IACP Names John Voliva Executive Vice President

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The International Academy of Compounding Pharmacists (IACP) has named John Voliva, RPh, as its new Executive Vice President. Voliva will assume IACP’s EVP role on Monday, April 4, 2016. The EVP search was managed by a six-person committee representing the interests of the IACP Board of Directors, the IACP Foundation Board, IACP members and industry suppliers.

“IACP’s Search Committee is extremely confident that we found the most qualified person to lead the organization forward. After a national search, John Voliva’s extensive experience made him the clear choice for the position,”said Gary McCrory, RPh, CCN, IACP President. “John brings a distinctive combination of compounding pharmacy ownership, legislative relations at both a federal and state level, and a strong pharmacist background. He is one of us; he truly understands the value compounding pharmacy brings to patients, and how compounding pharmacists are the best suited in providing customized medications.”

“I am looking forward to continuing my work with this important sector of the profession—the compounding pharmacist,” Voliva said. “The compounding pharmacist’s ability to individualize medications, ensuring the most appropriate dose and delivery system which improves compliance, adherence and overall patient health outcomes. The provision of personalized medication solutions is the epitome of a patient-centric approach to health care.”

After receiving his bachelor of science in pharmacy degree from the Purdue School of Pharmacy and Pharmaceutical Sciences in 1999, Voliva became the owner/pharmacist of Hook’s Apothecary, Indiana’s first compounding-only pharmacy. For the past several years, he has worked for PCCA, a licensed bulk pharmaceutical repackager, as part of PCCA’s Public Affairs team. He is a long-time member of the International Academy of Compounding Pharmacists, National Community Pharmacists Association, American Pharmacists Association and Indiana Pharmacists Association. For the past two years, he has served on the DQSA Coalition which IACP established to ensure that the Drug Quality & Security Act legislation enacted in 2013 is being implemented as Congress fully intended.

Save-the-Date: IACP Member Town Hall on April 20th

Meet your new EVP John Voliva! Please join us for an IACP Member Town Hall on Wednesday, April 20th at 3:00 pm ET – 2:00 pm CT – 1:00 pm MT – 12:00 pm PT.

Call-information has been sent to all members. Please email iacpinfo@iacprx.org if you did not receive.

Congressman Buddy Carter Asks Dept of Health & Human Services About Office-Use Compounding

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This morning in a House Education & Workforce Committee, Full Committee Hearing, “Examining the Policies and Priorities of the U.S. Department of Health and Human Services,” Congressman Buddy Carter (R-GA) questioned the Secretary of the U.S. Department of Health and Services Sylvia Mathews Burwell regarding office-use compounding.

Congressman Carter expressed concern that office-use provisions in the Drug Quality & Security Act (DQSA) are not being interpreted per congressional intent by the U.S. Food & Drug Administration (FDA). Secretary Burwell replied that office-use should be allowed per her understanding, and that she was prepared to work with Congress on this issue.

See the webcast archive link and the transcript below. Thank you Congressman Carter for placing this vital issue on the record!

Please click here to view the Archived Webcast from this morning’s session. Congressman Carter appears at the 2.00 portion of the webcast.

Transcript

Rep. Carter (R-GA-1): As a pharmacist I wanted to ask you about compounding for office-use. I am concerned about the FDA interpreting for legislative intent. The FDA continues to prevent medications to be compounded for office use. Many states have already allowed for this to take place. He pointed out that office use prevents patients from having to go to the doctor, get a prescription, then go to the pharmacists, and allows for doctors to dispense necessary medications to patients without the additional steps.

Sec. Burwell: We don’t have any guidance out preventing that, maybe my team can follow up with your staff. Right now compounding should be occurring and there should not be a problem with any rules.

Rep. Carter: The problem is that you are requiring each patient to have a prescription.

Sec. Burwell: It is my understanding that should be able to be allowed, so I look forward to working with you on that.

Rep. Carter pointed out that they are looking for a guidance on this topic, and the Secretary said they welcomed Congress’s input on any guidance.

IACP and the DQSA Coalition will continue to keep our Members apprised of updates as they are available. Please email questions to iacpinfo@iacprx.org

IACP Submits General Chapter 797 Comments

The International Academy of Compounding Pharmacists (IACP) has submitted formal comments to the United States Pharmacopeial Convention (USP) regarding General Chapter <797>. These comments are based upon IACP member input as well as the input of the IACP Legislative Committee and Board of Directors. Thank you to all members who provided feedback.

IACP General Chapter <797> Comments

Please click here to view IACP’s comments.

IACP Statement

IACP supports practices and quality standards for preparing compounded sterile human and animal drugs. However, IACP has strong concerns with several of the proposed revisions that would place an undue burden upon pharmacists and result in decreasing time spent with patients as well as patient access to vital compounded medications. At a time when patients are already facing decreased access to compounded medications due to skyrocketing drug shortages and new burdensome regulations, the Revised Chapter <797> will result in further decreasing patient access to these vital compounded medications. The burden that these revisions place on pharmacists will result in many pharmacists foregoing sterile compounding altogether resulting in further reducing patient access to medications. The sections within the Revised Chapter <797> that will burden pharmacists the most and have the greatest impact on decreasing patient access are the sections related to air quality monitoring, establishing beyond-use dates, and in-use times are of greatest concern.

