FDA Regulation of Pharmacies has Knotty History

By: Associated Press
By: Associated Press

WASHINGTON (AP) -- The deadly meningitis outbreak linked to contaminated pain injections has prompted renewed calls for tighter federal regulation of compounding pharmacies, which have periodically been blamed for crippling and sometimes fatal injuries.
Previous efforts have prompted vigorous pushback by compounding pharmacists, with the result being a patchwork of laws and uncertainty over how much power the Food and Drug Administration has to regulate compounders.
Several members of Congress this week have promised to introduce legislation giving the FDA greater authority to oversee the specialty pharmacies, which a trade group says have grown into a $3 billion business. An FDA official suggests the agency would support new laws on the issue as well.
The president of the International Academy of Compounding Pharmacists says he would "absolutely" cooperate with federal officials on new laws to prevent outbreaks. But he adds that the New England Compounding Center appears to have been acting as a manufacturer -- which he says "runs contrary to what a compounding pharmacy is all about."


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