November 10, 2022

Legal Considerations and Regulatory Updates for Psychedelic Medicine (2023)

Written by

Dr. Alison McInnes MD, MS

I recently attended the virtual Sana Symposium. The entire event served as a great overview of the state of psychedelic medicine and included notable speakers like Osmind scientific advisor, Dr. Robin Carhart-Harris.

At the time of writing this, Colorado just announced that proposition 122 passed and Psilocybin is now legalized! While clinical and research interest in psychedelic-assisted therapy is blossoming, legal regulations take time and know-how to navigate.

To help you make sense of the current landscape, I'll summarize what we currently know. Much of this content comes from Sean T. McAllister, Esq, an attorney specializing in regulatory law with over 25 years of experience working in drug policy reform.

The take-home message from Sean's presentation: Let’s celebrate our wins while remaining mindful of complications and gray areas that come with more widespread psychedelic adoption.

This article summarizes the current state of regulatory updates and legal issues surrounding psychedelic medicine.

We’ll cover:

  1. Regulation at the federal level.
  2. Regulation at the state level, highlighting exciting initiatives in Oregon, Colorado, and California.
  3. What clinicians in the space can do to protect themselves legally.

Federal-level Regulations for Psychedelics

Ketamine

Ketamine is the only psychedelic that is legal for off-label use at this time. As a schedule III substance, you have to follow all state and federal laws surrounding registration, storage, inventory management, security, record keeping, and prescription protocols. You have to follow rules about who is administering, manufacturing, storing, or distributing the drug, and must register with the DEA.

How far can off-label use go?

  • It can address pain, but everything for depression is for off-label use.
  • Doctors and NPs are allowed to evaluate if it’s good for other uses and prescribe it as long as they think the patient can benefit from it
  • Some MDS are prescribing ketamine for psycho-spiritual exploration—not exactly in the DSM.
  • No doctor to Sean's knowledge has been sued for off-label RX, but we need to think about how far we can go with off-label use.

What training do you need to sit with someone, or who do you need on-site to give IM ketamine?

The MD doesn’t have to sit with the patient—they just prescribe it and the patient can go get it and they can take it on their own.

  • There’s nothing illegal about being a trip-sitter.
  • But for licensed professionals, think about how far you’re willing to go sitting with them, and view it through your ethics and licensing board. (E.g., should an Acupuncturist feel comfortable trip sitting?)

MDMA is in FDA-approved clinical trials, with expected full approval in 2 to 3 years.

Psilocybin is in FDA-approved clinical trials, with expected full approval in 5 years.

States that decriminalized psychedelics (and in some cases, legalized Psilocybin)

Oregon

Oregon has quasi-personal decriminalization laws. What that means in practice:

Patients have to take the psychedelics in the clinic, and can’t take them at home. They can still be arrested for possession, but not put in jail. Rather, they’d be fined or mandated to go to a doctor to get an evaluation.

Takeaway: Oregon doesn’t really have decriminalization. Stay tuned for legal drafts coming out in April with updates. In the meantime:

  • There will be all types of opportunities to practice psychedelic therapy under a state-regulated system.
  • In Oregon, you don’t need to be licensed—you just need a high school diploma to be a facilitator.

Colorado

Initiative 58, aka prop 122 just passed in November 2022! This is the most aggressive decriminalization legislation effort in history for naturally occurring psychedelics. At a high level, prop 122 will take effect in the Fall of 2024, and will allow:

  • Anyone 21 and older to grow and share psilocybin, but not sell it for retail.
  • The creation of state-regulated centers where people could make appointments to consume psilocybin in “healing centers.”
  • All of these substances would happen in a regulated environment—not for at-home use.

To read more about this landmark legislation, head to naturalmedicinecolorado.org.

California

Right now, psychedelics are decriminalized in certain cities, but not at the state level.

To decriminalize psychedelics at the state level, many people think we need to go to the ballot initiative process—which wouldn’t happen until 2024.

SB 519 passed the Senate in June 2021, and now will be evaluated by the assembly, then the governor of California. If passed, the bill would decriminalize seven psychedelics and create a state task force on regulation.

Texas and Connecticut

Both states passed laws legalizing research on (but not the use of) psilocybin.

