In This Issue
1. Happy Labor Day! IACP Offices Closed on Monday, Sept. 6th
2. Take Action! Support the Carter Letter to Tricare
3. FDA Postpones Comments on Vet Guidance But Asks More Questions
4. IACP Interviewed by the Government Accountability Office
5. The AWP Coalition Requests Your Help
6. Compounding in the News
7. Support Your Future and Your Academy. Contribute to IACP's One Fund
8. Corporate Partner Spotlight: Dynalabs LLC
9. IACP Foundation News
10. Registration Opens October 5th for the ACA, IACP, ACVP Educational Conference
|Capitol Connections is a biweekly newsletter for IACP Members Only.
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Happy Labor Day! IACP Offices Closed on Monday, Sept. 6th
IACP wishes you a safe and happy Labor Day weekend. Our offices will be closed on Monday, September 6th, reopening on Tuesday morning. Please email firstname.lastname@example.org if you need to reach us in the interim.
Curious about the history of Labor Day? Click here to view.
Take Action! Support the Carter Letter to Tricare
Congressman Buddy Carter (R-GA), the only pharmacist in Congress, is asking tough questions of Tricare on their implementation of a restricted reimbursement program initiated by their contracted PBM Express Scripts in May. Those program changes, including a wholesale exclusion of many Active Pharmaceutical Ingredients (APIs), have forced pharmacists to use less-than-preferable finished manufactured drug products as the basis for fulfilling compound prescriptions.
Congressman Carter’s draft letter to Assistant Secretary of Defense for Health Affairs Jonathan Woodson, which you can read in its entirety here, says: While these changes were created with good intent, they have ultimately removed all access of compounded medications from patients, forcing them to look elsewhere for treatment and relief. Unfortunately, compounded medications are often the last option for many patients, and these changes force them to make difficult decisions, which sometimes involve illegal drug use as a last resort.
IACP has asked its members to help secure additional Congressional signatures before the letter is sent to Assistant Secretary Woodson. Already, Congressmen W. Jones, Farr, T. Ryan, Ribble, McClintock, Farenthold, Olson, Welch, Peterson, and Schweikert have committed their support.
Now we need your help. The deadline to sign onto the Carter Tricare letter is Friday, September 11, 2015. Call your Congressman’s office and ask for them to co-sign the letter. Your Congressman’s staff can contact Carter’s Legislative Director Chase Cannon with questions or their commitment by e-mailing him at Chase.Cannon@mail.house.gov or by calling (202) 225-5831.
FDA Postpones Comments on Vet Guidance But Asks More Questions
On the very day they were due, the Food & Drug Administration (FDA) granted IACP’s requested extension for comments from stakeholders on their Guidance for Industry: Compounding Animal Drugs from Bulk Substances: Please click here to view. As previously reported, this new guidance document replaces the previous 2003 Compliance Policy Guideline: Veterinary Compounding but includes what IACP believes to be a gross overreach of the FDA’s authority without Congressional authorization.
“Although the comment extension was a big win for IACP our work is now even more complicated,” said Legislative Committee Chair Erik Tosh, RPh. “FDA is asking for opinions and answers to questions that aren’t included in the draft GFI released in May. That means we need to get our member input because so many of those relate directly to day-to-day pharmacy/veterinary practice.” Some of the questions included in the FDA’s notice of August 17, 2015 include:
Please click here to read the entire article.
IACP Interviewed by the Government Accountability Office
Earlier this month, IACP participated in a lengthy interview on behalf of IACP Members with the Government Accountability Office (GAO) regarding a compounding study. IACP understands the GAO study will include language on the Drug Quality & Security Act. Click here to view the language.
IACP is expecting the GAO's final report to be released in November 2016. We will keep our members apprised of its publication.
