U.S. Senators, both Republicans and Democrats, introduced legislation today intended to prevent another public health crisis caused by compounding pharmacies operating as medicine manufacturers.
The Pharmaceutical Compounding Quality and Accountability Actclarifies oversight responsibilities. The legislation is in response to the fungal meningitis outbreak and related illnesses stemming from contaminated medicine made by New England Compounding Center that has sicked 741 people in the United States with 55 deaths.
Sen. Lamar Alexander, R-Tenn., introduced the bill along with Sen. Tom Harkin, D-Iowa; Sen. Pat Roberts, R-Kan. and Al Franken, D-Minn.
“My primary goal with this legislation is to erase the confusion over who regulates pharmacies and manufacturing facilities, and make it clear exactly who oversees each business,” Alexander said. “Putting one agency on the flagpole for each of these businesses will mean greater safety for American families so they don’t have to question whether the drugs they take are safe.”
Compounding manufacturers much register with the U.S. Food and Drug Administration and tell the agency what products they make and comply with good manufacturing processes. Traditional compounding pharmacies that mix smaller batches of drugs would remain under the purview of state regulators.
The Senate Health, Education, Labor and Pensions Committee will consider the bill next Wednesday.
Contact Tom Wilemon at twilemon@tennessean.com or 615-726-5961.
quoted from here