USA Today editorial by IACP’s David G. Miller, RPh, EVP/CEO. “We’re Dedicated to Patient’s Health: Another View.”

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compounded medications, compounding pharmacists, compounding pharmacy, independent pharmacists, International Academy of Compounding Pharmacists (IACP), Patients, Prescribers, state boards of pharmacy

IACP is continuing to get the word out about pharmacy compounding and the invaluable services our members provide to patients and their practitioners each and every day. Click here to read a USA Today editorial, “We’re Dedicated to Patient’s Health: Another View,” (4/28/2013) by IACP’s David G. Miller, RPh, Executive Vice President & CEO.

U.S. Senate HELP Committee Releases Draft Compounding Bill

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compounded medications, compounding pharmacists, compounding pharmacy, FDA, Food & Drug Administration, IACP, independent pharmacists, International Academy of Compounding Pharmacists (IACP), NECC, Pharmacists, state boards of pharmacy

The U.S. Senate HELP Committee has released a pharmacy compounding draft bill, today. Please click here to read the International Academy of Compounding Pharmacists’ (IACP) statement in response, and to view the draft bill.

David F. Chang, MD Reminds Ophthalmologists of Importance of Compounding Pharmacies

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compounded medications, compounding pharmacists, compounding pharmacy, IACP, International Academy of Compounding Pharmacists (IACP), NECC, New England Compounding Center, Patients

With the considerable amount of negative news about pharmacy compounding circulating in the press with last year’s meningitis outbreak, it is indeed refreshing to read a physician’s continuing support of compounding and affirmation of its necessity in his practice.

In the March 2013 edition of EyeWorld magazine, David F. Chang, MD, interviewed IACP Member Charles Leiter, PharmD, Leiter’s Compounding Pharmacy in San Jose, Calif. “As compounding pharmacies continue to reel from the devastating Meningitis outbreak caused by the negligence of New England Compounding Center, Dr. Chang reminds the industry of the importance of quality compounding in, ‘Compounding pharmacies: Let’s not throw the baby out with the bathwater.’”

Click here to read Dr. Chang’s EyeWorld article.

Dr. Chang is a clinical professor at the University of California, San Francisco, and the current president of the American Society of Cataract and Refractive Surgery. He is Chairman of the American Academy of Ophthalmology’s Cataract Preferred Practice Pattern Committee, and is considered a leading expert in cataract surgery. Dr. Chang is the chief medical editor of EyeWorld and was previously co-chief medical editor for Cataract and Refractive Surgery Today. Thank you, Dr. Chang and Chuck Leiter, for pointing out the vital importance and value of pharmacy compounding to patients and practitioners!

Look at your own pharmacy compounding practice.  What would your practitioners and patients do without the invaluable customized medication you bring to them?

 

 

 

 

HealthPolicy NewsStand Interviews IACP, “Compounders Tweak FDA’s Three-Prong Test, Say Expanding Agency Authority Is ‘Premature.’”

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compounded medications, compounding pharmacists, compounding pharmacy, Food & Drug Administration, IACP, International Academy of Compounding Pharmacists (IACP)

HealthPolicy NewsStand interviewed the International Academy of Compounding Pharmacists (IACP) regarding a letter the Academy sent last week to the U.S. Senate Committee on Health, Education, Labor & Pensions for their March 25th article, “Compounders Tweak FDA’s Three-Prong Test, Say Expanding Agency Authority Is ‘Premature.’” Click http://bit.ly/14sMzNb to read the story by Alaina Busch.

 

IACP Issues Statement Regarding Last Night’s 60 Minutes Broadcast, March 10, 2013

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compounded medications, compounding pharmacists, compounding pharmacy, FDA, Food & Drug Administration, IACP, independent pharmacists, International Academy of Compounding Pharmacists (IACP), NECC, New England Compounding Center, Patients, state boards of pharmacy

A Statement from the International Academy of Compounding Pharmacists, Washington, D.C. (March 10, 2013)

The recent reporting by CBS, on the “CBS Evening News” on March 7 and 8, 2013, and most recently this evening on “60 Minutes,” concerning the circumstances surrounding the tragic meningitis outbreak, deaths, and sickness associated with the products of New England Compounding Center in Framingham, MA, is important, and the findings are deeply troubling. These news accounts are consistent with our long-held belief that NECC acted illegally and outside of its license as a pharmacy.

Both the state board and the FDA in fact possessed the authority to close NECC, and both had been notified of issues and potential problems with that company before this series of tragic events occurred. Massachusetts and the FDA inspected NECC repeatedly as far back as 2004 over concerns about their sterile compounding practices.

Only after the tragedy began did the Massachusetts regulatory authorities deem NECC’s actions as manufacturing rather than compounding pharmacy practice.

IACP has worked and will continue to work with state and federal policy makers to do what is necessary to see that nothing like this ever happens again while assuring that physicians, pharmacists and patients can still work together to have access to customized medicines that are not available from manufacturers. Compounding pharmacists perform a vital function that must be preserved.

About The International Academy of Compounding Pharmacists

The International Academy of Compounding Pharmacists (IACP) is an association representing more than 2,700 pharmacists, technicians, students, and members of the compounding community who focus on the specialty practice of pharmacy compounding.

Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose health care needs can not be met by manufactured medications.

Public Policy Writer Charles Chieppo Weighs in on the Regulation of Pharmacy Compounding

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compounded medications, compounding pharmacists, compounding pharmacy, FDA, International Academy of Compounding Pharmacists (IACP), NECC, Patients, Pharmacists

“Government reaction to 45 deaths and nearly 700 being sickened from contaminated injectable medications from Framingham’s New England Compounding Center has been as sadly predictable as the original event was tragic. With the horse long gone from the barn, public officials are pursuing new remedies. But the outbreak was a result of state and federal governments’ failure to enforce existing laws and regulations.

The tragedy has resulted in heightened scrutiny for compounding pharmacies and calls, as voiced by legislation filed in November by U.S. Rep. Ed Markey of Massachusetts, to dramatically expand federal oversight of compounders.

Compounding pharmacies work directly with prescribers to create customized medications for patients whose needs can’t be met by off-the-shelf medicines.

The problem is that NECC apparently wasn’t acting as a compounder last fall when its products killed or harmed people in 20 states, and state and federal agencies had reason to know the company was an accident waiting to happen.

Both state and federal authorities can inspect compounding pharmacies at any time and pull the pharmacies’ licenses if they deem it necessary.”

Read more of this op ed piece printed in today’s Worcester Telegram.
Charles Chieppo is the principal of Chieppo Strategies LLC, a public policy writing and advocacy firm.

CBS News with Scott Pelley: “Pharmacy Insider Reveals Origin of Meningitis Outbreak.”

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compounded medications, compounding pharmacists, compounding pharmacy, IACP, International Academy of Compounding Pharmacists (IACP), NECC, New England Compounding Center

Click below to view the CBS News with Scott Pelley broadcast from last night, March 7th, “Pharmacy Insider Reveals Origin of Meningitis Outbreak.”

NECC former employees are now confirming what the International Academy of Compounding Pharmacists (IACP) has stated from day one of this very tragic situation.  This particular pharmacy crossed over the line and engaged in pharmaceutical manufacturing.

CBS Evening News is broadcasting a series of interviews leading up to this Sunday’s 60 Minutes show on NECC.

Click here to view the CBS News interview with NECC former employee.

 

 

 

 

What’s the Priority?

Check out “What’s the Priority,” written by IACP’s David G. Miller, RPh, Exec VP/CEO, in the current issue of IACP’s CustomRx Connection online magazine.

http://bit.ly/ThzjCY

“The autumn of 2012 will be remembered for many things – a hard-fought election, a devastating hurricane, looming uncertainty about the nation’s fiscal situation. For pharmacists – and the people they serve – it will be remembered as the year that our profession collectively and compounders specifically had its reputation tarnished, perhaps permanently, by one pharmacy and its actions.”

We look forward to receiving your comments/posts on this article.

 

 

 

IACP Responds to Today’s Media Reports on House Energy & Commerce Committee Requests for Information

IACP looks forward to providing all the documentation and information requested by the House Energy & Commerce Committee in their December 6, 2012 request.  The New York Times story referenced in the Committee’s request contains significant errors in fact.  Moreover, it has diverted attention away from the cooperative efforts of the Academy in working to prevent a future tragedy as that caused by NECC and the failure of swift and decisive action by the Massachusetts Board of Registration in Pharmacy and the federal Food and Drug Administration.  IACP’s submitted documents will not only refute the conclusions conveyed in the Times story but will also include correspondence with their reporters that clearly state the facts of the situation in question.

Click below link to view Associated Press article.

Congress probes ties between compounding trade group and meningitis-linked pharmacy

IACP Letter to FDA and Press Release Declaring FDA had Clear Authority

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compounded medications, compounding pharmacists, compounding pharmacy, FDA, Food & Drug Administration, International Academy of Compounding Pharmacists (IACP), NECC, New England Compounding Center

Last week, IACP sent a letter to Food & Drug Administration (FDA) Commissioner Margaret Hamburg, MD, requesting information on not only why the FDA failed to take prompt action against New England Compounding Center (NECC) but also directly challenging their claims that the administration does not have adequate regulatory authority to halt illegal drug manufacturing.

“The IACP and its members strongly urge the FDA to explain the delays and inaction in the tragic case of the NECC, to identify which staff members were involved, to provide a timeline surrounding complaints about NECC, and to specify why decisions were made to let the company continue operating,” IACP Executive Vice President & CEO David G. Miller, RPh, stated in the letter. Click here to view the letter.

The Academy is also distributing a statement this afternoon via PR Newswire to all national news, trade and medical press. Click here to view the press release.

Please email IACP at iacpinfo@iacprx.org with any questions.