Bi-weekly Member Newsletter                                             November 17, 2017
Keep up-to-date with the latest legislative and regulatory news. Visit IACP's websiteArchived  Capitol Connections  newsletters here. Send your suggestions and questions to  iacpinfo@iacprx.org .


Wishing you and yours a very Happy Thanksgiving!  The IACP office will be closed in observance 
of the holiday, November 23-24, 2017. We will reopen Monday morning at 8 am! Please email
iacpinfo@iacprx.org if you need to reach us in the interim.


IACP President Baylor Rice, RPh, FIACP
IACP/ABOUT

One-on-One with IACP President Baylor Rice

Do You Know Where Your IACP Dues and Donations Go?

Thank you for the opportunity to answer a lot of questions I've received over the past year about IACP Fundraising, and to help address some of the concerns I've heard about fundraising efforts in this three-part discussion! In my first One-on-One discussion, I shared our current IACP Member Initiatives, the missions of IACP, IACP Foundation, & IACP COMP PAC, and how you can contribute to each.

I hope to build onto that information in this second One-on-One by providing you with information on 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 is 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. Please click here to read more on how your IACP Dues and Donations are being employed!

Stay tuned next week - for another One-on-One as I describe in great detail IACP's Fundraising activities, and our inaugural President's Gala!
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!

Thank you to the following sponsors for their support of the 1st President's Annual Gala:
DoseLogix/Topi-CLICK (Bar Sponsor); Letco Medical (Entertainment Sponsor, Table Sponsor);  My USP 800 (Additional Gala Drink Tickets);  PCCA (Table Sponsor). 

Thank you,  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 have purchased Gala tickets! 

Find more information about the President's Gala, including how to attend/purchase tickets, how to sponsor, meal selection, and entertainment details here! All proceeds from the President's Gala will go to the IAC P One Fund.

IACP Executive Vice President Cynthia Blankenship ESQ. 
Member Initiatives: A Progress Report Card! 

Keep checking  IACP's Executive Vice President (EVP) Cynthia Blankenship's Member Initiatives  to 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  iacpinfo@iacprx.org .
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 Town Hall or meeting at your pharmacy! Next on Cynthia's travel plans: 
  • IACP's Educational Conference, Ft. Lauderdale, Fla., January 24-27, 2018
  • United States Pharmacopeia (USP) Compounding Expert Committee (CEC), April 2018
*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. 

IACP Board of Directors Nominations Have Closed - Here are Next Steps! 

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!
Join an IACP Committee!  

As part of the new member-driven initiatives, we are strengthening IACP Committees to make certain your needs are represented. Thank you to all of our new Committee members! We appreciate your commitment to IACP and pharmacy compounding! Check out the new list on the member-only website that details new Committees created, the Committee visions, current members, and meeting times. This is the time to join an IACP Committee! We need your insight!  From your input, IACP is also forming two new Committees soon to make sure your needs are represented - so stay tuned! 

 IACP President Baylor Rice and President-
Elect Erik Tosh
REGISTER TODAY for IACP's Educational Conference!

WATCH  IACP President Baylor Rice, RPh, FIACP and President-Elect Erik Tosh, BS, RPh, FIACP, FACA , as they urge you to attend IACP's Educational Conference & Inaugural President's Gala , January 24-27, 2018 in Ft. Lauderdale, Fla! #EduCon2018 ! More information and register here

Please join us and your colleagues at the Sonesta Fort Lauderdale Beach for a jam-packed agenda filled with exciting educational sessions and connect with your colleagues during the President's Gala, receptions, and time with IACP exhibitors! The IACP exhibit hall is already sold out and the room block is filling up quickly, so please register now! We look forward to seeing you in Ft. Lauderdale!
Let's Keep the Momentum Going! 
Please Contribute to IACP's One Fund!
Newsroom

