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# Guidance on Generic Abuse-Deterrent Opioids
- URL: https://www.fdaweb.com/guidance-on-generic-abuse-deterrent-opioids/
- Published: 2016-03-24T12:00:00.000Z
- Updated: 2026-09-14T20:51:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135175

> FDA has issued a draft guidance, *General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products*, to assist potential applicants to develop and submit an ANDA for a generic version of a solid oral opioid drug product that has the potential for abuse and which references an opioid drug product with abuse-deterrent properties described in its labeling. An agency [statement](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm492237.htm?ref=fdaweb.com) (includes link to guidance text) says that the document includes recommendations about studies, including comparative *in vitro* studies, that should be conducted to demonstrate that a generic opioid is no less abuse-deterrent than the innovator product across all potential routes of abuse, including mechanical manipulation, injection, ingestion, insufflation, and smoking.  
>  
> A public meeting will be held later this year, FDA says, to discuss the draft guidance on generic abuse-deterrent formulation products and a broad range of issues related to using abuse-deterrent technology as one tool to reduce prescription opioid abuse. The agency says it will consider feedback from that meeting in finalizing the guidance.