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Capitol Connections October 8, 2014
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October 8, 2014

In This Issue


1. USA Today Story Focuses on Pharmacy Recalls

2.IACP Submits Comments and Lists on 503A and 503B

3. GAO Releases Study: TriCare Coverage & Reimbursement of Compounds

4. IACP Member Q&A

5. Corporate Partner Spotlight: Torpac Capsules

 

6. 2015 Educational Conference Registration Now Open

 

7. Save the Date for CCH 2015!

 

8. IACP Welcomes Corporate Partner: Hardy Diagnostics


Capitol Connections is a biweekly newsletter for IACP Members Only.

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USA Today Story Focuses on Pharmacy Compounding Recalls as the Two-year NECC Tragedy Anniversary Approaches

A USA Today story, "Safety, Sanitation Problems Prompt Scores of Drug Recalls" was published online yesterday. The story appeared in USA Today's printed publication today. The article notes the two-year anniversary of the NECC tragedy, the ensuing increase in FDA inspections and recalls, as well as the confusion created as FDA employs cGMP manufacturing standards in these inspections that were never intended for compounding pharmacies.

The International Academy of Compounding Pharmacists (IACP)'s David G. Miller, RPh, Executive Vice President/CEO was extensively interviewed and quoted for the article.

"The FDA was caught by Congress and others for being asleep at the switch in the NECC tragedy. … So (the agency) said, 'OK, we're going to go in and inspect (compounders) as if they're a manufacturer,' " says David Miller, CEO of the International Academy of Compounding Pharmacists. "It's like going to the baseball diamond with your buddies, and the other team shows up wearing helmets, padding and carrying a football."

Please click here to read the USA Today story in its entirety.

Please click here to read the IACP Member Alert on this USA Today story.


IACP Submits Comments and Lists on 503A and 503B

The International Academy of Compounding Pharmacists (IACP) has submitted comments and Active Pharmaceutical Ingredient (API) lists to the Food & Drug Administration (FDA) for both 503A and 503B.

As covered in IACP's submission letter, the Academy is extremely concerned that the FDA is intentionally setting an "impossible to meet" standard by requiring descriptions and justification for the use of APIs in lieu of commercially available products. That is especially troubling given that the agency has yet to vet and begin the appointment process for the Pharmacy Compounding Advisory Committee (PCAC). Please click here to read the letters to FDA and bulk API list.


GAO Releases Study: TriCare Coverage & Reimbursement of Compounds

 

The Government Accountability Office (GAO) released its study on TriCare coverage and reimbursement of compounded prescriptions, today. The GAO recommendation? Though compounded drugs represent a small share of TRICARE’s overall drug costs, its costs for these drugs have risen significantly in recent years. Moreover, because most of these drugs contain bulk drug substances generally not approved by FDA, TRICARE’s practice of paying for them is inconsistent with its regulations and results in added costs for the program.

Please click here to read more.


IACP Joins PAPCC Effort

IACP has joined an organization, The Patient Access to Pharmacists' Care Coalition (PAPCC), which is working to develop and help enact a federal policy proposal that would increase patient access to pharmacists' patient care services. The legislative proposal will seek to amend Medicare law to cover and pay for pharmacists' services for some of our most vulnerable patients ― those in medically underserved communities. Click here to read more.


FDA Drafts Pharma Social Media Regs

​ The FDA in June released draft guidelines for how drug firms should use social networks like Facebook and Twitter. But pharmaceutical companies are concerned the FDA would hold them responsible for misinformation about their products posted online by third parties that the companies have little to no control over. Click here here to read the entire article.


IACP Member Q&A

​This week's question involves Office Use guidelines in California.

Question:

Our state says office use compounding is legal....but this seems like a clear statement from the FDA now. Should I NOT be doing any office use compounding? Click here to read more.


Corporate Partner Spotlight: Torpac Capsules

 

Torpac Capsules makes capsule filling machines, molds, blenders and empty capsules. Our ProFiller® (www.profiller.com) capsule fillers are high-output, easy to use, easy to clean and made from Stainless Steel (Inox) 316. ProFiller is available in 100, 120, and 300 holes. The 300 hole model is available in hand held and bench top versions. Torpac offers ProMixerTM for powder blending and ProMolds for making tablets and lozenges.

Click here to read more.


2015 Educational Conference Registration Now Open

Connect and network with fellow colleagues. #EduCon2015

 

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.

Why should you attend the Educational Conference 2015?

 

 

Who says the Educational Conference is for Pharmacists only, Technicians are welcomed too! Don’t miss this one-of-a-kind, 3-in-1 conference that brings the pharmacy profession together in paradise. #EduConf2015. For more Educational Conference videos, visit our YouTube page at http://bit.ly/1rnrDTs. #EduCon2015

Join your colleagues at the Celebration Dessert Reception!

 

 

Enjoy a beautiful evening overlooking the Atlantic ocean on Friday, February 27 from 8:00-10:00 p.m. during the Celebration Dessert Reception. Attend this casual reception for fellowship, an array of delicious desserts and cocktails. The evening dessert reception is open to all registered attendees, spouses and guests. ACA, IACP, and ACVP we would like to thank Letco Medical for their support of the Educational Conference as the Celebration Dessert Reception Sponsor and the ACA Education CEnter & IACP AdvanCE Education sessions Sponsor. #EduCon2015

Click here for more details!


Participate in the Educational Conference Spring 2015 Student Writing Competition

Essay Topic: Discuss the importance of being involved in a professional association as you’re starting your career.

The ACA, IACP, ACVP Educational Conference announces the Spring 2015 Student Writing Competition to recognize original papers on a particular topic affecting the future of independent pharmacy. Two winners will be selected by a review committee from the papers submitted. Thanks to the generosity of donors of both the ACA Foundation and IACP Foundation, the winners of this writing competition will each receive a scholarship to attend the Educational Conference February 25-28, 2015 in Fort Lauderdale, Florida. All pharmacy students are encouraged to compete.

Click here to download the Spring 2015 Student Writing Competition Flyer

Essay Topic: Why networking with professional colleagues helps identify career paths for pharmacy students.

Through the generosity of donors to Fund-the-Future at the annual Rx Mixer in 2014, the IACP Foundation will be offering five pharmacy students a scholarship to attend the Educational Conference February 25-28, 2015 in Fort Lauderdale, Florida. All pharmacy students are encouraged to compete.

Click here to download the IACP Foundation Fund-the-Future Scholarship Application

 


Meet the 2015 Exhibitors

The Educational Conference Exhibitor Experience has expanded to 29 exhibiting companies. Discover how you can work with them before you arrive. To learn more about the meeting Exhibitors and Sponsors and how their services can help you effectively manage and grow your business, click here. Make sure to stop by their booth when visiting the Exhibit Hall.


Save the Date for CCH 2015!

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.

Click here to read more.


IACP Welcomes Corporate Partner: Hardy Diagnostics

 

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

To learn more about Hardy Diagnostics, please visit www.hardydiagnostics.com.


Register Today for the Upcoming Washington, D.C. Regional Education Meeting!

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 to read more!

 

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