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. 
IACP News Tracking

  • AMA federal and state advocacy efforts to further drug price transparency will be expanded under new policies that take drugmakers, pharmacy benefit managers (PBMs) and health insurers to task for their roles they play in rising drug costs and less access to affordable treatment.
  • "As spikes in prescription drug prices occur without justification, the American Medical Association believes we need more transparency to protect patients from drug price gouging and manipulation," said AMA President-elect Barbara L. McAneny, MD.  "Greater transparency among pharmaceutical manufacturers, pharmacy benefit managers and health plans will shed light on the rationale for drug price increases and why patients pay what they do for their medications."
PoliticoPulse
  • On drug pricing, Azar said "a vigorous and profitable drug industry is not a problem to be solved" Azar has acknowledged that high drug prices are a problem for patients, but past statements suggest he'll do little to rein in the industry - even though Trump has frequently railed against drug companies and tweeted Monday that Azar will be a "star" for lower drug prices.
  • Instead, he may focus on how insurance company policies affect patients' out-of-pocket drug costs. Azar has spoken out against price controls for pharmaceuticals, saying they can squelch innovation.
  • "A vigorous and profitable drug industry is not a problem to be solved, but a goal to be encouraged. The future need not be a binary choice between each government doing the best it can on its own to lower drug prices, choking off medical innovation in the process, or raising health care costs still further to pay for medical innovation that our nations cannot easily afford when we act alone," Azar said in a 2006 speech, when he was deputy HHS secretary.
  • GAO: FEW PARTICIPATE IN FEDERAL DRUG TAKE-BACK PROGRAMS - A new report from the Government Accountability Office shows that very few eligible entities, including pharmacies & clinics, are participating in federal drug take-back programs, citing cost and confusion over federal regulations. The report, requested by Sens. Joni Ernst and Chuck Grassley, shows that in this year, about 3 percent of pharmacies & other entities eligible to collect drugs as part of the take-back programs volunteered did so. Those that did not, said the costs to purchase a bin and pay for the destruction of collected drugs prevented them from doing so. "One stakeholder told us that many eligible entities may decide that the benefit of participating does not outweigh the costs associated with doing so," the report said. The report comes as abuse of prescription painkillers and other opioids have plagued the country. About 3.8 million Americans reported abusing prescription drugs in 2015.
Membership

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 on "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!


This is the time to join IACP! Beginning Monday, November 20, 2017, 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!

New Membership Processes Coming Soon!  We want to make sure that your membership dues are utilized to provide you with all the resources you need! As such, we are revamping some of our membership processes such as going digital for new membership packets and renewals. You may have received a fax blast describing the new renewal process. If you have not received, you can find it HERE. Please take a moment to review these exciting and most cost-effective changes! We will continue to fax and email renewals. In addition, when the new website launches, new members will be directed to a new member packet with videos from IACP Board of Directors, tutorials, and all the latest compounding information! Just more ways we are making sure your membership dues are used to provide the resources that you need. 
IACP Member News 



Congratulations to IACP Members Alan Israel, Adam Israel and Beverly Israel on the expansion of their Cleveland Heights, Ohio-based Lee Silsby Compounding Pharmacy! Read more about their move to a new 20,000-square-foot building in Beachwood, Ohio.
Advocacy


Federal Advocacy
  •  The International Academy of Compounding Pharmacists (IACP) has submitted comments to the Food & Drug Administration (FDA) for its Pharmacy Compounding Advisory Committee meeting being held next week on November 20-21, 2017.  
IACP Members: Thank YOU for your input as we developed these comments! Your feedback was very helpful on the a) Do Not Compound List and b) the Active Pharmaceutical Ingredients (APIs) Positive List - which are both up for vote at next week's PCAC meeting. 

IACP will have a representative in attendance at the PCAC meeting being held next week on Monday & Tuesday, November 20th-21st. Please stay tuned to your email inbox and IACP's Breaking News Section on our website homepage for Member Alerts as we keep you updated on PCAC meeting with live news and voting results. Read more here. 
  • The U.S. Food and Drug Administration is withdrawing draft Guidance for Industry (GFI) #230, "Compounding Animal Drugs from Bulk Drug Substances." According to FDA's announcement, it's withdrawing the draft Guidance for Industry (GFI) "in order to clarify the agency does not plan to finalize the current draft; but, instead intends to issue a new draft for public comment next year." 
IACP had expressed concerns to FDA regarding the GFI in face-to-face meetings as well  as via formally submitted comments. In addition, IACP, working with the Coalition, requested Congressional Appropriations language to rescind the animal compounding guidance. IACP is grateful for Congressional Appropriators that helped preserve patient access to vital compounded medications by directing FDA in Appropriations Report language to rescind the animal compounding guidance.

IACP is pleased to see FDA's announcement to withdraw its animal guidance, and hopes that FDA will clearly state that the Drug Quality & Security Act (DQSA)does not apply to animal compounding. IACP hopes that FDA will help remedy the mass confusion the GFI and other FDA announcements and statements, intermingling human and animal compounding have caused for the States, providers, patients, and pharmacists and that FDA will take further action regarding human compounding to rescind additional guidance documents that are drastically decreasing patient access to life-saving compounds. More info here.
  • 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 - IACP Members : We have some very exciting news! 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 HUGE 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. 
  • Continue to collect patients' stories and let us know if a patient would like to get involved! We need patient stories for our Congressional documents as well as any potential future hearing.  Please let us know if you are willing to be the voice of your patients or whether you know of patients willing to provide quotes or speak on the record!
Congress and Agency Actions in the News

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 this 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, § 39G. More information including written testimony (due by November 30, 2017) submission instructions here. IACP plans to submit written comments and will be sharing these efforts soon!  
  • 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 WebsitePatient 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 525 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 dagmar@iacprx.org.
IACP Events & Education


IACP Educational Conference
Sonesta Fort Lauderdale Beach
Fort Lauderdale, Fla
January 24-27, 2018! #EduCon2018

Registration Discount Ends December 1, 2017!

