“For purposes of this guidance, abuse-deterrent properties are defined as those properties shown to meaningfully deter abuse, even if they do not fully prevent abuse. The term abuse is defined as the intentional, non-therapeutic use of a drug product or substance, even once, to achieve a desirable psychological or physiological effect. Abuse is not the same as misuse, which refers to the intentional therapeutic use of a drug product in an inappropriate way and specifically excludes the definition of abuse. This guidance uses the term abuse-deterrent rather than tamper-resistant because the latter term refers to, or is used in connection with, packaging requirements applicable to certain classes of drugs, devices and cosmetics.”

Source: April 2015 final guidance, Abuse-Deterrent Opioids – Evaluation and Labeling

‘Abuse-Deterrent’ Opioids May Be Headed For A Terminology Change

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