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IACP Capitol Connections, January 28, 2016
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January 28, 2016

In This Issue

1. Message from IACP President Gary McCrory


2. IACP's Year in Review


3. Announcing IACP's 2016 Board of Directors


4. Coalition Urges State Boards to Ensure DQSA Implemented as Congress Intended


5. IACP Town Hall - Save the Date


6. DC Report: IACP Meets with Congress


7. IACP Good News: Appropriations Report


8. Contribute to IACP's One Fund!


9.CCH Registration is Now Open


10. Educational Conference Extended Advanced Discount Ends January 31, 2016!

Capitol Connections is a biweekly newsletter for IACP Members Only.

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Message from IACP President Gary McCrory

Happy New Year, and Happy Anniversary! This year marks the 25th anniversary of IACP. Can you believe it? Your academy has been serving the pharmacy compounding profession for a quarter of a century!


No doubt much has changed in our industry, especially in the last few years. We've traveled through a very challenging time together, and we owe a great deal of thanks to our Members, to our Corporate Partners, and to our Affiliates.


Last year was an extremely active one - be sure to read the Year in Review article below, outlining IACP's efforts and accomplishments, led by IACP Chairman and Immediate Past President Dale Coker, RPh, FIACP. Please also read the Appropriations Update - this represents a major milestone for the Academy and one we couldn't have realized without your support.


The DQSA Coalition that IACP successfully launched along with a broad section of organizations representing varied health care providers and state pharmacy associations has been hard at work. Read below on how this Coalition has been reaching out to State Boards of Pharmacy and Medicine to engage them in the fight to implement DQSA as it was fully intended!


We've got a lot more work to do. With your continued participation, advocacy and contributions, IACP can continue to fight on your behalf, helping to ensure your patients have continued access to pharmacy compounding. We want to ensure FDA understands that DQSA must be implemented as Congress meant it to be! And, we will continue working to navigate the considerable divide between state and federal law, especially in regards to office use. This divide has caused confusion and has impacted patients' access to compounded medications! This situation must change.


This year, we also will continue our focus upon a myriad of reimbursement and third-party issues to ensure that your expertise and value to healthcare is fairly recognized.


I'm confident we can keep the momentum going on the Hill and on a state level because your incoming and returning IACP Board of Directors is a strong one. The Board will ensure that IACP continues to implement our strategic plan, keeping IACP a relevant resource and a powerful ally for our members, and for our profession.


Please continue to help IACP by renewing your memberships, and encouraging your staff and others to join us. Get involved on our committees! Attend the Educational Conference and CCH! And, please consider contributing to our fundraising efforts. IACP is passionate about compounding, and we intend to keep representing you on the Hill, at the State Board level, to healthcare consumers and in the press to keep compounding a vital profession for years to come!


Thank you for your support.



Gary McCrory, RPh, CCN

IACP President


IACP's Year in Review

It was a busy 2015 at IACP! Throughout the year, IACP accomplished many objectives specifically targeted at enhancing tools and resources offered to the IACP Membership. Please review below a few of the accomplishments provided by your Academy in 2015.

Legislative Report


Successfully lobbied to add four requirements to the 2016 Appropriations bills that direct the FDA to recognize and permit office-use compounding as Congress intended, to provide clear information on enforcement actions against the use of active pharmaceutical ingredients (APIs) that haven’t been reviewed by the Pharmacy Compounding Advisory Committee, and to change the draft Memorandum of Understanding (MOU). Congress denied all of FDA’s requests to increase funding under the DQSA to target compounding pharmacists.


Building a Drug Quality and Security Act (DQSA) Coalition of 25 physician and pharmacy organizations to work together and lobby Congress, speaking out about office-use, interstate dispensing of compounded preparations and the availability of needed APIs for custom-compounded medications.


Please click here to read more!


Announcing IACP's 2016 Board of Directors


Thank you to all IACP Members who took time to vote for the future of your Academy! Congratulations to all new and returning Board members.


Please click here to view the 2016 IACP Board of Directors.


Coalition Encourages State Boards to Ensure DQSA Implemented as Congress Intended


A broad cross-section of organizations representing varied health care providers, state pharmacy associations and the pharmacy community recently sent a letter to State Pharmacy and Medicine Boards expressing serious concerns with the federal government’s implementation of the Drug Quality and Security Act (DQSA), enacted in November 2013.


The coalition is asking these state Boards to delay consideration of any pending regulatory or policy decisions on the ability of practitioners to obtain and use office-use compounded preparations until such time as the Food & Drug Administration (FDA) issues its guidance in a manner that is consistent with DQSA as Congress intended.

“Specifically, we are deeply concerned about the implementation of the DQSA in regards to both compounded and repackaged medications for office-use,” says Gary McCrory, RPh, CCN, International Academy of Compounding Pharmacists (IACP) President, and lead DQSA Coalition organization. “Recent implementation actions by the FDA and the information being provided by the Agency to States have caused confusion amongst State boards of Medicine and Pharmacy and have adversely impacted practitioner and patient access to vital medications.”


