Outsourcing Compounder Receives Warning Letter Due To Sterility ...

Inside Health Policy-1 hour ago

Another outsourcer compounding a REMS-protected opioid has been hit with an FDA Warning Letter due to issues with sterility. FDA posted this week a Warning ...

Endo Sues FDA Over 503(B) Compounding Policy

Inside Health Policy-1 hour ago

Endo Pharmaceuticals and subsidy Par Sterile Products are suing FDA to block the agency's current interim policy on compounding of bulk substances by ...