FDA: New Compounding Guidance Will Help Outsourcing And Patients

FDA released new draft guidance on Monday (Dec. 10) that agency head Scott Gottlieb and Deputy Commissioner Anna Abram say will make it more feasible for compounding pharmacies to become outsourcing facilities and ensure those facilities maintain current good manufacturing practices (CGMP). The guidance, which revises a 2014 draft guidance on the same topic, is the first in a series of steps announced Monday that are meant to ensure outsourcing facilities stay compliant with FDA safety rules. The steps include...