IACP Distributes Press Release


Please click here to read more.

IACP Town Hall: Save the Date!



Make plans to attend IACP's first Town Hall of the new year on Tuesday, February 16th at 2 pm CST/3 pm EST.


IACP President, Gary McCrory, RPh, CCN, IACP Chairman Dale Coker, RPh, FIACP and Cynthia Blankenship will update you on current Washington DC initiatives, Fix DQSA efforts and Academy updates.


Stay tuned for a fax providing call-in information.

DC Report: IACP Meets with Congress

Cynthia Blankenship, who is employed by Rose Law Firm and recently rejoined IACP, and David Pore of Arnold and Porter, IACP's DC legislative counsel, went to the Hill to meet with Congress last week on behalf of compounding pharmacists.


Congress' recently passed Omnibus bill includes language requested by IACP members that mandates FDA to issue guidance within 90 days allowing office-use compounding, prohibits FDA from restricting dispensing practices under the MOU, and mandates FDA to report to Congress within 90 days regarding the finalization of the positive bulk ingredient lists.


Cynthia and David met with Appropriators to thank them for continuing to be champions for compounding pharmacists.


The Senate Appropriations Committee also was successful in denying all FDA's requests for increased funding in implementing the DQSA compounding provisions. This language could not have been possible without the dedication of our Congressional champions.


Please click here to read more DC details!


IACP Good News: Appropriations Report

On Friday, December 18th, 2015, President Obama signed the Consolidated Appropriations Act of 2016, which is often referred to as the “Omnibus” bill. This legislation includes all 12 appropriations bills, including the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill, which funds the Food and Drug Administration (FDA). The Omnibus bill funds the government through the end of the 2016 fiscal year, which is September 30, 2016, and totals approximately $1.15 trillion.

The Appropriations Committees, as they traditionally do, submitted a Committee Report accompanying the bill making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for fiscal year 2016.[1]


IACP is thrilled to announce that the House Appropriations Committee Report language which included all of the language requested by IACP regarding the Memorandum of Understanding (MOU), office-use, and Active Pharmaceutical Ingredients (APIs) was retained in the final Omnibus agreement reached by the House and Senate.


More here.



REMINDER: USP <797> Comments are Due January 31st


After several years in the making, the USP Expert Committee on Compounding released and advanced preview of its proposed revisions to General Chapter <797> Pharmaceutical Compounding/Sterile Preparations at the end of September.


The revisions can be found by clicking here. There is an open comment period through January 31, 2016. Please click here for more information including how to submit your comments!


IACP is finalizing its comments and will share with the IACP membership as soon as available.


IACP Provides Educational Resources on How to Work with Third Parties


IACP has several self-paced, on-demand CE offerings on how to work with third parties. Check our our expanding library below:


CMS and Reimbursement for Medicaid/Medicare Prescription Drugs

Third Party – Part 1 Private

Don’t Mess with Uncle Sam! How the Stark Law and the False Claims Act Impact Pharmacists

Contracting and Audit Considerations for Compounding Pharmacy

Medicare Part B: Documentation Requirements and 2013 Update

Hot Button Issues on the PBMs Radar Screen


Please contact IACP with questions at



Contribute to IACP's One Fund!


Help Us Reach $2 Million


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.


One Fund Contributors List


Please click here to view our One Fund Contributors to date!


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.


Please contact Jennifer Petska, BS, CPhT,IACP Director of Development & Membership, with questions about One Fund.




CCH Registration Now Open


Click here to attend #CCH 2016!


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.



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.
A bargain hotel group rate at $199 – that’s almost half the price from previous years!
Hear from experts during in-depth Continuing Education sessions on legislative and regulatory issues at the state and federal level affecting pharmacy compounding.
Expanded exhibit hall puts attendees face-to-face with 50 leading companies that serve compounding pharmacies.
Stay for Hill Day! Be an advocate for compounding during in-person Capitol Hill meetings with your state representatives.
Socialize and support the IACP Foundation during compounding pharmacy’s biggest party of the year – Rx Mixer on Sunday, June 12, 2016.
•On Monday, June 13, the COMP PAC Dinner and Fundraiser is an exclusive opportunity to hob-nob with the powerful movers and shakers of Washington, D.C. The COMP PAC will host a very high-profile influencer to talk face-to-face with our attendees about the future of health care.

Network! Reconnect with old friends and meet new colleagues who share your passion and interest in protecting, promoting and advancing pharmacy compounding!

June 11-14, 2016
Renaissance Washington, D.C.
999 Ninth Street NW
Washington, DC 20001


Exhibitor & Sponsorship Opportunities Available!


Click here to access the Online Commitment Form


Thank you to Our Exhibitors and Meeting Sponsors!

