First Consideration: Ketamine and Spravato® Are Controlled Substances That Are Subject to DEA Regulations
Ketamine and Spravato® are Schedule III controlled substances that are subject to controlled substance laws and regulations under the Drug Enforcement Administration (“DEA”). Providers who administer ketamine or Spravato® should have a DEA registration and may need a DEA registration for their facility if they are administering and storing ketamine or Spravato® from their office. The DEA also has specific regulations related to Schedule III drugs compared to Schedule II drugs, such as allowing refills for Schedule III drugs within six months of the prescription being issued while prohibiting refills for Schedule II drugs.
Second Consideration: Some States Have Not Promulgated Regulations for Ketamine Use for Treatment-Resistant Depression
Some states, such as Georgia, have not implemented specific regulations for ketamine infusions or for ketamine clinics in general, so the legal landscape for ketamine across states is uncertain. Although states have not implemented regulations for ketamine infusions, some state medical boards have provided guidance on how they might regulate ketamine. The Georgia Composite Medical Board, for example, has mentioned in a Board meeting on May 30, 2024, that the “existing statutes and rules governing IV sedation closely align with the considerations necessary for Ketamine.”
Third Consideration: Mid-Level Providers Should Be Aware of the Corporate Practice of Medicine and Scope of Practice Laws Before Administering Ketamine
Because administering ketamine or Spravato® is considered the practice of medicine, mid-level providers, including physician assistants and nurse practitioners, should be cautious about whether administering or prescribing ketamine or Spravato® falls within their respective scope of practice. If mid-level providers want to start a healthcare practice that administers ketamine or Spravato® to patients, they will need to be aware that the corporate practice of medicine may apply, prohibiting corporations from practicing medicine or mid-level providers employing physicians. Therefore, mid-level providers must have the proper safeguards and compliance measures to ensure their practice does not violate the scope of practice laws or the corporate practice of medicine.
If you need assistance setting up a practice that administers ketamine, have questions about whether your practice is compliant with the various laws and regulations surrounding ketamine, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.