• Legislators Threaten to Subpoena FDA over Requested Documents

    US regulators are coming under renewed scrutiny regarding their oversight of pharmaceutical compounders, with House legislators threatening to subpoena the US Food and Drug Administration for what they allege is a failure to provide relevant documents to the Energy and Commerce Committee despite repeated requests. Background In 2012, a rash of drug shortages caused an increase in the number of entities looking to utilize the services of pharmaceutical compounders, which...
  • Hamburg Calls for New Regulatory Authority in Wake of Compounding Scandal

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has called upon Congress to grant the agency new authorities to regulate and oversee pharmaceutical compounders with the help of a new regulatory paradigm, according to testimony scheduled to be delivered before a House subcommittee. Hamburg is scheduled to appear at a 10 a.m. hearing before the House Energy and Commerce committee to discuss FDA's response to the meningitis outbreak which has resulted ...
  • FDA Inspectors Find Insects, Animal, Contamination at Compounding Facility

    Inspectors with the US Food and Drug Administration (FDA) have found microbial contamination, unevaluated adverse event reports, ongoing water leaks, contaminated hoods, multi-colored residues, insects and at least one bird in a compounding pharmacy owned by the same company now associated with a massive outbreak of fungal meningitis. The observations-made in a FDA Form 483 inspection report of compounder Ameridose's Westborough, MA facility-closely track a 483 release...
  • 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 ...