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Ketamine Clinics and Compliance Plans

In prior posts, we discussed some of the common due diligence and compliance issues for ketamine clinics (see here and here). In this post, we discuss a healthcare compliance plan and the importance of having one in place for ketamine clinics. The Department of Health and Human Services (“HHS”) (which houses, among other agencies, the

ketamine off label use

Ketamine and Off-Label Issues

A common question that arises in Ketamine clinic transactions is whether a clinic or physician (collectively, “healthcare providers” or “providers”) can use or promote Ketamine for off-label uses. The short answer is yes, subject to several caveats, as discussed below. However, before reaching the answer, it is important to define what “off-label” use means and

MDMA Ecstasy fda maps

MDMA (Ecstasy) Nears FDA Approval for PTSD Treatment

Efforts by the Multidisciplinary Association for Psychedelic Studies (MAPS) to legalize prescription MDMA (Ecstasy) appear to have passed a gigantic hurdle earlier this month: MDMA is on track to meet the testing requirements to be a legalized prescription drug, specifically intended to treat the symptoms of post-traumatic stress disorder (PTSD). After analyzing the preliminary results

psychedelic decriminalization legalization

Psychedelic Decriminalization and Legalization Roundup

Cities and States Who Have Adopted Psychedelic Decriminalization It’s not been two years since Denver decriminalized psilocybin. In that span of time, cities and states across the country have adopted or are considering adopting sweeping decriminalization (and even legalization!) laws that apply to psilocybin and in some cases, even a host of other psychedelic substances.

california legalize psychedelics

California May Decriminalize Psychedelics

On February 17, 2021, California Senator Scott Wiener introduced SB-519, a bill that if passed, would decriminalize a host of both natural and synthetic psychedelic drugs. In this post, I’ll unpack what the law would do in its current form. Before I get into the specifics of the bill, there are three things that are

due diligence ketamine

Ketamine Due Diligence: What Any Buyer Should Know

We have worked on several ketamine acquisitions, and one of the most important aspects of any deal is due diligence. Shortly after term sheets or letters of intent are executed, most buyers send out a due diligence request list to the seller. This post will focus on the healthcare regulatory issues a buyer will want

psilocybin religious new hampshire

Another Win for Religious Use of Psychedelics: New Hampshire v. Mack

We’ve written a lot recently about the law concerning the religious use of psychedelics (see here and here). This is an incredibly broad area of the law that is still developing. Our focus has generally been on the federal laws and decisions affecting religious use of psychedelics, though today we turn our attention to an

Mushrooms Decriminalization

Citywide Psychedelic Decriminalization Doesn’t Protect Commercial Activities

Over the last year, a handful of cities have passed decriminalization measures for psilocybin and other plant psychedelics. Denver was the first jurisdiction to pass a decriminalization measure, and Oakland, Santa Cruz, Ann Arbor, and most recently, Washington, D.C., followed suit. Each of these decriminalization measures is different, but fundamentally they are the same in

Psychedelics and Cannabis

Top 10 Lessons from Cannabis for the Future Regulated Psychedelic Industry

On November 3, 2020, voters in Oregon approved Measure 109, paving the way for a regime of psilocybin for therapeutic uses in a few years. Oregon and Psilocybin: Does the Approved Ballot Measure Language Stand a Chance Oregon Psychedelics: Petition to Legalize Psilocybin for Therapy Moves Forward Oregon Psychedelics: Psilocybin on the Ballot this November!

Psilocybin and New Drugs

The “Right to Try” Psilocybin and New Drug Therapies

I was talking to another lawyer about last week’s vote by Oregonians to legalize psilocybin therapy here in the state. We discussed how licensed facilities won’t be up and running for a few more years, and how, in the meantime, people will have to make do with general decriminalization under Measure 109 and maybe, in