Bi-weekly Member Newsletter                                             February 23, 2018
Keep up-to-date with the latest legislative and regulatory news. Visit IACP's website.  Archived  Capitol Connections  newsletters here. Send your suggestions and questions to  [email protected] .
Executive Vice President Address

Cynthia Blankenship, Esq. IACP Executive Vice President

Last week we shared a three-part message from 
IACP EVP Cynthia Blankenship, Esq.,  "A Look Back on 2017, and a Look Forward on What's in Store for 2018!" and a Visual Look Forward.  This week we shared three of four part series "Meet IACP's Committee Chairs - Part One, Part Two and Part Three" The last installment will come early next week.  

IACP is so pleased and thankful for our IACP Committee Chairs members.  They have answered the call to help lead this organization by driving the committee agendas pursuant to the IACP Strategic Plan. Our Committee Chairs put their hearts and souls into making IACP a member-driven organization.  If you haven't checked out the email series, we encourage you to take a look.

We hope they inspire you as much as they inspire us!   

We have a lot on the horizon and we are excited to share it with you! Keep your eyes peeled for more emails detailing these programs.  We think you are you going to be excited at the changes that are coming - changes that came directly from our membership survey!

Be sure to check your email for IACP member alerts next week for more information! 

Let's Keep the Momentum Going - Please Contribute to IACP's One Fund! We need your help, TODAY!  Make the donation that will help Preserve Patient Access to Compounded Medications, and help support IACP's HR 2871 efforts. IACP is working to Protect, Promote & Advance Pharmacy Compounding!
Registration OPEN for IACP's 24th Annual Compounders on Capitol Hill!

June 23-26, 2018 
999 Ninth Street NW
Washington, DC 20001

The 24th Annual Compounders on Capitol Hill (CCH) will be held June 23-26, 2018 at the Renaissance Washington DC Downtown Hotel! With more than 400 expected attendees, Compounders on Capitol Hill brings together the top-level compounding pharmacists and technicians from across the country with the same goal - to protect pharmacy compounding. 

Network! Reconnect with friends and meet new colleagues who share your passion and interest in protecting, promoting and advancing pharmacy compounding!

Register Here! Reserve Your Hotel Room Here!
IACP Compounder Calendar

IACP's Compounder Calendar is your one-stop resource for all things compounding! Compounder Calendar provides a comprehensive listing of compounding events and continuing education programs.

New IACP Committees Getting Ready to Have First Meetings Soon

IACP is thrilled to see the outpouring interest we have had in joining IACP Committees and the fantastic chairs at the helm. The new committees and subcommittees below are really ramping up.  They are setting their meeting schedules and will be meeting soon.  If you are interested in joining one of these committees or subcommittees, or a different committee, please let us know! 

We are actively seeking Committee members!  
  • IACP 503B Committee - chaired by IACP Board Member A. J. Day, PharmD, RPh. 
  • IACP International Committee - chaired by IACP Board Member Marisol Lopez, RPh, MPh.
  • Infrastructure Review Subcommittee - chaired by IACP Board Member Jeffery Bray.  
  • Legislative and Regulatory Committee Announces New Subcommittees! The IACP Legislative and Regulatory Committee Chaired by IACP Board Member Anthony Grizib, recently announced, and the Board approved, the creation of two new Subcommittees regarding state compounding efforts and animal compounding efforts. With both State activity and FDA efforts on animal compounding ramping up, the Legislative and Regulatory Committee felt it is essential for IACP to continue to create Subcommittees that address all compounding activity in an effective and efficient manner. 
    • State Compounding Subcommittee - As IACP announced last year, IACP has undertaken a huge endeavor to increase state tracking, relationships with State Boards of Pharmacy and State Pharmacy Associations, and response to all state activity impacting compounding. The IACP Legislative and Regulatory Committee has been instrumental in helping to monitor all state activities and drafting responses. The State Compounding Subcommittee will allow the Legislative and Regulatory Committee to address more State action with an even quicker turnaround time. 
    • Animal Compounding Subcommittee - In addition, FDA recently released a 2018 regulatory calendar and listed animal compounding GFI as a document that FDA intends to put out in 2018. NABP is also meeting on this issue. Therefore, the IACP Legislative and Regulatory Committee felt it is vital that IACP continue to monitor and be ready to act on all animal compounding activities. This Subcommittee will allow the IACP Legislative and Regulatory Committee to monitor all state and federal activity impacting animal compounding and to respond effectively and efficiently to all actions.
Join a Committee and Help Work on the Exciting New Programs We Have in Store for 2018!  IACP is a success because of YOU! Please take a moment and look at what  IACP Committees  are doing and let us know if you would like to join a Committee. We would love to have YOU on an IACP Committee. In addition, in response to your direct feedback on the IACP Membership Survey, the IACP Board has responded by creating new Committees and one new Committee Subgroup. 


