Bi-weekly Member Newsletter                                             February 9, 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] .

About
Executive Vice President Address Coming Next Week!

Cynthia Blankenship, Esq. IACP Executive Vice President

Stay tuned for a comprehensive address next week from
IACP EVP Cynthia Blankenship, Esq.,  "A Look Back on 2017, and a Look Forward on What's in Store for 2018!"  

Cynthia will provide a progress report on her  2017 Member Initiatives and expansive efforts to return IACP to a member-driven organization, and will  reveal what IACP has in store for you in 2018! 

Be sure to check your email for IACP member alerts next week. Cynthia will be dividing her address into segments so stay tuned next week for her entire address! 



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!
Membership

IACP Announces New Committees - 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. 
  • IACP 503B Committee - IACP is establishing a 503B Outsourcing Facility Committee to be chaired by IACP Board Member A. J. Day, PharmD, RPh. We are actively seeking Committee members! If you are interested in serving on this committee, please email IACP's Jennifer Petska, BS, CPhT, IACP Director of Development & Membership, at [email protected].
  • IACP International Committee - For the first time in history, IACP is undertaking a massive State and International expansion. We are thrilled to be working with the State Pharmacy Associations to expand IACP state involvement, state tracking, and comments in response to state regulations and legislation. IACP also is thrilled to be working with our International members to expand IACP presence internationally. In order to further this expansion and ensure International Members are receiving the information they need, the IACP Board of Directors has launched an International Committee chaired by IACP Board Member Marisol Lopez, RPh, MPh. We will be starting meetings soon, so please let us know if you want to serve on this Committee! We are so excited to work with our International members and expand the IACP International presence! Please email IACP's Jennifer Petska, BS, CPhT, IACP Director of Development & Membership, at [email protected] for more information and to join this committee.
  • Infrastructure Review Subgroup - We need your help in reviewing IACP infrastructure! We want to make sure we have the best infrastructure that we can, and we need your help in doing so! This subgroup will serve as a function of the IACP Strategic Planning Committee and is open to all IACP members who have an expertise in IT or infrastructure review. IACP is looking at all of our internal processes to ensure we are employing members' dues and donations in the best manner, and to make sure we are operating as efficiently as possible. In order to do so, the IACP Board has created an Infrastructure Review Subgroup which will review internal IACP processes to help us select new future operational processes. If you have a background in IT or reviewing internal processes, or have experienced this process yourself, please consider joining this Subgroup! We would love to have your insight! Please email IACP's Jennifer Petska, BS, CPhT, IACP Director of Development & Membership, at [email protected] for more information and to join this committee.
IACP Installs 2018 Board of Directors at Inaugural President's Gala


Thank you to everyone who attended and supported our first  President's Gala ! A great time was had by all, and importantly, proceeds from the President's Gala supported IACP's One Fund  fundraising effort.  

In addition to a delicious dinner and a hilarious comic/magician performance, the IACP 2018 Board of Directors was formally installed. Your 2018 Board of Directors has a big year ahead of them! Make sure you know who your Board of Directors are - Read more about your new Board here!

A huge thanks to our sponsors who helped to make the President's Gala a success!

DoseLogix/Topi-CLICK (Bar Sponsor); Letco Medical (Entertainment Sponsor, Table Sponsor); My USP 800 (Additional Gala Drink Tickets); B&B Pharmaceuticals, Inc. (Table Sponsor); PCCA (Table Sponsor). 

Thank you, IACP Member and Past IACP President Eldon Armstrong, RPh, FIACP, Sandlapper Consultant Pharmacists, Chapin, SC; and IACP Member Joseph Rossetti, RPh, Boulevard Pharmaceutical Compounding Center, Worcester, Mass., for your individual sponsorship of the 1st President's Annual Gala! And thank you to all members who purchased Gala tickets!
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 later this month!
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
Industry News

