Recently, we’ve been writing about ketamine-infusion clinics, which are increasingly popping up across the country (see a list of our past coverage at the end of this post). Over the coming weeks, we’ll dive deeper into individual laws and regulations governing clinics. Today, we focus on some of the high-level requirements of the Drug Enforcement Agency (DEA) on clinics and their personnel.
Ketamine is a Schedule III controlled substance, so the Controlled Substances Act (CSA) and federal regulations require that persons who manufacture, distribute, dispense, or otherwise deal in it obtain a DEA registration. “Dispensers” of ketamine who are required to receive registrations include:
- Practitioners must be specific licensed medical professionals like physicians;
- “Mid-level practitioners” are another defined class who can vary from state to state. In California, this would include professionals such as nurse practitioners. Mid-level practitioners are generally more restricted in what they an do than are practitioners.
- Retail pharmacies
- Teaching institutions
In other words, not just anyone can obtain a DEA registration and dispense ketamine. But determining who needs a ketamine-related registration is not always simple. Federal registrations require separate registrations for each premises in which controlled substances are dispensed, but also provide for exceptions to the registration requirement for certain employees or agents of registered dispensers. Whether or not a separate registration is necessary can be a highly fact-based analysis involving complex regulations.
To obtain DEA registrations, applicants must fill out specific forms and provide the DEA with certain information, which can vary depending on the type of registration sought. Dispenser registrations extend for three years, but other types of registrations may only last for one year. The processing time can take several months for new licenses and can even take a significant time for renewals. Registrations are also not transferable.
It’s also important to also consider the regulatory obligations for registered dispensers. There are complex reporting, security, and employee screening requirements when it comes to any controlled substance. Failure to strictly follow all the applicable regulations can lead to severe penalties, including revocation or suspension of registrations.
As discussed above, the registration requirement can be complex to navigate, and maintaining a registration can also be a challenge. In the coming months, we’ll look at more in-depth legal issues surrounding ketamine. But for some of our most recent posts on this area of the law, check out: