Suboxone DEA Schedule Classification
Suboxone (buprenorphine/naloxone combination) is classified as a Schedule III controlled substance in the United States. 1
Regulatory Classification Details
- Buprenorphine as a single agent is Schedule III 1
- Suboxone (the buprenorphine/naloxone combination product) maintains the same Schedule III classification 1
- This classification was established under the Comprehensive Drug Abuse Prevention and Control Act of 1970 and is determined by the Drug Enforcement Administration 1
Clinical Implications of Schedule III Status
Prescribing for pain management follows standard controlled substance protocols similar to other Schedule III opioids 1
Prescribing for opioid use disorder (OUD) requires additional regulatory compliance:
- Physicians must obtain an X-waiver (DATA 2000 waiver) after completing an 8-hour training course to prescribe buprenorphine for OUD treatment beyond 72 hours 1
- Without the X-waiver, DEA-licensed physicians may only administer (not prescribe) buprenorphine in emergency settings for up to 72 hours while arranging treatment referral 1
Comparison to Other Opioid Schedules
Schedule III represents a lower abuse potential classification compared to Schedule II opioids such as:
Schedule III opioids historically included hydrocodone combination products (though these were later reclassified to Schedule II) and codeine combination products 1
Abuse and Diversion Considerations
Despite Schedule III classification, buprenorphine contains a substance with high potential for misuse and abuse that can lead to substance use disorder 2
The naloxone component in Suboxone was specifically added to reduce (but not eliminate) diversion and abuse potential by precipitating withdrawal if the medication is administered parenterally rather than sublingually as prescribed 3, 4