What is the Process for Federal Psilocybin Registration?
By Shane Pennington
Oct 18, 2021
We’re fielding an increasing number of questions these days from companies and organizations about registering with the U.S. Drug Enforcement Administration (DEA) to handle psilocybin and psilocin in various ways. In light of the interest, this article is an introduction to the different registrations available for schedule I substances.
Because psilocybin and psilocin are schedule I substances, handling them—or even simply possessing them—without DEA authorization is a federal crime. DEA doles out that authorization in the form of “registrations” to conduct any of seven activities with specific schedule I substances:
- Reverse Distribution
- Chemical Analysis
As is true any time you’re dealing with federal law (especially federal law administered by one or more federal agencies), you should never assume that words like “manufacture” or “distribution” mean the same thing under a statute or regulation that they do when you or I use them in conversation. The statutory definition of “manufacture,” for example, is far broader than you might expect:
the production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice. The term "manufacturer" means a person who manufactures a drug or other substance.
Did your eyes glaze over while reading that? Well, don’t fall asleep yet. DEA has also defined “manufacture” by regulation. I won’t blockquote that one here. Instead, I’ll just say what should already be obvious: when you really need to know what the law is on this or anything else having to do with controlled substances, there is no substitute for hiring a lawyer. This overview is designed to give you the lay of the land. It is not a substitute for legal advice about how you should handle any particular real-world legal issue.
With that warning, here’s a somewhat oversimplified rule of thumb. If you’re thinking of doing any of the following things (among others—the list below is not exhaustive) with psilocybin or psilocin, you need to register with DEA as a “manufacturer”:
- Growing mushrooms that contain either substance
- Extracting either substance from any other material
- Labeling either substance
- Packaging either substance
- Repackaging either substance
- Producing either substance by any means or process
Some of the other activities that require DEA registration are more or less self-explanatory:
“Distribute” means to deliver or attempt to deliver.
Import, export, and research mean what we commonly understand them to mean. Regarding research, however, it is important to note that to research schedule I substances FDA will need to approve (1) you as a researcher and (2) your research “protocol.”
“Chemical analysis” is the sort of work an analytical laboratory does—i.e. analyzing a particular specimen or substance and reporting on its composition, contents, etc.
“Reverse distribute” means “to acquire controlled substances from another registrant or law enforcement for the purpose of: (1) Return to the registered manufacturer or another registrant authorized by the manufacturer to accept returns on the manufacturer's behalf; or (2) Destruction.”
In addition to understanding the core activity relevant to each type of registration, it is also important to understand the concept of “coincident activities.” Basically, DEA requires a separate registration for each of the seven core activities listed. Thus, if you want to manufacture and research, you need to submit two applications—one to register as a manufacturer and another to register as a researcher. Once you’re registered to conduct a specific activity, however, your registration also authorizes you to conduct specified “coincident activities.”
The chart below lists the coincident activities associated with each core activity referenced. It also tells you the cost associated with each application. Each of the registrations discussed here must be renewed annually. The DEA form associated with each of the applications discussed in this post is DEA form 225. The information in the chart below is excerpted from a similar chart available in DEA regulations.
|May distribute that substance or class for which registration was issued; may not distribute or dispose of any substance or class for which not registered.
|A researcher may manufacture or import the basic class of substance or substances for which registration was issued, provided that such manufacture or import is set forth in the protocol required in § 1301.18 and to distribute such class to persons registered or authorized to conduct research with such class of substance or registered or authorized to conduct chemical analysis with controlled substances.
|May distribute that substance or class for which registration was issued; may not distribute any substance or class for which not registered.
|May manufacture and import controlled substances for analytical or instructional activities; may distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances and to persons exempted from registration pursuant to § 1301.24; may export such substances to persons in other countries performing chemical analysis or enforcing laws related to controlled substances or drugs in those countries; and may conduct instructional activities with controlled substances.
We may dig deeper into the standards DEA applies when assessing applications to register in a future post.