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NCPA urges care as Congress scrutinizes compounding
September 6th, 2013
ALEXANDRIA, Va. – In a letter to congressional leaders, the National Community Pharmacists Association gave its take on how pharmacy compounding safety and oversight could be improved without impacting patient access to compounded medications.
NCPA said Thursday that chief executive officer B. Douglas Hoey wrote a letter to Reps. Fred Upton (R., Mich.) and Henry Waxman (D., Calif.), respectively chairman and ranking member of the House Energy and Commerce Committee, to reiterate the views of community pharmacists on how to help prevent a recurrence of the 2012 meningitis tragedy. At the same time, he noted that measures cannot impeding patients' ability to get customized medications, which are prescribed by doctors and prepared pharmacists when off-the-shelf manufactured drugs aren't an option.
"Compounding is the backbone of pharmacy practice and, for many decades, independent community pharmacists have provided millions of adults, children and animals with access to safe, effective and affordable medications through compounding services," Hoey explained in the letter. "Compounding can help bridge the gaps during times of drug shortages. Drug shortages have nearly tripled, according to the FDA, and their impact can be devastating."
The House committee has conducted an investigation and held hearings on how the meningitis outbreak was handled by the Food and Drug Administration and state regulators. According to NCPA, as Congress returns from its August recess, the panel is actively considering policy or legislative changes to prevent a similar public health crisis from reoccurring.
In the letter, NCPA commended the work done by the House panel to review the meningitis outbreak and noted that, going forward, lawmakers should avoid acting or legislating "in a manner that interferes with the triad relationship of patient-physician-pharmacist, and prevents patients from obtaining their necessary compounded medications."
The association indicated that it can't support a Senate proposal (S. 959) as currently written because it would inadvertently "create unnecessary federal regulatory burdens, hamper independent community pharmacies from providing medications to patients with unique health needs, and far exceeds a targeted approach to prevent another tragedy such as NECC." S. 959 would require community pharmacies to report directly to the FDA when compounding medications to alleviate a drug shortage.
In addition, NCPA pointed out in the letter, S. 959 would jeopardize patient access to vital medications by directing FDA to maintain a "do not compound" list, which could potentially be used by the agency to prevent compounding in response to a doctor's prescription for medications such as hormone medications, thyroid preparations, promethazine gels and medications to treat autism.
NCPA said that it supports the efforts of Rep. Morgan Griffith (R., Va.) to craft bipartisan House legislation based on the "discussion draft" legislation posted on the committee's Website. The proposal "rightfully maintains state board of pharmacy oversight of traditional compounding pharmacies while strengthening badly needed two-way communications between the FDA and state boards of pharmacy," the letter said.
Other provisions in the legislation would safeguard patient access to key medications from pharmacies at hospitals and doctor's offices and clarify the authority of FDA and other regulators to go after any "bad actors," such as the New England Compounding Center (NECC), according to NCPA.
"NCPA looks forward to working with Congress to preserve access to vital compounded medications while best addressing the practices surrounding the NECC tragedy," Hoey stated.