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B. Douglas Hoey, CEO of the National Community Pharmacists Association, this week testified before a congressional committee considering tightening FDA oversight of compounding pharmacies following last year’s New England Compounding Center’s fungal meningitis tragedy.
B. Douglas Hoey, CEO of the National Community Pharmacists Association, this week testified before a congressional committee considering tightening FDA oversight of compounding pharmacies following last year’s New England Compounding Center’s (NECC) fungal meningitis tragedy.
Hoey, RPh, MBA, spoke with members of Energy and Commerce Subcommittee on Health concerning draft legislation proposed by U.S. Rep. Morgan Griffith’s (R-Va.).
“NCPA supports the approach of Rep. Griffith’s discussion draft as it is not a broad expansion of FDA power over historically state-regulated pharmaceutical compounding but, to the contrary, strikes a proper balance of making certain that future tragedies are avoided while also preserving patients’ access to vital compounds,” Hoey said. “Representative Griffith’s discussion draft recognizes that pharmacist compounding is an integral part of the pharmacy profession and meets patients’ needs in a variety of care settings. When manufactured drugs aren't an option, independent community pharmacists prepare customized medications for patients in accordance with a prescriber’s prescription based on the patient's individual needs.”
Griffith’s legislation would preserve state board of pharmacy oversight over pharmacy compounding, and maintain anticipatory compounding and office use in instances where state law allows.
Contaminated injectable steroids from NECC led to a national meningitis outbreak, claiming 61 lives and sickening more than 700 people in 20 states.
“Throughout Congress’ efforts to determine the best course of action for preventing another NECC tragedy from occurring, NCPA has been a constructive force to find the best solution,” Hoey said. “We believe patient access to compounded medications must be preserved and that Rep. Griffith’s proposal is the best approach going forward.”