Advanced Hotel Discount ends December 24, 2017

Register HERE  for IACP's Educational Conference!  Come join us to obtain CE by the Sea! Make plans to attend IACP's Educational Conference in Fort Lauderdale, Florida, January 24-27, 2018! Enjoy southern Florida's soothing coastal ambience at the gorgeous Sonesta Fort Lauderdale Beach with every hotel room providing a gorgeous ocean view! More details here !

Click here for a Educational Conference Schedule Sneak Peek!

NEW!  IACP's Presidents Annual Gala - IACP will be premiering our First Presidents Annual Gala during the Educational Conference on Friday, January 26, 2018 at 7:30 p.m. in the Infinity  Ballroom at the Sonesta Fort Lauderdale Beach. Meet the new IACP Executive Vice President Cynthia Blankenship, Esq., and witness the installation of the IACP Board of Directors Officers! Enjoy an exquisite three-course meal, with your choice of Seared Sirloin Steak with Zinfandel Shallot Reduction, Petit Filet with Herb Grilled Jumbo Shrimp, Grilled Salmon with a  Roasted Garlic-Lime Emulsion, or a delicious Vegetable Pad Thai. One complimentary drink ticket and live entertainment will be included with your Gala reservation. Tickets can be  purchased during registration. Corporate Members - Please contact IACP's Ashlyn Grant  for exciting sponsorship opportunities

Thank you to the following sponsors for their support of the  1st President's Annual Gala:
DoseLogix/Topi-CLICK (Bar Sponsor); Letco Medical (Entertainment Sponsor, Table Sponsor);  My USP 800  (Additional Gala Drink Tickets);  PCCA  (Table Sponsor). 

Thank you,  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 have purchased Gala tickets! 

Find more information about the President's Gala, including how to attend/purchase tickets, how to sponsor, meal selection, and entertainment details hereAll proceeds from the President's Gala will go to the IACP One Fund.
Save the Date for #CCH2018!

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!
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.

IACP Foundation Update

IACP Foundation's Board of Directors 2018 Call for Nominations CLOSE TODAY! The IACP Foundation is looking for people interested in becoming more involved and actively working with rest of the IACP Foundation Board of Directors to advance the practice of pharmacy compounding through student interactions, educational and scientific programming, and research. The Bylaws of IACP Foundation set forth an open election process with nominations for candidates accepted directly from the community of pharmacists, pharmacy technicians, other healthcare professionals, patients, etc. More here

IACP Foundation Fund-the-Future now accepting applications for the 2018 IACP Educational Conference! It's that time of year again! 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 the International Academy of Compounding Pharmacists' (IACP) - Educational Conference on January 24-27, 2018 in Fort Lauderdale, Fla. All pharmacy student are encouraged to apply. More here!

Have You Read IACP Foundation Newsletter's November 13th edition? Check out the latest news from IACP Foundation here!  
IACP Corporate Member News 

 

  • IACP is pleased to send you information on continuing education resources! We are always looking for tools we believe will be beneficial for your pharmacy practices and professional development! Our Corporate Member LP3 Network is Offering IACP Members a Special Discount on all 2017 Continuing Education Training Activities! Check out below information from LP3 Network!

Key advantages offered by LP3 Network: 

  • A comprehensive portfolio of accredited hands-on programs that are designed to help your organization reach its full potential.
  • World-class learning environments equipped with the cutting-edge compounding technologies.
  • Scheduling flexibility - courses are available weekly throughout the United States including in California, Florida, Nevada, New York, and Texas.
  • Free access to a vast library of compounding webinars.

Click here to view the course catalogue.

 

Thank You, IACP Corporate Member LP3 Network, for offering our membership a special discount!

Corporate Member Spotlight: Kunesa LLC


IACP Corporate Member Since 2013

If you want to reconfigure your compounding facility according to USP 800 norms, KUNESA LLC is your partner.  All our fixtures and surfaces are USP <800> compliant.

Our architects will provide you with a layout that integrates all areas of your total space to give you an optimal solution, including retail Rx area, front end, offices, storage area, breakroom etc.



IACP Affiliate News  


New USP Activities/Resources: Safe Handling of Hazardous Drugs <800>
 

Coming soon... in 2018
  • Know your exposure: Awareness campaign
  • HazRx™ Mobile App:  At the point of practice tool to identify HDs and take measures to help decrease risk associated with handling hazardous drugs. 

Need CE ASAP?  

If you need CE credit, check out IACP AdvanCE's on-demand library. The library houses over 100 programs over various pharmacy topics. Please click here to access the self-paced programs.

Featured Webinar Programs:
IACP| 281.933.8400 | iacpinfo@iacprx.org | iacprx.org
STAY CONNECTED:

(C) IACP 2017