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IACP Capitol Connections, October 14, 2015
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October 14, 2015

In This Issue

1. Tricare Compound Exclusion Announcement

 

2. Step Up and Stop FDA's Misguided Vet Guidance

 

3. USP <797> Revisions – Impact on Sterile Compounders

 

4. Tricare Mail-Order Program Examined

 

5. IACP Foundation Board of Directors Call for Nominations is Now Open

 

6. Thank You to our Generous One Fund Contributors!

 

7. Corporate Partner and Affiliate News

8. IACP Members in the News

 

9. Educational Conference Registration is Now Open

 

10. #EduCon2016 Student Pharmacist Travel Grant

 

FDA Inspections for Sterile Compounders: The Impact of DQSA Webinar


 

On Thursday, October 29th, tune into IACP’s second continuing education webcast on FDA inspection preparation at 2:00 PM Eastern where sterile compounding will be the focus of our program.

 

Click here to register!


Capitol Connections is a biweekly newsletter for IACP Members Only.

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

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Tricare Compound Exclusion Announcement


 

 

The Express Scripts’ Network Pharmacy Weekly (click here to view) of September 24, 2015 announced that effective October 1, 2015, the Tricare prescription benefit program they administer was expanding the exclusions list for compounded preparations.

 

In addition to the already excluded APIs announced back in May, Express Scripts and Tricare are now excluding classes of solid dose forms as well. In other words, even manufactured drug products used in a compound will now be considered “non-covered.”

ESI did not provide a list of specific drugs. Instead, it published a very broad list of therapeutic classes as “exclusions” under which FDA-approved drug products could be rejected if they are used in a compound.

Those classes include: acne, pain/inflammation, skin disorders, infertility, vitamins/minerals, enzyme deficiencies, endocrine disorders, and the “catch all” category labeled “miscellaneous conditions.”

 

Please click here to read more.


Step Up and Stop FDA’s Misguided Vet Guidance

At its September meeting, the IACP Board of Directors unanimously voted to support a bipartisan Congressional letter (please click here to view the letter) demanding that the FDA withdraw its Guidance for Industry #230: Compounding Animal Drugs from Bulk Substances.

 

Led by Congressmen Matt Salmon (R-AZ) and Kurt Schrader (D-OR), the letter points out that the agency does not have statutory authority to interfere with the state-regulated practice of veterinary medicine.

 

More importantly, the Congressmen point out that as written, the guidance attempts to create new regulatory authority without legislation to support that effort.

What can you do to help with this important fight?

 

That's simple. Ask your Congressman to support and sign-on to the Salmon/Schrader letter requesting the FDA withdraw GFI #230 entirely.

This week, IACP will be sending you a special e-mail alert that will make it even easier for you to ask for your Congressman's sign on of this important letter.

 

Our objective is to get at least 50 Congressional signatures on this by the end of October!

Please click here to read more!


USP <797> Revisions – Impact on Sterile Compounders


 

 

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. When they are formally published on November 2, 2015, an open comment period will begin and run through January 31, 2016.

IACP already has reviewed the proposed revisions and its Legislative Committee has begun drafting comments on how these changes will affect sterile compounders in all types of pharmacy practice settings.

“One of our greatest concerns with the revised <797> standard is the elimination of a clinician’s ability to determine a beyond-use-date based upon the medical and scientific literature,” says David Miller, IACP executive vice president.

 

“Traditionally, USP has acknowledged that science evolves and that pharmacists have the ability to apply new information and incorporate that into their practices. By establishing specific limits on BUDs for sterile drugs using language similar to FDA guidelines, USP is inadvertently restricting professional decision making.”

 

Click here to read more.


Tricare Mail-Order Program Examined

 

As reported in our last newsletter,Tricare and Express Scripts implemented a full roll-out of a mandatory mail-order program for brand maintenance medications effective October 1, 2015.

