Is Suboxone® a controlled substance?

Learn about Suboxone's status as a controlled substance. Discover its schedule classification and how it impacts prescriptions and access to treatment.

Ophelia team
Suboxone packaging
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Fact checked by
Ashley Mazei, NP

Finding in-person treatment options for opioid use disorder can be challenging for many individuals due to lack of access and other concerns. Virtual clinics provide medications for addiction treatment (MAT) to overcome these hurdles, increasing access and patient retention while maintaining discreteness. A healthcare provider might recommend Suboxone® as part of a patient’s treatment plan (important safety information). In the U.S., the Drug Enforcement Administration (DEA)—a law enforcement agency overseen by the U.S. Department of Justice—regulates the use of controlled substances, including prescribed medication. If you’re wondering what a controlled substance is and what it means for a Suboxone prescription, you’re in the right place.     

What is a controlled substance?

Although certain substances can have medical and therapeutic benefits, misuse can result in dependency or harm. A “controlled substance” refers to a drug the DEA regulates to ensure it is used safely, legally, and for the intended purposes. 

Controlled substances fit into five separate “schedules” or classifications:

  • Schedule 1 drugs serve no medical purpose according to federal laws and are unsafe to use—even under supervision by a healthcare provider. The likelihood of misuse is also extremely high. Heroin, LSD, and ecstasy are a few of the substances in this classification and are typically not prescribed by medical professionals.
  • Schedule 2 substances also have a high potential for misuse, which is why they are administered under close monitoring by a healthcare provider. Methadone, oxycodone, and fentanyl are a few drugs under this classification. An "N" differentiates Schedule 2 drugs that are non-narcotic. The list of Schedule 2N substances includes amphetamines, such as Adderall®, and methylphenidate, or Ritalin®.
  • Schedule 3 substances have medical benefits, narcotic properties, and less risk of misuse when compared to Schedule 1, 2, and 2N substances. Schedule 3N drugs, such as ketamine, have non-narcotic properties.
  • Schedule 4 substances have proven medical benefits and a lower risk of misuse compared to Schedule 1–3 substances. Xanax®, Valium®, and Ambien® are included in this classification.
  • Schedule 5 substances, including Lyrica® and Robitussin® AC, have medical benefits and minimal narcotic properties. This category typically includes cough medications with limited amounts of codeine and pain relievers.

What schedule drug is Suboxone? The substance used to treat opioid use disorder is a Schedule 3 controlled substance because it contains buprenorphine, a partial opioid agonist. This is important information for patients because prescriptions in schedule classes 1, 2, and 3 have strict regulations around filling and dispensing

Pros + cons of the schedule system

The schedule system is in place to keep individuals safe by providing insight into which substances have medical benefits and whether they have the potential for misuse and dependency. Healthcare providers use the schedule system to better understand which substances can benefit or harm patients physically or psychologically.

However, the schedule system does present drawbacks for medical research on controlled substances. For example, researchers must gain permission from multiple agencies to begin research on Schedule 1 substances, starting with the DEA. This requirement under the Controlled Substances Act, established in 1970, regulates certain substances' manufacturing, use, possession, and distribution.

Researchers must also undergo an arduous approval process set by the Food and Drug Administration (FDA). It can take researchers many years before they can begin exploring the therapeutic benefits of potentially habit-forming substances. Obtaining funding through grants and ensuring academic institutions follow DEA guidelines and have approved research equipment can also add years to the process.

But there’s light at the end of the policymaking tunnel. Researchers who commit to the task of seeking approval have been able to effect change. For example, studies have shown the therapeutic benefits of marijuana, which is a Schedule 1 drug. This has led to many states decriminalizing the possession and use of the substance.

In recent years, the roadblocks to Schedule 1 substance research have eased with the support from the DEA and other regulatory agencies. The Biden-Harris administration has taken steps to cut through the red tape that makes researching controlled substances hard to achieve.  

What it means to be prescribed a controlled substance + how Ophelia helps

Those seeking a controlled substance for treatment purposes must get a prescription from a licensed healthcare provider. Buprenorphine has been a particular challenge in the past due to strict training requirements and waiver qualifications. Healthcare providers licensed by the DEA no longer need an X-waiver to prescribe buprenorphine for opioid use disorder. Buprenorphine is one of the ingredients in Suboxone, along with naloxone, an opioid antagonist that blocks the habit-forming effects of opioids and prevents overdose.

Although DEA-licensed healthcare providers are no longer required to have an X-waiver, patients who seek opioid use disorder treatment via telemedicine might still encounter roadblocks when it comes to filling prescriptions. Citing the Ryan Haight Online Pharmacy Consumer Protection Act of 2008—which limits the distribution of controlled substances via the Internet—and the expiration of the COVID-19 public health emergency that made virtual appointment rules more flexible, the DEA has proposed that telemedicine patients must complete an in-person exam to obtain a Suboxone prescription. But the agency made exceptions for patients undergoing treatment by a healthcare provider with a special registration following a public comment period that cited the success of patients receiving care through a virtual platform

There are other potential hurdles to getting prescriptions filled, including a patient’s insurance status and whether their clinician and pharmacist are communicating.

The good news is that Ophelia adheres to the proper guidelines to provide patients with the care they need. Our clinicians are DEA-licensed and state-licensed in the communities they serve patients with insurance and Medicaid, as well as those who prefer to pay for treatment out of pocket. It is important to note that frequency of use, strength of the prescription, and number of pills prescribed can affect the cost of Suboxone, so our care team gets to know your circumstances before making recommendations.

Patients have access to one-on-one virtual appointments with a dedicated care team who will tailor appointment plans based on each person’s needs. Appointments may be more frequent when adjusting to the medication and can decrease based on provider discretion. Clinicians are also available on an as-needed basis to handle questions, concerns, or any setbacks. 


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