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Capitol Connections December 17, 2014
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December 17, 2014

In This Issue

1.Senate Approves "CR/Omnibus" Legislation to Fund the U.S. Government Through Sept. 2015

 

2. Broad Provider and Pharmacy Coalition Urges Congress to Fix Drug Quality and Security Act

 

3. FDA Announces Pharmacy Compounding Advisory Committee Members

 

4. Last Call: Board of Directors Elections

 

5. IACP Members: Participate in a Veterinary Compounding Survey

 

6. U.S. Department of Justice Fines Rite Aid $2.99 Million for False Claims Act Violations

 

7. FDA Update

 

8. IACP Member News

 

9. IACP's Winter 2014 CustomRx Connection Magazine Now Available!

 

10. Corporate Partner Spotlight: B&B Pharmaceuticals, Inc.



Capitol Connections is a biweekly newsletter for IACP Members Only.

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




 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 




Senate Approves "CR/Omnibus" Legislation to Fund the U.S. Government Through Sept. 2015

 

Late on Saturday, December 13th, the Senate approved the "CR/Omnibus" legislation to fund the U.S. Government through September of next year. This was the legislation passed last week by the House before they adjourned with some last minute scrambling regarding Obama nominees and attempts by some legislators to limit funding to the Department of Homeland Security.

When the House bill passed, it retained as part of the accompanying report language (H Rpt 113-468) instructions to the FDA which the International Academy of Compounding Pharmacists (IACP) had strongly lobbied for as part of our 2014 Compounders on Capitol Hill event back in May. Please click here to read more.

Please email iacpinfo@iacprx.org with questions.

 


Broad Provider and Pharmacy Coalition Urges Congress to Fix Drug Quality and Security Act

 

 

 

Last week, a broad cross-section of organizations representing varied healthcare providers and the pharmacy community, brought together by the International Academy of Compounding Pharmacists (IACP), sent a letter to U.S. Senate and House leaders. The letter expresses serious concerns with the federal government’s implementation of the Drug Quality and Security Act (DQSA), enacted in November 2013, and is calling on Congress to fix the law.

IACP distributed a press release to the nation's media announcing the congressional letter, and the specific DQSA-related issues on which these health care providers are concerned.

 

Please click here to read more, including the IACP press release and letter to Congress.

 

Please click here to read more about Fix DQSA and how you can help.


FDA Announces Pharmacy Compounding Advisory Committee Members

 

 

 

The U.S. Food and Drug Administration (FDA) today announced the membership of the Pharmacy Compounding Advisory Committee. The committee is comprised of 14 members - 12 voting and two non-voting - who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

 

Please click here for FDA's announcement, including the panel names, as well as IACP's response.


Last Call: Santa Comes at Midnight Next Week. But, Your Vote Needs to Come by Midnight Tonight!

 

IACP Members: Check your inbox and look for 2015 Board of Directors Voting Ballot!

Vote by Midnight, Wednesday, December 17th!

The IACP Board of Directors sets direction for the organization, serves as visionaries for the future of pharmacy compounding, and generates results. Board members contribute their time, energy and ideas to lead the organization forward and in turn, lead the compounding profession to greater success.

Thank you for participating in the 2015 IACP Board of Directors Election. Your vote is important to IACP as we elect individuals to lead our association into the future. Results will be announced at the end of December.

 

If you did not receive a ballot via email, please let us know at iacpinfo@iacprx.org.

 


IACP Members: Participate in a Veterinary Compounding Survey


IACP believes that there will be veterinary compounding legislation coming in the new year, potentially bringing more federal oversight. The IACP Board of Directors would like to assess the impact this potential legislation could have upon our membership in order to determine the level of priority they should place on the issue. Your input is invaluable.

 

Please click here to participate in the survey. Please complete the survey by December 31, 2014. Your responses will be kept confidential.


U.S. Department of Justice Fines Rite Aid $2.99 Million for False Claims Act Violations

 

Rite Aid Corporation, a Delaware corporation and national retail drugstore chain with its principal place of business in Camp Hill, Pennsylvania, has paid the United States $2.99 million to resolve allegations that it violated the False Claims Act by inappropriately using gift cards as inducements, the Department of Justice announced today.

The settlement resolves allegations that Rite Aid offered illegal inducements to Medicare and Medicaid beneficiaries to transfer their prescriptions to Rite Aid pharmacies. The government alleged that from 2008 to 2010, Rite Aid had knowingly and improperly influenced the decisions of Medicare and Medicaid beneficiaries to transfer their prescriptions to Rite Aid pharmacies by offering them gift cards in exchange for their business.

Click here to read more.


CMS Pushes Back Part D Requirement For Prescribers to Be Enrolled in Medicare

The Centers for Medicare & Medicaid Services (CMS) said it will delay for six months a requirement that providers be enrolled in Medicare with approved status or have a valid opt-out affidavit on file for their prescriptions to be covered under Part D. In a memo to Medicare Advantage and Part D drug plans, the agency said that, although its final regulation stated that the effective date for the requirement would be June 1, 2015, it will delay enforcement until Dec. 1, 2015.

The rule also required plans to establish a comprehensive outreach and education plan to ensure that prescribers and enrollees were aware of the new requirement. Please click here to read more.

  



Gelatin Capsules Dissolution - Revision to USP <711> and <2040>

A revision is being proposed to the U.S. Pharmacopeial Convention (USP) general chapters: Dissolution and Disintegration and Dissolution of Dietary Supplements to address issues related to gelatin cross-linking.

The revisions were published in Pharmacopeial Forum 40(6) together with a Stimuli article with all the information and data to support the revisions.

The deadline to send comments and suggestions is Jan 31, 2015.





FDA Drug Shortage Update:


The FDA Drug Shortage Report


Please click here for the most recent Drug Shortage information.






Seasons Greetings: IACP Holiday Schedule

Seasons Greetings from the entire IACP board and staff! Please note that the IACP offices will be closed, beginning Wednesday, December 24th, reopening on Monday, January 5th. Please email iacpinfo@iacprx.org if you need to reach us in the interim.


IACP's Winter 2014 CustomRx Connection Magazine Now Available!

IACP proudly shares the Winter 2014 edition of our CustomRx Connection Online Magazine. In this edition, you'll find a "New Reality" perspective from IACP's President Pat Stephens, PharmD, an inside look into Washington DC from IACP's Government Affairs Vice President Cynthia E. Blankenship, Esq., Marketing Must Haves from Lauren Onsa, why involvement in your state society is so important from IACP Member Alfonse Muto, PharmD, FIACP, and some recent validation study information from IACP Corporate Partner MEDISCA.

 

With this issue also come some big announcements about IACP's future publications. We're thrilled to announce that we're joining forces with Pharmacy Marketing Quarterly, and together look forward to bringing you a dynamic quarterly magazine that will be available both in print and online. So click below to read all about it!

 

Please click here to view the Winter 2014 CustomRx Connection magazine.

Your input is vital to the health of our publications! Please provide us with feedback, editorial ideas, photos and "What Works for You" tips! Please email your information to iacpinfo@iacprx.org.






Member News

 

IACP Board Member Wade Siefert, RPh, Preckshot Professional Pharmacy, in Peoria, Ill., was named an American Academy of Anti-Aging Medicine (A4M) Fellow during the 22nd Annual World Congress on Anti-Aging Medicine held this month in Las Vegas, Nev.

 

QmedRx, a compounding pharmacy servicing patients in 49 states through in-home delivery, announces today the appointment of IACP Member and Previous IACP Board Member Scott Karolchyk,MS, RPh, FIACP, as the new Vice President of Formulations. Karolchyk will oversee formulation development, testing methods and clinical applications in his new role. His specialties include drug formulation and stability, high risk sterile admixtures, transdermal technology, as well as ophthalmic and veterinary compounds. Please click here to read more.

 

 


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:

 

Am I understanding correctly that chemicals submitted to the FDA for inclusion on the list of chemicals we can use for compounding had to be resubmitted?

 

Answer:

 

Yes, the resubmittals were due on September, 30, 2014. IACP submitted a list of more than 1,500 to the FDA.

Question:

 

Will MOUs be state specific or the same for all states?

 

Answer:

 

There will be a standard MOU template submitted to all states that is under development by the FDA in conjunction with the National Association of Boards of Pharmacy. That template MOU has not been released.

Question:

 

Will State Boards have any input as to what they will or will not accept?

 

Answer:

 

That will be up to the processes specified within each state's laws and regulatory process.





Corporate Partner Spotlight: B&B Pharmaceuticals, Inc.

 


Quality Compounding Chemicals at Affordable Pricing

B&B Pharmaceuticals, Inc. has been leading the Compounding industry in customer service and product quality for 18 years. We pride ourselves on our ability to manage each individual customer as if they are our biggest account. You will always speak with a live person when calling in and you will only receive material that has been evaluated, tested by an FDA registered third party testing lab, and approved by our Quality Control before it ever makes it to our shelves. We also provide same day turnaround service on all products that do not require additional regulatory forms.

