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Senate Passes Legislation regarding Compounding Pharmacy Legislation

Written by Ankin Law Office

A new law designed to enhance drug safety is one step closer to fruition. On November 18, the Senate voted to pass a bill to increase federal oversight of compounding pharmacies and establish a national prescription drug tracking system. With the Senate’s approval, the bill moves on to the President’s desk for signing. The bill had previously passed the House in September.

Health advocates have commended lawmakers for passing the law, which is a significant step toward improving the safety and security of the nation’s drug supply. According to an article at Politico, the new law – called the Drug Quality and Safety Act – encourages compounding pharmacies to register for Food and Drug Administration (FDA) regulation. Although registration is not mandatory, FDA registration is expected to increase a compounding pharmacy’s credibility in the marketplace since hospitals, doctors, and other healthcare providers want to be certain that they are purchasing quality drugs.

The law will also require a federal prescription drug track-and-trace system whereby drugs can be tracked through the entire supply chain – from drug manufacturer to pharmacy – in an effort to prevent counterfeit or contaminated drugs from entering the market and to facilitate more timely product recalls.

The legislation was prompted by last year’s meningitis outbreak caused by contaminated steroid shots  produced by New England Compounding Pharmacy (NECC), in which 64 people died and more than 750 became ill. Following the NECC meningitis outbreak, two other compounding pharmacies – Clinical Specialties and Med Prep Consulting – recalled certain drugs amidst safety concerns.

As we reported earlier this year, inspections by federal health officials found dozens of potentially dangerous safety problems at 30 specialized pharmacies. According to officials for the FDA, the inspections show that compounding pharmacies are failing to ensure the safety of their products in many cases. During the inspections, FDA officials found “black particles of unknown origin” in vials of an injectable medicine, rust and mold in “clean rooms,” inadequate microbial testing, and tears in gloves worn by technicians — all of which could result in potentially fatal drug contaminations.

The Chicago unsafe pharmaceutical attorneys at Ankin Law Offices, LLC are committed to protecting the public from dangerous pharmaceuticals. If you have been injured by the meningitis outbreak or another unsafe pharmaceutical, contact the skilled Chicago unsafe pharmaceutical drug law firm of Ankin Law Offices, LLC at (312) 600-0000 to discuss a possible personal injury or product liability lawsuit.

Categories: Product Liability