Endo Sues FDA Over 503B Compounding Policy

Endo Pharmaceuticals and subsidiary Par Sterile Products are suing FDA to block the agency's current interim policy on compounding of bulk substances by outsourcers, which they argue ignores congressional intent under the Drug Quality and Security Act (DQSA) and violates drug law by allowing copies of FDA-approved drugs to be compounded in bulk while bypassing the FDA approval process “FDA has ignored that Congressional mandate for four years and has instead chosen to implement its own 'interim' bulk compounding program...