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Pharmacists Endorse House Bill to Clarify Compounding Oversight, While Preserving Patient Access to Customized Medications
Date:9/12/2013

ician's prescription.) If a pharmacy prepares sterile medications for office use (such as by a physician or hospital), ships those medications across state lines, and such medications account for more than five percent of drugs it produces, then the compounding provider would fall under the legislation's newly established category of "outsourcing facilities" subject to Food and Drug Administration (FDA) regulation. Moreover, the bill would help ensure more effective coordination and communication between FDA and state boards of pharmacy, thereby directly addressing one of the key breakdowns that helped facilitate and prolong the meningitis outbreak.

NCPA members and staff have delivered expert testimony at congressional hearings and spent countless hours working constructively and discussing legislative proposals with House and Senate lawmakers and staff members. Throughout the legislative process, NCPA has urged focus on ensuring that federal and state regulators fully exercise their existing oversight authority and that any new legislation preserves patient access to customized medications from independent community pharmacists, without burdening pharmacy small business owners who had no role in the tragic events of the meningitis outbreak.

Unfortunately, an alternative proposal, S. 959, as currently written would subject community pharmacists to broadly expanded FDA authority that could jeopardize patient access to essential medications. For example, it would require community pharmacists to notify FDA every time they compound a medication that is in shortage. In addition, it would give FDA blanket authority over what a community pharmacist can compound in response to a physician's prescription for a pat
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SOURCE National Community Pharmacists Association
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