It will take 10 years to fully phase in a new law intended to better protect consumers from counterfeit, stolen, contaminated or otherwise harmful prescription drugs, like the tainted pain medications from a Massachusetts pharmacy that killed 64 people in a national fungal meningitis outbreak, federal regulators said Monday.
Under a time frame outlined by US Food and Drug Administration Commissioner Margaret Hamburg, manufacturers and companies that repackage medications will be required within four years to attach unique product identification information to each package of most prescription drugs. The information will include the lot number and its expiration date.
Within six years, wholesale drug distributors, followed by companies that dispense drugs, such as pharmacies, will be required to sell only products that contain the unique product identification information.
However the law, signed by President Obama last week, exempts a number of prescription drugs, such as certain blood products and homeopathic drugs.
Within a decade, the FDA anticipates a fully functioning electronic tracking system that will be able to trace the production and sale of each prescription drug covered under the law, and allow regulators to more efficiently recall harmful products.
“We have a lot of work to do now,” Hamburg said during a conference call with reporters.
Key provisions aimed at compounding pharmacies, like the now-closed New England Compounding Center in Framingham that made tainted steroids, depend on them voluntarily submitting to enhanced regulation from the FDA by registering as “outsourcing facilities.”
More than 750 people in 20 states were sickened by the steroids, including the 64 who died, according to regulators. Critics are skeptical that the law would prevent another public health tragedy similar to that outbreak.
Compounding companies typically have custom-mixed small batches of medicines for individual patients who can’t take over-the-counter medications, and these operations have been regulated and inspected at the state level.
But in recent years, large-volume compounding pharmacies, like New England Compounding, have sprung up, operating more like manufacturers that are supposed to be regulated by the FDA. Jurisdiction over these large-volume compounding companies has been murky, and the new law was intended to address this void.
Hamburg acknowledged that the voluntary nature of the law will make it difficult for her agency to track the quality of medicines made by compounding pharmacies that choose not to register for oversight.
“There does remain some uncertainty if a company chooses not to register with us,” she said.
Hamburg said she believes market pressures will encourage many compounding companies to eventually register with her agency.
“We certainly plan to talk to all the various stakeholders and organizations that are involved in our health care system about this new program so they can understand the benefits of an FDA-reviewed product,” she said.
Regulators said they didn’t know how many larger compounding companies existed in the United States that would fall under the new category of outsourcing facilities.
“The statistics are not very good,” said Jane Axelrad, as associate director in the FDA’s Center for Drug Evaluation and Research. “From conversations we have had ... the rough estimate is 700 to 1,000.”