The Beginner's Guide to Suboxone Laws
Suboxone is a medication — containing buprenorphine and naloxone — FDA-approved for opioid use disorder (OUD). According to Harvard Health, using treatments like Suboxone for OUD can reduce the risk of fatal overdoses by as much as 50 percent.
Unfortunately, past Suboxone prescribing regulations were very strict, with up to 64% of physicians unable to prescribe Suboxone. This meant individuals who needed the drug could not get it. Addiction treatment advocates are looking to address this problem with new Suboxone laws in 2021.
This article will discuss the new suboxone laws and what they mean for you. Read on to learn more.
Is Suboxone Regulated?
Yes, the Department of Health and Human Services (HHS) and Substance Abuse and Mental Health Service Administration (SAMHSA) regulate Suboxone. Also, the Drug Enforcement Administration (DEA) oversees all Suboxone prescribers.
What DEA Schedule (Category) Does Suboxone Fall Under?
The DEA categorizes drugs into “schedules” based on their potential for dependence. These can range from I to V. Schedule III substances have a lower misuse potential than Schedule II substances but a higher abuse potential when compared to Schedule IV substances.
Suboxone, like all buprenorphine-containing medications, is a Schedule III substance. In other words, it has a low to moderate potential for dependence.
Previous Prescribing Laws in the United States
Before April 2021, prescribing laws only allowed qualified providers to prescribe Suboxone if:
They had completed eight hours of training and
Obtained a waiver from the Substance Abuse and Mental Health Services Administration.
The laws also capped the number of OUD patients a qualified professional could treat to 30 during the first year. The guidelines also required providers to refer every patient with OUD for counseling before prescribing medications.
What Are the New Suboxone Laws 2022?
The Department of Health and Human Services (HHS) introduced new prescribing guidelines in spring 2021 to adjust the Suboxone certification requirements. These differ from the old laws in two main ways:
1. Waiver For Federal Training
The Biden administration has amended buprenorphine prescribing laws to exempt qualified prescribers from federal training. This means prescribers no longer need to complete 8 hours of training.
However, providers still need to get waivers before prescribing buprenorphine products. They can obtain these by submitting notices of intent to the Substance Abuse and Mental Health Service Administration (SAMHSA). The first-year patient cap of 30 also remains in place.
2. No Counseling Requirements
Suboxone providers are now exempt from having to refer patients to counseling services before prescribing the medication.
What Do the New Suboxone Regulations Mean?
The law removes regulatory barriers that previously limited patient access to medications for OUD. Researchers expect that these changes will reduce opioid misuse, lower relapse rates, and improve patient outcomes.
Overview of 2022 Suboxone Prescribing Guidelines
Here's a rundown of how Suboxone prescribing laws stand in 2022:
Prescriptions are still only available from eligible prescribers.
Prescribers can still only treat up to 30 OUD patients at a time during the first year. Beyond this, the number expands to 100 patients.
Providers must still submit a notice of intent — with proof of DEA registration — as part of buprenorphine prescribing requirements.
It is still illegal to get Suboxone without prescriptions from certified buprenorphine prescribers.
Providers no longer have to complete eight hours of training before they can prescribe Suboxone.
Referrals to counseling services before providing a prescription are no longer necessary.
Can Any Doctor Write a Script for Suboxone?
Only qualified practitioners with DEA clearance can prescribe controlled substances such as Suboxone. These include:
Clinical nurse specialists
Certified registered nurse anesthetists
What Medications are Affected by the New Suboxone Laws In 2022?
The Suboxone laws affect any medication containing buprenorphine, such as:
Suboxone (brand name for the combination drug buprenorphine and naloxone)
Zubsolv (another brand name for buprenorphine and naloxone)
Bunavail (brand name for the combination of buprenorphine and naloxone)
Subutex (contains only buprenorphine)
Frequently Asked Questions
Is Subutex being discontinued?
No. The new Suboxone treatment guidelines do not change the production of Suboxone, Subutex, or buprenorphine.
Do these laws apply to methadone?
The new guidelines are exclusive to Schedule III, IV, and V drugs. They do not apply to methadone which is a schedule II drug.
Can I get Suboxone online?
Yes, the new guidelines still allow virtual practitioners to prescribe Suboxone.
Online Suboxone clinics — such as Confidant — have made access to Suboxone easier than ever before. This means even if you cannot travel to hospitals or residential treatment centers, you can still get Suboxone.
There's Much More to Know: Chat With One of Confidant's Online Suboxone Doctors
Don't let confusion over changing opioid use disorder guidelines stop you from getting help.
Confidant provides confidential and discreet access to a virtual Suboxone clinic accessible around the clock. Our team stays updated with the latest Suboxone prescribing information and regulations, so you have nothing to worry about.