Friday, September 13, 2013

House bill gives FDA new power over compound pharmacies

House lawmakers are introducing a bill that would give drug regulators more authority over compounding facilities.

The Compounding Clarity Act, introduced on Thursday by Reps. Gene Green (D-Texas), Morgan Griffith (R-Va.) and Diana DeGette (D-Colo.), would give the Food and Drug Administration (FDA) power to oversee major drug manufacturing facilities.

The legislation comes nearly a year after an outbreak of fungal meningitis, during which 64 people were killed. Those deaths have been blamed on contaminated drugs from a Massachusetts facility.
“For the last several weeks, a bipartisan and bicameral group of lawmakers have been meeting to make sure we never relive the tragedy of the 2012 fungal meningitis outbreak that originated in a compounding pharmacy in Massachusetts,” Green said in a statement.

Griffith added that the bill would “prevent another [New England Compounding Center]-type outbreak from occurring and ensuring the quality and safety of all compounded drugs in the country.”
The legislation expands the authority of the FDA to oversee large compounding pharmacies, which alter strength, dosage and ingredients of drugs to make customized batches of medication. Large facilities like the one at the root of the 2012 outbreak are largely exempt from FDA oversight under current law.

The bill also calls for a new notification system to make sure that the FDA acts on complaints it receives from state pharmacy boards.

Only large compounding pharmacies would be subject to the new restrictions, not traditional facilities.

The National Community Pharmacists Association applauded the legislation.
In a letter to the heads of the Energy and Commerce Committee asking them to support the legislation, the pharmacist association’s chief executive wrote that the bill “rightfully maintains state Boards of Pharmacy oversight of compounding pharmacies while strengthening badly needed two-way communications between the FDA and state Boards of Pharmacy.”

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