FDA Releases Human Drug Compounding MOU – FDA Call Today at 2 pm Eastern

Today, the U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging, “that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.”

From the FDA news release, “The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013 in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products. Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use. Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.”

IACP is reviewing these documents now, and will be creating a summary for our Members. Please click here to read more. 

Join the FDA Phone Call Today

IACP Members – There is an FDA call today, providing an overview of the four draft guidances. Please see call-in information below.

The call will be today, Friday, February 13, 2015 at 2:00 p.m. ET. The call-in number is 1-888-989-4391. The passcode for all callers is “FDA.”

Jane Axelrad, Associate Director for Policy in FDA’s Center for Drug Evaluation and Research (CDER) and Agency Lead on Compounding, will provide an overview of the four draft guidances, which are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians.  She will also discuss the fifth document, the draft memorandum of understanding, which addresses interstate distribution of compounded drug products under section 503A of the Food, Drug, and Cosmetic Act.

A Question and Answer Session will follow the speaker’s presentation. Anna Fine with the FDA Office of Health and Constituent Affairs will moderate the call.

A replay of the briefing will be available one hour after the call ends until March 13, 2015.  To hear the replay callers in the United States and Canada can dial 800-947-5189.

IACP will be in attendance on this FDA phone call, and urges our Members to join as well.

Save Rx Access & IACP to the Defense Health Agency: Cover Compounded Medications Without Restriction

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Patients and Physicians for Rx Access and the International Academy of Compounding Pharmacists (IACP), today urge the Defense Health Agency to cover compounded medications without restriction under the TRICARE Health Plan, which provides healthcare benefits to more than 9.5 million uniformed service members, and their families.

In late 2014, the Department of Defense Pharmacy and Therapeutics (P&T) Committee recommended significant restrictions on ingredients commonly used in compounded formulations and a strict manual prior authorization process for prescribers and patients. In a win for patients and patient advocates, TRICARE’s Beneficiary Advisory Panel (BAP) rejected the P&T Committee’s unnecessarily restrictive and burdensome recommendations. Now faced with divergent committee recommendations, the final determination on the fate of compounded medication coverage for military heroes and families rests in the hands of the Director, TRICARE Management Activity.

“We understand the Defense Health Agency’s need to balance budget realities with patient access to care,” said Jay McEniry, executive director of Patients and Physicians for Rx Access. “In the span of a year, 140,000 military heroes and families filled 360,000 prescriptions for compounded medications. This includes children and veterans whose healthcare needs cannot be met by manufactured medicines. Clearly there is a need, and as a coalition we are committed to helping the Defense Health Agency find a way to manage costs without sacrificing care.”

IACP’s Executive Vice President/CEO David G. Miller, RPh, says, “IACP believes that all patients, regardless of their insurance plan, should have access to compounded medications whenever their physician determines that a compound is the best treatment for them.”

Please click here to read the press release.

GAO Releases Study: TriCare Coverage & Reimbursement of Compounds

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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.

Compounded Drugs:

TRICARE’s Payment Practices Should Be More Consistent with Regulations

GAO-15-64: Published: Oct 2, 2014. Publicly Released: Oct 2, 2014.
Click here to read a one-page GAO Summary.

Click here to read the full GAO Report.

IACP Submits Comments and Lists on 503A & 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 view IACP’s letter to FDA re: Nominations on Bulk Ingredients 503A Non-USP, Non-FDA Approved

Please click here to view IACP’s letter to FDA re: Nominations on Bulk Ingredients 503B Non-USP, Non-FDA Approved

Please click here to view IACP’s Bulk Drug Submission List for 503A Traditional Compounders (Please note this API list also was submitted for 503B.)

Please email IACP with questions. iacpinfo@iacprx.org

IACP Successful in Introducing Senate Bill 2825

Working with U.S. Senators John Cornyn (R-TX) and Sherrod Brown (D-OH), the International Academy of Compounding Pharmacists (IACP) successfully has introduced legislation that would allow a pharmacist to deliver a controlled substance to a practitioner.

S. 2825 ‘‘Ensuring Safe Access to Prescription Medication Act of 2014’’ is designed to “amend the Controlled Substances Act to treat as dispensing the delivery of a controlled substance by a pharmacy to a practitioner, pursuant to a patient-specific prescription of the practitioner, under certain circumstances.”

“This has been a long-term goal of the Academy,” said IACP President Pat Stephens, PharmD. “When we established our 2014 legislative agenda in February, resolving the constructive transfer issue once and for all was one of the top three directives we gave our Washington offices. Even while we keep our focus on monitoring the implementation of the Drug Quality & Security Act, IACP continues its work on other critical issues affecting our members.”    

Please click here to read the entire bill.

How IACP Members Can Help!

Please contact your Senators and ask them to sign onto S. 2825. In doing so, they will be ensuring that patients have continued and safe access to the medications they need.

IACP is working with the House to generate a companion bill for S. 2825 and that is expected to be filed in the next few days.

Please email IACP at iacpinfo@iacprx.org with any questions or input and don’t forget to check out this Friday’s Capitol Connections newsletter for additional details on our constructive transfer activities.

IACP Submits 503A and 503B Comments to FDA

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IACP Submits Comments on FDA’s Draft Guidance for Industry on Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act

IACP filed yesterday the second of two formal comments to FDA – FDA’s Interim Guidance for Human Drug Compounding Outsourcing Facilities 503B.

IACP also filed comments on September 2nd regarding the FDA’s “do not compound” list focusing primarily on the agency’s circumvention of the Pharmacy Compounding Advisory Committee and a lack of procedures for adding or modifying the list in the future – 503A.

Please click here to read IACP’s FDA comments regarding 503A, and the “Do Not Compound” list.

Please click here to read IACP’s extensive comments to FDA regarding 503B.

 

IACP Provides Timely AdvanCE Webinar on CGMPs


Register today to attend IACP’s September live webinar Current Good Manufacturing Practices – A Compounding Pharmacy Perspective, presented by Matt Bestercy and Nancy Daniels. This one-hour webinar will discuss the importance of the Food & Drug Administration (FDA) Code of Federal Regulations, Current Good X Practices (CGXPs), and how they impact the compounding pharmaceuticals industry. 

With more and more compounding pharmacies being inspected and held to CGMP standards by the FDA, this webinar is a “must” to understand what the differences are between them and, USP <795> and <797>.  For any IACP member considering opening or working for a 503B outsourcing facility, this educational program will provide a solid basis in the “new world” of working under CGMPs in those entities.

This program is made possible through an unrestricted educational grant-in-aid from Associates of Cape Cod, Inc.

Click here for more information and to register.

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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