Please click here to read more!


Registration Closes Jan 22nd!

Connect and network with fellow colleagues.

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 25-28, 2015, at the ocean front property, the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida.

 

Click here for more!


Advocate: Why You Should Attend #EduCon2015!

Take advantage of the Educational Conference 2015 Justification Letter and explain to your supervisor all the benefits you’ll receive from attending the ACA, IACP, ACVP Educational Conference!

 

The justification letter template includes how the conference will make you a better employee and what you and the pharmacy can expect to receive from attending. Click here to access the Educational Conference 2015 Justification Letter.


ACA, IACP, ACVP Educational Conference Graphic Toolkit Now Available!

 

This is an opportunity to let your patient and prescriber communities know that you will be attending the Educational Conference this year! Promote the Conference on your pharmacy or company website, Facebook page and even in print! Attendees, Corporate Partners and Exhibiting Companies are all encouraged to promote their support by using the Graphic Toolkit. The Educational Conference Graphic Toolkit includes a logo/web banner, Facebook Cover Image, “I’m Attending” e-mail signature as well as full page, ¼-page, and ½-page print ads.

Share that you’re attending! Click here to download the Graphic Toolkit.


The 2015 Educational Conference E- brochure is Now Available!

 

Review the complete meeting agenda; learn what's new in 2015; why pharmacy students should attend, and much more!

 

Click here to download the 2015 Educational Conference E-brochure, sponsored by ACA & IACP Corporate Partner Humco Compounding. The Flipbook technology for the E-brochure was generously provided by RXinsider.


IACP Members: Don't Miss the Only Political Action Committee for Compounders

Please plan to join IACP's Executive Vice President & CEO David G. Miller, RPh, and Vice President of Government Affairs Cynthia E. Blankenship, Esq., at IACP’s COMP PAC Reception Friday, February 27, 2015 during the 2015 ACA, IACP, ACVP Educational Conference.

Why is a political action committee and COMP PAC important?

COMP PAC uses its funds to support those legislators that have demonstrated a commitment to compounding pharmacy and have expressed interest in advancing our legislative goals.

When the 114th Congress takes its oath of office on January 3, IACP will already have three major legislative priorities in the works that directly address YOUR needs.

Please click here to read more!


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

 

Please click here for more.

 


IACP Welcomes Two New Corporate Partners: INTERPHEX and EAS Consulting Group, LLC


 

 

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 60 corporate partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.

To learn more about INTERPHEX, please visit www.interphex.com.

 

To learn more about EAS Consulting Group LLC, please visit www.easconsultinggroup.com.

 

 


CCH Registration is Open!

 

 

The 21st Annual Compounders on Capitol Hill (CCH) will be held June 6-9, 2015 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.

 

Click here to read more!


Schemes, Scams and FlimFlams: How the Pharmacy Can Recognize Landmines - IACP's January Webinar

It would be nice if pharmacies operated in the “real world”…. The world inhabited by auto parts stores and widget manufacturers. Unfortunately, pharmacies are not in the real world.They are in Alice in Wonderland where “up is down, down is up, and every day they climb through the proverbial rabbit hole.” In this alternative universe, pharmacies are subjected to numerous federal and state anti-fraud statutes and regulations. What would be perfectly acceptable in the auto parts world may be a felony in the health care world. This program will discuss the many anti-fraud statutes and regulations that the pharmacy must follow. More importantly, this program will teach the pharmacy how to recognize fraud landmines so that the pharmacy does not step on them.

 

Click here for more information, and to register!


Need CE Before 2015? Check Out the Best of IACP AdvanCE's 2014 Programs in the Self-Paced Library!

 

If you were unable to attend our live webinars, they have been added to the IACP AdvanCE self-paced online program line-up so that you can review at your convenience 24/7. Please click here to access the self-paced programs.

Webinar topics include:

 

Endotoxin Testing and Environmental Monitoring for Your Pharmacy

 

Regulatory Guidelines and Standards of Practice for Pharmacy Compounding

 

Overcoming USP <797> Common Non-Compliance Issues for Sterile Compounding

 

“Constructive Delivery” Under the Controlled Substances Act

 

Building a Compounding Pharmacy: Lessons Learned

 

Essentials of Non-Sterile Compounding

 

Compounding Pharmacies and the USP <71> Sterility Tests

 

Practicing Evidence Based Medicine: From IRB Approval to Bench Research




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