FDA Issues Draft Guidances
The Food & Drug Administration (FDA) has announced three new draft guidances related to the compounding of human drugs. Please click here to view.
IACP: "It's Clear FDA is Still Ignoring Congressional Intent"
IACP thoroughly is reviewing the three guidances, and will provide a detailed summary to members. Based on what we've analyzed to date, IACP is disappointed, once again, that the FDA is ignoring Congressional intent in regards to office-use compounding with the publication of these drafts. It is clear the FDA believes that non-hospital owned 503A pharmacies cannot participate in office-use compounding while in the same breath, allowing hospital-owned pharmacies (which are still under the jurisdiction of 503A) CAN participate in office-use compounding as long as certain restrictions are met. Statutorily, this makes absolutely no sense – how can one “type” of 503A pharmacy perform office-use while another may not? In addition, FDA’s draft guidance on anticipatory compounding is confusing at best and may ignore the clear language of the bill when it comes to defining this practice.
Please keep in mind this guidance is labeled as DRAFT guidance and as such, comments can be submitted within 90 days. Once IACP performs a thorough review of the proposed FDA guidances, IACP will engage the agency in the commenting process.
IACP Members: File Your Comments!
We recommend our Members also file comments to show the Agency this is a very important issues for our patients and prescribers! IACP will make our formal comments available to Members as soon as completed. You are welcome to use this content in your own submission.
We Need You in DC! Register for CCH 2016!
Your presence will be critical at Compounders on Capitol Hill (CCH), June 11-14, 2016. Go to the Hill with IACP and let them know how important pharmacy compounding is to their constituents!
Congressman Buddy Carter Keeps Office-use in Front of Congress
IACP thanks U.S. Congressman Buddy Carter (R-GA) for keeping the office-use issue front & center, and on public record!!
Watch Hearing Coverage
Click here to view Congressman Carter question the U.S. Dept. of Health and Human Services in a House Oversight & Government Reform Hearing yesterday morning on why they had not followed up with him on office-use.
Click here for more information on yesterday's Oversight hearing.
Thank you, Congressman Carter, for all you're doing to help protect patient access to compounded medications!
IACP in the News
Bloomberg BNA: FDA Offers Three Guidances on Drug Compounding
ModernHealthcare.com: FDA Compounding Enforcement Draws Ire from Congress
Stat News: Proposed Federal Legislation Could Heighten Controversy Over Compounding Pharmacies
Bloomberg BNA: Texas Drug Compounder to Resume Operations
2016 USP Compounding Compendium with General Chapter <800> Now 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.
The FDA Drug Shortage Report
Please click here for the most recent Drug Shortage information.
CDER's Jane Axelrad Announces Retirement
Corporate Partner Spotlight: Total Pharmacy Supply
Total Pharmacy Supply strives to be a one-stop-shop for all your supply needs, because your time is valuable and the work you do demands the highest level of quality. We are a wholesale distributor of pharmacy supplies to businesses nationwide, carrying over 3,000 products and constantly working to keep up with the latest products and services.
Click here to read more.
#CCH2016 Extended Advanced Discount Ends Monday, May 2nd!
Reserve your Renaissance DC hotel room asap! Rooms in the IACP block are going fast.
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.
On Monday, June 13th, COMP PAC will host the U.S. Congressman Doug Collins as the keynote speaker for the COMP PAC Fundraising Dinner. 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. Why is CCH important to attend?
CCH is a vital event for anyone who is a compounding pharmacist or owns/manages a compounding pharmacy. On a daily basis, we all see the clear benefit of what compounding, or more specifically - customized medication, can do in the lives of our patients. The least we can do is join IACP once a year to educate and appeal to our Senators and Representatives to protect our profession, which ultimately protects our patients by ensuring continued access to safe, effective, personalized medication. The most important players in the compounding industry are all at CCH – and anyone who plans to be around in 5 years would do themselves a great service by attending CCH 2015.
Joseph T. Huntsman, Jr., Owner & CEO, Southern Orthocare
Why is CCH important to you? Email a brief statement to Ashlyn Grant.
Please click here for more on CCH 2016!
Compounders on Capitol Hill Graphic Toolkit Now Available!
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.
Loud and Proud! Let everyone know you're going to D.C.! Click here to download the CCH 2016 Graphic Toolkit.
Hey Pardner: Got your Rx Mixer Tickets?
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.
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 or donation form, and to learn more about Rx Mixer please click here.To register online, please click here.
Thank you Rx Mixer Sponsors! Thank you Rx Mixer Donors!
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.
Need CE, ASAP?
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: