IACP Launches New Compounding Advocacy Society – Partnership for Personalized Prescriptions (P3)

IACP’s new compounding advocacy society, Partnership for Personalized Prescriptions (P3), brings together more than 150,000 patients and practitioners, providing them with a forum to share their support and passion for compounding. Importantly, P3 members are provided with the tools to advocate on their own behalf. P3 also provides an ongoing educational resource for those interested in pharmacy compounding and its value for patients and the practitioners who serve them. A compounding pharmacist locator service is provided so that patients, physicians, veterinarians and nurses can conveniently find compounders in their area.

Pat Stephens, PharmD, IACP President, says, “IACP has a rich heritage that began years ago with the advocacy program, Patients and Professionals for Customized Care (P2C2). With the creation of P3, which will rebrand our original advocacy efforts, we are expanding our educational, testimonial and advocating tools to provide a strong platform to help raise compounding awareness  as well as restore the reputation of our profession.”

Please encourage your patients, practitioners and your fellow pharmacist colleagues to join Partnership for Personalized Prescriptions, and share their testimonial stories of how pharmacy compounding has made a difference for them! Together we can work to ensure continued access to personalized medications.

Click here to visit the Partnership for Personalized Prescriptions (P3) Website.

Click here to access P3’s new graphics toolkit to help you spread the word about this new compounding advocacy group.

Click here to visit P3’s Facebook page.

Click here to visit P3’s Twitter page.

IACP Responds to Insurance Business America’s Erroneous Portrayal of Compounding in Recent Article

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IACP strongly believed a Letter to the Editor was needed after reading Insurance Business America’s April 3rd article, “’Self-interested Providers’” Drive up Workman’s Comp Costs with Compound Drugs.”

Click here to read the Insurance Business America Article. See below to read IACP’s resulting Letter to the Editor, taking issue with the article’s content, intent and negative description of compounding.

 

April 14, 2014

To the editor:

Insurance Business America has done a disservice in its April 3 story on worker compensation costs (“‘Self-interested providers’ drive up WC costs with compound drugs”) not only to our nation’s compounding pharmacists, but to the millions of patients across the U.S. who rely upon compounded medications.

While we understand that CompPharma President Joseph Paduda is clearly watching a bottom line in relation to worker compensation costs, he is missing the big picture: the goal of worker compensation programs is to get workers back to work, and compounded medications – like commercially manufactured medications – play a role in returning these individuals to health and to work.

Compounded medications are vital for patients who have an allergy or sensitivity to a commercially manufactured drug or who need a drug in a particular strength or form. Moreover, compounded medications are essential for patients whose commercially manufactured drug is backordered or unavailable, which is increasingly common. Which drugs does Mr. Paduda want to restrict? Chemotherapy for the oncology patient whose commercially manufactured medication is unavailable? Liquid medications for patients on feeding tubes who cannot swallow oral medications?  We are eager to know.

Compounded medications have uses, however, beyond patients needing a particular ingredient, strength, form, or dosage, or when a drug is unavailable. Compounded pain medications, for instance, are non-addictive. So as our nation faces a staggering human and fiscal cost relating to abuse of opioids, compounded pain gels and creams offer a safe alternative. Yet increasingly, insurers won’t cover this cost, and instead pay exponentially more as a result of abuse and diversion of Oxycodone and similar drugs.

Regarding Mr. Paduda’s comments on safety, where is the source that forms the basis of his opinion? He relates the story of New England Compounding Center, which we all know now to have been a drug manufacturer masquerading as a pharmacy and whose problems were known to, but ignored by, both state and federal regulators. There was not one mention of the thousands of compounding pharmacies across the U.S. every day providing medication according to the highest standards of pharmacy, United States Pharmacopeia (USP) 795 and 797, nor a mention of the new federally regulated class of outsourcing facilities that will be required to follow the same standards as drug manufacturers.

We would encourage Mr. Paduda and Insurance Business America to take a closer look at the benefits of compounded medications to patients and not just the bottom line cost 

Sincerely,
David G. Miller, R.Ph., EVP & CEO
IACP

 

IACP is Protecting, Promoting & Advancing Pharmacy Compounding.

 

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IACP Summarizes the FDA Fiscal Year 2015 Budget

IACP Summarizes the FDA Fiscal Year 2015 Budget

The President released his budget on March 4th, requesting $4.7 billion for the Food and Drug Administration (FDA), which is $358 million, or 8% above the FY 2014 Enacted level. The President specifically requested $25 million of the total for agency-wide oversight of drug compounding, including enforcement, inspections, and collaboration with States.

Click here to read IACP’s Summary of the FDA FY 2015 Budget http://bit.ly/1gueIZE

IACP Issues Nominations for FDA’s Request for Bulk Drug Substances – for both 503A & 503B Facilities

The International Academy of Compounding Pharmacists (IACP) is the first pharmacy association to submit comments to the FDA on its Request for Bulk Drug Substances for both Section 503A and 503B of the Federal Food, Drug and Cosmetic Act.

IACP is ensuring that the voice of our pharmacy compounding members is heard! We urge our members to use our language or positions in submitting your own bulk drug lists to the FDA, which are due by March 4, 2014. 

“IACP is committed to working closely with the FDA and Congress to assure that the Drug Quality and Security Act is implemented swiftly so that no patient or physician experiences any disruption in medication treatment,” said IACP President Pat Stephens, PharmD.  “Thanks to the efforts of our members and the leadership of the IACP Foundation, we were able to identify and present our comments on the request for APIs that traditional compounders need access to in order to assure patient care.”

There are four submission letters for each type of compounder – a pharmacy or an outsourcing facility. One is a nomination letter that submits all homeopathic medications. One is a nomination letter requesting acceptance of drug monographs and standards in alternative compendia (e.g., the British Pharmacopeia). One is a nomination letter requesting acceptance of all nutritional/dietary supplements and food chemicals that appear in USP publications other than the official USP/NF. One is a nomination letter and spreadsheet of more than 2,400 drug substances. That spreadsheet was created by the IACP Foundation leadership and without the Foundation’s expertise in research, education and quality, we could not have assembled such an extensive set of documentation in the very short timeline provided to us by the FDA.

What can YOU do? 

The more submissions the FDA and the Pharmacy Compounding Advisory Committee receives, the greater the likelihood that they will initiate a review of the nominated bulk ingredient. It’s simple.  We’ve done the hard work…all you have to do is take the language in our submissions, put it on your own letterhead, and follow the instructions further down on how to file your own nomination electronically with the FDA.

Remember, the deadline is before midnight on Tuesday, March 4, 2014.

PLEASE NOTE: You must be an IACP Member to access this material. Please click here to log into the IACP Member Center to view the documents below.

IACP Comments to FDA Regarding 503A for Your Review

IACP’s Bulk Drug Nominations for Substances that may be used in Pharmacy Compounding for 503A – En Bloc Submission of The Homeopathic Pharmacopeia of the United States.

IACP’s Bulk Drug Nominations for Substances that may be used in Pharmacy Compounding as Defined by 503A – En Bloc Submission of The British Pharmacopeia (BP), The European Pharmacopeia (EP) and The Japanese Pharmacopeia (JP).

IACP’s Bulk Drug Nominations for Substances that may be used in Pharmacy Compounding as Defined by 503A – En Bloc Submission of The Food Chemicals Codex (FCC) and The USP Dietary Supplements Compendium (DSC).

IACP’s Nominations on Bulk Ingredients 503A.

IACP Nominations on Bulk Ingredients 503A Non USP Non Approved Drug Substances – List.


IACP Comments to FDA Regarding 503B for Your Review

IACP’s Bulk Drug Nominations for Substances that may be used in Compounding by Outsourcing Facilities as Defined by 503B – En Bloc Submission of The Homeopathic Pharmacopeia of the United States.

IACP’s Bulk Drug Nominations for Substances that may be used in Compounding by Outsourcing Facilities as Defined by 503B – En Bloc Submission of The British Pharmacopeia (BP), The European Pharmacopeia (EP) and The Japanese Pharmacopeia (JP).

IACP’s Bulk Drug Nominations for Substances that may be used in Compounding by Outsourcing Facilities as Defined by 503B – En Bloc Submission of The Food Chemicals Codex (FCC) and The USP Dietary Supplements Compendium (DSC).

IACP’s Nominations on Bulk Ingredients 503B.

IACP Nominations on Bulk Ingredients 503B Non USP Non Approved Drug Substances – List.


Instructions for Submitting Your Own Bulk Drug Comments to FDA

IACP’s Comparison Chart of 503A and 503B – The Drug Quality and Security Act of 2013.

Instructions on how to Submit your Own Bulk Drug List to FDA – Due by March 4, 2014.

 

The International Academy of Compounding Pharmacists (IACP) is an association representing more than 3,600 pharmacists, technicians, students, and members of the compounding community who focus upon 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 healthcare needs cannot be met by manufactured medications. Visit www.iacprx.org to learn more.

Please email iacpinfo@iacprx.org with any questions regarding this information.

 

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A Message from William A. Stuart, RPh

Recently, I had the honor and privilege to present a webinar on behalf of the International Academy of Compounding Pharmacists; titled, Endotoxin Testing and Environmental Monitoring for Your Pharmacy. There were more than 130 attendees for this webinar which was aimed to present information for compounding pharmacists and technicians. I want to thank Associates of Cape Cod, Inc., for sponsoring this webinar and their commitment to compounding pharmacies. It is my understanding that IACP shall be offering  numerous webinars for 2014 that will contain more technical information with a focus on quality. I look forward to the future presentations.

About the Program: As the demand for compounded medications has increased and in light of recent tragic events, the pharmaceutical sterile compounding profession requires a greater understanding of quality assurance testing. This presentation educated individuals about sterile compounding principles of bacterial endotoxin testing and environmental monitoring. Attendees gained technological knowledge about how to provide the highest quality compound preparations for their patients.

About the Presenter: William A. Stuart, RPh, practicing pharmacist with more than 28 years in sterile compounding. Graduate of University of Arizona, certified in Aseptic Compounding from American College of Apothecaries and Bacterial Endotoxin Testing from Associates of Cape Code USA.

Click here for more information on the webinar. 

Click here for more information on how to access this webinar via IACP’s On-demand capability.

IACP Sets the Record Straight with Ocala Star-Banner

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IACP’s David G. Miller, RPh, EVP/CEO, wrote a Letter to the Editor last week to Florida’s Ocala Star-Banner on their recent series of articles written about compounding, much of it negative.

IACP is continuing to work to set the record straight about pharmacy compounding, and its necessity for patients. Click here http://bit.ly/1dJvTUC to read the original Ocala Star-Banner article series, and here http://bit.ly/1dqfiBy to read IACP’s response.

IACP: Protecting, Promoting & Advancing Pharmacy Compounding.

REGISTER NOW: Thursday’s IACP AdvanCE Webinar – “Pharmacy Compounding Laws and Regulations: Staying Current in a Changing World.”

Register for this Thursday’s CE-accredited AdvanCE Webinar – “Pharmacy Compounding Law and Regulations: Staying Current in a Changing World.” IACP’s David G. Miller, RPh, EVP/CEO, will provide you with an in-depth look at federal and state legislative and regulatory issues that are affecting today’s compounders.

Thanks to Freedom Pharmaceuticals for making this program possible through an unrestricted educational grant-in-aid. Click here for more information http://bit.ly/1cS71fm

Have you seen the New “Poll” Claiming Strong Support for Effective FDA Regulation of Compounding Pharmacies?

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This week, the “Working Group on Pharmaceutical Safety” released poll results they say indicate key findings from an “independent survey” of registered voters, claiming strong support for effective FDA regulation of compounding pharmacies.
The recently formed Working Group on Pharmaceutical Safety is led by Tommy Thompson, former Wisconsin governor and U.S. Secretary of Health and Human Services, and current chairman of TherapeuticsMD, a specialty pharmaceutical company as well as Sarah Sellers, self- proclaimed FDA expert and current KV Pharmaceutical employee (manufacturers of Makena (17-P)).
The Working Group’s key survey findings are:
  • 87% say it is very important for their doctor to inform them if they prescribe non-FDA approved prescription drugs
  • 83% say if their doctor would like to prescribe a drug for them that is not FDA-approved, it is very important for their doctor to tell them about FDA-approved alternatives, if one exists
  • 77% are concerned that the FDA does not verify the safety, effectiveness, or manufacturing quality of compounded drugs
  • 86% are concerned that not every prescription drug sold to patients in the United States has been reviewed and approved by the FDA
  • 77% support legislation to give the FDA more authority to regulate compounding pharmacies and compounded drug

The Survey Says…

All sounds pretty straight forward, right?  Uhhh – not so much when you dive into the actual survey details.

For example, take a look at their question #21 – Have you ever heard of a type of pharmacy called a compounding pharmacy?
73 percent of their respondents said, “no.”
Question # 22 – To the best of your knowledge, have you or has anyone in your immediate family ever used a compounded drug?
73 percent said, “no.”
Question #23 – Over the past few months, have you heard or read anything in the news about compounding pharmacy or compounded drugs?
85 percent of their respondents said, “no.”
So….the majority of these survey participants are completely unaware of compounding, yet the public is being told that these same respondents have a very clear opinion on how medications should be regulated and that they should be FDA-approved.
Something not adding up here? IACP doesn’t think so.
When asked by an FDA Week reporter to comment on this new “survey,” IACP responded that our policy is to only comment on legitimate, independent surveys.
Please email iacpinfo@iacprx.org if you have any questions or comments!

IACP Summarizes the House Compounding Bill Draft, Released on Sept. 12, 2013

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On September 12, 2013, Rep. Morgan Griffith of Virginia (R-VA), Diana DeGette (D-CO) and Gene Green (D-TX) released a bipartisan legislation, House Resolution 3089, the “Compounding Clarity Act of 2013.”  

Over the past few months, the International Academy of Compounding Pharmacists (IACP) has worked closely with the House Energy & Commerce Committee on behalf of our membership in an effort to incorporate needed provisions that Senate S. 959 does not address.

IACP is continuing to review the Bill, and believes it offers a significant improvement over the Senate bill. We look forward to continued collaboration with Congress on this draft.

There are some issues that will need to be resolved, including those that pertain to federal vs. state authority, and we are eager to begin that process.

IACP’s Summary of House Resolution 3089, The Compounding Clarity Act of 2013   

Click here to review IACP’s detailed summary of the House’s Draft Bill.      

House Resolution 3089 Draft Bill Introduced on September 12, 2013  

Click here to review the House Compounding Bill introduced, September 12, 2013      

Congressman Griffith’s Draft Bill Summary, September 12, 2013  

Click here for Congressman Griffith’s Compounding Summary of the Draft Bill    

IACP Members: Please forward your comments on this Draft Bill to iacpinfo@iacprx.org.

IACP is working to Protect, Promote & Advance Pharmacy Compounding.  

Posted September 16, 2013

Working the Hospital Side of S. 959

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(article reprinted from IACP’s Capitol Connections newsletter, Sept 11, 2013)

By IACP Member Linda F. McElhiney, PharmD, RPh, FIACP, FASHP, FACA

After attending IACP’s 2013 Compounders on Capitol Hill, I spoke to our VP of Government Affairs at Indiana University Health about the proposed S.959 bill, and sent her the information that was provided to the Congressman. Within a few weeks, we had conference calls with the American Hospital Association (AHA), the Children’s Hospital Association (CHA), and members of the Senate HELP Committee to discuss how S.959 was going to have a negative impact upon hospital compounding practices, such as anticipatory or batch compounding, compounding for hospital subsidiaries, compounds as “new drugs,” notification to the FDA for compounded backorder items, and the FDA “Do Not Compound” list. The discussions were very positive and I think that we are gaining support for changes to the S.959 from the various hospital organizations.

About a month ago, the president of the American Society of Health-system Pharmacists (ASHP) urged the entire membership to fully support the passage of S.959 without revisions and to talk to their Congressman. As a fellow of both ASHP and IACP, I was alarmed that ASHP was fully supporting this proposed bill, so I sent an e-mail to ASHP’s Government Affairs department and listed the problems with S.959 that would have a negative impact on hospital compounding. The “hospital exemption” that ASHP helped to write does not exempt hospitals from following all of the regulations that “traditional compounders” must follow; it only exempts hospitals from registering as “compounding manufacturers.” Within a couple of hours after that e-mail was sent, I was on a conference call with ASHP’s Government Affairs department, and they are now seriously reviewing how S.959 will impact hospital compounding practices, too.

Last week, to my surprise, Senator Dan Coats’ (R-Ind) legislative aide came to our compounding laboratory at the hospital to get a better understanding about hospital compounding and the impact that S.959 will have upon health-systems. It was a great visit and helped us to present our point-of-view with all of the show-and-tell visuals, such as our quality assurance program, anticipatory/batch compounding process, and examples of unique compounds that we need to prepare for our patients that could potentially be banned by the FDA. The legislative aide seemed very impressed and assured us that she would reinforce our concerns to the Senate HELP Committee and talk with the other Senate staff members.

Click here to read the rest of the story.

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