Under a proposed legislation announced recently, the U.S. Food and Drug Administration (FDA) would gain greater authority over compounding pharmacies. According to a Reuters news report, the proposal came from a bipartisan group of U.S. senators in the aftermath of a deadly fungal meningitis outbreak that killed 53 people across several states and made more than 700 sick. This outbreak was linked to vials of tainted steroid injections produced at the New England Compounding Center in Massachusetts.

New Rules for Compounding Pharmacies

Traditionally, compounding pharmacies that make very specific types of medications come under the purview of state health agencies and not the FDA like other large pharmaceutical companies that mass-produce drugs. However, under this legislation, a new class of drug manufacturer will be created that would then be regulated by the FDA. This category will be exempt from regulations that apply to large pharmaceutical companies.

For example, the drugs produced at the compounding pharmacies for individual patients will not need approval from the FDA and are not subject to labeling standards. But, there will be changes. These companies will no longer be registered as “pharmacies.” They would be required to register with the agency and must report any problems reported by patients or physicians with regard to their products. In addition, they must pay an annual fee to the FDA to cover inspection costs. There are about 2,800 compounding pharmacies nationwide.

Product Liability Issues

All facilities that manufacture medications have an obligation to maintain a safe and clean environment. A recent FDA sweep of a number of compounding pharmacies found dangerously unhygienic conditions at a number of these facilities, according to recent media reports. While these pharmacies do come under the purview of the states, the state departments apparently do little to regulate these facilities.

Anyone who has been seriously injured or has lost a loved one as the result of a defective drug would be well advised to contact a product liability attorney who will fight for their rights and ensure that they receive just compensation for their significant losses.