 
Modification to FDA’s Opioid Analgesic Risk Evaluation and Mitigation Strategy Is Fully Implemented
In October 2024, the U.S. Food and Drug Administration (FDA) approved a modification to the Opioid Analgesic (OA) Risk Evaluation and Mitigation Strategy (REMS) stating that participating companies must begin providing prepaid mail-back envelopes (MBEs) upon request to outpatient pharmacies and other opioid analgesic dispensers.
As of March 31, 2025, this program is fully implemented. Pharmacies and other opioid analgesic dispensers can order MBEs from the OA REMS manufacturers at no cost. Prescribers and other health care professionals can learn more, including information on how to order prepaid MBEs, by visiting the OA REMS website.
FDA intends for pharmacies and other dispensers to provide these free, prepaid MBEs to patients and caregivers. This REMS modification does not prohibit pharmacies and other dispensers of opioid analgesics to offer other disposal options to patients.
Other changes to the OA REMS include:
- Updates to the Patient Guide to include information about the risk of unused opioid analgesics and the importance of safe disposal;
- A new Patient Education Sheet explaining the risk of unused opioid analgesics and the importance of safe disposal to be included with each prepaid drug MBE.
The OA REMS modification followed several agency actions related to FDA requiring an OA REMS modification, namely an April 2022 Federal Register notice seeking public comment on the potential OA REMS modification; an April 2023 letter FDA sent to manufacturers of opioid analgesics used in outpatient settings informing them that they were required to submit a proposed modification to the OA REMS within 180 days of the notice date; FDA’s participation in the National Academies of Sciences, Engineering, and Medicine’s June 2023 public workshop evaluating in-home drug disposal options; publishing an updated version of FDA’s Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (FDA Blueprint) in November 2023; and awarding a grant through the University of Maryland to study commercial in-home disposal products in June 2024.
More information about safe disposal of medicines is available here.
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