The Drug Quality & Security Act (DQSA) Coalition is working with the offices of Congressmen Chris Stewart (R-UT-2) and Henry Cuellar (D-TX-28) to gather congressional signatures and send a letter to the Food & Drug Administration (FDA) Commissioner Dr. Robert M. Califf regarding office use.
From the letter: As the Congress considers appropriations for the Food and Drug Administration (FDA) for Fiscal Year 2017, we write to express our concern that the FDA has ignored a clear directive in the House Report accompanying the FY2016 FDA appropriations legislation (House Report 114-205). That report language directed the FDA, within 90 days of enactment, to issue a guidance document on how state-licensed compounding pharmacies can provide healthcare providers with compounded medications for administration to their patients in an office setting (commonly referred to as “office-use”) consistent with Section 503A of the Food, Drug and Cosmetic Act (FDCA).
Coalition Next Steps
The DQSA Coalition is moving forward on a Senate letter mirroring the House letter.We will keep you apprised on the availability of this letter for signatures.
IACP Member Action Requested:
The letter to FDA will be available for signatures until June 17th.Please click here to view the entire letter. IACP Members are encouraged to tell their respective Representatives to contact or call Luci Arveseth in Rep. Chris Stewart’s office to sign on!
IACP will be emailing an Action Alert to all IACP Members next week providing an easy-to-use platform to send the letter to your respective Congressional members. Stay Tuned!
IACP recently attended the National Association of Boards of Pharmacy’s (NABP) 112th Annual Meeting where all 50 State Boards of Pharmacy were in attendance. While compounding was not a major topic of discussion nor was it part of any policy resolutions, IACP was able to network, establish new relationships with several Boards & strengthen longstanding relationships already created over the last 25 years.
There are currently 12 compounding pharmacists serving on 10 State Board of Pharmacy across the country and, possibly the most exciting bit of news from the meeting, one of our own was elected to serve on the Executive Committee of NABP. IACP member Timothy Fensky, RPh, FACA from the Massachusetts Board of Registration in Pharmacy was elected to represent District 1 on NABP’s Executive Committee.
IACP looks forward to forging new and maintaining current relationships with both the Boards of Pharmacy and NABP. As part of these efforts, Executive Vice President John Voliva, RPh, was invited to speak at this summer’s District 5 meeting in Lincoln, Neb., this August. These efforts are just one of the many initiatives IACP takes on day-to-day to protect, promote and advance pharmacy compounding.
COMP PAC Chair Shawn Hodges, PharmD and the COMP PAC committee are picking up steam as they work on several important initiatives this year.
“COMP PAC will focus upon several critical issues including TriCare, reimbursement and billing, as well as complications the current FDA inspection & office-use interpretation, which falls outside of the Drug Quality and Security Act (DQSA) congressional intent, has been causing,” says, Shawn.
“We will continue to work closely with the IACP-led DQSA Coalition to ensure COMP PAC's objectives are integrated with IACP and its membership."
Please click here for more COMP PAC information!
The IACP Board of Directors welcomes new board member Marisol Lopez, RPh, MPh, University of Puerto Rico School of Pharmacy in Trujillo Alto, Puerto Rico.
Effective immediately, Marisol has assumed a board seat in District I. Congrats and welcome, Marisol!
Please click here to read more about Marisol.
Every week, IACP members contact our offices for questions about practice, business, legislation and other issues. We’ll highlight a question we've been asked that affects many of our members.
If you have a question you'd like answered, please send to firstname.lastname@example.org.
Question: Am greatly concerned about how the FDA Memorandum of Understanding (MOU) could impact my patients and my practice.
Answer: Many of your colleagues share your concerns. It is important to note that the current MOU released by FDA is only a DRAFT MOU. It’s not final and therefore not enforceable.
Please click here to view IACP's comments to FDA regarding this MOU.
Errata for USP General Chapter <800> Published
The errata for USP General Chapter <800> regarding HEPA filtration has been posted and is available on USP's website here.
2016 USP Compounding Compendium with General Chapter <800> Available – Discount for IACP Members
The 2016 USP Compounding Compendium which includes General Chapter <800> is now available. The IACP Member price is $150, a $25 savings.
Please click here for more information or to purchase. USP Chapter <800> will become official on July 1, 2018.
Corporate Partner Spotlight: Life File
Corporate Partner Since 2012.
Starting June, 2016 Life File is proud to offer
*** Provider and Pharmacy side certified EPCS solutions ***
Life File is a privately held San Diego health information company that delivers powerful cloud solutions to the compounding industry.Life File technologies are used by pharmacists, doctors, patients, salespersons, and other stakeholders in the compounding/specialty medication service areas.
