• Sterility Issues Found at Second Compounder as FDA Anticipates New Drug Shortages

    Officials with the US Food and Drug Administration (FDA) have announced the voluntary recall of all products made by Ameridose, a pharmaceutical compounder whose sister company is linked with a massive outbreak of fungal meningitis , as well as the possibility that the massive recall could lead to new shortages of pharmaceutical products. According to Ameridose , FDA had informed it that it would be, "Seeking improvements in Ameridose's sterility testing process." The ...
  • Troubling Sterility Lapses Found at Compounding Facility

    The US Food and Drug Administration (FDA) has identified a number of troubling lapses in good manufacturing practices at the New England Compounding Center ( NECC ), the Massachusetts-based pharmaceutical compounding facility now linked to a massive outbreak of fungal meningitis, after an inspection revealed widespread and unaddressed sterility problems. Regulators released a Form 483 , a form FDA uses to list potential violations of the Federal Food, Drug and Cosmet...
  • State and Local Officials Launch Criminal Probe of Compounder as FDA Criticized

    The US Food and Drug Administration (FDA) continues to grapple with problems stemming from an outbreak of fungal meningitis caused by tainted steroid injections manufactured by the Massachusetts-based New England Compounding Center (NECC). The saga is now moving steadily into an investigative stage, with state and federal officials announcing the launch of a criminal probe, legislators calling for a government investigation into the compounding sector, and outside groups ...
  • Analysis: Compounding Crisis Leaves Regulators With Few Good Options

    Extensive problems with a compounding pharmacy in Massachusetts have left US regulators in a complicated bind: They can err on the side of caution and shut down the company's sister organization until it receives regulatory approval, but doing so would likely exacerbate drug shortages already near record highs thanks to similar shutdowns related to regulatory deficiencies in larger pharmaceutical establishments. The owners of the New England Compounding Center (NECC), th...
  • Congressional Investigators Ramp up Pressure on FDA over Meningitis Outbreak

    What did the US Food and Drug Administration (FDA) know, and when did it know it? That's the question being asked of agency officials this week as legislators with the House Energy and Commerce (E&C) Committee sent FDA a letter asking for all details regarding its oversight of a compounding pharmacy. The E&C Committee is in the midst of investigating the New England Compounding Center, which has been linked to a massive outbreak of meningitis that has thus fa...
  • FDA Raids Compounding Facility Linked to Meningitis Outbreak

    Criminal investigators from the US Food and Drug Administration (FDA) have raided the New England Compounding Center (NECC), the facility linked with supplying tainted injectable steroid products that have infected hundreds with a dangerous form of fungal meningitis that has already claimed the lives of 19. The move, made 17 October, is perhaps FDA's most forceful yet against the pharmacy. NECC has thus far been cooperating with the agency on an extensive but voluntary b...
  • Regulators Scramble to Contain Compounding Crisis as Industry Scrutinized

    • 16 October 2012
    The US Food and Drug Administration (FDA) continues to warn consumers and healthcare providers about drugs manufactured by the New England Compounding Center (NECC), saying two additional drugs could be contaminated with dangerous types of fungus. ( Regulatory Focus ) - FDA has warned of two additional drugs potentially infected with either fungal meningitis or aspergillus fumigatus , possibly widening the pool of patients affected by drugs compounded at NECC. The a...
  • FDA Identifies Two Additional Compounded Drugs as Potentially Contaminated

    The US Food and Drug Administration (FDA) issued a statement on 15 October indicating two additional products manufactured by the New England Compounding Center (NECC) could be contaminated by fungal meningitis, further exacerbating an already complex crisis. In its statement, FDA said it was aware of at least one patient potentially associated with an epidural injection of triamcinolone acetonide and two transplant patients who received a cardioplegic solution who hav...
  • Compounding Crisis Continues as Reports Raise Questions of Quality

    • 15 October 2012
    US regulators continue to scramble to understand the extent of a meningitis outbreak linked to a compounding pharmacy in Massachusetts as the death and infection count continue to rise day by day-an unfortunate side effect of a disease with an incubation period that can last months. ( Reuters ) - The Centers for Disease Control and Prevention has confirmed more than 15 deaths and 200 cases of meningitis from steroid injections manufactured by the New England Compounding ...
  • House Democrats Take Aim at FDA, Call for Agency to Release Information

    The US Food and Drug Administration (FDA) is increasingly finding itself at the center of a burgeoning crisis involving steroid injections compounded by a Massachusetts pharmacy that have so far killed 12 and sickened dozens with meningitis. Two prominent members of the US House of Representative's Energy and Commerce Committee-the House's legislative vehicle for overseeing FDA and the pharmaceutical industry-have aimed their sights squarely on FDA, calling on the agen...
  • As Compounding Crisis Widens, Legislators Propose Regulatory Fixes

    US legislators are scrambling to get to the bottom of a burgeoning crisis involving products compounded at a Massachusetts pharmaceutical compounder's facility that have thus far killed 11 people and infected more than 100, announcing hearings and new legislation meant to plug oversight gaps in the regulatory system. In a 9 October announcement , the House Energy and Commerce Committee said it had requested briefings from both the US Food and Drug Administration (FDA) a...
  • In Wake of Meningitis Outbreak, Senator Calls for New FDA Authority to Regulate

    In the wake of a widespread outbreak of meningitis, at least one US senator is calling for new authority to be given to the US Food and Drug Administration (FDA) to make its authority to oversee compounding pharmacies clearer and more robust. In remarks reported by CBS New York , Sen. Richard Blumenthal (D-CT) said he remained concerned that FDA did not have sufficient authority to investigate compounders. "We need to bolster the authority of the FDA and make sure ...