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  • Regulatory NewsRegulatory News

    FDA Appoints Members to New, Influential Advisory Committee

    Almost a year after announcing the re-creation of its Pharmacy Compounding Advisory Committee (PCAC), the US Food and Drug Administration (FDA) has announced that it has selected 12 experts who will serve on the influential committee as it considers how best to regulate the pharmaceutical compounding sector. Background The re-creation of the PCAC was called for under the Drug Quality and Security Act (DQSA) , which sought to update the way in which FDA regulated p...
  • Regulatory NewsRegulatory News

    In FDA Effort to Strengthen Regulation of Compounded Drugs, Protections and Profits Intersect

    A new law meant to protect consumers from unsafe pharmaceutical compounding practices is drawing interest from pharmaceutical companies, who are petitioning the US Food and Drug Administration (FDA) to add some of their products to a new list of restricted drugs that could protect patients from deficient drugs—and likely companies from compounded competition as well. Background The Drug Quality and Security Act (DQSA) of 2013 was passed into law in the wake of a massi...
  • As Compounding Framework Takes Shape, So Does Influential Advisory Committee

    The US Food and Drug Administration (FDA) has announced the formation of an eagerly awaited advisory committee set to offer critical input in deciding which drug products will no longer be allowed to be compounded under the terms of a recent piece of legislation. Background That legislation, the Drug Quality and Security Act ( DQSA ) , was passed into law on 27 November 2013, and contained numerous provisions intended to regulate pharmaceutical products produced by...
  • FDA Prepares Compounding Blacklist of Banned Products

    The US Food and Drug Administration (FDA) is calling for help in compiling a blacklist of sorts of drugs that should not be permitted to be compounded under the terms of the just-passed Drug Quality and Security Act ( DQSA ) of 2013. Among the law's many provisions is one that allows FDA to establish a list of products that no federally regulated compounded pharmacy-also known as "outsourcing facilities"-can manufacture by virtue of their complexity. Edit: Per FD...