• Regulatory NewsRegulatory News

    Drug Compounding With Bulk Substances: FDA Offers Interim Policies

    The US Food and Drug Administration (FDA) late Friday issued revised versions of two final guidance documents explaining the use of bulk drug substances in compounding and clarifying that the agency does not intend to take action against certain outsourcing facilities and compounded drugs. The policies also clarify that the two guidance documents do not apply to inactive ingredients, which can be used in compounding without appearing on the bulk drug substances lists dev...
  • 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...
  • FDA Guidance Sets up User Fee System for Pharmaceutical Compounders

    The US Food and Drug Administration (FDA) has published a new guidance document intended to establish user fees to fund its inspections of a new category of compounding pharmacy established under the Drug Quality and Security Act (DQSA) of 2013. Background In late 2012, a massive outbreak of fungal meningitis was traced to deficient manufacturing at a Massachusetts compounding pharmacy. In the wake of the outbreak, which killed more than 60 and left hundreds more inju...