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IACP: FDA Authority Is Clear, Direct, And Certain
Date:11/20/2012

achusetts State Board of Pharmacy and the FDA. The FDA has not yet produced those documents, and Miller said he agreed with U.S. House and Senate members that the internal history regarding NECC is important before changes in the law are contemplated.

Miller further asked the FDA to provide a description of its standard operating procedure for cases – like that involving NECC – where a company is identified as being a manufacturer of drugs, and a possible violator, even though it is not registered as a manufacturer.

"The IACP and its members strongly urge the FDA to explain the delays and inaction in the tragic case of the NECC, to identify which staff members were involved, to provide a timeline surrounding complaints about NECC, and to specify why decisions were made to let the company continue operating," Mr. Miller said in his letter.

Although NECC portrayed itself as a compounding pharmacy, it in fact operated as a drug manufacturer. Though it was not formally registered as a manufacturer with the FDA, the company was clearly subject to oversight by the FDA, Miller said in his letter today to Hamburg, elaborating on his testimony before Congress last week.

Miller's testimony was at odds with that of with that of Hamburg, who contended that the FDA's authority over companies like NECC is unclear. "IACP insists that we determine what went on with NECC, and why the FDA did not act under existing regulations," Miller said.

A copy of the letter to the FDA from the IACP was also sent to the President of the Massachusetts State Board of Pharmacy, which has jurisdiction over compounding pharmacies in the state and had been notified of complaints about NECC.

ABOUT THE INTERNATIONAL ACADEMY OF COMPOUNDING PHARMACISTS

The International Academy of Compounding Pharmacists (IACP), based in Missouri City, TX, is an international, professional association established in 1991 to protect, promote and advance the art an
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SOURCE International Academy of Compounding Pharmacists (IACP)
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