Good news! The FDA is interested in using opioid labels to mandate packaging standards, as well as offer claims similar to those available for abuse deterrent products.
Per Commissioner Scott Gottlieb, labeling claims describing the benefits of packaging could be connected to agency efforts to work with medical societies to create better opioid prescribing guidelines.
Package design "opens up certain possibilities about how we drive more appropriate prescribing," Gottlieb said at the beginning of a two-day meeting on opioid packaging, storage and disposal options to enhance safety. "Could we, for example, require that the immediate-release drugs be packaged in units that comport with the majority of these consensus durations?"
Stand by.
Per Commissioner Scott Gottlieb, labeling claims describing the benefits of packaging could be connected to agency efforts to work with medical societies to create better opioid prescribing guidelines.
Package design "opens up certain possibilities about how we drive more appropriate prescribing," Gottlieb said at the beginning of a two-day meeting on opioid packaging, storage and disposal options to enhance safety. "Could we, for example, require that the immediate-release drugs be packaged in units that comport with the majority of these consensus durations?"
Stand by.
