IACP News Roundup - December 21, 2017

To keep you informed on all of IACP  member-driven initiatives  and latest legislative & regulatory updates, IACP has debuted a weekly  News Roundup ! Check out this week's report below, and email us at  [email protected]   with questions.



Happy Holidays to You and Yours! Upcoming IACP Holiday Schedule: IACP will be closed Monday, December 25th through Tuesday, January 2nd. Please email us at [email protected] if you need to reach us! 

ABOUT

IACP Presidents' Address: A Look Back, and a Look Forward.

A Conversation with Baylor Rice and Erik Tosh
IACP President Baylor Rice, RPh, FIACP

Happy Holidays! Happy New Year!  As we near the end of 2017, I'd like to take few moments to review the last year with you. I firmly believe we cannot hope to go forward if we don't take time to review and assess the road travelled. When I became your IACP President last December, I  wrote you  about all the things I wanted to accomplish during my term. 

Looking back at this list - I am so proud on how much we have accomplished, TOGETHER!  One of the best things we did this year was hire new Executive Vice President Cynthia Blankenship, Esq. In her brief tenure as EVP, Cynthia has brought a burst of high-octane energy into our world. 

Read her  Member Initiatives  Progress Report and you will get an idea of just how much has been accomplished! After you read these Member Initiatives, you will understand that we are undergoing a dramatic revitalization at IACP. A transformation that is designed  specifically for YOU the member.
 
Please click here to read  IACP Presidents' Address: A Look Back and a Look Forward, including remarks from IACP President-elect Erik Tosh BS, RPh, FIACP, FACA !  



EVP Tracker
  • IACP wants you to have access to the EVP, the staff, as well as the Board of Directors. Stay up-to-date on where IACP's Executive Vice President Cynthia Blankenship, Esq. is traveling, and set-up meetings or come by and say hi! Keep up-to-date on Cynthia's whereabouts with the EVP Tracker and let her know if you would like to host a townhall or meeting at your pharmacy! 
Next on Cynthia's travel plans:
Cynthia Blankenship,Esq.
IACP Executive Vice President

* IACP EVP Cynthia Blankenship has been appointed as the United States Pharmacopeia (USP) delegate representing IACP. The delegate is invited to attend the USP five-year meeting in 2020 and the twice per year Compounding Expert Committee (CEC) meeting as an observer. 

Member Initiatives
  • IACP Initiatives - A Progress Report Card! Keep tuning in to IACP's  Executive Vice President (EVP) Cynthia Blankenship's Member Initiatives  t o see where we're making progress and what we're checking off the list! You asked IACP for several key changes - and we're making them! IACP is in the midst of reviewing & revitalizing ALL of our current programs. We want to ensure we're completely in tune with our membership, providing you with what you need. Do you have suggestions or questions? Please email  [email protected] .   
IACP Board of Directors Results to be Announced Soon!
  • Thank you to all those who voted in the IACP Board of Directors election, which closed on December 15th! The Board sets direction for the organization, serves as visionaries for the future of pharmacy compounding, and generates results. Board members contribute their time, energy and ideas to lead the organization forward and in turn, lead the compounding profession to greater success. Your vote is important to IACP as we elect individuals to lead our association into the future. Stay tuned as results to be announced soon!
NEWSROOM

Member Alerts
Media

  • To prepare for USP Chapter <800>, pharmacies must ensure that they are meeting the right compounding compliance standards. A presentation held at the ASHP 2017 Midyear Clinical Meeting and Exhibition provided an overview of the key steps pharmacists should take to improve their compounding practices.
  • Kevin Hansen, PharmD, MS, BCPS, who is the Assistant Director of Pharmacy at Moses H. Cone Memorial Hospital addressed priority areas that pharmacists should focus on ahead of USP <800>, which takes effect July 1, 2017. 
Politico -  Pulse
  • Justice settlement may be first of many on drug coupons. United Therapeutics has reached a $210 million settlement with the Justice Department over its handling of a drug coupon program, marking the start of what could be a broader crackdown on pharmaceutical industry-funded copay charities, POLITICO's Sarah Karlin-Smith reports.
  • At least four other major drugmakers - Jazz Pharmaceuticals, Celgene, Pfizer and Gilead - have received subpoenas recently about their relationships with charities. The Justice Department accused United Therapeutic of violating the False Claims Act by paying kickbacks to induce Medicare patients to purchase the company's drugs. More for Pros.
  • Boehringer Ingelheim pays $13.5 million settlement to resolve multistate probe. The pharmaceutical company's settlement with all 50 states and the District of Columbia followed charges about its off-label marketing of its prescription drugs Aggrenox, Atrovent, Combivent and Micardis.
MEMBERSHIP

