Bill to Regulate Compounding Pharmacies, Prevent Outbreaks like Last Year’s Meningitis, Passes House and Senate Unopposed
A new piece of legislation, which began forming last year just weeks after the horror of the meningitis outbreak news broke, aims to heavily regulate compounding pharmacies, which had previously flown under the radar of FDA regulations.
The bill passed the House and the Senate without opposition on Monday, November 18th, and is now moving to President Obama for final approval.
Although the bill does not give complete authority to the FDA to regulate compounding pharmacies, which tailor-mix drugs for individual patients and occasionally mix large batches for hospitals with barely-legal excuses, the bill does provide significant new safeguards to help prevent another tragedy, like the national meningitis outbreak last year which began at the New England Compounding Center, or NECC.
“It has very sharp teeth,” said Sarah Sellers, a drug safety consultant who has tracked the issue for years.
“This bill will improve oversight of high-risk drug compounding,” said Senator Tom Harkin, Democrat of Iowa, who was one of the authors.
The outbreak of fungal meningitis was tied directly to the NECC, which, like many compounding pharmacies, had been skirting the law by making large, unregulated batches of drugs. The Centers for Disease Control found that injectable steroids at the compounding pharmacy were visibly tainted – investigations found that the Massachusetts-based company was not leaving enough time for proper sterilization of their products – the investigators found “dirty mats and hoods, a leaky boiler, dark debris floating in vials of medicine.” The steroids, made to be injected into the spine, caused non-contagious fungal meningitis that sickened 751 people across the US, and eventually killed 64 patients.
Originally, compounding pharmacies were subject to state regulations, but federal agencies like the FDA, CDC, and USDA had almost no control over them. They were not subject to requirements to report problems with illnesses, unlike other pharmaceutical manufacturers.
The new bill – the Drug Quality and Security Act – would require compounding pharmacies that wished to produce large batches of drugs for mass consumption to register with the FDA, like other pharmaceutical manufacturers, so they would be subject to the same sort of inspections and oversight. Compounding pharmacies that did not wish to make this change would be unable to make large batches of drugs, and would be required to stick to the original definition of “compounding,” meaning they would tailor-make drugs for specific prescriptions. Although these compounding pharmacies would not be required to meet traditional FDA drug regulations, they would be required to open their books to the FDA when the agency received complaints.
“Hospitals and doctors would have to seriously consider the implications of buying from a facility that does not meet those quality standards,” said Allan Coukell, senior director of drugs and medical devices at the Pew Charitable Trusts. “This doesn’t necessarily preclude the risky practices we’ve seen in recent years. But it’s a big improvement.”
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If you or a loved one have been injured, harmed, or killed by a medical product such as a drug or device, from medical device manufacturers or compounding pharmacies, you may be entitled to file a personal injury lawsuit. Defective medical devices and dangerous drugs can hurt you to such a great extent that you are unable to work, with mounting medical bills The attorneys at the Strom Law Firm can help get you the compensation you deserve, to get you through these tough times. We are licensed to practice across South Carolina, Georgia, and New York. To help you with your case, we offer free, confidential consultations. Do not hesitate to contact us. 803.252.4800