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Compounding Pharmacists Oppose Greater U.S. Oversight
Date:11/15/2012

By Steven Reinberg and Margaret Steele
HealthDay Reporters

THURSDAY, Nov. 15 (HealthDay News) -- The head of the lobby that represents compounding pharmacies will tell a U.S. Senate committee Thursday that tighter federal regulations aren't needed to oversee his industry, despite the ongoing meningitis outbreak that has killed 32 people and has been linked to tainted medications made by a compounding pharmacy.

The Associated Press reported that the head of the International Academy of Compounding Pharmacists will testify that existing regulations, which primarily put oversight responsibility on individual states, are enough to monitor compounding pharmacies.

Compounding pharmacies combine, mix or alter ingredients to create drugs to meet the specific needs of individual patients. Such custom-made drugs may include a smaller dose, for example, or the removal of an ingredient that might trigger an allergy in a patient, according to the U.S. Food and Drug Administration.

These specialty pharmacies aren't subject to the same FDA oversight as regular drug manufacturers. But some members of Congress are calling for greater FDA oversight in response to the meningitis outbreak linked to contaminated steroid injections made by a Massachusetts compounding pharmacy. Besides the 32 deaths, the outbreak has sickened 461 people in 19 states.

But David Miller, chief executive officer of the compounding pharmacies' lobbyist group, will tell the senators that current state laws, if enforced, would have prevented the meningitis outbreak. And the Massachusetts company in question, the New England Compounding Center in Framingham, was shipping medication without first receiving prescriptions from doctors, a violation of its state-issued pharmacy license, Miller said in prepared testimony, the AP reported.

"The operations of NECC were clearly outside of the scope of the state's licensure requirements and
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