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Capitol Connections, July 21, 2015
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July 21, 2015

In This Issue

1. IACP Files Formal Comments on Proposed FDA Memorandum of Understanding


2. Veterinary Guidance Document Strengthens Relationships


3. IACP Membership Survey Closes this Friday: Help Shape Your Academy's Future!


4. IACP Board Elections: Call for Nominations


5. Support Your Future and Your Academy. Contribute to IACP's One Fund.


6. IACP Welcomes New Corporate Partner: International Filter Products


7. Corporate Partner Spotlight: BiosRx, Inc.


8. Compound Conference Hotel Room Block Extended Until July 24th!


9. IACP Foundation 2015 Fall Grant Program: Request for Proposals


10. Save the Date for CCH 2016! June 11-14, 2016

Capitol Connections is a biweekly newsletter for IACP Members Only.

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IACP Files Formal Comments on Proposed FDA Memorandum of Understanding


In formal comments filed yesterday with the U.S. Food & Drug Administration (FDA), the International Academy of Compounding Pharmacists (IACP) has raised serious concerns about patient access to vital medications, as the agency develops a new regulatory framework for pharmacy compounding based upon the Drug Quality and Security Act (DQSA) of 2013.


From today's IACP press release, “We believe the FDA’s draft guidance overreaches far beyond the intentions of Congress and contradicts the clear language of the DQSA and previous federal legislation – to the point that, if left intact, it will hinder patient access to compounded medications, limit patient choice of their pharmacist, and disrupt the essential physician-patient-pharmacist triad relationship,” said David G. Miller, RPh, the IACP’s Executive Vice President and Chief Executive Officer.


“Our organization, along with a diverse group of stakeholders in the health care industry, has worked cooperatively with the FDA as the agency implements the DQSA, and we urge the FDA to incorporate our feedback,” Miller said. “The fact that more than 3,000 individuals and organizations have commented on the draft guidance underscores that the agency has a great deal of work to do before finalizing this document and ensuring that it does not negatively impact patient access to compounded medications.”


IACP Press Release


Click here to read the entire IACP press release.


IACP Comments to FDA


Click here to read IACP's submitted MOU comments to the FDA.


Please email IACP at with any questions.

Veterinary Guidance Document Strengthens Relationships

Comments are due in just a few short weeks on the FDA's proposed Guidance for Industry - Compounding Animal Drugs from Bulk Drug Substances. Click here for reference. When this GFI was issued in late May, IACP and the American Veterinary Medical Association (AVMA) began identifying areas of common interest and how to respond to the many restrictive and potentially precedent-setting requirements contained in the agency's proposed draft. Those include requirements for individual patient specific prescriptions, mandatory statements regarding the use of a compound instead of an FDA-approved drug product, new prescription label statements, and mandatory participation in the FDA's adverse event reporting system.


Last week, IACP was the only compounding pharmacy organization invited to participate in an hour-long AVMA-hosted discussion with FDA. Included in the call were representatives from the veterinary subspecialty groups, the animal prescription drug industry, and the academic veterinary community. Almost all of the practitioner groups decried what is perceived to be an inappropriate incursion by a federal regulatory agency into the traditionally state-regulated practice of both pharmacy and veterinary medicine.


FDA representatives did not explain the rationale for specific positions within the draft GFI while on the call but strongly encouraged all groups and interested practitioners to submit comments and recommendations to the docket. Those comments are due on August 17, 2015. Click here for more information.

IACP Membership Survey Closes this Friday: Help Shape Your Academy's Future!

Please complete by this Friday, July 24th.



Last summer, the IACP leadership developed a multi-year strategic plan to guide the Academy in tackling many of the opportunities and challenges facing the compounding pharmacy community. In addition to expanding our educational programs, publications, and our legislative efforts at the federal and state level, this plan directly guides our organization as it enters its 25th year.


To see how we're doing and where YOU want us to go, we've created this brief member survey. It will take less than five minutes of your time but that investment will bring enormous return to IACP.


The survey will be available until Friday, July 24.


Please click here or on the graphic above to take the survey.

IACP Board Elections: Call for Nominations

IACP’s 2015 Call for Nominations and the 2015 Election Cycle for the new 2016 Board members is now open! The Bylaws of IACP set forth an open election process with nominations for candidates accepted directly from the membership. Nominations will close on Tuesday, September 8, 2015.


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 call Jennifer Petska with questions about One Fund.

IACP Welcomes New Corporate Partner: International Filter Products

The IACP Corporate Partner program engages corporate leaders in the pharmacy compounding community by connecting them with IACP’s more than 4,000 members who are focused upon the specialty practice of pharmacy compounding. We encourage all IACP members to support IACP's 74 corporate partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.

To learn more about International Filter Products, please visit


FDA Update


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



Can I send a controlled substance compound to a physician office for them to administer to a specific patient?



No. “Constructive transfer” of a controlled substance is deemed an illegal and prohibited act by the Drug Enforcement Administration (DEA).

Under current DEA interpretation, the dispensing and delivery of a controlled substance medication -- either manufactured or compounded -- when that prescription is labeled for a specific patient, must only be to the patient themselves or their designated agent.

What's also important to understand is that the DEA holds that neither a DEA registrant nor his/her employees can serve as a designated "agent" of the patient. A DEA registrant’s spouse would also be considered an agent of the prescriber and therefore could also not receive or accept a patient-specific prescription for a controlled substance.

