US Senate Committee on Health, Education, Labor, & Pensions

Recall of Sterile Products from Specialty Medicine Compounding Pharmacy Highlights Urgency of Compounding Legislation

Thursday, October 24, 2013

WASHINGTON, D.C.—Yesterday, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of certain sterile products supplied by Specialty Medicine Compounding Pharmacy in South Lyon, Michigan because “unidentified particulate matter was found floating in a sterile product from the same lot as products that may have been administered to patients at a Michigan hospital,” according to the FDA. The agency is recommending that health care providers immediately discontinue the use of any sterile product from this pharmacy. This latest contamination involving compounded drugs brings renewed focus to the Drug Quality and Security Act, which passed the House in September. Last year, tainted drugs produced by a compounding pharmacy in Massachusetts sickened more than 750 and killed more than 60 individuals. 

The legislation would address high-risk drug compounding practices, improve drug safety, and help prevent a public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center. It would also secure the pharmaceutical supply chain by tracking all prescription drugs from the time they are manufactured to the moment they are picked up at the drugstore. Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, is one of the co-authors of the legislation.

"Americans should not have to worry that the drugs they receive may be tainted or otherwise adulterated. While the FDA continues to examine the scope of this incident, this latest in a series of events involving compounding pharmacies brings to the forefront Congress’ need to act to protect consumers,” Harkin said.  “The Drug Quality and Security Act is a bipartisan bill, with broad support, that will help improve the safety of compounded drugs. I hope that the Senate takes up and passes this critical legislation as soon as possible, so that it can be sent to the President's desk to be signed into law."


Click here for more details on the legislation.  Click here to see a list of endorsements for the legislation.

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