Friday, 13 September 2013

House bill gives FDA new power over compound pharmacies


Regular readers will know about the current issues with many U.S. compounding pharmacies (see for example the Digital Journal). Many of these issues have related to sterility assurance.

Pharmaceutical Microbiology has run a series of investigative articles on the crisis facing U.S. compounding pharmacies as the U.S. Food and Drug Administration (FDA) embarks on a series of inspections into issues of quality and sterility of medicines.
These different events, in short time frame, suggest that the continuing problems with quality control in certain U.S. pharmacies continues to be an issue of major concern, especially in relation to the potential risks of microbiological contamination.

In light of this, the news has come in that U.S. lawmakers are introducing a bill that would give drug regulators more authority over compounding facilities. 'The Compounding Clarity Act', introduced on September 12, 2013, 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 (the New England Compounding Center). 

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

For further details, see this letter from the NPCA.

Posted by Tim Sandle