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Is Belbuca a controlled substance?

Medically reviewed by Judith Stewart, BPharm. Last updated on Feb 13, 2024.

Official answer


Yes. Belbuca (buprenorphine) is a schedule III controlled substance.

What is Belbuca?

Belbuca is a partial opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Belbuca is a buccal film formulation designed to allow the active ingredient buprenorphine to be absorbed through the inner lining of the cheek and into the bloodstream. Belbuca is administered every twelve hours. It is not indicated for use as an 'as-needed' analgesic.

What is a Schedule III Controlled Substance?

Drugs placed in Schedule III of the Controlled Substances Act (CSA) have a moderate potential for abuse and dependence.

Schedule III drugs have less abuse potential than Schedule II drugs (which includes most opioid analgesics).

Examples of Schedule III drugs include codeine (<90 mg per dosage unit), ketamine, anabolic steroids, testosterone, and buprenorphine.

  • Belbuca should be stored securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
  • Selling or giving Belbuca away may harm others and is against the law.

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