Please email IACP's Jennifer Petska, BS, CPhT, IACP Director of Development & Membership, at [email protected] for more information or if your are interested in joining any committee.
NEWSROOM


Congressman Buddy Carter and IACP Vice President Shawn Hodges, PharmD Featured in Inside Health Policy Article on E&C Hearing

Carter Alleges FDA Guidance Improperly Drives Compounding Enforcement

Inside Health Policy featured a wrap-up article from the Energy & Commerce Health Subcommittee pharmacy compounding hearing. From IHP - "FDA came under fire from Representative Buddy Carter (R-GA) Tuesday (Jan. 30) for what he alleges is the agency's use of guidance documents as the basis for compounding enforcement actions. Carter's concerns were buoyed by a new policy from the Department of Justice which bars use of guidance to create binding standards, or to take enforcement action based solely on noncompliance with guidance -- although there is some debate as to how that policy will impact FDA."

"Carter, who has been one of the most outspoken members of Congress against FDA's stance on office use compounding, also took FDA to task for ignoring appropriations language directing it to change course. Commissioner Scott Gottlieb, MD, largely punted on the issue, but in a separate line of questioning indicated that the compounding office is underfunded."

"How are you justifying that you're going to use guidance policy for rulemaking here?" Carter asked Gottlieb during the Energy & Commerce health subcommittee hearing on implementation of the compounding law.'"

IACP Vice President Shawn Hodges, PharmD, and witness at this hearing also is quoted, "We have some ideas about what we can do to ensure the quality and access but we are looking for a sit down with commissioner. We've requested this year, years prior we've sent letters and we're not getting a response."

Please click here to read this entire Inside Health Policy article.


IACP MEMBER ALERTS

IACP WEEKLY ROUNDUP

IACP Weekly Roundup  provides a new way to keep you up-to-date on IACP's Member Communications! We know you're busy, so we are making sure you don't miss a beat by rounding up all the IACP news that goes out to members in one location to make it easier for you to never miss any news on compounding!  Check out what news  your Academy has been sending. 


INDUSTRY NEWS
FOR IMMEDIATE RELEASE
 February 21, 2018
 Contact: Press Office
(202) 226-4972   

#SubHealth to Review Legislation in Response to Opioid Crisis and Enforcement Issues

WASHINGTON, DC - The Health Subcommittee, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today scheduled a hearing for Wednesday, February 28, 2018, at 10 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, "Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety."
In the first of three legislative hearings to examine the opioid crisis and possible legislative solutions, #SubHealth will review several bills pertaining to the Controlled Substances Act.
"As we continue our efforts to tackle this epidemic, it's imperative we strike the right balance between necessary enforcement and patient safety," said #SubHealth Chairman Burgess. "As the people's representatives, we need to make sure law enforcement can get dangerous, illicit drugs out of our communities and licensed health professionals are able to safely dispose of unused prescriptions, particularly opioids. We'll examine a number of important policies that will improve access to treatment for mental health and substance use disorders, make important updates to outdated laws, review ideas on how providers and pharmacists can better inform patients, all with the common goal of protecting our family, friends, and neighbors."
The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted.
# # #
PERMALINK
    • Pharmacy Benefit Managers (PBMs) would be required to obtain a license from the state to do business in Arkansas, under proposed legislation announced Wednesday. The potential mandate is part of a law-making effort to provide oversight to prescription reimbursement practices that some pharmacists have said are threatening their businesses and the ability of patients to access needed care.
    • Hired by insurers, including health plans and employers, PBMs serve as fiscal intermediaries between their clients and pharmacies to manage prescription drug programs.1 PBMs require pharmacy owners to sign a nonnegotiable contract to receive reimbursements for prescriptions, and over time, payments to pharmacies often drop.2
  • Inside Health Policy - States Push Closed Formularies, Pharmacy Networks As CMS Considers Allowing Those Arrangements In Medicaid - February 21, 2018
ADVOCACY 

