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ALEXANDRIA, Va. — The National Community Pharmacists Association CEO Douglas Hoey testified Tuesday before the U.S. House of Representatives Energy and Commerce Subcommittee on Health’s hearing on “Reforming the Drug Compounding Regulatory Framework.”
His remarks focused on discussion draft legislation offered by U.S. Rep. Morgan Griffith, R-Va., that seeks to address the concerns raised by the New England Compounding Center’s fungal meningitis tragedy late last year.
“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.”
The provisions in the discussion draft that NCPA supports include:
- Preserving state Board of Pharmacy oversight over pharmacy compounding;
- Maintaining anticipatory compounding and office use in instances where state law allows; and
- Recognizing the need to strengthen the lines of communication between the state Boards of Pharmacy and the Food and Drug Administration.
NCPA also expressed concerns about three particular legislative proposals circulating that would grant the FDA unrestricted authority over a “do not compound” list, which could impact patient access to such compounded drugs as hormone medications, thyroid preparations, promethazine gels and medications to treat autism. These proposals also require notification requirements from pharmacies to the FDA when compounding medications are in short supply, which could exacerbate the impact of drug shortages. And these proposals exempt pharmacies within health systems from compounding standards, which sets up a dichotomy of care where patients are not assured they are receiving safe, customized medications regardless of where the patients obtain these compounded medications.
“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.”