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Article: The global regulatory landscape for psychedelic drugs

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Jessica Riggleman, Owner of Raeco, LLC, examines the global regulatory landscape for psychedelic drugs, with a particular focus on Schedule I classification

Depending on the country and specific drug, the global regulatory landscape for psychedelic drugs is complex and variable. Generally, most countries regulate psychedelic drugs as controlled substances, with varying degrees of legal and medical restrictions on their use, possession, and distribution.

Canada

Psychedelic drugs are regulated under Canada’s Controlled Drugs and Substances Act, which restricts their use, possession, and distribution. However, Health Canada has recently begun to grant exemptions for using psilocybin in end-of-life care and research purposes.

Europe & The United Kingdom

In Europe, the regulatory landscape for psychedelic drugs varies by country.
In the Netherlands, for example, some psychedelic mushrooms are legal to possess and use under certain circumstances. In most other countries, they are regulated as controlled substances. In the United Kingdom, psilocybin is a Schedule I drug, although there are growing calls for its reclassification to allow for therapeutic use.

South America

In South America, traditional indigenous use of psychedelic plants such as ayahuasca is legal and widely practiced, although the use of these substances outside of traditional contexts is typically prohibited.

The United States

Psychedelic drugs such as lysergic acid diethylamide (LSD), psilocybin, and 3,4 Methylenedioxymethamphetamine (MDMA) are classified as Schedule I substances under the Controlled Substances Act, indicating that they have a high potential for abuse and no accepted medical use. However, some states have recently passed laws allowing for the therapeutic use of these drugs under certain circumstances.

Deep Dive into psychedelic regulation: Schedule I classification

Overall, the global regulatory landscape for psychedelic drugs is complex and evolving, with increasing recognition of their potential therapeutic benefits and growing calls for their reclassification and increased access for medical and research purposes. However, significant legal and regulatory barriers remain, particularly in countries where these drugs are classified as Schedule I substances with no accepted medical use.

The U.S. Food and Drug Administration (FDA) has not approved any psychedelic drugs for therapeutic use except for ketamine, which is approved for treatment-resistant depression. Ketamine is often classified as a dissociative anesthetic, rather than a classical psychedelic like LSD or psilocybin. However, it does have some psychedelic properties, particularly at higher doses. There has been growing interest in the potential therapeutic benefits of psychedelic drugs such as psilocybin, MDMA, and LSD for various mental health conditions, including depression, anxiety, addiction, and post-traumatic stress disorder.

The FDA regulates drugs based on their intended use, and the approval process typically involves several stages, including preclinical research, clinical trials, and review processes.
For psychedelic drugs, the regulatory pathway is complicated by their Schedule I classification under the Controlled Substances Act, which means that they are considered to have a high potential for abuse and no accepted medical use.

Protecting against the abuse of psychedelic drugs

The potential for abuse of psychedelic drugs is influenced by a number of factors, including the dose, the route of administration, the setting in which the drug is used, and the individual’s past experiences and expectations. In a controlled therapeutic setting, the risk of abuse is generally considered to be low, as the drugs are administered under careful supervision and in a supportive environment.

The Schedule I classification of psychedelic drugs poses significant challenges to their development and research as potential therapeutics. The Controlled Substances Act of 1970 classifies Schedule I drugs as substances with a high potential for abuse, no accepted medical use, and a lack of accepted safety for use under medical supervision. This classification imposes several restrictions and barriers to the development of psychedelic drugs as therapeutics.

The Schedule I classification restricts the availability of these drugs for research purposes. Researchers must apply for a special license from the Drug Enforcement Administration (DEA) to conduct studies with Schedule I drugs, and the application process can be lengthy and cumbersome. This creates a significant barrier to entry for researchers who want to study the therapeutic potential of these drugs.

There is limited funding available for research into these drugs. Some government agencies are generally prohibited from funding research into Schedule I drugs, which limits the available resources for studying their potential therapeutic effects.