Federal Advocacy



IACP Testifies at U.S. House of Representatives Energy & Commerce Health Subcommittee Pharmacy Compounding Hearing
 

IACP Vice President Shawn Hodges, PharmD testifies at the Energy & Commerce Health Subcommittee Hearing 

The International Academy of Compounding Pharmacists (IACP) testified Tuesday, January 30, 2018, before the U.S. House of Representatives' Energy & Commerce's Health Subcommittee Hearing on pharmacy compounding, "Examining Implementation of the Compounding Quality Act." The Subcommittee on Health is chaired by U.S. Congressman Michael C. Burgess, MD (TX).

IACP Vice President Shawn Hodges, PharmD, served as a witness representing 503A compounding pharmacies at the Congressional hearing. Dr. Hodges' written testimony submitted to the Congressional Health Subcommittee can be viewed in its entirety here.

On behalf of the IACP Board of Directors, we thank Shawn Hodges for his willingness and dedication to serve our patients, and our profession, at this hearing!

IACP Press Release on the Hearing - Read here.

Excerpt from Dr. Hodges' Testimony

"Every day, compounding pharmacists serve patients in a variety of areas including: autism, oncology, dermatology and pediatrics, in a variety of practice settings including hospice in-patient units, emergency rooms, surgical centers, physician clinics, and even Federal Facilities like the VA. Compounding pharmacists also have served patients such as pre-term infants who require parenteral nutrition (PN). PN provides intravenous lifesaving therapy for patients whose gastrointestinal (GI) tracts are not functioning or cannot be accessed, or where nutritional needs cannot be met with oral or enteral diets. These are just a few examples of how compounding pharmacists are working with physicians to provide life-saving medications for patients."

Dr. Hodges' written testimony submitted to the Congressional Health Subcommittee can be viewed in its entirety here. Please click here for more information on this critical hearing.

E&C Health Subcommittee Hearing Video Clips Available

To help you navigate this week's E&C Health Subcommittee Hearing recording - below are specific clips for appearances by IACP Vice President Shawn Hodges, Representative Buddy Carter (GA) and Representative Morgan Griffith (VA).

Thank you to all for going to bat for patients' continued access to compounded medications!
  • IACP Vice President Shawn Hodges Testimony - please click here.
  • Congressman Buddy Carter (GA) Comments - please click here.
  • Congressman Morgan Griffith (VA) Comments - please click here.
  • Congressman Griffith asks IACP Vice President Shawn Hodges questions on how FDA's MOU could affect patients and their access to compounded medications - please click here.
  • Entire hearing recording can be found here.

  • On Thursday, January 25th, the Associate Attorney General issued a memorandum that prohibits the Department of Justice from using civil enforcement authority to "convert agency guidance documents into binding rules." According to the Memorandum published on the Department of Justice website, Justice Department civil litigators are prohibited from using guidance documents - or noncompliance with guidance documents - to establish violations of law in affirmative civil enforcement actions. Further, in that same news release, DOJ Associate Attorney General Brand stated "Although guidance documents can be helpful in educating the public about already existing law, they do not have the binding force or effect of law and should not be used as a substitute for rulemaking."

