Bill > HR5687

This bill, the Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 (SOUND Disposal and Packaging Act), amends the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration (FDA) to require certain packaging and disposal technologies, controls, or measures to help mitigate the risk of abuse or misuse of drugs, particularly opioids. The bill allows the FDA to issue orders requiring drug manufacturers to implement or modify packaging or disposal methods for their products, as long as the requirements are commensurate with the specific risk and not unduly burdensome on patient access. The bill also sets timelines for manufacturers to comply with such orders and allows them to propose alternative measures if supported by data. Additionally, the bill requires certain information to be included in abbreviated new drug applications for opioids, and provides rules of construction to clarify how the new requirements interact with existing drug approval processes.

Business and Industry, Health and Social Services

https://www.congress.gov/bill/115th-congress/house-bill/5687/all-info