The AWP Coalition Requests Your Help
There is still time before the Congressional Recess ends. On behalf of the Any Willing Provider (AWP) Coalition, IACP encourages you to contact your members of Congress (MOCs) in support of legislation that has been introduced in both the House and Senate. The AWP Coalition, comprised of national and state pharmacy associations, is working to preserve your right to serve Medicare Part D patients by assuring that a pharmacy has the ability to participate in a Part D provider network.
The Coalition has been successful in introducing two bills - H.R. 793/S. 1190 - that would allow pharmacies located in medically underserved areas to participate in Part D preferred pharmacy networks if they can meet comparable terms and conditions that other in-network pharmacies meet. H.R. 793 currently has 56 co-sponsors and S. 1190 has 10.
Please click here to view a list of the co-sponsors.
Please call your Congressman's and Senators' offices and ask for their support of these two important bills that are intended to assure open access for all Medicare Part D patients to the pharmacy of their choice.
Compounding in the News
Medical Press: Fears of Potentially Blinding Complication from Avastin Eye Injections Overblown, Study Says
Boston Herald: State Boosts Pharmacy Checks Uncovers More Regulatory Violations
InPharma Technologist: Italy Bans 7 APIs from Compounding Pharmacies After Off-label Abuse
Outsourcing Pharma: QuVa Pharma Buys Healix's 503B Facility
IACP in the News
Bloomberg BNA: IACP's David Miller Comments on Texas State Auditor Report - See State News
LAST CALL Sept 8th: IACP Board Election Nominations
IACP’s 2015 Call for Nominations and the 2015 Election Cycle for the new 2016 Board members will close on September 8th! The Bylaws of IACP set forth an open election process with nominations for candidates accepted directly from the membership.
Interested candidates may be nominated or may be self-nominated to the IACP Nominating Committee chaired by IACP Immediate Past President Pat Stephens, PharmD. The IACP Board of Directors receives the Nominating Committee report at its October Board Meeting, approves the slate of candidates, and then all qualified IACP members are able to participate in the election process held each November. This year, there are four Board of Directors’ seats for which candidates are sought as well nominees for the position of IACP Vice President.
Please click here to read more about the nomination process.
Please click here to access the nomination form.
Support Your Future and Your Academy. Contribute to IACP's One Fund.
Help IACP reach our fundraising goal of $2 million dollars by the end of 2016. This funding allows us to continue our efforts to Fix DQSA and to be ready for the next challenge on the horizon. Through your generosity and support we are shaping the future of compounding.
At Compounders on Capitol Hill this year, IACP President Dale Coker, RPh, FIACP, issued a personal challenge to our membership and Corporate Sponsors to donate to IACP’s One Fund.
"IACP has a clear goal to be proactive rather than a reactive organization," says Coker. "To accomplish this, it requires capital. We need to replenish our reserves used in defending compounding in the wake of the NECC crisis of 2012. We need to build our war chest for the next coalition that will need to be formed. There are many issues on the horizon, with the Veterinary Compounding Compliance Policy Guide, third party reimbursement and third party credentialing to name a few. We need funding available to act NOW, not after a crisis sets in.
During CCH, we raised an additional $52,000 and $15,000 in future donations from members for a total of $87,000. To date we are at $413,000 which is about 21 percent of our goal with a quarter of our timeline already gone.
IACP Members and Corporate Partners: Please join us in our efforts to Protect, Preserve and Advance Pharmacy Compounding by making a donation to IACP’s One Fund fundraising campaign. Please click here to donate online, or click here to access a One Fund donation form.
Corporate Partner Topi-CLICK Donates $25,000 to IACP's One Fund Fundraising Campaign!
Corporate Partner Topi-CLICK heard our call and donated $25,000 to One Fund. Their generosity will help us reach our goal of $2 million dollars by the end of 2016.
Thank you, Topi-CLICK, for your ongoing generosity to the Academy. We greatly appreciated your support. On behalf of our Board and Members, thank you.
Please contact Jennifer Petska, BS, CPhT, IACP Director of Membership and Development with questions about One Fund.
