"The Department of Health and Human Services (HHS) has stated that addressing opioid abuse is a high priority and is promoting access to medicationassisted treatment (MAT)—an approach that combines behavioral therapy and the use of medications—to combat the problem. Three medications are currently approved for use in MAT for opioid addiction—methadone, buprenorphine, and naltrexone. Methadone and buprenorphine are regulated like other controlled substances under the Controlled Substances Act (CSA) when used to treat pain and have additional requirements that apply when used to treat opioid addiction. The third medication—naltrexone—is not a controlled substance and is therefore not subject to the CSA. Methadone is a Schedule II controlled substance, which indicates a higher risk of abuse. Buprenorphine is a Schedule III controlled substance, with lower risk, and so generally has fewer requirements. For example, when used to treat pain, methadone generally may not be dispensed without a written or electronic prescription. In contrast, buprenorphine may be dispensed based on a written, electronic, or oral (phone) prescription. When used for opioid addiction treatment, the CSA and implementing regulations impose additional requirements for methadone and buprenorphine:
• Methadone may generally only be administered or dispensed within an opioid
treatment program (OTP), as prescriptions for methadone cannot be issued
when used for opioid addiction treatment.
• Buprenorphine may be administered or dispensed within an OTP and may
also be prescribed by a qualifying practitioner who has received a waiver
from the Substance Abuse and Mental Health Services Administration.
Practitioners who received this waiver are limited in the number of patients
they may treat for opioid addiction..."