This classification imposes additional regulatory requirements on drug developers who want to bring psychedelic drugs to market as therapeutics. The FDA requires a higher level of evidence for drugs in Schedule I compared to those in other schedules, which can make the approval process more difficult and time-consuming.

Schedule I classification closing thoughts on the regulatory landscape for psychedelic drugs

Finally, the Schedule I classification carries a significant stigma and cultural baggage, which can make it more difficult to conduct research and bring these drugs to market. Many people still associate psychedelic drugs with the counterculture of the 1960s and 1970s and view them as dangerous and potentially harmful.

Read full article at  https://www.openaccessgovernment.org/article/the-global-regulatory-landscape-for-psychedelic-drugs/155963/



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Article: Early 2025 Empire State Psychedelic Policy Roundup

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Unique NY-Born Licensing Model for Therapeutic Psilocybin Use Gains Momentum in State Senate Amid Flurry of Psychedelic Bills Filed Across the US

(Albany, NY) As New York’s cannabis industry continues to turn a hefty profit in the earliest days of 2025 so far, many plant medicine community members both within and just beyond the cannabis industry have been steadily laying the groundwork for the next state-level drug policy reform movement rife with seemingly-incompatible, arguably-intertwined intersectional equity enhancement opportunities and profit margin maximization priorities at play: psychedelics.

For those unfamiliar, 2024 brought about a number of presumed-to-be momentum-stalling psychedelic setbacks – first with the FDA’s stunning rejection of a first-of-its-kind MDMA-Assisted Therapy Treatment developed by the Multidisciplinary Association of  Psychedelic Studies (MAPS) and their Public Benefit Corporation (PBC) spin-off Lykos Therapeutics. To compound public misperception of psychedelic policy reform efforts further, a much-discussed and deep-pocketed legal psychedelic therapy-personal possession and home cultivation decrim-focused psychedelic ballot campaign in Massachusetts failed spectacularly – leading some pundits – both pro-legalization and prohibitionists alike – to speculate that “the psychedelic renaissance” as it’s been called by some, had in fact stalled out at large.

Fortunately for the plant medicine community, those naysayers were largely wrong, as in January 2025 alone, a record-breaking 38 psychedelics-related bills were filed in 14 states across the country. Here in New York, prominent psychedelic policy reform advocates have gained serious traction within the state’s legislature, especially after a recent lobbying day at the state Capitol.

Led by the increasingly diverse coalition known as New Yorkers for Mental Health Alternatives and backed by a growing bipartisan interest in alternative mental health treatments, New York’s burgeoning intersectional community of psychedelic activists and legal experts recently gathered in Albany to rally support for two proposed bills aimed at expanding access to psychedelics for therapeutic and personal use.

Avery Stempel NYMHA

“Our 2025 New York State Capitol Lobby Day was a huge success,” said Avery Stempel, co-founder of New Yorkers for Mental Health Alternatives (NYMHA) and founder of Collar City Mushrooms. “Advocates, doctors, and lawyers from Brooklyn to Buffalo traveled to Albany to participate. We had individual meetings with 10 senators and assembly members and talked to many more in the hall while they passed by our tables. There is a lot of energy gathering around the New York bills, and we are hopeful that we will be making some serious traction this year.”

At the forefront of the legislative push is Assembly Bill A2142, introduced by Assemblywoman Amy Paulin (D) alongside four co-sponsors. The bill would create a state-supervised program allowing licensed facilitators, including health and social care professionals, to administer psilocybin-assisted therapy to eligible patients. The measure mirrors a growing movement across the country, following in the footsteps of states like Oregon and Colorado, which have already established legal frameworks for psychedelic-assisted treatment.

A second measure, House Bill 628, introduced by Assemblymember Linda Rosenthal (D) with eight co-sponsors, takes a broader approach. If passed, the legislation would legalize the adult possession and use of several plant- and fungus-based hallucinogens, including psilocybin, mescaline, DMT, ibogaine, and psilocin. The bill is currently under review by the state’s public health committee and, if advanced, would require approval from Governor Kathy Hochul (D) to become law.

