Comment Deadline: FDA Packaging, Storage, and Disposal Options To Enhance Opioid Safety—Exploring the Path Forward
The Food and Drug Administration (FDA) is soliciting public comments for the previously-held public workshop entitled “Packaging, Storage, and Disposal Options To Enhance Opioid Safety—Exploring the Path Forward.” The purpose of this workshop is to host a scientific discussion with experts and seek input from interested stakeholders regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products (opioids); guiding principles and considerations for the design of packaging, storage, and disposal options for opioids; integrating packaging, storage, and disposal options into existing health care and pharmacy systems, including both open and closed health care systems (e.g., a closed system such as the U.S. Department of Veterans Affairs); data needs and how to address challenges in assessing the impact of packaging, storage, and disposal options in both the premarket and postmarket settings; and ways in which FDA could encourage the development and assessment of packaging, storage, and disposal options for opioids that have the potential to enhance opioid safety.
The original comment deadline of February 12, 2018, was extended on that same date to March 16, 2018 (83 FR 6030). Members of the public may submit comments at Regulations.gov or via the Postal Service. More information is available via the Federal Register notice.