FDA announced yesterday it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients. When implemented, outpatient pharmacies and other dispensers of opioid analgesics will have the option of ordering prepaid mail-back envelopes from opioid analgesic manufacturers for distribution to patients prescribed opioid analgesics. All manufacturers of opioid analgesics used in outpatient settings must submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days of the date of their notification letter. The agency anticipates approval of the modified REMS in 2024. The REMS modification also requires manufacturers to develop educational materials for patients on the safe disposal of opioid analgesics, which outpatient pharmacies and other dispensers may also provide to patients.
