New Study Highlights Key Quality Standards for Large-Scale Sterile Compounding

A new study comparing safety measures used by pharmaceutical manufacturing facilities with those used by compounding facilities highlights the quality standards that are needed by all compounding facilities, including those engaged in large-scale compounding. Quality Standards for Large-Scale Sterile Compounding Facilities (PDF), authored by Clinical IQ, LLC, and commissioned by Pew Charitable Trusts, provides information about the changes in scope and magnitude of sterile drug compounding from the 1980s to the present. The study also provides information for stakeholders and regulators on important quality standards needed to ensure safety in large-scale compounding facilities, and on Title I of the Drug Quality and Security Act, which establishes the new category of “outsourcing facility” for large-scale compounding operations and requires these entities to be regulated by Food and Drug Administration (FDA).