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Capitol Connections, July 10, 2015
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July 10, 2015

In This Issue

1. House Appropriations Committee Passes 2016 Agriculture Appropriations Bill!

2. IACP Membership Survey: Help Shape Your Academy's Future!

3. IACP Board Elections: Call for Nominations

4. July 20th Deadline Approaching - Comments Due for FDA MOU

5. NASPA-Convened Workgroup Develops Collaborative Practice Authority Recommendations

6. Corporate Partner Topi-CLICK Donates $25,000 to IACP's One Fund Fundraising Campaign!

7. Corporate Partner Spotlight: GRX Marketing

8. IACP Welcomes Corporate Partner: Cleanroom Connection Inc.

9. The Compound Conference Hotel Room Block Ends July 15th!

10. IACP Podcast: A Conversation with Ernie Boyd, Ohio Pharmacists Association



Capitol Connections is a biweekly newsletter for IACP Members Only.

Please email iacpinfo@iacprx.org with your editorial ideas and suggestions.



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

House Appropriations Committee Passes 2016 Agriculture Appropriations Bill!

Yesterday, the House Appropriations Committee approved the fiscal year 2016 Agriculture Appropriations bill on a voice vote. The proposed legislation funds important agricultural and food programs and services, including food and medical product safety, animal and plant health programs, rural development and farm services, marketplace oversight, and nutrition programs.

IACP is extremely pleased to announce that several of the sections affecting compounding upon which we have lobbied very hard and also were part of our IACP Compounders on Capitol Hill (CCH) "Ask" documents were included in the approved Appropriations bill.

Please click here to view the full committee bill.

Please click here to review the specific parts of the bill affecting compounding.

A huge thank you to all of our members who have advocated along with the Academy to ensure that this language was included in the Appropriations bill. Your efforts have made a huge difference!

Please email IACP at iacpinfo@iacprx.org if you have any questions.


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

Please complete by 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.

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.

 


July 20th Deadline Approaching - Comments Due for FDA MOU

The Food and Drug Administration (FDA) extended the comment period in the notice of availability that originally appeared in the Federal Register of February 19, 2015 to July 20, 2015. The Agency extended the comment period both for the draft standard Memorandum of Understanding (MOU) and for information collection issues under the PRA for 30 days, until July 20, 2015.

Please click here for FDA's website to view information and comment.

Please click here to view IACP's draft comments to FDA. We are still making modifications and the link to the document is marked as a draft.

Background

The U.S. Food & Drug Administration (FDA) established a public docket to receive information, recommendations, and comments on matters related to the Agency’s regulation of compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

This docket is intended for general comments related to human drug compounding that are not specific to documents or issues that are the subject of other dockets. So, while IACP and compounders can submit comments on the draft guidance documents that are directly related to repackaging, adverse event reporting, and the Memorandum of Understanding there has been no place where physicians, patients, pharmacists and others can voice our concerns about office-use.

If office-use is important to your practice or your prescriber clientele, this public docket is the perfect place to file your comments about how the FDA is ignoring Congressional intent and disregarding state laws and regulations permitting office-use.

IACP has filed comments on the FDA Guidance Document with the Agency. Please click the below links to view IACP's comments.

FDA's "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities"

"Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act"

"Repackaging of Biologics"

Letter from Congress

Click here to view a Congressional letter regarding the repackaging of biologics.

FDA Public Docket


IACP Members! Click here to access the FDA Public Docket, which includes comment submission instructions.

Make your voice heard! Let the FDA know of your concerns on the recent compounding implementation plan.

IACP Summary on FDA Four Draft Guidance Document

Please click here to view.


NASPA-Convened Workgroup Develops Collaborative Practice Authority Recommendations

The Collaborative Practice Workgroup, convened by the National Alliance of State Pharmacy Associations (NASPA), has developed recommendations for the elements of pharmacist collaborative practice authority that should appropriately be defined under state law or regulation and which are best left to be determined between pharmacists and other practitioners when developing their specific collaborative practice arrangement.

Workgroup participants, pharmacists from a variety of settings who were appointed by the NASPA Executive Committee and the national pharmacy associations, considered the existing landscape of state laws and regulations, patient access, and pharmacist education and training in compiling their recommendations.

NASPA CEO, Becky Snead, on the importance of this work: “It is critical to have a national set of collaborative practice authority recommendations for state policy makers that are based on the best interests of patients and the education and training of pharmacists. This work builds on and supports the policy considerations from the National Governors Association in their 2015 paper, The Expanding Role of Pharmacists in a Transformed Health Care System.”

Please click here to read the report.


Corporate Partner Topi-CLICK Donates $25,000 to IACP's One Fund Fundraising Campaign!


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.

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.

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.

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.

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.


IACP Member News

Kevin Borg Named 2015 Next-Generation Pharmacist Finalist

IACP Board Member and Peoria, Ariz. business owner, Pharmacist Kevin Borg, PharmD, FIACP, has been named a finalist for the nationally recognized 2015 Next-Generation Pharmacist awards for the entrepreneur category.

The award honor pharmacists, technicians, student pharmacists and industry advocates who are defining the future of the industry. Please click here for more information.

Congrats, Kevin!

Eddie Glover Installed as President-elect of the Arkansas Pharmacists Association

IACP Member and Former Board Member Eddie Glover, P.D., of Conway, Ark., has been installed as President-Elect of the Arkansas Pharmacists Association (APA) at its 133rd Annual Convention held June 11-13 at the Little Rock Embassy Suites.

He has served for the past year as APA Vice President. Before that, he served as APA Area 3 Representative and District 1 President. He is a member of the National Community Pharmacists Association (NCPA) and served on its Multi-Location Committee. He is also a member of the board of directors for Pharmacy Partners of America. Glover was named NCPA “Pharmacist of the Year” in 2012. Please click here to read more.

Congrats, Eddie!

 


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 iacpinfo@iacprx.org.

Question:

Is a physician's office legally able to prescribe as well as dispense medications in the same facility?

Answer:

Except in a very few states (Georgia and Arkansas), a prescriber is permitted to dispense medications to his/her patients. Some states do require a special "physician dispensing permit" which includes compliance with certain labeling and recordkeeping laws.

Because of that, there is nothing that prevents a physician from having a compounding pharmacy of their own in their office. We've seen situations in California, for example, where physicians contract with a compounding pharmacist and technician to come on-site, do the preparation, and then dispense directly to the patient.

All compounding by physicians, however, also falls under section 503A of the Drug Quality & Security Act so they, too, have to comply with the federal law. Many physicians are unaware that they are included.


Corporate Partner Spotlight: GRX Marketing


 

GRX Marketing specializes in offering marketing services to independent pharmacies across the United States. Our program includes detailed marketing plan, custom designed in-store and out-of-store marketing materials, doctor detailing program, social media management, marketing consultation and more. Through this comprehensive approach, current patients and potential ones will see the same, consistent message in the various mediums available, thus increasing the probability of adding sales and new patients.

Everything is customized to the pharmacy’s individual needs and goals, it’s not a cookie-cutter program. The best part is we do most of the implementation of the ideas for our clients, leaving them more time to spend with patients. We also have extensive experience and proven results helping pharmacies grow their compounding business. Our staff has a combined 15 years of pharmacy marketing experience, it's all we do!


Hotel Room Block Ends July 15th! Don't Delay. Sign up, Today!

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.

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.

 


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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