IACP shares the concerns of many other organizations that the current revisions provide very few citations in support of the specific proposed requirements.  As the burden that is being placed on pharmacists is so high by these revisions as to lead to drastically reducing patient access to medications, IACP strongly encourages that any revisions proposed be based on data, studies, and specific information.

Therefore, while IACP appreciates USP’s work on this issue, IACP has strong concerns as to the unintended consequences of the proposed revisions on patient access to medications. IACP urges USP to consider patient access to compounded medications and revise the proposed revisions as detailed in our comments.

PLEASE NOTE: USP Extended the Comment Period to TODAY, Monday, February 1, 2016

If you have any questions, please email iacpinfo@iacprx.org.

USP Approves Chapter 800

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On Friday, November 20, 2015, the United States Pharmacopeial Convention (USP) announced that their Compounding Expert Committee has formally approved new General Chapter, <800>Hazardous Drugs—Handling in Healthcare Settings. The purpose of this General Chapter is to provide standards to protect personnel, patients and the environment when handling hazardous drugs (HDs). The chapter applies to all healthcare personnel and all entities which handle HDs. Building on existing standards and guidelines, General Chapter <800> provides a comprehensive approach for handling HDs in healthcare settings with the ultimate goal of preventing and/or limiting potential exposures to HDs.

The revised General Chapter <800> will be published on February 1, 2016 in the First Supplement to USP 39–NF 34. Additionally, the Expert Committee approved a delayed official implementation date of July 1, 2018 to allow entities more than two years to implement the chapter.

“The International Academy of Compounding Pharmacists (IACP) had requested many changes in the original published General Chapter earlier this year and we are very pleased to see that the Expert Committee took our concerns seriously.  Although the final chapter represents a significant improvement, there are still challenges that remain as pharmacies and health care professionals adapt to the new requirements,” says IACP Executive Vice President David Miller.  “We are especially glad that USP recognized the potential financial ramifications and the changes that compounding pharmacy practices will need to implement and provided two years for preparation.”

To see the official announcement, please click here. 

IACP Submits Comments to FDA on the Draft Guidance for Compounding Animal Drugs from Bulk Drugs

This week, the International Academy of Compounding Pharmacists (IACP) submitted formal comments to the Food & Drug Administration (FDA) regarding the Draft Guidance for Compounding Animal Drugs from Bulk Substances (GFI #230).

IACP’s Comments to FDA

Please click here to view the entire comments submitted to FDA regarding the GFI #230. To date, there have been 24 sets of comments sent to the FDA.

Why is GFI 230 a problem for compounders? “As proposed, the FDA’s Center for Veterinary Medicine (CVM) is attempting to circumvent the legislative process and, instead, create an entirely new approach to compounding,” says IACP Executive Vice President David Miller. “It’s not just that which concerns our membership and our Board, it’s that if left unopposed, these new policies could set a precedent to justify the FDA’s further efforts to regulate human compounding.”

For example, the GFI does away entirely with office-use for veterinarians and instead requires a patient-specific prescription for each and every compound. It applies language in federal human compounding statute to veterinary compounding without authorization from Congress and even gives human compounding registered 503B outsourcing facilities the ability to prepare veterinary compounds without authorization from Congress. Congress specifically provided for 503B outsourcing facilities to prepare sterile compounds for human use. FDA attempts to interfere with the traditional role of the states in defining what constitutes a valid prescription by requiring a series of specific statements on a ‘script before the pharmacist would be able to prepare and dispense the medication, potentially delaying prompt therapy for an animal in need.

“Additionally, for the first time ever, a health care practitioner – either a veterinarian or a pharmacist – would be required to report any and all adverse events to the FDA’s reporting system. Traditionally, doctors, pharmacists, nurses, and vets have participated in the voluntary MedWatch adverse event reporting program. If this goes into effect, how long before pharmacists will be required to report adverse events in compounded prescriptions for humans or, possibly, for any prescription they dispense?” explains Miller.

Thank You for Taking Action!

A big thank you to the more than 300 members who sent in their action alerts to your congressional representatives asking them to sign a letter to FDA to withdraw its Guidance for Industry #230: Compounding Animal Drugs from Bulk Substances. Your participation resulted in generating 20 congressional co-signers on the effort led by Congressmen Matt Salmon (R-AZ) and Kurt Schrader (D-OR).

The letter points out that the agency does not have statutory authority to interfere with the state-regulated practice of veterinary medicine. More importantly, the Congressmen point out that as written, the guidance attempts to create new regulatory authority without legislation to support that effort.

Please click here to view the final letter featuring 20 co-signers.

