• Regulatory NewsRegulatory News

    FDA Considers Compounding Restrictions on Four Drugs, Including Acetaminophen

    The US Food and Drug Administration (FDA) is preparing to ask one of its newest advisory committees to decide if some compounding pharmacies should be allowed to make four drugs, including the widely used painkiller acetaminophen. Background The advisory committee, known as the Pharmacy Compounding Advisory Committee (PCAC) , was re-created under a piece of 2013 legislation known as the  Drug Quality and Security Act (DQSA) . The law, passed in the wake of a major drug...
  • Regulatory NewsRegulatory News

    FDA Committee Prepares to Decide if Six Drugs Can be Made by Compounding Pharmacies

    The US Food and Drug Administration (FDA) has announced it will soon hold the first meeting of a new and influential advisory committee that is set to make recommendations about which drugs will not be allowed to be made by compounding pharmacies in the US. Background The advisory committee, known as the Pharmacy Compounding Advisory Committee (PCAC), was re-created under a piece of 2013 legislation known as the Drug Quality and Security Act (DQSA) . The law, passed in...
  • 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...