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Possible Enactment of Bill to Regulate Bulk Drug Compounding

Christine Eke3 years ago

Reuters reports that the U.S. Senate has approved a bill known as the Drug Quality and Security Act that the House of Representatives has already passed and President Obama is expected to sign into law.

The bill is designed to prevent quality control problems and prevent future deadly outbreaks like what happened last year where fungal meningitis contaminated pharmaceuticals from a Massachusetts pharmacy.

What the Drug Quality and Security Act Entails

  • The bill will create a new category of compounding pharmacies known as “outsourcing facilities” and create a national set of standards to track pharmaceuticals through the distribution chain to help prevent the introduction of fake medications into the drug supply.
  • Traditionally, pharmacists who compound medications mix tailore d doses for individual patients in response to a specific prescription; that practice has ballooned, and some pharmacies sell thousands of doses of regularly used mixtures without prescriptions for physicians to keep for future use.
  • The “outsourcing facilities” will be able to sell to hospitals in bulk; they can choose to register with the U.S. Food and Drug Adminitration (FDA), where they will undergo regular inspections and will be subjected to tighter quality controls.
  • Lawmakers expect that hospitals will prefer to buy from facilities regulated by the FDA as to encourage registration.
  • This bill is to be the nationwide standard to address conflicts with states’ regulations.

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If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.


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