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Drug Quality and Security Act Passes in the House

David Turnbull3 years ago

The Drug Quality and Security Act has been passed in the U.S. House of Representatives and is proceeding onto the Senate with the aim of giving the FDA greater authority to regulate compound sterilization companies as opposed to efforts being left to underfunded state regulators.  An additional purpose of the act is to create national standards that prevent the introduction of placebo or fake medication into the base drug supply, which is later divided and compounded to meet an individual’s medication needs and dosage.

Definition of Drug Quality and Security Act

  • According to Reuters, the Drug Quality and Security Act provides that traditional compounding pharmacies will remain under state control and mass-producing compounding pharmacies that ship drugs across state lines will be regulated by the Food and Drug Administration. 
  • Further, standards will be in place to track pharmaceuticals during distribution in order to prevent fake medications from being introduced into the drug supply.
  • The Drug Quality and Security Act was passed in the U.S. House after the New England Compounding Center prepared corticosteroids that led to potentially harmful fungal infections and put 13,000 people in 23 states at risk.  700 people developed serious infections and 63 people died according to Center for Disease Control and Prevention reports. 
  • Additionally, Specialty Compounding near Austin, Texas had received a FDA Form 483 after behaviors and conditions were observed that violate the Food Drug and Cosmetic Act.  There was also an outbreak recently in Corpus Christi, Texas where patients were treated with a tainted batch of calcium gluconate related to Specialty Compounding, some of whom died from infections from Rhondococcus bacteria.

Limited State Regulation for Drug Compounding Industry

  • State pharmacy boards currently regulate and monitor compounding pharmacies operating within state boundaries, regardless of whether or not compounded drugs are shipped across state borders.  
  • In Texas, Representative Joe Barton (R) of Arlington has lobbied for increased federal oversight stating that the meningitis outbreak would have been prevented if a federal law was enabled. 
  • The Enforcement Chief for the Texas State Board of Pharmacy, Carol Fisher has stated that only 100 pharmacies of 6,500 in Texas were inspected in 2013 to date, with only seven inspectors monitoring the compounders, both traditional and mass-producing.
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