House and Senate Agree on Drug Quality and Security Act
Reuters reports that the Senate and the House of Representatives have come to an agreement on a new bill that will allow the U.S. Food and Drug Administration to better regulate compounding pharmacies.
Drug Quality and Security Act
“This legislation will improve the safety of the compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards.” – Senate HELP Committee Chairman Tom Harkin as published in a Senate press release
- The Drug Quality and Security Act is the proposed bill that aims to put large compounding pharmacies under FDA authority.
- Currently, compounding pharmacies are regulated at the state level; however, as some of these companies have grown into corporations that distribute their products across state lines, concern has grown that states may lack the resources to adequately monitor larger compounding pharmacies.
- According to the new bill, traditional compounding pharmacies (those who compound drugs on an individual basis) will remain under state authority.
- Compounding pharmacies that mass produce compounded medications and ship the drugs across state lines (called “outsourcing facilities” in the new bill) will now be regulated by the FDA.
- The bill also calls for a set of standards to track pharmaceuticals throughout the distribution process to prevent the introduction of fake medications into the drug supply.
New England Compounding Center and Specialty Compounding
- The new bill aims to prevent pharmaceutical contamination related deaths like those caused by the New England Compounding Center and Specialty Compounding.
- The New England Compounding Center in Framingham, Massachusetts was linked to an outbreak of fungal meningitis that infected hundreds and has left over 50 people dead.
- A more recent incident occurred when a number of patients were diagnosed with bloodstream infections caused by Rhodococcus bacteria after receiving IV infusions at Corpus Christi, Texas hospitals, resulting in the death of a growing number of patients.
- The bacteria was traced back to Specialty Compounding near Austin, Texas which was revealed to have been issued a Form 483 by the FDA after an inspection cited conditions that violated the Food Drug and Cosmetic Act.
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