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Bill Improve Compounding Drug Safety Moving Congress

Legislation that would improve oversight over the country’s compounding pharmacies is currently making its way through Congress. The House of Representatives recently passed the Drug Quality and Security Act, which will now head to the Senate.

While Congress cannot seem to agree on much lately, the bill received support from both parties and has a strong chance of becoming law. The call for new regulations follows the widespread meningitis outbreak of last year in which more than 50 patients died.

“It is because of our collaborative and tireless efforts that we are near the resolution of last year’s deadly outbreak. To all the families who have lost loved ones and to those who are still suffering today, with this bill we say ‘never again,’” said sponsor Fred Upton (R-MI).

As we have previously discussed on this San Diego Injury Blog, compounding pharmacies make customized medications for specific patients in doses or forms not otherwise available. However, the industry has grown in recent years with many compounding pharmacies producing large shipments of drugs that are shipped across the country.

The Food and Drug Administration (FDA) currently lacks the authority to implement strong oversight of compounding pharmacies under current legal precedent and regulations, leaving licensing of compounding pharmacies to the states. Under the proposed bill, the FDA would be given greater authority to regulate these pharmacies, including the establishment of national standards to trace drugs through the distribution chain.