Membership Surveys
  • IACP's Veterinary Compounding Survey is Out! We have heard your suggestions through the Membership survey, and your Educational Committee has developed a Vet Compounding Survey to make sure IACP is providing the resources you need. Survey was emailed to all IACP Members. Please take a moment to fill out the survey by December 25, 2017! Take the survey here.
ADVOCACY

Federal Advocacy
  • DQSA Coalition - Appropriations Update  - IACP Members: the Appropriations deadline is rapidly approaching! We are diligently working with the  DQSA Coalition  to ensure language is included in  FY 2019 Appropriations  that addresses our continuing concerns on how the  Food & Drug Administration (FDA)  has not implemented the  Drug Quality & Security Act (DQSA)  according to Congressional intent. We will keep our members updated on this process!  
  • API Category 3 List - IACP has heard your feedback from the Membership Survey regarding your concerns about the FDA API Category 3 list that is now being enforced during inspections. Your IACP Legislative Committee is working diligently to analyze the FDA API Category 3 list and will be working on a letter to FDA to address your concerns. Coming soon! 
  • Your Efforts are Making a Difference! We Now Have 40 HR 2871 Cosponsors! Has Your Representative Signed On? Please send a direct communication to your Member of Congress. HR 2871 will help clarify the Drug Quality & Security Act (DQSA) in a way that will better align the statute with congressional intent and most importantly, better balance public safety and patient access. Act, Today!
State Advocacy


 
 
  • The California State Board of Pharmacy has issued emergency rules addressing beyond use dating and non-sterile compound drug preparations. The Board finds that there is a significant adverse impact to patients related to the current requirements for establishing beyond use dates (BUDs) for non-sterile compounded drug preparations. "Each day that the board's existing regulations are in place, there is a significant risk that patients will be deprived access to needed medications. In addition, the board finds that it is necessary to clarify the requirements to extend the BUDs for sterile compounded drug preparations in order to allow for the BUDs of non-sterile to be emended." Read IACP's Member Alert here.
  • The New Jersey Board of Pharmacy voted at its recent Board Meeting to delay implementation of USP Chapter <800> until December 2019. The Board had planned to implement the original effective date of July 2018 - despite USP's delay of 800. Please click here to view the Agenda. Please view IACP's Member Alert on this Board Meeting here.
  • IACP Submits Comments on Sterile Compounding Beyond Use Dating to California State Board of Pharmacy - IACP worked with the California Pharmacists Association to submit formal comments to the California State Board of Pharmacy today regarding Sterile Compounded Medications Beyond Use Dating. IACP applauds the California Pharmacists Association for their leadership role on this vital patient issue. 
Please click here to read IACP's comments.
Please click here to read California Pharmacists Associations comments.

I ACP urges our members and corporate members also to  submit their own comments to the state Board . You are welcome and urged to use our comments in submitting your own. Read more on how to submit your comments here.
  • IACP State Board of Pharmacy Member Alert - California, Florida, New Jersey and Washington - Click here to view IACP's comprehensive State Update on USP <800> and office use compounding. IACP is working to keep you in the know on what's going on in your states! 
  • IACP Submits Comments to Massachusetts State Board of Registration in Pharmacy on Sterile Compounding - IACP submitted comments to the Massachusetts State Board of Registration in Pharmacy. The Massachusetts Board of Registration in Pharmacy (Board) within the Department of Public Health (Department) held a public hearing on the Board's proposed new regulation on Sterile Compounding (247 CMR 17.00) on Monday, November 13th. The proposed regulation sets standards for sterile compounding practice, as mandated by M.G.L. c. 112, ยง 39G. Please read IACP's comments to the Massachusetts State Board of Registration in Pharmacy.

