Ketamine is a substance growing in popularity as a treatment for, among other things, depression and pain management. Ketamine clinics are quickly increasing in popularity. Why Ketamine-Assisted Therapy Has Gone Mainstream, Forbes (Oct. 18, 2021). Our healthcare and business law firm assists clients in understanding the rules and requirements around opening and operating Ketamine clinics, understanding the unique issues that face innovative clinics where no clear guidance or oversight has yet been established. With this post, Total Health Law intends to present three considerations for a provider thinking about opening a Ketamine clinic in Georgia. If you have questions regarding this blog post, opening a Ketamine clinic, or operating your existing Ketamine clinic, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, firstname.lastname@example.org. You may also learn more about our law firm by visiting www.hamillittle.com.
- Ketamine is a controlled substance.
Ketamine is a Schedule III controlled substance, which means providers must comply with the registration requirements in Title 21 of the Code of Federal Regulations, Part 1301. Using Ketamine for ketamine infusion therapy is an “off label” use of Ketamine. Using drugs for off label uses is not prohibited. According to the FDA, “once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.” Be conscious, however, that if you are a provider prescribing ketamine, that you have the authority to do so. Hamil Little works with many mid-level providers, such as APRN’s and CRNA’s, to ensure compliance with their governing rules and regulations.
- Some Ketamine clinics may qualify as Pain Management Clinics.
Many providers have found success using Ketamine to treat patients for pain. Georgia has strict oversight of pain management clinics. Under Georgia Rule 360-8-.01(9), a “Pain management clinic’ means a medical practice advertising ‘treatment of pain’ or utilizing ‘pain’ in the name of the clinic or a medical practice or clinic with greater than 50% of its annual patient population being treated for chronic pain for nonterminal conditions by the use of Schedule II or III controlled substances.” If there is the potential that your Ketamine clinic could qualify as a Pain Management Clinic, it is important to understand the specific rules you must follow. For more information about Pain Management Clinics, review the Total Health Law blog post “3 Facts About Pain Management Clinics in Georgia” or contact us.
- The Georgia Composite Medical Board’s stance regarding Ketamine.
The use of Ketamine for the treatment of pain was raised to the Georgia Medical Board in 2020, so the growing use of Ketamine clinics in Georgia is on the Medical Board’s radar. The question raised to the Board by the Assistant Attorney General was about using ketamine to treat pain. Both times this question was presented to the Medical Board, it tabled the discussion pending further information. See Sept. 3, 2020 and Oct. 1, 2020 Georgia Medical Board Meeting Minutes. For the benefit of our client’s and readers, Total Health Law will stay abreast of any discussion from the Medical Board about ketamine.
If you have questions regarding this blog post, opening a Ketamine clinic, or operating your existing Ketamine clinic, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, email@example.com. You may also learn more about our law firm by visiting www.hamillittle.com.
*Disclaimer: Thoughts shared here do not constitute legal advice.