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# Opioid REMS to Require Mail-Back Envelopes
- URL: https://www.fdaweb.com/opioid-rems-to-require-mail-back-envelopes/
- Published: 2024-11-01T12:00:00.000Z
- Updated: 2026-09-14T14:46:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158105

FDA has approved a modification to the opioid analgesic risk evaluation and mitigation strategy (OA REMS) to require manufacturers of such products that are dispensed in outpatient settings to provide pre-paid drug mail-back envelopes (MBEs) upon request to pharmacies and other opioid dispensers. “The manufacturers have developed a Patient Education Sheet for patients on [safe disposal](https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know?ref=fdaweb.com) of opioid analgesics, which is included with each MBE, and an updated patient guide that health care providers can use to counsel patients on the options for safe disposal of unused opioid analgesics,” an [agency notice](https://lnks.gd/l/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDMsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvZHJ1Z3MvZHJ1Zy1zYWZldHktYW5kLWF2YWlsYWJpbGl0eS9mZGEtYXBwcm92ZXMtcmVtcy1tb2RpZmljYXRpb24tYWR2YW5jaW5nLW5ldy1kcnVnLWRpc3Bvc2FsLW9wdGlvbj91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkiLCJidWxsZXRpbl9pZCI6IjIwMjQxMDMxLjI3MTkzMDEifQ.wxypzidRywGPAC9mWN%5FpyIfmESW7kkkwxwIF%5FCLddMA/s/2961292317/br/252127092081-l?ref=fdaweb.com) says. MBE ordering is expected to become available by 3/31/2025.

The OA REMS became effective in 2018 to ensure that the benefits of the drugs continue to outweigh the risks. It is one strategy among multiple national and state efforts to reduce the risk of abuse, misuse, addiction, overdose, and deaths from opioid products, the agency says.