Oregon Psilocybin Advisory Board Release Draft Rules; Rules Advisory Committee to Discuss Draft Psilocybin Training Rules Tomorrow (2/14) and Draft Psilocybin Products Rules Thursday (2/17)

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Oregon Psilocybin Advisory Board Release Draft Rules; Rules Advisory Committee to Discuss Draft Psilocybin Training Rules Tomorrow (2/14) and Draft Psilocybin Products Rules Thursday (2/17)

The Oregon Psilocybin Advisory Board (the “Board”) has released a set of draft rules that cover what psilocybin testing, psilocybin production, and training requirements for psilocybin service providers might look like come January 2023 when the Psilocybin Services Program gets off the ground here in Oregon.  The draft rules will be discussed by the Rules Advisory Committee (“RAC”) over the course of the month.

The first meeting will be held tomorrow, February 15th from 1:00 pm – 4:00 pm to discuss the draft training rules, which will also be discussed on February 25^th. The draft products rules will be discussed this Thursday, February 17^th from 9:00 am – 12:00 pm and the draft testing rules will be discussed on February 24^th from 9:00 am – 12:00 pm.

Zoom links and call-in information for the aforementioned RAC meetings can be found here.

To prepare you for tomorrow’s RAC meeting discussing the draft psilocybin training rules and Thursday’s meeting discussing the draft psilocybin products rules, here’s a quick summary of some of the highlights in the draft psilocybin training and draft psilocybin products rules. While the draft rules are likely to see many different iterations before the final product is adopted by the Oregon Health Authority come December this year, a look at these first drafts is a good lens into what’s to come from the Board over the course of this year.

Draft Training Rules: Modules on Modules, Babe!

So, how exactly are we going to set up a state-legal program with individuals who are properly trained and qualified to handle a high-volume of clients dosing on psilocybin? My first thought is to recommend my best friend, Lauren, who has (hypothetically) been a sober sage through many a trip over the years, but, I’m just not sure that’s scalable. That’s where the draft training rules come in.

The draft training rules set out the qualifications for the folks who will be establishing the curriculum and training psilocybin service center operators and psilocybin facilitators down the road.

All prospective psilocybin training program licensees must demonstrate that their curriculum consists of the requisite number of hours of curriculum in each of the following nine modules: (a) Historical, Traditional, and Contemporary Practices and Applications; (b) Cultural Equity in relation to Psilocybin Services; (c) Safety, Ethics and Responsibilities; (d) Psilocybin Pharmacology, Neuroscience, and Clinical Research; (e) Core Facilitation Skills; (f) Preparation and Orientation; (g) Administration; (h) Integration; and (i) Group Facilitation. The rules further set out specific characteristics and information that each of the above modules must contain.

The draft rules also set out the practicum (or “training”) requirements for psilocybin service facilitators to “facilitate and observe the facilitation of non-ordinary states of consciousness.” In order to serve as a psilocybin service facilitator students must complete a minimum of 40 hours of practicum training, at least 30 of which must be direct practice and at least 10 of which must be consultation relating to the student’s direct practice. The draft rules also contemplate accelerated training programs for “advanced” students.

Draft Products Rules: One Species to Rule Them All?

Interestingly, the draft rules limit the kind of mushrooms psilocybin manufacturers can produce to a single species–Psilocybe cubensis.

Why, you ask? It’s safe and studied. Despite hundreds of mushroom species producing psilocybin, Psilocybe cubensis is one of the most studied species of psychedelic mushrooms, which is likely why the Board opted to use it as the pioneer species. 

Further, Psilocybe cubensis is not among the species of mushrooms that has been shown to cause wood lover’s paralysis, a rare condition that creates muscle weakness after the ingestion of certain wood-growing mushroom species in some folks. Further, fear of certain bacteria, such as E. Coli, have caused the Board to oust mushroom species that grow from dung.

While some Board members believe that keeping things simple and starting with a single mushroom species is the way to go, others believe that by limiting mushroom species to a single species, the program may be limiting the benefits offered by varying species of mushrooms. My guess is that while the Board will likely limit the type of mushroom species in some meaningful capacity, there will be more than one type of mushroom species that psilocybin manufacturers can produce when the final rules are promulgated.

The draft rules also prohibit manufacturers from manufacturing synthetically derived psilocybin or producing psilocybin by using genetically modified organisms. This piece more than any other comes as a surprise to me, as many folks in the industry have been speculating that the rules might favor synthetically-derived psilocybin due to the relative ease of controlling dosage/potency.

The draft rules include three types of manufacturer endorsements: 1) a fungi cultivation endorsement which would authorize its holder to produce whole fungi, mycelium, and homogenized fungi; 2) a psilocybin extraction endorsement which would authorize its holder to produce psilocybin extract; and 3) an edible production endorsement which would authorize its holder to produce edible psilocybin products. So, unless, something changes drastically during the rule-making process, it looks like extracts and edibles will be in play!

The draft products rules expressly prohibit any and all psilocybin products that cannot be consumed orally – meaning that psilocybin products delivered to clients via transdermal patches, inhalers, nasal sprays, and suppositories and injections are all expressly prohibited.

Stay tuned for more updates as Oregon’s psilocybin program progresses, including for a break-down of the draft psilocybin testing rules in advance of the RAC’s February 24^th meeting discussing them. For questions about Oregon’s psilocybin program please contact lindsey@gleamlaw.com.