  • 2019 Appropriations Season is HERE! Congress will soon turn to 2019 FDA Appropriations, and FDA is working with the DQSA Coalition to draft and submit legislation! We will be sharing efforts with IACP members as well as a deadlines chart that lets you know when appropriations deadlines are approaching.
  • Your Efforts are Making a HUGE Difference! We Now Have 43 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. 
  • Continue to collect patients' stories and let us know if a patient would like to get involved! We need patient stories for Congressional documents as well as any potential hearings.  Please let us know if you're willing to be the voice of your patients or whether you know of patients willing to provide quotes or speak on the record!
State Advocacy  

  • IACP Submits IL Comments! Thank you to the Legislative and Regulatory Committee and Chair Anthony Grizib for your help in drafting and submitting comments to IL. IACP submitted formal comments to the Illinois Department of Financial and Professional Regulation on Proposed Amendments to Regulations Implementing Illinois Pharmacy Practice Act. 
This submission reflects IACP's continuing effort to respond to each and every state action impacting pharmacy compounding.  IACP will continue these efforts and will work closely with State Pharmacist Associations and State Boards of Pharmacy to support all state action preserving patient access to compounded medications.  The  IACP Legislative Committee chaired by  IACP Board Member Anthony Grzib, RPh is continuing to look for additional ways IACP can engage in preserving patient access to compounded medications. 

 

Excerpt from IACP's Comments: 

IACP would like to thank the Illinois Department of Financial and Professional Regulation ("IDFPR") for this opportunity to present thoughts on the proposed amendments to Section 1130.640 of the Illinois regulations implementing the Pharmacy Practice Act (the "Proposed Rules"). IACP supports the IDFRP's mission to ensure that patients throughout the State of Illinois receive safe, effective and quality compounded medications. IACP understands and supports the need to protect public health. When developing and implementing regulations, it is essential to preserve patient access to vital compounded medications, the prescriber-patient-pharmacist triad, and the right of a patient to choose their pharmacist. Prescribers must have the right to prescribe medications that best fit the needs of their patients. 

 IACP has reviewed the Proposed Rules and would like to recognize the IDFPR for incorporating much of the stakeholder input submitted during prior comment and review periods. IACP has heard from pharmacists as well as prescribers who will be impacted by the Proposed Rules that specific provisions still exist within the Proposed Rules that need further clarification or will cause unnecessary constraints in patients being able to access needed compounded preparations.

 First, IACP had the opportunity to review the recommendations being submitted by the Illinois Pharmacists Association ("IPhA") and would like to express support for the IPhA's proposed modifications to Sections 1130.640(c),(d),(e), and (f) of the Illinois regulations. IPhA's proposed changes are necessary to ensure that these portions of Section 1130.640 incorporate consistent practice requirements that align with United States Pharmacopeia ("USP") General Chapters 795 and 797 standards currently governing compounding pharmacies. The IPhA's recommendations in these areas will safe-guard patient safety and place the Proposed Rules in line with best practices while also preserving patient access to compounded medications. Read the entire letter here.

 
  • Check out IACP's 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 we ekly 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 Advocacy  


  • Tell Your Patients and Providers to sign up for the 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 540 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? Share YOUR Stories! Please ask your patients and providers to also share their stories on the P3 website! 
IACP COMP PAC NEWS


U.S. Congressman Rep. Gus Bilirakis (FL) (2nd from right) visits with IACP Legislative Committee Chair Anthony Grzib, IACP Member Tara Thompson and IACP Vice President Shawn Hodges at IACP's COMP PAC Reception held during #EduCon2018.

IACP Vice President & COMP PAC Chair Shawn Hodges, PharmD and the COMP PAC Committee welcomed  U.S. Representative Gus Bilirakis (FL) to a COMP PAC reception held during the January Educational Conference in Fort Lauderdale, Fla. 

Under Shawn's leadership, COMP PAC has evolved into a powerful force and has undertaken a multitude of strategic steps to ensure IACP can continue to effectively work with our compounding champions on Capitol Hill.