Decriminalized Cities

To make matters more confusing, certain cities have decriminalized psilocybin and/or all entheogens. Note that decriminalization doesn’t always decriminalize the sale or sharing of these substances, and doesn’t address state laws around regulated therapists and doctors.

Cities that decriminalized all entheogens:

  • Oakland, CA
  • San Francisco, CA
  • Santa Cruz, CA
  • Ann Arbor, MI
  • Detroit, MI
  • Washington, DC
  • Somerville, Easthampton, Northampton, Cambridge, MA
  • Seattle and the city of Port Townsend, WA

Cities that decriminalized psilocybin, but not other entheogens:

  • Denver, Co

The decriminalization of peyote and the inclusion of native American voices in this field

  • These decriminalization movements are all over the country. Bills exist for peyote and ayahuasca (which are already approved for religious exemptions).
  • Unfortunately, native voices are not normally included in regulation conversations.

Uncertainties surrounding legal issues remain for professionals

Regulations surrounding psychedelics are ever-evolving. Even if you’re in a decriminalized state, you ideally should consult with a regulator in advance before practicing with psychedelics. The following are questions that remain in a gray area:

1) Once legalized in state, how will state regulators view licensed professionals who want to participate in hybridized medical–therapy practices?

2) Are you in scope to do psychedelic-assisted therapy?

  • Ideally, you should have some specialized training, but is that enough to go to your regulator? Sean—the legal expert speaker at Sana—says generally yes, but it will be decided state-by-state. You are detecting a theme here—once approved, even at the federal level, it's up to individual states to decide how they will handle the provision of the medicine. Also, training is essential to help defend you in front of a peer jury should an adverse event occur.

3) Can you go to countries where psychedelics are legal (e.g., Jamaica) and facilitate a retreat? Legally you can, but what would your licensing board say?

4) What can clinicians do to protect themselves legally?

  • Get training for whatever modality is available.
  • Seek guidance from well-known institutions in the psychedelic space such as CIIS and the Board of Psychedelic Medicines and Therapies.
  • Experiential training programs/retreats for ketamine are not legal because a scheduled drug can only be given to a person for a medical condition, but no one enforces this and no participants have brought suit against any clinicians providing experiential training.

These questions and considerations aren’t prescriptive or meant to shame you if you’re called to offer psychedelic treatments. Rather, they’re signposts to help guide you. As with anything in medicine, reflecting and answering honestly will help protect you and your patients.

Predictions to pathways to access/parallel tracks of coming legalization:

  • Rescheduling of FDA-approved psychedelics is performed by the DEA on a state-by-state basis.
  • State-sponsored regulatory systems.
  • State-sponsored decriminalization regimes.
  • City-sponsored decriminalization regimes. These are not that useful because the DEA needs to reschedule psychedelics at the state level.
  • Religious use of psychedelics. The use of entheogen (psychedelics used in religious ceremonies) is restricted by definition to those whose culture includes the ceremonial use of psychedelics.

Recommended legal resources for clinicians interested in providing psychedelic experiences:

  • Portasofia.org—reach out to them with any legal questions.
  • Read the case of a nurse in Indiana microdosing.
  • Natasha Sumner and Kimberly Chew of Husch-Blackwell are lawyers dedicated to helping clinicians who would like to prepare for the provision of MDMA when it is FDA-approved. They are also an excellent resource for other matters relating to the use of psychedelics including ketamine.

Conclusion

With all the data available, we're still in the early stages, so there’s no guarantee of zero risk when dealing with psychedelics. The real question is how to put yourself in a position you’re comfortable with to practice in harmony with your values and minimize risk.

There doesn’t seem to be a huge resistance to rescheduling psychedelics. It’s more of a question of what will be involved for them to be approved. If these compounds are FDA-approved, some states will be rescheduled quickly, while others will be maddeningly slow.

Either way, the FDA is requiring larger studies than entities initially anticipated. Psychedelics require longer-term studies. Unlike SSRIs, psychedelics are taken episodically. Questions remain like when to re-dose as the treatment fades. To address similar unanswered questions, studies need to be longer—up to a year. MDMA for PTSD will be a good test run to see how this process unfolds in the coming months and years.

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