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FDA Approves Risk Evaluation and Mitigation Strategy (REMS) Modification, Advancing New Drug Disposal Option for Opioid Analgesics

Today, the U.S. Food and Drug Administration is announcing approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS).

With this approval, companies participating in the OA REMS Program have been notified that they will be required to begin providing pre-paid drug mail-back envelopes upon request to outpatient pharmacies and other dispensers of opioid analgesics by March 31, 2025.

Once fully implemented, FDA intends for patients and caregivers to be provided a free, pre-paid drug mail-back envelope by outpatient pharmacies or other dispensers of opioid analgesics that order MBEs from the OA REMS. Other changes to the OA REMS enacted by this approval include:

• updates to the related Patient Guide to include information about the risk of unused OAs and the importance of safe disposal;
• a new Patient Education Sheet explaining the risk of unused OAs and the importance of safe disposal to be included with each pre-paid drug MBE.

Approval of this OA REMS modification is a testament to FDA’s continuing efforts and progress towards implementing the FDA Overdose Prevention Framework, which provides our vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths. As we move forward in fully executing that vision, we remain focused on responding to all facets of substance use, misuse, overdose, and death through the four priorities of the framework: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

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