NBC -  You're Paying T Much for Prescription Drugs - and Your Pharmacist Can't Tell You
  • While most people believe that using insurance reduces prices, sometimes medication is cheaper when you don't use insurance.
  • However, pharmacists can't tell you that because of the gag clause in their contracts with none other than the PBM's.
  • "We would like to save the patient money, but the information would have to come from the patient first," said Nelson.
  • Several states have outlawed clawbacks and gag clauses, but Florida isn't one of them.
  • Donald Trump's health-care chief said he plans to take up the president's promises to do something about pharmaceutical prices, targeting some of the U.S.'s costliest drugs with proposals to reduce patients' out-of-pocket spending.
  • "The president is firmly committed in this space," Health and Human Services Secretary Alex Azar said in a briefing with reporters Thursday. "I am now less than two weeks on the job and have been working a great deal, let's just say, on these issues already. We do think drug prices are too high."
  • Azar laid out several ideas that will appear in Trump's budget proposal when it's released Monday. Many would have to be legislated by Congress, which typically ignores presidents' budgets and lays out its own framework.
  • All drugs should be compounded under suitable quality standards, but who should be ensuring those standards among traditional compounders and outsourcing facilities was debated at the House Energy and Commerce Subcommittee on Health.
  • In written testimony, FDA Commissioner Scott Gottlieb, MD, cited a litany of manufacturing problems at compounding facilities, including mold contamination of the type that caused lethal fungal infections during the New England Compounding Center (NECC) crisis in 2012. In most cases, Dr. Gottlieb testified, these violations are occurring at smaller-scale facilities designated as 503A operators under the Drug Quality and Security Act (DQSA), which was enacted in 2013 to clarify the FDA's authority over these firms.
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. 
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.


  • The  International Academy of Compounding Pharmacists (IACP) has submitted comments to the Food & Drug Administration (FDA) for its Docket No.: FDA-2017-N-5101 for "Review of Existing Center for Drug Evaluation and Research Regulatory and Information Collection Requirements." 
Please click here to view IACP's comments on the Guidance for Industry: Prescription Requirement Under 503A of the Food, Drug and Cosmetic Act.

Please click here to view IACP's complete comments on the  Draft Standard Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration .

Thanks to all IACP Members submitting comments! IACP's objective is to provide our comments to our members before they're due for submission. That way you can take our comments for your own formal submissions. Stay tuned to our Member Alerts such as the one on this  FDA's Review of Existing Center for Drug Evaluation and Research Regulatory and Information Collection Requirements so that you can view our comments and submit your own. For your convenience, IACP will provide you submission deadlines as well as links to instructions and submission sites. Please email [email protected] with any questions.
   
  • 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."
PLEASE NOTE: IACP currently is reviewing this information and determining what impact this has for current FDA Guidance for Industry (GFI) documents. IACP will send you additional updates as they become available.  Please click here to view the Department of Justice's press release.
  • 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  
  • Arkansas -  State Attorney General Leslie Rutledge to investigate reimbursement rates from CVS Caremark. Read more .  
  • 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! 
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.
Corporate Member Spotlight: LP3 Network


LP3 Network Aventura Learning Center Grand Opening!


LP3 Network has reinforced its long-term commitment to healthcare education with the grand opening of its  new state-of-the-art Learning Center in Aventura, Florida , officially opened in January by  Enid Weisman, City of Aventura Mayor, Tony Dos Santos, President of Medisca Pharmaceuticals, and Maurizio De Stefano, LP3 Network General Manager . 

Featuring distinctive, transparent architecture and progressive design elements, this unique 7500-square-foot facility will offer a controlled environment where pharmacists, physicians, and allied healthcare providers can learn from industry experts, surrounded by top-of-the-line equipment. It will also serve as a resource for participants to develop or expand their current pharmaceutical compounding services through a demonstration center, on-demand workshops, and customized training courses.

The grand opening was celebrated with a ribbon-cutting ceremony attended by industry leaders and notable guests, including Tony Dos Santos, President of Medisca Pharmaceuticals, representing LP3 Network's educational supporter, and Congresswoman Debbie Wasserman Shultz.

This facility will further strengthen LP3 Network's position as a Global Leader in Continuing Healthcare Education, highlighting its commitment to quality, and providing healthcare professionals with an optimal educational experience. Merging exquisite aesthetics with functionality, the facility offers top-of-the-line sterile and non-sterile compounding rooms for hazardous and non-hazardous drug compounding, a classroom with the newest technology, and sophisticated audio-visual equipment which enhances the learner's experience.

The addition of this new facility to LP3 Network's offerings will support the company's commitment to future growth and ensure that unparalleled service is provided to its clients in the healthcare community. Read press release here.
Corporate Member News





Two Pharmaceutical Industry Veterans Join the Eagle Analytical Services Leadership Team 

Press release here.


Fagron, Inc. Extends Pharmaceutical Ingredient Supply Chain To American Pharmaceutical Ingredients' Customers

Press release here.


Letco Med, L.L.C. Announces Partnership with ARL Bio Pharma to Launch Quality Savings Program for Compounding Pharmacists

Press release here.


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

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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