FDA Drug Shortage App
FDA Launches Drug Shortage App
What's New on the FDA Drugs Site
Drug Firm Annual Registration Status (updated)
Drug Firm Annual Registration Status Download File (updated)
The FDA Drug Shortage Report
Please click here for the most recent Drug Shortage information.
IACP Member Q&A
Every week, IACP members contact our offices for questions about practice, business, legislation and other issues. In every issue of Capitol Connections, 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 email@example.com.
We were recently asked to compound with Squaric Acid (squaric acid dibutyl ester) for topical use from a dermatology office. Our lab pharmacists referenced information they have and it shows no USP monograph, no FDA approved product and is not on the positive list. Or actually not on the “do not compound” list.
While researching this chemical, we located a Medscape article stating the FDA Pharmacy Compounding Advisory Committee voted it ONTO the positive list in February 2015.
Is there a current list published? Would this medical article be enough backing to legally compound with it and stay in compliance with 503A?
•A 503A traditional compounder can use an Active Pharmaceutical Ingredient (API) if it has one of the following: a USP monograph, or be part of a current or previously FDA approved product, or is on a list created by the Secretary of Health and Human Services (commonly called the "positive" list).
•Squaric Acid does not have a USP monograph nor is it part of a current or previously FDA approved product.
•The drug was nominated to the FDA for consideration for addition to the "positive list" and was approved by the Pharmacy Compounding Advisory Committee on 23/24 February 2015.
•Even though the Committee approved two bulk drugs (cantharidin and squaric acid) and several more at its June 2015 meeting, the list itself has not yet been formally issued by the Secretary in The Federal Register.
Technically, until the list is published, the law is fairly specific in that a medication without a monograph or without being a component of an approved drug cannot be compounded using an API. There are no current enforcement discretion or other "passes" that have been stated by the FDA or by Congress. At the same time, they've taken no action against any compounding pharmacist who is continuing to use APIs that don't meet those criteria.
Also, just because the Committee approved the drugs for addition on to the "positive list" doesn't require, mandate or in any other manner obligate the Secretary to add it to the list. The Secretary can reject all of the Committee's decisions. Therefore, having an article from the press doesn't provide any sort of justification.
Corporate Partner Spotlight: Dynalabs LLC
DYNALABS LLC partners with you to improve your business with consultation, data analysis, and analytical testing. We provide solutions, not just services, by working to understand your specific business and quality goals, and implementing a carefully designed plan to address those goals within your budget.
Since 2004, our expert staff combined with our state-of-the-art laboratory has helped retail, industrial, and hospital pharmacies improve quality assurance in important areas, such as Vendor Qualification, Training Verification, Equipment Qualification, Facility Qualification, Stability Validation, Process Validation, and Product Verification.
DYNALABS LLC core lab provides pharmaceutical testing of sterile and non-sterile dosage forms to address the challenges associated with drug compounding.
DYNALABS LLC’s consultation services expert staff work with you to establish effective testing programs and analyze the resulting data to identify and address opportunities to improve products, processes, and personnel. The resulting improvements increase quality and grow revenues.
DYNALABS LLC is FDA registered, licensed by the DEA and Bureau of Narcotics and Dangerous Drugs, as well as ISO 9001:2008 certified. The services provided by DYNALABS are protected by U.S. Patents No 7,197,405.
DVxtm - On Site Drug Verification System
DYNALABS LLC offers the fourth-generation DVx to bring the analytical lab into your pharmacy or hospital. It now takes only 4 seconds in your facility to ensure the drug in the container matches the label. This easy to use tool enables enables any qualified person on your staff to instantaneously and objectively verify drug identity and strength. The DVx small size (20cm wide X 33cm deep X 16cm high) ensures you can easily fit the DVx where you need it.
Please click here to read more!
