ALEXANDRIA, Va. — Former National Community Pharmacists Association president Joseph Harmison testified at a House committee hearing that examined regulation of pharmacy compounding.
His testimony came as lawmakers scrutinize the current level of supervision at the federal and state levels in the wake of the New England Compounding Center’s (NECC) fungal meningitis tragedy.
NCPA said Harmison stressed at Thursday’s House Energy and Commerce Subcommittee on Health hearing the importance of state boards of pharmacy oversight responsibilities, enhancing information sharing between the Food and Drug Administration and state regulatory bodies, and recognizing what constitutes traditional pharmacy compounding.
"Compounding is a 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 traditional compounding services," said Harmison, owner of DFW Prescriptions in Arlington, Texas. "When manufactured drugs aren’t an option, independent community pharmacists provide traditional pharmacy compounding to prepare customized medications for patients in accordance with a doctor’s prescription based on the patient’s individual needs.
"Traditional compounding services can also help bridge the gaps during times of prescription drug shortages," he added.
Common instances of patient need for compounded medicines include allergic reactions to mass-produced drugs, flavoring medications for children, creating a liquid version for those who have difficulty swallowing pills and hormone replacement therapy.
In his testimony, Harmison gave several recommendations for regulatory oversight of compounding, including maintaining state board of pharmacy regulation over every aspect of pharmacy and, when a situation arises where the FDA is concerned, the agency should work in concert with the state board. Clearer lines of communication, by requiring the FDA to share all inspection data and any requests for follow-up actions with the state pharmacy boards, would help as well.
He also said that state pharmacy boards must be properly funded to execute their regulatory duties and encouraged to require compliance with USP 797 in order to provide more uniform production standards.
Harmison, too, noted that it must be recognized that traditional compounding also includes pharmacists preparing customized medications in anticipation based on historical prescribing patterns.
"NCPA is committed to working with Congress on the issue of practices that exceed state-regulated compounding," he stated. "We believe the committee is taking the proper steps to address this tragedy by focusing on investigations into what steps should have been taken and oversight to ensure that the appropriate regulatory bodies are exercising their full authority."
