FDA chief renews push for specialty pharmacy rules

SILVER SPRING, Md. — The Food and Drug Administration met with representatives of all 50 states Wednesday to examine bridging regulatory gaps relating to compounding pharmacies, to prevent a recurrence of the type of contaminated drug shipments that caused widespread sickness and deaths this fall.

"We do strongly believe we need additional legislation," FDA Commissioner Margaret Hamburg said, adding she is "guardedly optimistic" Congress will approve a bill that will clarify exactly how entities such as the New England Compounding Center of Framingham, Mass., should be regulated.

The NECC was the source of mass-produced steroid injections that led to 620 cases of fungal meningitis in 19 states this fall, resulting in 39 deaths. With 14 deaths so far, Tennessee has had more than any other state.Source found here