Butrans (Buprenorphine) is a Schedule III Controlled Substance
Butrans (buprenorphine) is classified as a Schedule III controlled substance in the United States. 1
Classification Details and Implications
Buprenorphine is a semisynthetic opioid that functions as a partial agonist at μ-opioid receptors. Despite being 25-50 times more potent than morphine, its partial agonist properties give it a more favorable safety profile compared to full μ-opioid agonists 2, 3.
The Schedule III classification has several important clinical implications:
- Lower abuse potential than Schedule II opioids (like morphine, oxycodone, or methadone)
- Subject to fewer prescribing restrictions than Schedule II medications
- Refills are permitted (up to 5 refills in 6 months)
- Prescriptions can be called in to pharmacies
Regulatory Framework
The Drug Addiction Treatment Act of 2000 created special provisions for buprenorphine when used for opioid use disorder (OUD) treatment:
- Physicians need a special waiver (commonly called an "X-waiver") to prescribe buprenorphine for OUD treatment 1
- Without this waiver, physicians may only administer (not prescribe) buprenorphine for acute opioid withdrawal under specific conditions:
- Maximum one day's medication at a time
- Treatment limited to 72 hours
- Cannot be renewed or extended 1
Available Formulations
Buprenorphine is available in multiple formulations:
- Transdermal patches (Butrans) for chronic pain management 4
- Sublingual tablets/films (Subutex, Suboxone) for OUD treatment 5
- Injectable formulations for pain management 6
Clinical Considerations
When prescribing Butrans (transdermal buprenorphine), be aware that:
- It's indicated for moderate to severe chronic pain 4
- Its pharmacokinetic properties allow for use in patients with renal or hepatic impairment, though monitoring is recommended 2
- As a Schedule III substance, it must be stored in a locked cabinet according to federal and state controlled substance requirements 7
- Any unused or expired medication must be properly disposed of through appropriate channels 7
Potential Pitfalls and Precautions
- Avoid concurrent use with benzodiazepines due to increased risk of respiratory depression 8
- Monitor for cardiovascular effects, particularly in patients with pre-existing conditions 8
- Be aware that naloxone may have delayed onset when reversing buprenorphine-induced respiratory depression 7
- Implement structured prescribing practices to minimize potential for misuse 8
Buprenorphine's unique pharmacological profile makes it valuable both for pain management and OUD treatment, with its Schedule III classification reflecting its lower (but still present) abuse potential compared to Schedule II opioids.