Implementation Timeline For Opioid REMS And National Rx Abuse Plan

Date	Action
Aug. 16, 2011	Deadline for affected companies to respond with proposed REMS program.
Early 2012	FDA expects to have all REMS programs approved and all materials agreed upon.
April 2012	Goal for REMS to be fully implemented.
Mid-2012	First opioid REMS assessment is due.
Early 2013	Second opioid assessment due (and annually thereafter).
April 2013	Goal to issue guidance on abuse-deterrent drug formulations and post-market performance assessments.
	Goal for passage of legislation requiring prescriber opioid training as part of DEA registration.
April 2014	Goal to have legislation passed in all states establishing prescription drug monitoring programs.