IACP Files Formal Comments on Proposed FDA Memorandum of Understanding
In formal comments filed yesterday with the U.S. Food & Drug Administration (FDA), the International Academy of Compounding Pharmacists (IACP) has raised serious concerns about patient access to vital medications, as the agency develops a new regulatory framework for pharmacy compounding based upon the Drug Quality and Security Act (DQSA) of 2013.
From today's IACP press release, “We believe the FDA’s draft guidance overreaches far beyond the intentions of Congress and contradicts the clear language of the DQSA and previous federal legislation – to the point that, if left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 “The fact that more than 3,000 individuals and organizations have commented on the draft guidance underscores that the agency has a great deal of work to do before finalizing this document and ensuring that it does not negatively impact patient access to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.”
IACP Press Release
Click here to read the entire IACP press release.
IACP Comments to FDA
Click here to read IACP's submitted MOU comments to the FDA.
Please email IACP at email@example.com with any questions.
Veterinary Guidance Document Strengthens Relationships
Comments are due in just a few short weeks on the FDA's proposed Guidance for Industry - Compounding Animal Drugs from Bulk Drug Substances. Click here for reference. When this GFI was issued in late May, IACP and the American Veterinary Medical Association (AVMA) began identifying areas of common interest and how to respond to the many restrictive and potentially precedent-setting requirements contained in the agency's proposed draft. Those include requirements for individual patient specific prescriptions, mandatory statements regarding the use of a compound instead of an FDA-approved drug product, new prescription label statements, and mandatory participation in the FDA's adverse event reporting system.
Last week, IACP was the only compounding pharmacy organization invited to participate in an hour-long AVMA-hosted discussion with FDA. Included in the call were representatives from the veterinary subspecialty groups, the animal prescription drug industry, and the academic veterinary community. Almost all of the practitioner groups decried what is perceived to be an inappropriate incursion by a federal regulatory agency into the traditionally state-regulated practice of both pharmacy and veterinary medicine.
FDA representatives did not explain the rationale for specific positions within the draft GFI while on the call but strongly encouraged all groups and interested practitioners to submit comments and recommendations to the docket. Those comments are due on August 17, 2015. Click here for more information.
IACP Membership Survey Closes this Friday: Help Shape Your Academy's Future!
Please complete by this Friday, July 24th.
Last summer, the IACP leadership developed a multi-year strategic plan to guide the Academy in tackling many of the opportunities and challenges facing the compounding pharmacy community. In addition to expanding our educational programs, publications, and our legislative efforts at the federal and state level, this plan directly guides our organization as it enters its 25th year.
To see how we're doing and where YOU want us to go, we've created this brief member survey. It will take less than five minutes of your time but that investment will bring enormous return to IACP.
The survey will be available until Friday, July 24.
Please click here or on the graphic above to take the survey.
IACP Board Elections: Call for Nominations
IACP’s 2015 Call for Nominations and the 2015 Election Cycle for the new 2016 Board members is now open! The Bylaws of IACP set forth an open election process with nominations for candidates accepted directly from the membership. Nominations will close on Tuesday, September 8, 2015.
Interested candidates may be nominated or may be self-nominated to the IACP Nominating Committee chaired by IACP Immediate Past President Pat Stephens, PharmD. The IACP Board of Directors receives the Nominating Committee report at its October Board Meeting, approves the slate of candidates, and then all qualified IACP members are able to participate in the election process held each November. This year, there are four Board of Directors’ seats for which candidates are sought as well nominees for the position of IACP Vice President.
Please click here to read more about the nomination process.
Please click here to access the nomination form.
Support Your Future and Your Academy. Contribute to IACP's One Fund.
Help IACP reach our fundraising goal of $2 million dollars by the end of 2016. This funding allows us to continue our efforts to Fix DQSA and to be ready for the next challenge on the horizon. Through your generosity and support we are shaping the future of compounding.
At Compounders on Capitol Hill this year, IACP President Dale Coker, RPh, FIACP, issued a personal challenge to our membership and Corporate Sponsors to donate to IACP’s One Fund.
"IACP has a clear goal to be proactive rather than a reactive organization," says Coker. "To accomplish this, it requires capital. We need to replenish our reserves used in defending compounding in the wake of the NECC crisis of 2012. We need to build our war chest for the next coalition that will need to be formed. There are many issues on the horizon, with the Veterinary Compounding Compliance Policy Guide, third party reimbursement and third party credentialing to name a few. We need funding available to act NOW, not after a crisis sets in.
During CCH, we raised an additional $52,000 and $15,000 in future donations from members for a total of $87,000. To date we are at $413,000 which is about 21 percent of our goal with a quarter of our timeline already gone.
IACP Members and Corporate Partners: Please join us in our efforts to Protect, Preserve and Advance Pharmacy Compounding by making a donation to IACP’s One Fund fundraising campaign. Please click here to donate online, or click here to access a One Fund donation form.
Corporate Partner Topi-CLICK Donates $25,000 to IACP's One Fund Fundraising Campaign!
Corporate Partner Topi-CLICK heard our call and donated $25,000 to One Fund. Their generosity will help us reach our goal of $2 million dollars by the end of 2016.
Thank you, Topi-CLICK, for your ongoing generosity to the Academy. We greatly appreciated your support. On behalf of our Board and Members, thank you.
Please call Jennifer Petska with questions about One Fund.
IACP Welcomes New Corporate Partner: International Filter Products
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 IACP's 74 corporate partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.
To learn more about International Filter Products, please visit www.internationalfilterproducts.com.