On February 16, 2022 and October 10, 2023, the FDA issued two warnings about the use of compounded ketamine. The first warning is entitled, “FDA alerts health care professionals of potential risks associated with compounded ketamine nasal spray,” and the second warning is entitled, “FDA warns patients and health care providers about potential risks associated
Perhaps inevitably, lawmakers introduced a very skinny bill last week to protect states that legalize psilocybin from federal intervention. Specifically, it requires that: [n]o Federal funds may be used to prevent any State or unit of local government from implementing such State’s or unit of local government’s own laws that authorize the use, distribution, sale,
Ketamine telehealth has been a wild ride these last few years. Every few months I give an update, and every time I do, things seem to change dramatically. For example, in just a few short weeks in February 2023, the situation went from “bad” to “good” (at least sort of) as it became clear that
A handful of entities are in various stages of the FDA approval process for MDMA and psilocybin drugs (see here and here for some of our prior analysis of the issues). FDA approval could happen in the next few years. But there’s a catch: psilocybin and MDMA are both schedule I drugs under the Controlled Substances Act (CSA).
A few weeks ago, we held a webinar about ketamine regulation and the future of psychedelic medicine (for a recording, click here). At the time, there were big changes on the horizon for ketamine telehealth. In the last few weeks, there have been a few pretty significant developments that merit some attention. For some background,
There are lots of psychedelics and psychedelic adjacent substances that are not scheduled under the Controlled Substances Act (CSA). Recently I wrote about amanita muscaria mushrooms and their legal status. Today, I want to talk about a different one: salvia divinorum. Salvia divinorum Salvia divinorum is a psychedelic substance. It was often used for religious
Click HERE to register for our upcoming FREE Q&A webinar on ketamine regulations and the future of therapeutic psychedelic medicines! In the next few years, the FDA will likely approve drug formulations containing psilocybin and MDMA. While there are still many unknowns concerning how psilocybin and MDMA-based drug therapies will be regulated, we believe that
Over the last year and change, I’ve written quite a bit about how the ketamine telehealth industry was in store for a rude awakening when the COVID-19 public health emergency (PHE) declaration ended. My most recent post, entitled “Bad News for Ketamine Telehealth” predicted an imminent shakeup in the industry due to the looming end
Earlier this week, President Joe Biden’s administration made an announcement that signals potential bad news for the ketamine telehealth industry. Effective May 11, 2023, the federal COVID-19 public health emergency (PHE) declaration will end. This is likely to plunge the entire ketamine telehealth industry into chaos in the coming months. If you are unfamiliar with
Last week, we presented a psychedelics webinar entitled “How to Protect Your Psychedelics Business.” The panelists were Paul Coble from our Phoenix office), me (Griffen Thorne from our Los Angeles office), and Graham Pechenik of Calyx Law in San Francisco. In the webinar, we presented on business law and intellectual property issues that will affect
