Ketamine is a Schedule III drug under the federal Controlled Substances Act (CSA). Physicians who dispense or administer it therefore must comply with a host of federal and state laws and regulations. This includes registering with the DEA at each location where the physician administers ketamine. But what about physicians who travel to a patient’s home to administer ketamine? Do they have to register at each patient’s house? Today, we’ll discuss an exception to DEA ketamine registration that can apply in this situation – commonly referred to as the “black bag” exception.
DEA Ketamine Registration Overview
A while back, I wrote a post detailing the physician registration requirement. As I noted, applicants must fill out specific forms and provide the DEA with certain information which varies across registration types (there are many). 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 not transferable and are license specific. There are almost zero exceptions to registration.
Location Specific Registration
DEA regulations require different registrations for “each principal place of business or professional practice at one general physical location where controlled substances are . . . dispensed by a person.” In plain English, a physician must register at each location where they dispense ketamine. If a physician only works out of a single office, the process is more straightforward. But as ketamine concierge medicine and ketamine telehealth services expand, things become more complicated.
The Black Bag Exception to DEA Ketamine Registration
In October 2020, the DEA issued guidance for physicians who want to dispense controlled substances (not just ketamine) at a patient’s house. The guidance states in part:
Question: Can a physician transport controlled substances and administer at the patient’s home residence (the so-called “black bag exception”)?
Answer: Yes, with a limit. DEA will permit a physician who is registered with DEA to dispense controlled substances at a particular location in a state to travel to other unregistered locations in the same state to dispense controlled substances on an “as-needed and random basis,” so long as the physician does not maintain a principal place of professional practice at any of those unregistered locations. . . . If a physician intends to dispense controlled substances from a particular location several times a week or month, he must first file a separate registration for the location. . . . Registrants should keep themselves apprised of state and local laws otherwise consistent with DEA regulations regarding the dispensing of controlled substances in a patient’s home residence.
This is what’s known as the “black bag exception.”
Analyzing the Black Bag Exception
While the DEA’s guidance is not binding, it gives good insight into the agency’s thought process around ketamine. It seems clear that a physician dispensing ketamine to patients in the same state they are licensed and registered in won’t have to register at the patient’s house. But there are a few other key takeaways.
The reference to an “as-needed and random basis” suggests that DEA considers this exception to be for emergency-type situations. It’s not clear how this would apply to a situation like concierge medicine where a physician may come on a scheduled (non-random) basis. Further, DEA says that physicians who dispense ketamine “from a particular location several times a week or month” must register there. This means that concierge ketamine or telehealth ketamine services that may face additional issues when providing ongoing services to the same patient.
Ketamine clinics, ketamine telehealth businesses, ketamine concierge medicine services, and ketamine dispensing physicians who plan on administering ketamine outside a clinical setting need to be aware of their registration obligations. DEA’s ketamine registration exceptions are narrow and may not apply in many circumstances. And failure to comply can lead to devastating circumstances.
In a (sort-of) post-COVID world, medical practice and laws in the United States are vastly different from just a few years ago. We expect many more significant changes to ketamine law and policy in the coming years. Please stay tuned to the Psychedelics Law Blog for more developments.