Friday, September 27, 2013
IACP: COMPROMISE COMPOUNDING BILL WILL NOT ADVANCE QUALITY AND SAFETY!
The International Academy of Compounding Pharmacists (IACP) believes that the compromise compounding bill that has emerged from Congress will not protect the American public; contains significant gaps because it does not provide key definitions to govern compounding practice; and does not take into account any of the input from the compounding profession provided to Congress over the last year.
“This bill, in its failure to recognize the very real problems in the draft legislation that we have identified over many meetings, will without question result in patients’ inability to obtain access to needed medications,” said David G. Miller, R.Ph, Executive Vice President and CEO of the International Academy of Compounding Pharmacists. “This bill will not further the safety of compounded medication, which was its only purpose.”
Below are some of the serious concerns that IACP has with the bill:
• The current bill does not recognize the need for “office use” for patients that have an emergent and vital need for medical treatment by physicians who have long relied upon having these drugs available, such as a patient at risk of vision loss if not treated immediately.
• Anticipatory compounding, the practice of making medication available in adequate supply ahead of expected needs (such as a compounder preparing a batch of poison ivy cream at the beginning of summer) is not defined or provided for in this bill.
• While the bill creates a new category of outsourcing facilities, which we have previously supported, it does not adequately define these entities, which will lead to more confusion about federal authority and legal challenges.
• Although states have long had sufficient authority to regulate compounding, the bill grants the FDA sweeping, unprecedented authority in determining what pharmacies can compound.
“IACP has made every effort and done its due diligence in working on a regular basis with House and Senate staff members and with the FDA, and thus it is unfortunate that the very businesses that help your local communities – through health care, employment and serving patient and practitioner needs – are being ignored in this ‘compromise,’” said Wade Siefert, RPh, President of IACP.
“For these reasons, IACP regretfully must strongly oppose this bill."
IACP Members: Please tell your respective congressional representatives asap to oppose this compromise bill! Please have your patients tell their representatives that this bill is not in their best interest!!
IACP will be sending an urgent request to our P2C2 advocacy grassroots base, today - now comprising more than 164,000 patients and practitioners - to let their representation in D.C. know that this bill does not protect their health!!
An IACP press release stating the Academy's strong opposition to this compromise bill has distributed to all major media outlets today. Click here to view the release.
Senate-House Compounding Compromise Legislative Draft
House Energy & Commerce Committee's One-page Summary of the Compromise Legislative Draft
Click here to review the E&C Committee's One-page Summary
House Energy & Commerce Committee's Section-by-section Summary of the Compromise Legislative Draft
Click here to access the E&C's Section-by-section Summary
What to Do Should you Receive Media Calls
If you receive calls from the media, IACP encourages you to direct these press inquiries directly to your Academy's PR Firm, David Ball, Ball Consulting Group This media assistance is part of your benefits as an IACP member.
David Ball, Ball Consulting Group, LLC
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. More than 164,000 patients and prescribers also belong to our organization via the grassroots advocacy group, P2C2 (Patients and Professionals for Customized Care). IACP's mission of protecting, promoting and advancing personalized medication solutions is critical for patient healthcare. Visit www.iacprx.org to learn more.
IACP is continuing to monitor this situation and will provide updates as available. Please email firstname.lastname@example.org with questions regarding this IACP Member Alert.
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