Accreditation Commission for Health Care (ACHC); AirClean Systems; American College of Apothecary (ACA); Analytical Research Laboratories (ARL); Associates of Cape Cod, Inc.; B&B Pharmaceuticals, Inc.; bioMerieux, Inc. ; BiosRx, Inc.; Compounders International Analytical Laboratory (CIAL); DoseLogix; EXAKT Technologies, Inc.; Fagron, Inc.; Freedom Pharmaceuticals; Hardy Diagnostics; Health Engineering Systems; Humco Compounding; ICA Health; International Journal of Pharmaceutical Compounding; International Medical Industries, Inc. (IMI); Kunesa LLC; Letco Medical; LP3 Network; MEDISCA; PCCA; RxCoop, LLC; Storey Marketing; Topi-Pump; Torpac Capsules Inc.; Willow Birch Pharma.


We would like to thank the following meeting sponsors for their support of the Educational Conference: DoseLogix (Conference Pen/Notepad); Letco Medical (Hotel Room Keys, Welcome Reception, Education Session); MEDISCA (Name Badge Holder); PCCA (Meeting T-shirt, Meeting Tote Bags, Meeting Syllabus); Topi-Pump (Travel Mugs).


Save the Date: Rx Mixer Roundup Saddling Up for Research and Education


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.


Your support and involvement is crucial in raising funds for the IACP Foundation. Click here to access the Rx Mixer Prospectus with corporate sponsorships, reserved seating, and donation opportunities.


To register online, please click here.


Yee-haw! It’s a Party with a Purpose! Now saddle up, Pardner. We’ll see you in June!


There's Still Time to Register! Extended Advanced Discount Ends January 31, 2016!


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, 2016 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.


What you can expect in 2016:


Benefit from multiple education tracks; practice-based, compounding, and veterinary clinical and compounding.
Earn up to 12.0 contact hours (1.2 CEUs) of continuing education credit including 3.0 contact hours (.3 CEUs) of LIVE Pharmacy Law.
Early release on Friday, February 26 to enjoy dining out, snorkeling, water sports, and local shops.
• Local pharmacists, technicians, and marketers enjoy a special one-day Saturday rate. Network with your colleagues from across the country in your home state.
• In 2016, visit with exhibiting companies showcasing services that can improve your business.


By morning – experience a unique menu of CE programs merging the best of ACA, IACP and ACVP. Gain information and skills you can implement immediately to your pharmacy practice.


By afternoon – connect with your colleagues and enjoy an array of thrill-seeking water adventures, a luxurious Sea spa and dining overlooking shimmering bay waters and the San Diego skyline at the Loews Coronado Bay Resort in San Diego, California.

Friday, February 26 Workshops Include:


ACA- How to Develop a Stress and Adrenal Fatigue Consulting Practice Within Your Pharmacy
Presented By: Dr. James Wilson, PhD, ND, ICA Health

IACP- Changing Environment and Expectations of Accreditation in Compounding
Presented By: Jon Pritchett, PharmD, RP, Accreditation Commission for Health Care (ACHC)

ACVP- Species Toxicities Of NSAIDS In Animals
Presented By: Sue Hudson Duran, RPh, MS, PhD, FSVHP, AACVP, Auburn University College of Veterinary Medicine

Please click here for more information!


Learn More About the #EduCon2016 Exhibitors

Visit our ACA, IACP, ACVP Educational Conference YouTube channel to checkout exclusive videos from our 2016 Educational Conference Exhibitors. Learn more about these companies and how you can improve your practice with their latest products and services!



Compounding Pharmacy Enforcement Update: Nationwide Increase in Civil and Criminal Investigations - NEXT TUESDAY!

Brian E. Dickerson, Partner, FisherBroyles LLP

Nicole H. Waid, Partner, FisherBroyles LLP

Tuesday, February 2, 2016

1:00 - 2:00 p.m. CST (2:00 ET/11:00 PT/12:00 MT)


The Department of Defense has labeled compounding pharmacies as dodgy companies that peddle pricey and unnecessary drugs through abusive marketing and pricing schemes to patients who use the military health benefit program, TRICARE.

The recent FBI raids on compounding pharmacies in Mississippi should serve as a clear and present danger warning of the government’s enforcement focus for 2016. Pharmacies that employ or engage outside sales and marketing professionals should heed the government’s warning by taking stock now to ensure they are in compliance with federal regulations. This program will address the do’s and don’ts of marketing and business operations for compound pharmacies as well as provide a practical how-to-guide should your pharmacy face a whistleblower lawsuit or government investigation.

At the conclusion of this program, the attendee will be able to:

•Explain the False Claims Act and how to structure business operations to be in compliance with federal regulations.
•Define outside sales and marketing activities that are not permitted under current federal regulations.
•Discuss how to implement business arrangements that do not violate federal regulations.
•Explain Whistleblower or qui tam lawsuits and the DOJ’s implementation of the Yates Memo to target individuals for criminal and civil liability.



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