Momentum for these reforms received a boost with the recent filing of Senate Bill S5303 by State Senator Julia Salazar (D). The measure serves as a companion bill to A2142, signaling increased legislative interest in the possibility of a hearing on psychedelic policy in Albany later this year. According to NYMHA leaders, this marks a critical step in New York’s efforts to bring psychedelic-assisted therapy into the mainstream.

Jonah Martindale, Rick Doblin, Gina Giorgio

“We are seeing that in the last few years, there has been a shift in the popularity of alternative treatments for the worsening mental health crisis, such as psychedelics,” said Jonah Martindale, a New York City resident, NYMHA coalition member, and advocate with Students for Sensible Drug Policy (SSDP). “The openness of various politicians across the political spectrum for these bills seems to reflect that. Now is the time to keep building momentum.”

Supporters of the bills argue that psychedelic-assisted therapy has the potential to revolutionize mental health care, offering new hope for individuals suffering from treatment-resistant conditions such as PTSD, depression, and substance use disorders. Medical research and clinical trials have shown promising results in recent years, prompting lawmakers in various states to reconsider their stance on these substances.

However, despite the growing enthusiasm, challenges remain. Critics have raised concerns about public safety, regulatory oversight, and the potential for misuse. Law enforcement officials and some health professionals caution that broader legalization could lead to unintended consequences, particularly if access to psychedelics is not accompanied by rigorous safety protocols.

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Early 2025 Empire State Psychedelic Policy Roundup

 



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Linked In Post – Jon Dennis, Psychedelic Lawyer: Washington SB 5201, the regulated psilocybin access bill, was considered today by the Senate Committee on Labor & Commerce ( 18 Feb 2025)

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Washington SB 5201, the regulated psilocybin access bill, was considered today by the Senate Committee on Labor & Commerce. The bill would require low-income and other taxpayers to subsidize regulated access that is cost-prohibitive for many, while continuing to criminalize the same activities outside of the regulated marketplace.

For context, Oregon’s regulated system was promised to be self-funded by licensing fees and sales taxes, but the program needed a $3.1MM bailout in 2023, and the program is now seeking an additional $3.5MM bailout from the legislature. This is despite already-exorbitant licensing fees, including a $2,000 annual fee for facilitators. (By contrast, the annual fee for an Oregon law license is $683; the annual fee for medical doctors is $702.)

Taxing residents for the administration of a costly access program, while criminalizing affordable access outside the program, is problematic–particularly in Washington where local governments representing 14% of the entire population have already called on state lawmakers to decriminalize psilocybin and other plant-based psychedelic substances. Washington lawmakers must do better and not ignore the socio-economic and criminal justice impacts of a regulated-only access program.



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Alert: We are just over a week away from the Natural Medicine Division opening our application process to individuals who are interested in becoming business Owners or Natural Medicine Handlers, and to business applications for Healing Centers, Cultivations, Testing Facilities and Product Manufacturers.

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Dear Interested Parties:

 

We are just over a week away from the Natural Medicine Division opening our application process to individuals who are interested in becoming business Owners or Natural Medicine Handlers, and to business applications for Healing Centers, Cultivations, Testing Facilities and Product Manufacturers.

 

This week, we wanted to share some logistical information about the application process.

 

We encourage you to submit your application online, and there will be instructions on how to submit applications on the Natural Medicine Division website.

However, based on stakeholder feedback, we will be opening up limited appointment slots for in-person assistance at our Lakewood office starting on Friday, Jan. 10, 2025. At this time, Fridays will be the only day that we will be offering in-person natural medicine licensing application assistance. We will be open from 9 a.m. to noon and 1 p.m. to 4 p.m. for in-person Friday appointments.

We are finalizing the applications and will be sharing those prior to our application process coming online. You can always check out our Public Resources folder to find information and compliance tools.

As always, please reach out to us at [email protected].us if you have any questions.

 

Stay tuned!

The Natural Medicine Division



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