Take Action! Stop FDA’s Misguided Veterinary Compounding Guidance

At its September meeting, the International Academy of Compounding Pharmacists (IACP) Board of Directors unanimously voted to support a bipartisan Congressional letter, http://tinyurl.com/ptjdcw7, demanding that the Food & Drug Administration (FDA) withdraw its Guidance for Industry (GFI) #230: Compounding Animal Drugs from Bulk Substances. Led by Congressmen Matt Salmon (R-AZ) and Kurt Schrader (D-OR), the letter points out that the agency does not have statutory authority to interfere with the state-regulated practice of veterinary medicine. More importantly, the Congressmen point out that as written, the guidance attempts to create new regulatory authority without legislation to support that effort.

Why is GFI 230 a problem for compounders? “As proposed, the FDA’s Center for Veterinary Medicine (CVM) is attempting to circumvent the legislative process and, instead, create an entirely new approach to compounding,” says IACP Executive Vice President/CEO David G. Miller, RPh.  “It’s not just that which concerns our membership and our Board, it’s that if left unopposed, these new policies could set a precedent to justify the FDA’s further efforts to regulate human compounding.”

For example, the GFI does away entirely with office-use for veterinarians and instead requires a patient-specific prescription for each and every compound. It applies language in federal human compounding statute to veterinary compounding without authorization from Congress and even gives human compounding registered 503B outsourcing facilities the ability to prepare veterinary compounds without authorization from Congress. Congress specifically provided for 503B outsourcing facilities to prepare sterile compounds for human use. FDA attempts to interfere with the traditional role of the states in defining what constitutes a valid prescription by requiring a series of specific statements on a ‘script before the pharmacist would be able to prepare and dispense the medication, potentially delaying prompt therapy for an animal in need.

“Additionally, for the first time ever, a health care practitioner – either a veterinarian or a pharmacist – would be required to report any and all adverse events to the FDA’s reporting system. Traditionally, doctors, pharmacists, nurses, and vets have participated in the voluntary MedWatch adverse event reporting program. If this goes into effect, how long before pharmacists will be required to report adverse events in compounded prescriptions for humans or, possibly, for any prescription they dispense?” explains Miller.

What can you do to help with this important fight? Contact your Congressman’s office today and ask them to support the Salmon/Schrader letter requesting that FDA withdraw GFI #230. You can direct your Congressman’s staff to reach out to contact Greg Soften (greg.safsten@mail.house.gov) in Rep. Salmon’s office, or Chris Huckleberry (huck@mail.house.gov) in Rep. Schrader’s with questions and to sign onto the letter.

Watch for additional information and outreach from IACP on this important initiative in your e-mail and in our future publications.

IACP Podcast #15: Jay McEniry & David Miller Discuss Tricare

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IACP has developed an exciting Podcast series, bringing listeners the latest news, stories and discussions on pharmacy compounding. We’re featuring guests from throughout the industry, discussing issues that hit home for pharmacy compounders, prescribers, and the patients they serve.

Stay Tuned: New episodes of the IACPodcast come out each Wednesday at noon CST. Visit IACP’s Podcast/Publications webpage here.

IACP Podcast #15: Jay McEniry & David Miller Discuss Tricare

Please click here for a Podcast interview with special guests, David G. Miller, RPh, IACP Executive Vice President/CEO, and Jay McEniry, Executive Director, Patients and Physicians for Rx Access (SaveRxAccess.org). The topic is Tricare, and the current issues facing compounding pharmacists, and most importantly, the patients they serve.

Have an idea for a topic? Want to give us a suggestion? Maybe you have a question? Give us a call at the IACPublication line: 713-730-9043.

IACP Files Formal Comments on Proposed FDA Memorandum of Understanding

The International Academy of Compounding Pharmacists (IACP) has raised serious concerns about patient access to vital medications in formal comments submitted on July 20, 2015, to the U.S. Food and Drug Administration, as the agency develops a new regulatory framework for pharmacy compounding based upon the Drug Quality and Security Act (DQSA) of 2013.

“We believe the FDA’s draft guidance overreaches far beyond the intentions of Congress and contradicts the clear language of the DQSA and previous federal legislation – to the point that, if left intact, it will hinder patient access to compounded medications, limit patient choice of their pharmacist, and disrupt the essential physician-patient-pharmacist triad relationship,” said David G. Miller, RPh, the IACP’s Executive Vice President and Chief Executive Officer.

“Our organization, along with a diverse group of stakeholders in the health care industry, has worked cooperatively with the FDA as the agency implements the DQSA, and we urge the FDA to incorporate our feedback,” Miller said. “The fact that more than 3,000 individuals and organizations have commented on the draft guidance underscores that the agency has a great deal of work to do before finalizing this document and ensuring that it does not negatively impact patient access to compounded medications.”

The International Academy of Compounding Pharmacists (IACP) is an association representing more than 4,000 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.

IACP Comments to FDA

Click here to read IACP’s submitted MOU comments to the FDA.

IACP Press Release

Click here to read the IACP press release announcing its formal comments submitted to FDA.

For more information, please visit www.iacprx.org, or email iacpinfo@iacprx.org

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.

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