IACP News Roundup - November 22, 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.



Wishing you and yours a very peaceful and happy Thanksgiving! The IACP office will be closed Thursday & Friday, reopening at 8 am on Monday. Please email us at [email protected] in the interim.



One-on-One with IACP President Baylor Rice, RPh, FIACP

IACP President Baylor Rice, RPh, FIACP
Thank you for the opportunity to answer a lot of questions I've received  o v er the past year about IACP Fundraising, and to help address some of the concerns I've hear d about fundraising efforts in this three-part discussion! In my second One-on-One discussion, I shared how your dues and donations are being utilized in order to help preserve patient access to compounded medications. 

The IACP Board of Directors and staff are working tirelessly to ensure that we are strategically applying your contributions to our ongoing efforts, while also being vigilant on where we can be more efficient and save money.

It's vitally important to the IACP Board of Directors and staff that IACP operates in a fully transparent manner. As such, we wish to provide you with a comprehensive view of how we are using your dues and donations in IACP's daily operations.

In this One-on-One, I'd like to talk with you about IACP's Fundraising activities, and talk about the new IACP Fundraiser, the President's Gala, taking place during IACP's Educational Conference this year! Read more here.

ABOUT

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 Nominations Now Closed
  • The nominations period for the  IACP Board of Directors 2018-2020 election cycle has closed. Thank you for all the suggested candidates we received! The number of suggested candidates was tremendous and we are so grateful to have members as engaged and excited about the organization as you. IACP is a success because of YOU! Your work is what helps make us the great organization that we are. 
Now the process begins! We have reached out individually to each suggested candidate to discuss the process, and will be providing a final slate and bios for each candidate to our members after Thanksgiving! We urge you to vote in the IACP Board of Directors election so that you have a hand in shaping the future of IACP!  Be sure to vote!

NEWSROOM

Member Alerts
Member Newsletter
Media

Pharmacy Times -  8 Ways to Leave a Legacy in Pharmacy
  • Believe it or not, the journey from pharmacy student to licensed pharmacist is similar to what can be called a hero's journey. Yes, just like Harry Potter, if you can break down the elements required to create this hero's journey, you can take those elements and transpose them onto your own life's journey.
  • Whether you are a pharmacist, pharmacy student, or other health care professional, if you aspire to live a full and phenomenal life, you are on your own hero's journey. No, I am not saying that you are pretending to be Hercules or slinging a slingshot at a giant. What I am saying is that if you will not settle for an ordinary life, the road to extraordinary will require you to overcome trials and tribulations and use what you have learned to make yourself better than you were before beginning your quest for excellence.
Washington Times -  FDA pushes companies to develop opioids that resist abuse
  • The Food and Drug Administration issued guidance Tuesday to push drugmakers to craft cheaper generic painkillers that are more difficult to snort, inject or otherwise abuse than standard opioids.
  • FDA Commissioner Scott Gottlieb said it's part of his push to get doctors to look at drugs less susceptible to abuse, amid the growing opioid epidemic. His agency wants to promote alternatives to expensive name-brand pain relievers.
MEMBERSHIP

Membership Survey
  • IACP's Membership Survey has closed. Thank you to all participants and your incredible feedback! We will use YOUR feedback to shape not only the direction of IACP, but also the resources IACP provides, our communications to you, and our events! We are currently in the process of reading every response that was sent in! Stay tuned for a comprehensive results report and how IACP will be implementing your ideas! 
Survey Feedback Sneak Peak! - You told us you wanted IACP to create more effective education and legislative platforms! IACP is working on this request and to facilitate this process, we'd like to begin by updating the demographics within your profile. It only takes a moment and will ensure that IACP is always representing your voice and providing the resources you need! Please log-in to the Members-Only site and update your profile. Once you have logged in, click "Manage Profile" on the right-hand rail, then click on "Edit Bio" and answer the questions housed there. IACP has many ideas that we are working on in the future, and it starts with knowing more about you!  