 

That same day, the General Accountability Office (GAO) issued its review of the pilot program that Tricare and Express Scripts did in 2014 that was the basis of this significant benefit change.

The GAO was asked to determine if the program assessed the impact on patient access, timeliness and accuracy of mail-order prescription dispensing, and whether the change would result in cost savings to the Department of Defense (DOD) and the Tricare system.

 

What did they find?

 

According to the GAO report (click here to read the full report), Tricare achieved a $123 million savings against a projected $120 million in savings from the pilot.

 

At the same time, the study report notes that the DOD didn’t fully monitor the overall pilot program and was unable to identify the extent to which beneficiaries were satisfied with the transfer of prescriptions to mail order or MTF pharmacies for the pilot.

 

Without this input from those impacted by a mandatory mail-order requirement, DOD lacks important information as to whether pilot beneficiaries faced any difficulties, including with obtaining their medications.

 

Because of this, the GAO has recommended that the full roll-out of the mandatory mail-order program for maintenance medications needs to be monitored on an ongoing basis. Language in the still pending National Defense Authorization Act for 2016 does require a quarterly report to Congress on how the program is affecting military members and their families.


IACP Foundation Board of Directors Call for Nominations is Now Open

 

IACP Foundation’s 2015 Call for Nominations and the 2015 Election Cycle for the new March 1, 2016 – February 28, 2018 Board members is now open!

The Bylaws of IACP set forth an open election process with nominations for candidates accepted directly from the community of pharmacists, pharmacy technicians, other healthcare professionals, patients, etc.

 

Nominations close on November 20, 2015.

Please click here for more information as well as a nomination form.


Thank You to our Generous One Fund Contributors!


 

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.

 

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


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.

 

Please click here to view IACP President Dale Coker's video message.

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.


Corporate Partner and Affiliate News


 

DoseLogix Awarded U.S. Patent for Top-Filler Filling Station


DoseLogix, the parent company of the highly acclaimed Topi-CLICK® topical dispenser, was recently awarded a U.S. Patent for its Topi-Filler TM Filling Station.

The Topi-Filler allows pharmacists to fill prescriptions for topical creams, ointments and gels with less time, effort, waste, and trapped air.

 

Please click here to read more.

 

MEDISCA Launches 6th Annual Student Pharmacist Compounding Competition


MEDISCA announces the launch of their 6th Annual Student Pharmacist Compounding Competition (SPCC). If you are a pharmacy student, pharmacy school faculty member or compounding industry leader, MEDISCA and MEDISCA NETWORK invite you to join them at SPCC.

 

This event is more than just a competition; it is an interactive venue designed to raise awareness of the challenges that are currently facing the compounding industry.

 

Please click here to read more!

 

ACHC Announces Addition of Accreditation University

 

The Accreditation Commission for Health Care (ACHC) announces the addition of Accreditation University as a division of ACHC.The expansion will create a foundation for additional educational offerings aimed at helping providers with the accreditation process.

 

Accreditation University will continue to offer existing educational products in the form of expanded workbook and workshop opportunities. Additional products and services will support providers where they may experience a gap in expertise, resources, or time. These customized educational solutions will be available in a wide array of policy manuals, forms, and other tools to be introduced in 2016.

 

Please click here to read more.


IACP Members in the News

 

Michael Collins Partners with SVSU in Lab Safety Research

 

IACP Member Michael Collins, RPh, FIACP, Healthway Compounding Pharmacy in Saginaw, Mich., is featured in a Midland Daily News article, SVSU Partners with Healthway Compounding Pharmacy in Lab Safety Research.

 

"Saginaw Valley State University students and faculty will spend the next year helping a local pharmacist create a cleaner environment for the medicine formulated at his Saginaw Township-based compounding pharmacy laboratory."

Click here to read the article.

 

Jenny Yoakum Appointed to Texas State Board of Pharmacy

 

Congratulations to IACP Member Jenny Yoakum, RPh-PIC, Med Shop Total Care in Longview, Texas, for being appointed by Governor Abbott to the Texas State Board of Pharmacy. Her term expires on August 31, 2021.

