real-life clinical, the savings in cost from all sales of generic regulatory, ethical, and business issues arising from states legalizing medical and recreational drugs, the thousands of transactions raised marijuana. by the plaintiffs failed to highlight relevant • Pharmacy Law Educators. On Saturday afternoon, a session for pharmacy law educators transactions —those in which a generic drug will be dedicated developing strategies for improving courses and student assessment was dispensed in place of a brand-name drug. materials. These overbroad claims could not satisfy the requirement that allegations of fraud be pleaded with particularity. Ultimately, the Court upheld the trial court’s grant of summary disposition, finding that plaintiffs failed to state a claim upon which relief could be granted. Roger N. Morris, JD, RPh, is Partner and 2014 Developments in Pharmacy Law Chairman of Quarles & Brady’s Health & Life Sciences Industry Group, and Christopher Dang, Seminar XXV JD, is Associate at Quarles & Brady’s Phoenix November 6-9, 2014 office. Hyatt Regency Indian Wells Resort & Spa Indian Wells, California Register Today at www.aspl.org

American Society for Pharmacy Law 7 Presorted First Class Mail U.S. Postage PAID American Society for Pharmacy Law Springfield, IL 3085 Stevenson Drive, Suite 200 Permit No. 500 Springfield, IL 62703

Editor: William E. Fassett, PhD, RPh, FAPhA Professor Emeritus of Pharmacy Law & Ethics Washington State University – Spokane [email protected]

Contributing Editor: Roger Morris, JD Quarles & Brady, LLP [email protected]

ASPL Business Office: 3085 Stevenson Drive, Suite 200 Springfield, IL 62703 217-529-6948 Phone 217-529-9120 Fax

Complete Board contact information can be found on the ASPL website Thank you to our Sponsors www.aspl.org Gold Level

Bo a r d o f Di r e c t o r s BulaLaw and Carpenter Law Firm Pr e s i d e n t King & Spalding LLP Laura Carpenter Quarles & Brady LLP Pr e s i d e n t El e c t Steve Gray Silver Level Tr e a s u r e r AbbVie James Boyd Hall, Render, Killian, Heath & Lyman Im m e d i a t e Pa s t Pr e s i d e n t William Stilling MedAvail Technologies, Inc National Association of Boards of Pharmacy

Di r e c t o r s Rite Aid Corporation Brian Guthrie Aaron Moore Bronze Level Karen Peterson Affiliated Monitors Michael Yount Akerman Senterfitt Alixa Rx Baer Law Firm Ex e c u t i v e Di r e c t o r California Northstate University College of Pharmacy Nathela Chatara [email protected] DaVita RX Duane Morris, LLP Rx Ipsa Loquitur Fredrickson, Mazeika & Grant LLP July/August 2014 Lane Powell PC ©2014, American Society for Pharmacy Law Parsons Behle & Latimer All rights reserved. No part of this publication may be reproduced or transmitted in any form or Pharmacists Mutual Insurance Company by any means without the written permission of Roetzel the copyright holder.

8 American Society for Pharmacy Law