Sunday, September 29, 2013

IACP: Compromise Compounding Bill Will Not Advance Quality, Safety

WASHINGTON — 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.”

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