 

Click here to read more!

 

Janis Randall Featured in Local Newspaper Story

 

IACP Member Janis Randall, RPh, Compounding Solutions, Trussville, Ala., was profiled recently in the St. Clair-News Aegis, Compounding Solutions - Personalized Answers for your Medication Needs.

 

Says, Janis, “I am a clinician trying to run a business, and I’m not a businessman trying to run a pharmacy. My desire to help others always comes first.”

 

Click here to read the article.




 

 

ACA IACP ACVP Educational Conference Registration is Now Open!

 

Register, Today!

 

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 located in San Diego, California.

 

Perched on its own 15-acre peninsula, Loews Coronado Bay Resort 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 even more 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.

This is destination education at its finest. We'll send you and your staff back to your practice energized, motivated and ready to conquer the world!

 

Please click here for more information and to register!


#EduCon2016 Student Pharmacist Travel Grant


Calling All Students!

 

Are you interested in learning more about independent pharmacy and compounding? The International Academy of Compounding Pharmacists (IACP), American College of Apothecaries (ACA) and American College of Veterinary Pharmacists (ACVP) Foundations are offering up to four (4) pharmacy students a travel grant to attend the joint 2016 Educational Conference, being held at the Loews Coronado Bay Resort, February 24-27, 2016, in beautiful San Diego, California.

 

Who Can Apply?

 

All student pharmacists are encouraged to compete.

 

What’s Available?

 

Travel grants, up to $2,500 each!

When Can I Apply?

 

Applications for the 2016 Educational Conference Travel Grant should be submitted no later than October 31, 2015.


Here's the Application

 

Student Pharmacist Travel Grant Application link here.

 

For More Information

 

Click here for more information. If you have any questions, contact ACAFoundation@acainfo.org or foundation@iacprx.org.


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.

 

For more information, please email Jennifer Petska, BS, CPhT, IACP Foundation Administrator and Director of Development.


Did You Miss the FDA Inspection Webinar? It's Available on Demand! And, Another One is Coming

IACP recently hosted the webinar - FDA Inspections for Compounders: The Impact of DQSA. We had more than 100 participants. If you missed it, you can view in our Self-paced Webinars available through IACP AdvanCE.

 

Click here to learn more!

 

Office-Use + FDA = cGMP

 

That’s a heck of an equation! The Food and Drug Administration is directing its inspectors to find one… just one… instance of an office-use compound to justify allegations that a compounding pharmacist isn’t eligible for the exemptions provided for within section 503A of the Food, Drug and Cosmetic Act. And without those exemptions any compounder can then be held to Current Good Manufacturing Standards.

If you are a sterile compounder, understanding the approach and the areas which FDA inspectors are told to check is absolutely critical. For example, did you know that you are expected to validate and document the efficacy of your disinfectant? that you are supposed to audit your testing laboratory? That you must have SOPs to demonstrate assessments of the sterility of your containers and your container closures?

On Thursday, October 29, tune into IACP’s second continuing education webcast on FDA inspection preparation at 2:00 PM Eastern where sterile compounding will be the focus of our program.

 

Click here to register!

 


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 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.

 

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!


Marketing Research for Compounding Pharmacies

 

 

Daniel Faintuch, MBA
Lee Silsby Compounding Pharmacy
Thursday, October 22, 2015
1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00MT)

 

Success in business (compounding pharmacies included) is dependent on understanding the target consumer, whether it is a patient or practitioner. The design and application of market research allows one to uncover the thoughts, reasons, behaviors and opinions of the parties you interact with, allowing the pharmacy to address those aspects more effectively.

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

Describe the risk pharmacy owners face when processing sensitive customer data.
• Discuss the financial and brand impact of a data breach.
• List the best practices/measures to take to avoid a data breach.
• Prepare a crisis management plan in the event of a breach.

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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