  • The DQSA Coalition, a broad cross-section of organizations representing varied healthcare providers, state pharmacy associations, pharmacists and patients, sent a letter to all state Boards of Pharmacy and Medicine, expressing continued concern regarding the Food & Drug Administration's (FDA) implementation of the Drug Quality & Security Act (DQSA) without following Congressional intent. The letter emphasized that FDA's actions consequently are affecting patient access to compounded medications, and causing mass confusion for the States, providers, patients, and pharmacists. Please click here to read more! 
States Respond to DQSA Coalitions Letter to State Boards of Pharmacy and Medicine!  Just a few days after sending, a dozen states have responded to the Coalitions Letter to State Boards of Pharmacy and Medicine to date including these states that have responded that the letter will be discussed during the next Board Meeting:  Georgia; Pennsylvania; New York; Indiana; and Washington .  
  • AVAILABLE FROM IACP! State-by-State Analysis of Office-Use Compounding Regulations! Your Government Affairs team just released a State-by-State Analysis of Office-Use Regulations! We researched State regulations, State notices, State activity, and called State Boards of Pharmacy when regulations conflicted with actions to determine each State's office-use actions. In the instance where a State had recently changed its office-use practices, we called to determine why, and the response was noted when FDA had communicated that State law was pre-empted with Federal law.
You will find two documents - (1) the State-by-State analysis and (2) a complete supplemental document where all State regulations and actions are housed. The State-by-State analysis is a quick reference guide that demonstrates State regulations and current thinking on office-use and all supporting documents to this research can be found in the supplemental document. The DQSA Coalition intends to use this document to see whether model office-use State laws exist, to educate and assist States that are attempting to change office-use practices on the intent of Congress, and to focus on specific states for the State Board of Pharmacy/Board of Medicine Coalition Letter that is coming soon!  
  • IACP provides our members with a  weekly state tracking report - including legislative and regulatory updates! Check out this week's Compounders Stateside report here - you will need to log-in to view this members-only report.   
  • USP General Chapter <800> State Adoption Status Chart. NASPA has developed a chart providing each state's current adoption status of USP's General Chapter <800>. Thank you, IACP Affiliate NASPA, for developing this invaluable tool!
Grassroots



FDA Launches New Patient Engagement Collaborative, Call for Nominations

IACP Members: Encourage Your Patients to Get Involved - Make Their Voices Heard on FDA's New Site - Why Access is NEEDED to Compounded Medications!

The Food & Drug Administration (FDA) is launching a Patient Engagement Collaborative and has issued a Call for Nominations. According to the Agency, "FDA is committed to collaborating with patients, caregivers, and advocates, as well as incorporating the various perspectives from these groups into the FDA's regulatory decision-making processes. And we know that patients and other stakeholders agree with the agency's commitment to improving and increasing patient involvement in FDA matters. In fact, members of the patient and stakeholder communities commented in public feedback on Section 1137, Patient Participation in Medical Product Discussions, of the Food and Drug Administration Safety and Innovation Act (FDASIA). Stakeholders recommended that the FDA create an outside group to provide input on patient engagement across the agency. We are pleased to announce that in response to that feedback and to accelerate the FDA's efforts in this area, today the FDA published a request for nominations to join the FDA's Patient Engagement Collaborative (PEC)."  Click here for more FDA information.

  • Grassroots Advocacy - Tell Your Patients and Providers to sign up for the Partnership for Personalized Prescriptions P3 Patient Advocacy Website! Patient Advocacy efforts make a real difference. That's why we need our IACP members' help to encourage more people to Join P3 and to Share their Stories! So many of our own IACP members have joined the P3 effort. Share this resource with everyone in your communities - your patients, your providers, your staff, your friends and family.
  • Your Patients and Providers are Asking their Representatives to Support HR 2871 with 527 messages sent to the Hill! Encourage your patients and providers to visit P3's Patient Advocacy Website. Advocates can instantly send a direct message to their Congressional Representatives, asking them to cosponsor the bipartisan legislation, HR 2871. Visit P3's Patient Advocacy Website. It's easy to use and will only take a few minutes to send an important HR 2871 message to Congress.
  • IACP MEMBERS: We NEED your patient stories to feature on the P3 website - how have compounded medications helped your community? Please email Dagmar Anderson Climo, VP of IACP Communications at [email protected].