Registration Opens October 5th for the ACA, IACP, ACVP Educational Conference
Don’t miss this one-of-a-kind, 3-in-1 conference that brings the pharmacy profession together in paradise. The American College of Apothecaries (ACA), the International Academy of Compounding Pharmacists (IACP) and the American College of Veterinary Pharmacists (ACVP) are joining forces again to bring you an extraordinary Educational Conference, February 24-27, 2015, at the Loews Coronado Bay Resort. Perched on its own 15-acre peninsula, Loews Coronado Bay is a private oasis of tranquility with views of the shimmering bay waters and the San Diego skyline.
Please click here for more information!
IACP Foundation News
IACP Foundation Seeking Grant Proposals
The IACP Foundation Research Committee is now seeking proposals for funding consideration. Please click here to read the Grant Request for Proposal, and submission guidelines. Please click here to read more about IACP's Grant Proposal program.
The Application Deadline is November 1, 2015. Grant Awards will be announced on December 15, 2015.
NEW! Announcing the Fall 2015 Student Writing Competition
Essay Theme: "How is the Drug Quality & Security Act Affecting the Future of Compounding?"
The IACP Foundation created its semi-annual Student Writing Competition to recognize outstanding original papers by student pharmacists on a particular topic affecting pharmacy compounding. THREE winners will be selected by a review committee from the papers submitted. The winners of this writing competition will each receive a $500 cash prize. All student pharmacists are encouraged to compete.
The submission deadline is Monday, November 30, 2015. Please Click Here to obtain a Guidelines/Requirements document for essay submission.
IACP Foundation August Newsletter
Please click here to read the August Newsletter!
For more information, please email Jennifer Petska, BS, CPhT, IACP Foundation Administrator and Director of Development.
IACP Podcast #17: The DQSA Coalition
Please click here for a Podcast interview with special guests, Cynthia Blankenship, Esq., IACP Vice President of Government Affairs and David Pore, Arnold & Porter.David is an attorney licensed in Texas and in Washington, DC who currently serves as Counsel at the DC-based law firm of Arnold & Porter, LLP. The topic is the DQSA Coalition.
For more information on IACP's Podcasts and Publications, please contact Scot Maitland.
Mark your Calendars - 2016 CCH Exhibitor Prospectus will be Released November 2015!
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 2015, 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. Don’t miss the only pharmacy compounding event that takes our issues directly to Washington, D.C.’s doorstep.
CCH returns to Downtown Washington, D.C.! Conveniently situated in the Penn Quarter district, this premier location is surrounded by shops, a variety of dining options, the Spy Museum, Chinatown, the National Portrait Gallery, the Smithsonian American Art Museum, and world-famous National Mall monuments.
More details to come!
Save $100 on Freedom’s 4th Annual Seminar and Attend the IACP Regional Education Meeting in Denver, CO!
The IACP Regional Education Meeting brings 2.0 contact hours (.20 CEUs) of live pharmacy law continuing education credit to pharmacists and technicians all across the United States. Listen to David G. Miller, RPh, IACP’s Executive Vice President & CEO as he presents Pharmacy Compounding Law and Regulations: Staying Current in a Changing World, an in-depth presentation on federal and state legislative and regulatory issues that are affecting compounders today.
Click here for more information!
RESCHEDULED to Sept 1st - Hot Button Issues on the PBM Radar Screen with Bradley W. Howard, Atty. at Law
Bradley W. Howard, Attorney at Law
Brown and Fortunato, P.C.
Tuesday, September 1, 2015
1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00MT)
Pharmacies rely upon their participation in many different insurance programs. However, the PBMs that regulate pharmacy participation have taken a very aggressive stance against various business practices of pharmacies. This program will familiarize you with recent trends in PBM audits of pharmacies and better prepare you for the future.
At the conclusion of this program, the attendee will be able to:
•Describe recent trends in PBM audits of pharmacies.
•List pharmacy practices that PBMs will not tolerate.
•Describe the business arrangements that may lead to PBM scrutiny.
Need Additional CE Credit?
If you need CE credit, check out IACP AdvanCE's on-demand library, which houses more than 100 programs on various pharmacy topics. Please click here to access the self-paced programs.
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