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New Bill Gives FDA More Power To Regulate Compounding Pharmacies

History has shown time and again that under-regulated drug production can have widespread, deadly results. Victims often find little solace in government legislation that only subsequently comes into effect to prevent further harm.

Deadly meningitis outbreak blamed on faulty pharmacy

In 2012, tainted drugs that were specially mixed or “compounded” by a Massachusetts pharmacy were found to be the cause of a meningitis outbreak that killed 64 people and sickened hundreds more across the country. Instead of producing drugs that were specially mixed for individuals, as the law allowed, the company turned into a major drug producer that supplied drugs to hospitals throughout the country with little oversight from government regulators.

A federal inspection of the company found a number of violations, including greenish-yellow residue on sterilization equipment, surfaces coated with levels of mold and bacteria that exceeded the company’s own environmental limits, and an air conditioner that was shut off nightly despite the need to control temperature and humidity during the production process.

New federal legislation cracks down on negligent pharmacies

In response to the meningitis outbreak, Congress recently approved a bill that would give the federal Food and Drug Administration (FDA) more authority to monitor and police compounding pharmacies. Under the law, compounding pharmacies would be subject to a number of rules on quality control and oversight in a manner similar to large drugmakers.

The FDA said the bill showed progress but still fell short of giving the agency the necessary regulatory power it needs to properly control compounding pharmacies. For instance, the FDA said that it still will have to ask for subpoenas to gain access to company records. The agency had sought additional powers to avoid this obstacle.

The effects of tainted or otherwise defective drugs can be devastating and even deadly, and government action may come too late. To seek compensation for injuries that may have been caused by a defective drug, it is best to seek the guidance of a knowledgeable personal injury attorney.

The attorneys at Hensley Cloninger & Greer, P.C. will use their experience with personal injury claims to assist you with your claim.

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