Developing Specifications for In-Home Disposal Systems for Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to solicit public comment on what specifications for in-home disposal systems, if application holders are required to make them available under the Opioid Analgesic Risk Evaluation and Mitigation Strategy, would be necessary to show that these systems may mitigate the serious risks of abuse or overdose involving these medications.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.