FDA approves REMS, advancing new drug disposal option for opioid analgesics

The US Food and Drug Administration (FDA) has announced 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, the 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: