The US Food and Drug Administration (FDA) has announced that opioid analgesics manufacturers are to be required to make pre-paid mail-back envelopes available to dispose of unused opioid analgesics.

It issued a notice to all opioid analgesics manufacturers to submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days of the date of the notification letter.

The regulatory authority expects to receive approval for the modified REMS next year.The new approach will allow outpatient pharmacies, as well as other dispensers, to order the mail-back envelopes from the opioid manufacturers.

The envelopes will serve as an additional opioid analgesic disposal option for patients.

The modification of the REMS also requires manufacturers to develop educational materials for patients regarding the safe disposal of opioid analgesics.

FDA noted that patients commonly report having unused opioid analgesics left over after surgery and that many Americans then gain access to these through friends or relatives.

FDA Commissioner Robert Califf said: “Expanding impactful opioid disposal options such as mail-back envelopes and in-home disposal for patients to safely and securely dispose of their unused opioid medications, is part of the agency’s comprehensive approach to addressing the overdose crisis.

“We believe these efforts will not only increase convenient disposal options for many Americans, but also reduce unfortunate opportunities for non-medical use, accidental exposure, overdose, and potential new cases of opioid use disorder.

“We’re pleased to take this first critical step to increase mail-back envelope options in partnership with the US Postal Service.”

Many mail-back envelope programmes are currently operating in the US, and mail-back envelopes are commercially available from several entities.

There is also consideration of whether opioid analgesics manufacturers need to make in-home disposal products available to patients.


This content, FDA to Require Mail-Back Envelopes for Unused Opioids Disposal, was originally shared by Pharmaceutical Technology on April 4, 2023.

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