The U.S. Senate passed a bill designed to tighten government oversight of pharmacies that custom-mix prescription drugs. This comes in the wake of last year’s deadly meningitis outbreak tied to contaminated pain injections distributed by New England Compounding Center (NECC). The legislation, previously passed by the House in September, also creates a national system for tracking prescription drugs from manufacturers to retail pharmacies. President Obama promptly signed the bill into law.
Compounded medicines have been tied to contamination problems for years. But jurisdiction over them has been murky. Pharmacies are typically regulated through state boards, but the federal Food and Drug Administration (FDA) has the duty to regulate manufacturers of medicines. This new law attempts to sort out that legal gray area, which allowed NECC and other large pharmacies to avoid both state and federal regulations. Specifically, the measure clarifies when the FDA can intervene against compounding pharmacies.
Pharmacies that operate as traditional compounders, producing small batches of medications to fill doctors’ prescriptions, will continue to be regulated by state pharmacy boards under the new law. Pharmacies that expand into shipping drugs without doctors’ prescriptions can voluntarily register with the FDA and submit to federal inspections and quality standards similar to manufacturers. But the bill won’t require these large-scale compounders to register with the FDA. This is a step that the agency’s leaders have consistently said is crucial to preventing future outbreaks. Safety advocates also say the voluntary approach leaves consumers vulnerable to more rogue pharmacies like NECC, which operate like manufacturers under the guise of compounding.
The compounding industry’s chief lobbying group opposed the bill, claiming it would further complicate pharmacy regulations. Despite complaints about the bill’s shortcomings, it garnered broad support, in part because it contains a separate measure for tracking prescription drugs. The so-called “track-and-trace system” is designed to help authorities catch counterfeit or stolen drugs, which have increasingly been making their way into the U.S. supply chain from overseas.
Under the track and trace legislation, drug makers will be required to add serial numbers to all drug containers within four years. After 10 years, the industry will have to upgrade to electronic tracking codes that can be used to trace medicines from factory to pharmacy. Obviously, there was a serious problem and while the new law doesn’t appear to be perfect, I believe it’s a needed step in the right direction.
Sources: Matthew Perrone, Associated Press and the Insurance Journal
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