New Drug Safety Regulations Signed into Law…but They’ll Take 10 Years to Implement

Friday, December 06, 2013
(photo: Minnesota Department of Health/AP)

The latest attempt by the federal government to improve drug safety involving pharmacies and manufacturers will take a decade to fully implement. Also, some of the key provisions are strictly voluntary on the part of industry.


Crafted by the Food and Drug Administration (FDA) and signed into law by President Barack Obama last week, the new rules were prompted by the tragedy involving a Massachusetts compounding pharmacy that killed 64 people who developed fungal meningitis from tainted medication.


One new regulation will kick in within four years: the requirement that drug companies and manufacturers that repackage medications attach “unique product identification information to each package of most prescription drugs,” Kay Lazar wrote for the Boston Globe.


Within six years, wholesale drug distributors and pharmacies will be required to sell only products that contain the unique product identification information.


But it will take 10 years for the FDA to develop an electronic tracking system that allows regulators to trace the production and sale of each prescription drug covered under the law and allow the agency to recall dangerous products more efficiently.


“We have a lot of work to do now,” FDA Commissioner Margaret Hamburg told reporters.


In addition, new rules aimed at better regulating compounding pharmacies, like the New England Compounding Center in Framingham that went out of business after making tainted steroids, are not mandatory. Instead, the FDA hopes these businesses voluntarily comply.


Also, not all prescription drugs are covered by the law. A number of them, such as certain blood products and homeopathic medicines, are exempted.

-Noel Brinkerhoff


To Learn More:

Long Phase-In for Drug Safety Law (by Kay Lazar, Boston Globe)

Failure to Regulate Leads to Deadly Outbreak of Meningitis (by Noel Brinkerhoff, AllGov)


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