New Legislation Introduced to Oversee Compounding Pharmacies

Last summer, patients who received steroid injections for back ailments began to experience meningitis and other complications in record numbers. Authorities scrambled to understand an infectious outbreak that has so far taken the lives of 53 people in more than 700 reported cases.

The steroids injected into victims in this case were compounded at the now-defunct New England Compounding Center (NECC). Investigation of those premises by the FDA found substandard conditions, including mold in and around products marketed as sterile, rooms operated with little regard for a sterile or stable environment, and other problems.

While pharmacies compound substances in response to individually issued prescriptions, compounding companies develop and market large quantities of specialized medications for use in hospitals and other outpatient agencies.

Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration (FDA), wrote a blog post where she notes similar unsanitary conditions recently found in other compounding pharmacies across the United States. In order to provide standards, oversight and regulation needed to safely operate compounding pharmacies, Ms. Hamburg called for increased legislative authority to the FDA. Consumers should be happy to know that her post led to more recalls.

In April, a draft bill was introduced in the Senate to give the FDA authority to oversee compounding pharmacies that have traditionally been regulated at the state level. Prior to the meningitis outbreak, attempts to legislate stronger authority for the FDA failed, largely due to lobbying efforts by the International Academy of Compounding Pharmacists.

With 53 people dead and hundreds more injured, something needs to be done. If you have been injured by a defective or improperly prescribed medication, obtain experienced advice from a products liability lawyer. We represent clients injured by defective products, including medications.

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