The affected opioid drugs include long-acting and extended-release brand name and generic products and are formulated with the active ingredients
fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone.
Under the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85), FDA has the authority to require persons submitting certain drug approval applications to submit a proposed REMS as part of the application.