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FDA regulation of pharmacies has knotty history



Published: Fri, October 12, 2012 @ 2:45 p.m.

WASHINGTON (AP) — The deadly meningitis outbreak linked to contaminated pain injections has prompted calls for tighter federal regulation of compounding pharmacies, which have periodically been blamed for crippling and sometimes fatal injuries.

But this isn't the first time Congress has pushed for more authority over the industry.

Such efforts stretch back to the 1990s, and after vigorous pushback by compounding pharmacists, they have left a patchwork of incomplete, overlapping laws, contradictory court rulings and overall uncertainty about how much power the Food and Drug Administration has to regulate compounders.

And with a gridlocked Congress at its most unproductive in decades, experts don't expect to see new laws passed anytime soon.

The issue flared up in the past several days after the New England Compounding Center of Framingham, Mass., came under suspicion as the source of the tainted steroid shots that have sickened at least 184 people in 12 states, causing 14 deaths.

Several members of Congress this week promised to introduce legislation giving the FDA greater authority to oversee the specialty pharmacies, which custom-mix drugs for patients for everything from menopause symptoms to cancer.


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