FDA Alert - Sterile Products from Specialty Compounding in Cedar Park, TX

WASHINGTON, D.C. - Yesterday, the U.S. Food and Drug Administration (FDA) warned health care professionals against using sterile products supplied by Specialty Compounding in Cedar Park, Texas because bacterial infections have been potentially associated with contaminated calcium gluconate infusions produced by the company.  According to the alert, 15 patients developed bacterial bloodstream infections thought to be related to drug infusions produced by the compounder.  Though this case is still under investigation by the FDA, this latest in a string of incidents involving compounders brings renewed focus to the U.S. Senate’s bipartisan Pharmaceutical Quality, Security, and Accountability Act.
 
The legislation would improve the safety of compounded drugs by making clear the compounding oversight responsibilities of state and federal authorities.  The bill would also protect the nation’s drug supply chain by establishing a uniform, national prescription drug-tracing framework.  It was approved by the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee in May, and is now pending consideration by the full Senate. 

“I am saddened to learn of yet another incident where patients have been potentially harmed due to tainted drugs produced by a compounder,” said HELP Committee Chairman Harkin.  “The Senate has before it a unique opportunity to take bipartisan action and improve the safety of compounded drugs.  I hope that the Senate takes up and passes the bipartisan Pharmaceutical Quality, Security, and Accountability Act as soon as possible so that the FDA and state boards of pharmacy can have the guidance necessary to carry out their work to protect all Americans.”

Click here for more details on the legislation.  For more information on the issue in general or other HELP Committee efforts, please visit https://www.help.senate.gov. 

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