ALEXANDRIA, Va. (May 23, 2013)
– Joseph H. Harmison, RPh, owner of DFW Prescriptions in Arlington, Texas and past president of the National Community Pharmacists Association
(NCPA), testified today at a hearing of the U.S. House Energy and Commerce Subcommittee on Health as lawmakers examined the importance of compounding prescription drugs for patients and the current level of regulation at the federal and state levels in the wake of the New England Compounding Center’s (NECC) fungal meningitis tragedy.
In his remarks
, Harmison stressed the importance of state boards of pharmacy oversight responsibilities; enhancing information sharing between the Food and Drug Administration (FDA) 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. “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, “NCPA is committed to working with Congress on the issue of practices that exceed state-regulated compounding. 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.”
Patients need access to specially tailored medications through pharmacy compounding for a variety of reasons. Some common examples include averting certain allergic reactions to mass-produced drugs; flavoring medications for pediatric patients; creating a liquid version for patients who have difficulty swallowing pills; and hormone replacement therapy.
Harmison’s testimony contained several recommendations for regulatory oversight, including:
Maintaining state board of pharmacy regulation over every aspect of pharmacy and, when a situation arises where the FDA is concerned, that it should work in concert with the state board;
Guaranteeing that state boards of pharmacy are properly funded to execute their regulatory duties;
Encouraging state boards of pharmacy to require compliance with USP 797 in order to provide more uniform production standards;
Recognizing that traditional compounding also includes pharmacists preparing customized medications in anticipation based on historical prescribing patterns; and
Producing clearer lines of communication by requiring the FDA to share all inspection data and any requests for follow-up actions with the state boards of pharmacy.