STAY TUNED for a new COMP PAC newsletter debuting next week!
IACP AFFILIATE NEWS 


USP Offers IACP Members Special Discount for Spring Session of Safe Compounding & Safe Handling of Hazardous Drugs Week Course!
USP is offering IACP Members special Early Bird Discount rates for its Live Courses <800>, <797>, <795> - Spring Session to be held March 21-23, 2018:  Safe Compounding & Safe Handling of Hazardous Drugs Week.  Please click here  to access more information including Special Codes created just for IACP Members. 
USP Debuts New Resource - USP <800> HazRx™ Mobile App. 
The <800> HazRx™ Mobile App  is an innovative tool that combines information from three trusted data resources (NIOSH, RxNorm, General Chapter <800>) to help identify hazardous drugs at the point of practice and to inform the healthcare worker on what measures to take to help reduce their risk in accordance with established standards.
As we all move toward safer handling of hazardous drugs in the work place, USP encourages early adoption and implementation of USP General Chapter <800> to protect the public health in all healthcare settings.  Read more here!  
IACP FOUNDATION NEWS



14th Annual Rx Mixer -  Aloha State of Mind   
Plans to Raise More than $200,000!


IACP Foundation's 14th Annual Rx Mixer - Aloha State of Mind benefiting the IACP Foundation is being held Sunday, June 24, 2018 from 6:30 pm - 11:00 pm at the Renaissance Washington D.C. Downtown.  Early Bird Price is $150 per person until March 31, 2018 (one event ticket and three drink tickets).  The Regular Price is $175 and Late Registration is $200 after June 10, 2018. This is a separate ticketed event.

Join us in paradise and come relax with your colleagues and friends.  Our guests will be treated to a fun evening of classic food, cold drinks, fellowship, and Dueling Pianos to lead us in song and cheer!  Try your hand at the Live Auction, Silent Auction by the IACP Foundation, Memorabilia Silent Auction by GrandStand Sports and the Reverse Card Draw!All for a really good cause as we support the IACP Foundation's research and education initiatives. As we gather again with our colleagues and friends, we want to emphasize that Rx Mixer is much more than a fun party. It's a Party with a Purpose!

Want to get involved?  Interested in volunteering the day and/or evening of the event? 
 Fill our Desire to Serve form.



Any questions, please contact Jennifer at  [email protected] 



It's that time of year again! The  IACP Foundation has two exciting opportunities to announce - the  Fund-the-Future Travel Grant for 2018  Compounders on Capitol Hill and the  Spring 2018 Student Writing Competition .  

2018 - Fund-the-Future Travel Grant 

Do you know a pharmacy student interested in learning more about independent pharmacy and compounding? Through the generosity of donors to our Fund-the-Future campaign the IACP Foundation is offering up to two (2) pharmacy students a travel grant to attend IACP's annual meeting - Compounders on Capitol Hill on June 23-26, 2018 in Washington D.C. All pharmacy students are encouraged to apply. 

What's Available? -  Travel grants, up to $2,500 each!
When Can I Apply? -  Applications for the 2018  Compounders on Capitol Hill Travel Grant   should be submitted   no later than March 15, 2018. Winners will be notified in April 2018.
  • Click here for the direct link for the Fund-the-Future Student Travel Grant.
  • Click here for more information about the Travel Grant or go here.  
  • Click here for more information about Compounders on Capitol Hill. 

IACP Foundation Spring 2018 - Student Writing Competition

The IACP Foundation also has announced their Spring 2018 Student Writing Competition. The IACP Foundation was formed in 2003 with an ongoing mission of supporting research and education initiatives that advance the art and science of pharmacy compounding.

The IACP Foundation created its semi-annual Student Writing Competition to recognize outstanding original papers by pharmacy students on a particular topic affecting pharmacy compounding. Up to   two (2)   winners will be selected by a review committee from the papers submitted. The winners of this writing competition will each receive a $1,000 cash prize.  All pharmacy students are encouraged to compete. Winners announced: May 2018
What's Available? - $1,000 cash prize per winner!
When Can I Apply? - Submission deadline is March 15, 2018.
  • Click here for the direct link for the essay competition.

U.S. Congressman Representative Gus Bilirakis  (FL) flashes 
'hook em' horns' with  The University of Texas at Austin   The University of Texas at Austin College of Pharmacy  Students Christine Borunda  and Ralph Galega at IACP's  Educational Conference. Christine and Ralph attended #EduCon2018 as part of IACP Foundation's Fund-the-Future scholarship program.


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