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In a worrisome press release, officials with the U.S. FDA have discovered potentially life-threatening safety issues at more than 30 specialized pharmacies across the country. The issues were uncovered after an investigation prompted by the tainted steroid medications that were found at a Massachusetts compounding pharmacy.
One frightening example was one Florida pharmacy where the FDA said it had discovered black particles in several vials of injectable medication. At another facility, inspectors found rust and mold in what were designated “clean rooms.” Still other facilities had sterilization issues or workers with tears in their gloves, all serious safety lapses that could lead to yet another deadly outbreak.
The series of inspections took place across the country over the last two or three months, the result of a major enforcement effort by the FDA that targeted small compounding pharmacies in the wake of the deadly fungal meningitis outbreak. The outbreak was caused by unsterile conditions at the New England Compounding Center and led to ore than 50 deaths and more than 700 people seriously injured.
In it’s statement, the FDA also revealed that several of the pharmacies targeted by investigators at first refused to grant access to the FDA, refusing to allow entry to their facilities or to view their records. Eventually the FDA prevailed, but the episode highlighted not only the deficiencies that exist in some operations, but the real challenge the agency must overcome at those facilities where cooperating with regulators is clearly not a priority.
Incidents involving drug recalls due to unsterile conditions have been everywhere over the past few months. Only a few weeks ago, a compounding pharmacy in New Jersey recalled its products after a nurse in a hospital discovered particles floating in bags of medication which were eventually found to be mold. A few days later, a company based in Georgia issued a recall of 60 products after patients said they began suffering eye infections after using an eye drop made by the company. Just yesterday, a company in Tennessee recalled all of its sterile products after the FDA uncovered several safety issues, including improper sanitizing procedures.
Though the recent enforcement effort by the FDA is good news, it’s hardly cause for celebration. The problems discovered are likely only the tip of the iceberg in terms of safety violations that have gone unchecked for years. Moreover, the law has a long way to go before the FDA truly has the power to effectively monitor and punish compounding pharmacies. As it stands now, state authorities license the pharmacies and serve as their primary regulators, meaning the FDA must coordinate any investigation with various state regulatory agencies, a confusing and cumbersome process in the best of circumstances.
If you, or someone you know, have any questions regarding personal injury claims, please feel free to contact the experienced personal injury attorneys and lawyers in Charlotte, North Carolina at Arnold & Smith, PLLC for a free consultation. Call at 704-370-2828.
“Meningitis Deaths Prompt FDA Crackdown on Drug Mixing,” by Anna Edney, published at Bloomberg.com.
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