Membership Drive

  • This is the time to join IACP!  Now through December 1st ,  IACP will be have a  Black Friday / Cyber Monday 25 percent off sale on NEW Memberships!  Please use code: CYBERSALE (code is case sensitive) when registering online at  www.iacprx.org/membership . Don't delay! These prices won't last long -  offer available thru 12/01/2017!  
ADVOCACY

Federal Advocacy

Pharmacy Compounding Advisory Committee (PCAC) Meeting Report
IACP attended the Food & Drug Administration's (FDA) Pharmacy Compounding Advisory Committee Meeting this week on November 20-21, 2017 in White Oak, Maryland. Please see above IACP's summary of the first day's voting. Please click here to view a report that has voting results from the two-day meeting.

PLEASE NOTE: These votes are NOT final. FDA must release final guidance for this to be FINAL. These are the Committee's votes on FDA's recommendations for the API Positive List. 

Please note that IACP and other pharmacy organizations previously let Congress know that these meetings should be webcast to the public and a webcast was provided over the two-day meeting period.

Also, as IACP stated within its comments submitted to FDA for the PCAC meeting that you can read here, IACP is still very disappointed that while two PCAC members were allowed to participate via conference call for this meeting, FDA denied all stakeholder participation via conference calls even during the public meeting sections.

IACP will forward additional updates as we monitor the final disposition of these votes as they are presented to FDA. Please email IACP at [email protected] with any questions.

  • IACP attended the Food & Drug Law Institute (FDLI)'s Drug Quality Security Act Conference on November 15th in Washington, D.C. Please click here for the agenda and PowerPoint presentations. The conference presented panels of government regulators and industry experts to explore current issues surrounding the DQSA's Title I (Compounding Quality Act) and II (Drug Supply Chain Security Act) - four years after implementation. 
Speakers included IACP Corporate Member PCCA's A.J. Day, PharmD and
IACP Member Alexander Pytlarz, PharmD. The conference presented panels of government regulators and industry experts to explore current issues surrounding the DQSA's Title I (Compounding Quality Act) and II (Drug Supply Chain Security Act) - four years after implementation.  
  • FDA Commissioner Gottlieb Grants DQSA Coalition Meeting Request - Due to the incredible diligence and hard work of the DQSA Coalition, the Food & Drug Administration (FDA) Commissioner, Scott Gottlieb, MD, has granted our request for a meeting. Read here Dr. Gottlieb's letter sent to David Pore of Hance Scarborough LLP, IACP's D.C. legislative counsel. 
The DQSA Coalition, comprised of more than 30 provider and pharmacy organizations and led by IACP's Executive Vice President Cynthia Blankenship, was created with a primary goal of ensuring the FDA implements the Drug Quality & Security Act as Congress fully intended in order to preserve patient access to vital compounded medications. As such, the DQSA Coalition has steadily worked over the past year to communicate its concerns that patients are being prevented critical access to the essential compounded medications upon which they depend. Please click here to view the letter the DQSA Coalition sent last June to the United States Secretary of Health and Human Services Dr. Thomas E. Price, requesting a meeting to discuss these concerns on behalf of your patients. We are pleased our efforts have resulted in scheduling a meeting with Dr. Gottlieb and will keep you apprised of all updates. IACP is working hard to preserve your patients' access to life-saving compounded medications!
  • 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 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 .  
  • Important Notice from the Ohio State Board of Pharmacy - Due to reports of critical drug shortages, the State of Ohio Board of Pharmacy has postponed the rescission of pharmacy compounding rules 4729-16-10 and 4729-16-07 of the Ohio Administrative Code to a date to be determined later. Read more here. 
  • Massachusetts State Board of Pharmacy Public Hearing Held Last Week - the Board of Registration in Pharmacy (Board) within the Department of Public Health (Department), held a public hearing on the Board's proposed new regulation at 247 CMR 17.00, Sterile Compounding on Monday, November 13th. The proposed regulation sets standards for sterile compounding practice, as mandated by M.G.L. c. 112, ยง 39G. More information including written testimony submission instructions here. IACP plans to provide written testimony for this hearing. 
  • 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
  • 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 526 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].