Welcome to the third installment in my write-up of the proposed Oregon psilocybin program rules. I’m jumping in midstream from where I left off the last few days in Part 1 and Part 2. Similar to those installments, I will highlight the major areas, and skip or skim less prominent stuff. This batch of proposed rules is 65 pages, after all. You can read them for yourself here.
Licensed Premises Location Requirements (333-333-4300)
An Oregon Health Authority (OHA) licensed manufacturer, testing lab or service center licensee cannot be located on publicly owned land (of course) or at the same location as:
- a medical or adult use cannabis licensee or registrant;
- a liquor licensee;
- a health care facility;
- a location operating as a restaurant, commissary, mobile unit, B&B or licensed warehouse; or
- a residence
Some of that is too conservative, and certain of our clients already have issues with this rule. I’ll probably think hard about this one and submit a comment. For context, the adult use cannabis rules allow multiple licensees to be at the same “location” as that term is defined in these proposed psilocybin rules, provided they are siloed into separate suites or units (with separate entries and security). If there’s no concern about untracked cannabis spilling over from one licensee to another at a “location”, there should be none as to psilocybin and cannabis.
On the “health care facility” item, OHA obviously is taking pains to separate out any “medical” or “licensed therapy” portion from this supported adult use program (See: Warning: Oregon Legalized Supported Adult Use of Psilocybin, Not Psychedelic Therapy). Still, the prohibition on a co-located health care facility and psilocybin center seems unnecessary. Beyond that, I’ll reserve thoughts on (d) and (e) above. Those aren’t as big a deal.
When it comes to service centers, there are two further prohibitions on location. These include a prohibition on siting:
- within 1,000 feet of a public or private elementary or secondary school; or
- in an area zoned exclusively for residential use within city limits.
With respect to manufacturers who carry an “edibles” endorsement, they may not:
- process at a restaurant, mobile unit, BYB or licensed warehouse site;
- share a food establishment with another party;
- process non-psilocybin food for commercial sale; or
- operate in a kitchen that is not licensed by the Oregon Department of Agriculture.
Finally, there’s a prohibition for all psilocybin licensees on sublicensing their premises. The rule also exists in Oregon cannabis and people violate it frequently and unwittingly.
Licensed Premises Operating Requirements (333-333-4400)
This is another meaty section of the rules, though none of it is surprising. Here are some highlights beyond the “everyone everywhere needs to be 21 years old” criteria.
- Nothing intoxicating (including psilocybin) can be consumed onsite by a client outside of the psilocybin that is administered at the session itself;
- Limited access areas have to be strictly cordoned off and policed; the “general public” can never see behind the curtain here;
- Licensees must keep daily logs (and maintain them for two years) of both employees and permitted visitors;
- Everyone, including employees, must wear badges; non-employees must be accompanied by licensee reps at all times;
- Licensees must record a host of information for each employee and licensee representative in their training, licensing and compliance system; and
- No pets except service animals.
Client Administration Areas (333-333-4450)
This is a bunch of safety and “set and setting” requirements. There are some necessarily subjective standards here like “appropriate and comfortable.” Objectively, clients must be able to sit and recline. With indoor sessions, you’ve got to have climate control and “adequate” lighting. For outdoor sessions, no “falling” or drowning hazards. Psilocybin can only be consumed in the client administration area regardless.
A very important rule here is that only pre-authorized parties may enter a client administration session while ongoing. A client may leave an administrative session “briefly” if accompanied by a facilitator and if the service center makes “reasonable efforts to ensure that the client does not interact with vendors, contractors, other clients, or any persons who may be present at the service center.” Fortunately, no bathroom escort is required, though a later section of the rules requires that service centers offer access to a single occupancy restroom.
Stay tuned for follow-up posts in this series on Oregon’s proposed psilocybin rules. We’re close to halfway done. Also, remember to follow the RAC process (calendar is here) and take the opportunity to submit public comment on these rules if you’d like to see something changed or added. In the meantime, check out the following:
- Oregon Proposed Psilocybin Rules: Part 1
- Oregon Proposed Psilocybin Rules: Part 2
- Oregon Psilocybin Calendar
- Oregon Psilocybin Draft Rules: Products
- Oregon Psilocybin Draft Rules: Testing
- Oregon Psilocybin Draft Rules: Training
Finally, for any Oregon lawyers in the crowd, I am presenting on these proposed rules on September 23. I will be joined by Mason Marks, Board appointee and Harris Bricken attorney, and OHA’s Jesse Sweet, who is the primary drafter of these rules.