October 14, 2022

Legal settlement spurs FDA to develop 503B bulks list

The Outsourcing Facilities Association announced this week that it reached a settlement agreement with the FDA that will spur the agency to promptly review long-pending nominations for active pharmaceutical ingredients for use by FDA-registered 503B outsourcing facilities to compound drugs needed by patients.

OFA says the settlement of an OFA-supported lawsuit will allow 503B facilities to improve health care provider and patient access to certain medications and to ease drug shortages in a timely manner.