Please click here to read more.
Reserve Your Room as soon as possible to receive the IACP Group Rate. Rooms are selling quickly therefore it is strongly recommended that you make your reservation as soon as possible.
Online Registration Still Open - Register Now!
The 22nd Annual Compounders on Capitol Hill (CCH) will be held June 11-14, 2016 at the Renaissance Washington, in Washington D.C. With more than 400 expected attendees in 2016, 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. Please click here for more information!
Why is CCH important to attend?
CCH is important to me because if I am not willing to take the time to advocate for my profession I cannot expect anyone else to do so on my behalf.
Steve Moore, PharmD, Condo Pharmacy, Plattsburgh, NY
Why is CCH important to you? Email a brief statement to Ashlyn Grant.
Please click here for more on #CCH2016!
On Monday, June 13th, 7:30-9:30 pm, COMP PAC will host the U.S. Congressman Doug Collins as the keynote speaker for the COMP PAC Fundraising Dinner at Ruth's Chris. The COMP PAC Dinner is an exclusive opportunity for IACP members to have a candid and direct dialogue with the Congressman to talk about the future of health care and compounding as well as the current regulatory and legislative issues facing compounding pharmacies.
To attend the COMP PAC Dinner or to make a donation, please click here.
Tell your patient and prescriber communities know that you will be attending Compounders on Capitol Hill this year! Promote the Conference on your pharmacy or company website, Facebook page and even in print! Attendees, Corporate Partners and Exhibiting Companies are all encouraged to promote their support by using the CCH 2016 Graphic Toolkit. The Toolkit includes a logo/web banner, Facebook Cover Image, “I’m Attending” e-mail signature as well as full page, ¼-page, and ½-page print ads.
Be Loud and Proud! Let everyone know you're going to D.C.! Click here to download the CCH 2016 Graphic Toolkit.
The good guys in the white lab coats are riding to Rx Mixer Roundup - Saddling up for Research and Education! Join us as we gather for the IACP Foundation’s 12th Annual Rx Mixer, a fundraising event to be held at the Renaissance Washington DC on Sunday, June 12, 2016. Event Co-Chairs, Erin Michael, MBA, CPhT and Richard Harwood, CPhT, with their Live Auction, Big Board and Reverse Card Draw Committees, plan to raise more than $205,000 through sponsorships and the auction to benefit the IACP Foundation! Since the first Rx Mixer was held in 2005, supporters of the pharmacy compounding profession generously have contributed more than $1.8 million to IACP's educational and research mission.
Check out the Online Rx Mixer Program Auction!
Click on the program cover to see what's up for auction!
For more information about volunteering, donating an auction item, or becoming a sponsor, please email Jennifer Petska, BS, CPhT, IACP Foundation Administrator and Director of Development, or call the IACP office at 281/933-8400.
To obtain a sponsorship, a donation form, buy tickets, and to learn more about Rx Mixer please click here.
Mark Your Calendars!
The 2016 Compound Conference will return to Columbus, Ohio on Sunday, October 9, 2016!
Exhibitor Prospectus Now Open
Click here to access the Online Commitment Form
Attendee registration will open on Monday, June 20th
The Compound Conference is the only conference annually partnering with a state pharmacy association, bringing together the leaders in the pharmacy compounding profession. At the Compound Conference, attendees have an unprecedented opportunity to meet face-to-face with compounding pharmacists, technicians, and marketing representatives in their home state.
Offering a variety of Continuing Education sessions focused on understanding the essentials in building a compounding practice, the 2016 Compound Conference is a joint meeting with the Ohio Pharmacists Association (OPA), the International Academy of Compounding Pharmacists (IACP) and the Ohio Society of Health Pharmacists (OSHP).
For more information, pleaseclick here.
Don’t miss these upcoming LIVE webinars!
Thursday, June 9, 2016
11am - 12 pm CST
2016 OSHA Training – Bloodborne Pathogens
Multiple webinars throughout the year - please click title for exact dates
Prioritizing USP <800>: Separating the ‘Musts’ from the ‘Shoulds’
Wednesday, August 10, 2016
12 pm - 1 pm CST
Check out the “Best of 2015” Webinar Programs in the IACP AdvanCE On-Demand Library!
If you need CE credit, check out IACP AdvanCE’s on-demand library. The library houses more than 100 programs with a variety of pharmacy topics. Please click here to access the self-paced programs.
Featured Webinar Programs: