Heads Up, Compounders!
In early August 2016, FDA issued a Guidance document for “Insanitary Conditions at Compounding Facilities” that states that under Section 501(a)(2)(A) of the FD&C Act that any drug prepared under insanitary conditions is adulterated. This document defines a drug as any compounded human or animal drugs; repackaged drug products; compounded or repackaged radiopharmaceuticals; and mixed, […]