• Regulatory NewsRegulatory News

    FDA Singles Out 9 More Drug Substances Not for Compounding

    Following a court win late last month to keep one such drug substance out of the hands of compounders, the US Food and Drug Administration (FDA) pointed to nine more bulk drug substances for which it has concluded that there is no clinical need for outsourcing facilities to compound them. For the nominated substances — dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue...
  • Regulatory NewsRegulatory News

    GAO Survey of State Regulation of Drug Compounding Offers Mixed Results

    Among the local drug compounding regulators for 50 states, Washington, DC, Guam, Puerto and the US Virgin Islands, many say they are working with and appreciate the help of the US Food and Drug Administration (FDA), but only seven out of 50 respondents could differentiate all data on drug compounding for human use versus animal use. Building on a 2016 report , the new survey  results released by the US Government Accountability Office on Friday on the state regulatio...
  • 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 ...
  • 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 ...
  • Meningitis Outbreak Places Spotlight on FDA's Regulation of Compounding Pharmacies

    The US Food and Drug Administration's (FDA) regulation of compounding pharmacies has come under fire in the wake of a drug safety problem involving steroid injection shots infected with the meningitis virus. The tainted drugs, traced back to a Massachusetts pharmacy, have already been implicated in five deaths and 35 cases across 23 states-a number officials said is likely to rise in light of the scope of the drug's distribution. But almost as much as the crisis itself,...
  • FDA Maintains Compounding Exemption for KV Pharmaceuticals' Makena

    The US Food and Drug Administration (FDA) has announced the results of an investigation into compounded versions of KV Pharmaceutical's Makena (hydroxyprogesterone caproate), used to prevent pre-term births, which the company alleged were compounded to a lesser standard than allowed under the company's approved New Drug Application (NDA). The agency said in a statement it would continue to allow compounding of the drug after its investigation yielded no significant concer...