Pharmacists Endorse House Bill to Clarify Compounding Oversight, While Preserving Patient Access to Customized Medications

Published Online: Thursday, September 12, 2013

Alexandria, Va. Sept. 12, 2013 - The National Community Pharmacists Association (NCPA) strongly supports bipartisan House legislation introduced today that is intended to prevent a recurrence of the 2012 meningitis outbreak, the association said in a letter to House lawmakers.

The Compounding Clarity Act, H.R. 3089, sponsored by U.S. Reps. Morgan Griffith (R-Va.), Gene Green (D-Texas) and Diana DeGette (D-Colo.), would better enable regulators to protect the public from any entities like the New England Compounding Center (NECC) without harming patients or saddling independent community pharmacists with new red tape.

"Our independent pharmacies provide a needed service in compounding medications and have a long history of protecting patient safety while preserving patient access to vital medications," wrote NCPA CEO B. Douglas Hoey, RPh, MBA. "The House legislation appropriately addresses the issues that led to the NECC tragedy and prevents another tragedy from occurring while also not interfering with the physician-patient-pharmacist relationship and maintaining critical patient access to compounded medications."

H.R. 3089 would preserve state board of pharmacy oversight of the vast majority of independent community pharmacies that compound medications. (When off-the-shelf, manufactured drugs are not an option, pharmacists prepare or "compound" customized medication for a patient in accordance with a physician'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 patient. NCPA reiterated these views recently in a Sept. 4 letter to leaders of the House Energy and Commerce Committee.
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