Here's the core section of the Controlled Substances Act upon which the agency makes that determination - Please click here.

That's also referenced (dispensed to the "ultimate user") in the Pharmacists' Manual. Please click here.

Lastly, IACP has a formal letter from the DEA that clearly states that "office-use" is not permitted for controlled substances; that was in follow-up to a formal inquiry asking for clarification from the agency. Please click here.

IACP and other professional pharmacy associations continue to work on changing this DEA policy.

Corporate Partner Spotlight: BiosRx, Inc.


BiosRx, Inc., is a medical device manufacturer and protocol development company that develops proprietary delivery systems for pharmacists and physicians.

As a leader in topical dispensing systems, BiosRx, Inc. has recently launched the HRTicker®: the most advanced metered transdermal delivery applicator – allowing for maximum dosing specificity to meet individual patient needs. The HRTicker is a patented delivery system, compact, elegant, and it offers patients the ability to self-administer large and micro doses of topical preparations. *Each Click delivers 0.05gram. *One complete turn of the dial delivers One gram. Furthermore, the user is able to hear the dosage as a secondary feedback mechanism to ensure the exact amount is applied.

The HRTicker US Patent 8,544,684 B2 is a novel clinical tool that brings to the anti-aging market alternatives to the delivery of topical medications. Patients are able to self-administer deliver static, variable, and rhythmic doses of hormones as part of comprehensive anti-aging programs.

LifeLike28® is a program that uses standardized compounding methodologies, prescribing forms developed for safety through FMEA, and accurate delivery systems to optimize patient health outcomes.

With Lifelike28, calling the prescription to the pharmacy is streamlined in a 10 step system. Pharmacies are able to dispense the program efficiently due to standardized formulas and processes. In most cases, all the patient needs to start using the program is a dosing schedule, and their topical bio-identical hormones dispensed in the HRTicker. The program is provided by an affiliate compounding pharmacy that has undergone training.

We take pride in the opportunity to positively impact the lives of patients through working with physicians and pharmacists around the globe. Whether you are a compounding pharmacist or healthcare practitioner– BiosRx, Inc. has the solution to help your business grow.

To learn more visit our website or call us at (800) 280-9277.

Hotel Room Block Extended Until July 24th!

Click here to reserve your hotel room.


Don’t miss this unique conference bringing together two leading pharmacy associations, August 15, 2015 at the Hilton Columbus at Easton in Columbus, Ohio.


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 2015 Compound Conference is a joint meeting with the Ohio Pharmacists Association (OPA) and the International Academy of Compounding Pharmacists (IACP).

Over the course of one day, attendees will experience unique continuing education programming including an overview of Trends and Growth in the Compounding Industry, Getting Started - Niche or All In?,Standards and Laws - USP/State/Federal, Testing and Equipment Resources, Marketing Your Compounding Practice, and innovative practice ideas in the Idea Exchange panel discussion from Ohio and IACP Members.

Join us for this unique conference to make a finished preparation that builds your business and practice.


Thank you to Our Exhibitors and Meeting Sponsors!


We would like to thank the following exhibitors for their commitment to the Compound Conference: Analytical Research Laboratories (ARL); ASI; Associate of Cape Cod, Inc.; Biomerieux; Cleanroom Design LLC; Humco Compounding; Letco Medical; MEDISCA; P&C Pharma; PCCA; Pharmacists Mutual Companies; Rx30 Pharmacy System; Storey Marketing; Topi-CLICK; Topi-Pump

We would like to thank the following meeting sponsors for their support of the Compound Conference: Letco Medical (Refreshment break with Exhibitors).

There are exhibitor and sponsor opportunities still available! Click here to download the Exhibitor Prospectus.


The Compound Conference eBrochure

Click here or on the graphic above to view our Compound Conference eBrochure! View the program schedule, speaker line-up and hotel information.

IACP Foundation 2015 Fall Grant Program: Request for Proposals

The IACP Foundation Research Committee is now seeking proposals for funding consideration. Please click here to read the Grant RFP, and submission guidelines.

The Application Deadline is November 1, 2015. Grant Awards will be announced on December 15, 2015.


Since 2015, IACP Foundation has awarded more than $275,000 in grants to academicians and practitioners. The IACP Foundation strongly believes pharmacy compounding research is vital to further exemplifying the role of pharmacy in personalized medicine.


For more information, please email Jennifer Petska.

IACP Podcast #13: A Conversation with Ernie Boyd, Ohio Pharmacists Association


Please click here for a Podcast interview with Ernie Boyd, Executive Director of the Ohio Pharmacists Association. Ernie talks about The Compound Conference taking place in Columbus, Ohio, on August 15th.


For more information on IACP's Podcasts and Publications, please contact Scot Maitland.


Next IACP Publication Issues Arriving Soon!


Our next issues of Compounding Matters Quarterly and Pharmacy Marketing Quarterly are coming out soon! Get caught up on our past issues and read them online at


Have an idea for a story? What to share some feedback? Send us an email to Scot Maitland or give us a call on the IACPublications line 713-730-9043.


Save the Date for CCH 2016! June 11-14, 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 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!

IACP Regional Education Meeting Heading to Chicago, IL and 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!

Need CE ASAP? Check out the IACP AdvanCE On-Demand Library!


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

Featured Webinar Programs:

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