Many people struggling with treatment-resistant depression, which does not respond to at least two types of treatment, are finally experiencing relief with intravenous ketamine therapy.
Hundreds of ketamine clinics have been popping up across the country in recent years, and researchers claim infusing or injecting the drug has the potential to treat a wide range of conditions that have been difficult to manage in the past.
The treatment is still relatively new, so the legal landscape surrounding it is continuously developing. If you’re considering opening a ketamine clinic, you may be wondering how you can do so without running into legal issues. In this post, we’ll briefly discuss the legal status of ketamine under the Controlled Substances Act (CSA), including how it applies to off-label treatments.
Is Ketamine Legal?
Under the CSA, ketamine is classified as a Schedule III drug — the same classification as anabolic steroids and low-dose codeine products. Schedule III drugs have a low to moderate risk of abuse and dependence as well as approval for use in medical treatments.
It also means recreational ketamine use is illegal. Anyone who possesses and uses ketamine without a prescription will be found guilty of a felony. Penalties for violating this law typically include spending time in prison and/or paying a fine.
While ketamine has only received FDA approval for use as an intravenous anesthetic, a derivative called esketamine (brand name Spravato®) has become available as a nasal spray for treatment-resistant depression.
What About Off-Label Use?
One treatment that’s garnered a lot of interest recently is ketamine infusion therapy, which has the potential to treat a wide range of physical and mental conditions including but not limited to:
- Treatment-resistant depression
- Bipolar disorder
- Post-traumatic stress disorder (PTSD)
- Anxiety disorders
- Chronic pain
- Migraines
- Phantom limb pain
Because this treatment falls outside of the acceptable uses specified by the FDA, it is considered an “off-label” use. Off-label prescribing is extremely common in the medical field, and it’s completely legal as long as providers have a strong justification for it.
There is a bit of a risk when it comes to state medical boards, however. These entities are responsible for determining whether a provider has engaged in unprofessional conduct — which differs from state to state. Generally speaking, a provider has acted unprofessionally if the state determines they have deceived or caused harm to a patient during treatment.
Here’s where it applies to infusion therapy. If a patient experiences adverse effects following off-label ketamine treatment, the drug’s unclear legal status could be grounds for legal action. So without taking the proper steps, your state’s medical board could determine that the treatment is unethical, and you could face serious penalties.
Can I Legally Open and Operate a Ketamine Clinic?
Short answer — yes, you can run a ketamine clinic as long as your state allows it. You just need to be a licensed medical practitioner with the authority to prescribe medications. You must also be very thorough in documenting patient intake and treatment procedures.
There are currently no federal regulations governing the control and oversight of ketamine infusion clinics, so it falls to the state to regulate them. Most states permit off-label ketamine treatments in clinical settings under the supervision of a medical professional — check your state’s specific rules to make sure you can comply.
That said, anyone involved in handling, prescribing or administering ketamine must register with the DEA in accordance with Title 21 of the Code of Federal Regulations.
Providers intending to prescribe ketamine off-label must also carefully adhere to CSA guidelines for Schedule III drug use, including:
- Storage
- Security
- Distribution
- Prescription
- Inventory management
- Record keeping
- Registration
Failure to follow these guidelines can result in serious criminal penalties, though the specifics vary depending on which state you’re in.
What if I’m Not a Medical Practitioner?
Because of the strong interest in ketamine clinics, many nonphysicians are considering breaking into the industry. But this poses a bit of a problem when it comes to practice ownership.
Ketamine is a medicine, so clinics offering this treatment must comply with medical practice ownership laws. In states where traditional corporate practice of medicine (CPOM) laws apply, nonphysicians cannot be the sole owners of a medical practice.
While some states do allow nonphysicians to own clinics, they must be careful to follow their state’s other ownership laws. There are other potential alternative routes you could take, such as the management services organization (MSO) model.
An MSO business structure allows nonphysicians to legally own a company that provides administrative support to a clinic. It’s an indirect route, but it does remove some of the traditional barriers of entry to opening a clinic.
What About Online Ketamine Clinics?
In the aftermath of the pandemic, we’ve seen the rise of online ketamine clinics like Joyous and Mindbloom. Prior to the COVID-19 pandemic, these services would have been illegal due to the Ryan-Haight Act (RHA) of 2008, which barred telehealth services from prescribing any controlled substance without first conducting at least one in-person consultation.
But during the pandemic, it became clear that telehealth services made treatment more accessible, and the DEA temporarily loosened restrictions to allow telehealth providers to prescribe controlled substances for at-home use.
This exception allowed registered telehealth providers and online ketamine clinics to prescribe the drug to patients after a virtual consultation via a real-time, audio-visual communication method like Zoom. And the recently proposed DEA rules are likely to continue this practice.
How Can Clinics Legally Obtain Ketamine for Treatment?
Like with other medications, providers can purchase ketamine from pharmaceutical wholesalers. But what about importing drugs? Generally, anyone but the manufacturer may face a penalty for importing prescription drugs. This is because the government does not allow the importation or reimportation of prescription drugs that have not been evaluated by the FDA. Even if a drug containing the same active ingredients has been approved by the FDA, foreign-made versions are generally considered “unapproved” and, therefore, illegal.
The Legal Future for Ketamine Clinics
Because ketamine infusion is still developing as a therapeutic method, it’s hard to predict what the industry will look like moving forward. The treatment is seeing a boom in popularity now, but there is a chance it will fall out of favor in the near future.
It’s entirely possible that clinicians may need to continue with off-label prescriptions. If this is the case, practitioners will need to be doubly sure they do their due diligence in staying compliant with state and local regulations on ketamine.
It’s also possible that, with enough long-term evidence demonstrating the success of ketamine therapy, the FDA may approve this treatment. We’ll just have to wait and see — and we’ll keep you posted along the way. The ketamine lawyers at Harris Bricken are dedicated to helping our clients understand the challenges and opportunities of this industry.
Where do you think ketamine therapy is headed?
Treatment-resistant depression
Bipolar disorder
Post-traumatic stress disorder (PTSD)
Anxiety disorders
Chronic pain
Migraines
Phantom limb pain
Because this treatment falls outside of the acceptable uses specified by the FDA, it is considered an “off-label” use. Off-label prescribing is extremely common in the medical field, and it’s completely legal as long as providers have a strong justification for it.
There is a bit of a risk when it comes to state medical boards, however. These entities are responsible for determining whether a provider has engaged in unprofessional conduct — which differs from state to state. Generally speaking, a provider has acted unprofessionally if the state determines they have deceived or caused harm to a patient during treatment.
Here’s where it applies to infusion therapy. If a patient experiences adverse effects following off-label ketamine treatment, the drug’s unclear legal status could be grounds for legal action. So without taking the proper steps, your state’s medical board could determine that the treatment is unethical, and you could face serious penalties.”
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But during the pandemic, it became clear that telehealth services made treatment more accessible, and the DEA temporarily loosened restrictions to allow telehealth providers to prescribe controlled substances for at-home use.
This exception allowed registered telehealth providers and online ketamine clinics to prescribe the drug to patients after a virtual consultation via a real-time, audio-visual communication method like Zoom. And the recently proposed DEA rules are likely to continue this practice.”
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While some states do allow nonphysicians to own clinics, they must be careful to follow their state’s other ownership laws. There are other potential alternative routes you could take, such as the management services organization (MSO) model.
An MSO business structure allows nonphysicians to legally own a company that provides administrative support to a clinic. It’s an indirect route, but it does remove some of the traditional barriers of entry to opening a clinic.”
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