Ketamine Legal Services
Overview
Ketamine, a quick-acting anesthetic, is used by doctors in the field of medicine and veterinary care. It gained attention and massive expansion in recent years due to its potential ability to treat certain mental health conditions such as depression, PTSD and chronic pain.
Ketamine clinics have opened across the United States offering infusion therapy. However, because ketamine is classified as a Schedule III substance and is used for an unapproved purpose (or off-label), strict rules and liability issues may affect these clinics. They must adhere to the Drug Enforcement Administration (DEA) requirements and work through a complex landscape to conduct business lawfully and ethically.
History of the ketamine industry in the US
In the 1960s, ketamine showed promise as a faster-acting and less toxic anesthetic compared to phenylcyclohexyl piperidine (PCP) when it was synthesized and tested on animals. It gained FDA approval in the 1970s and was used by American soldiers during the Vietnam War. Unfortunately, it was illicitly abused over the years and in the 1980s, it was commonly sold as ecstasy or a party drug. Because of this, ketamine was classified as a controlled substance in the 1999, leading to its decline in use.
Medical professionals began researching ketamine’s possible medical benefits, particularly its treatment to alleviate depression and suicidal thoughts. Results from studies between the years 2000 and 2006 showed its effectiveness. This led to off label use for depression and the rise of ketamine clinics in the US.
Today, health professionals prescribe ketamine off-label to patients with treatment-resistant depression, PTSD, and other mental conditions.
Is ketamine legal in the United States?
Under the federal Controlled Substances Act (CSA) in the United States, ketamine is categorized as a controlled substance of Schedule III. This means that it is a controlled substance with recognized medical uses but also a potential for abuse and dependence. Its non-medical use is prohibited.
There has been growing interest in its potential therapeutic benefits, leading to off-label use in specialized clinics or treatment centers. Off-label use refers to the use of a medication for purposes not specifically approved by regulatory authorities like the US Food and Drug Administration (FDA). In the case of ketamine, off-label use may involve its prescription for conditions or in dosages not specifically listed on the FDA-approved label. The use of ketamine for medical purposes is tightly regulated and typically administered by licensed healthcare professionals in approved settings.
Opportunities in the ketamine industry
The ketamine treatment market has witnessed substantial growth in recent years and is poised to continue its upward trend in the next decade. According to a report, the global market size for ketamine treatment was valued at USD 306.41 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 43.74% until 2030, reaching USD 2702.67 million.
Over the years, numerous patients have undergone legal ketamine therapy. Since the treatment is typically conducted in outpatient clinics, there are specific requirements that must be met, such as state medical board licenses, proper storage and handling of controlled substances, adherence to OSHA standards, insurance coverage, and obtaining county/city licensing.
However, it’s important to note that the ownership and operation of ketamine clinics can be influenced by the Corporate Practice of Medicine (CPOM) Doctrine. This legal principle prohibits non-medical entities from hiring medical professionals to provide medical services or engaging in medical practice themselves. The CPOM Doctrine aims to minimize potential conflicts of interest and maintain ethical standards of the medical profession. As the use of ketamine continues to grow, compliance with CPOM becomes a significant concern for businesses and individuals involved in the ketamine market.
CPOM laws vary across states, and it is important to understand the local regulations when establishing or funding a ketamine clinic. In many states, the dispensing or administration of ketamine is restricted to business entities solely owned by physicians or licensed healthcare providers. States such as New York, California, Texas, and Washington are known for their strict regulations regarding the ownership and management of ketamine clinics.
To navigate the complexities of CPOM and ensure compliance, thorough research of state laws, careful planning, and seeking legal advice are essential for companies and individuals interested in entering the ketamine market. By taking these steps, potential business owners can adequately prepare for the operation of ketamine clinics, tapping into the growing demand for ketamine treatment while abiding by the regulatory landscape.
Contact Moriconi Flowers for Legal Support
Moriconi Flowers’s attorneys provide a wide range of business services specifically designed to assist ketamine clinics. We have expertise in helping those involved in the industry understand and comply with federal and state-level regulations.
Our knowledge and experience with the DEA and other government entities enable us to provide valuable insights and guidance regarding the requirements that must be met to operate within the legal framework governing ketamine-related activities.
We can help you navigate the complexities of the industry and provide the necessary support in legal representation, contractual agreements, licensing, risk assessment, and more. For more information about our business services, read here.
Are you looking to navigate the ketamine industry with confidence? Moriconi Flowers is here to help. Contact us today and let our experienced attorneys provide the expert guidance and services you need.
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