RAPS: FDA Releases Long-Awaited Policies on Regulation of Pharmaceutical Compounders

The US Food and Drug Administration (FDA) has announced the release of four guidance documents intended to help increase regulatory oversight of the pharmaceutical compounding industry. The documents come nearly three years after an outbreak of fungal meningitis was linked back to drug products compounded by the New England Compounding Center (NECC). In the aftermath of that outbreak, legislators passed the Drug Quality and Safety Act (DQSA), which clarified FDA\'s authority to oversee compounding pharmacies. The law established a two-part system of compounding oversight. Some compounding pharmacies—referred to as 503A compounders—would continue to be overseen by state regulators, but would be subject to several manufacturing restrictions. Other compounding pharmacies—known as \"outsourcing facilities,\" of 503B compounders—would need to register with FDA and be subject to federal inspections.