We’re finally ready to launch. After a two-year advisory and developmental period, the Oregon Health Authority (OHA) has adopted and released final rules to implement a first-of-its-kind, regulated psychedelics program. You can find the new rules here. OHA will also begin accepting applications for psilocybin service centers, testing labs, manufacturers and facilitators next Monday, January 2. Should be an interesting ride!
Final rules, finally
Anyone familiar with this blog may recall that we plumbed the depths of these rules when comprehensive drafts were released this fall. See:
- Oregon Proposed Psilocybin Rules: Rule Highlights
- Oregon Proposed Psilocybin Rules: License Fees
- Oregon Proposed Psilocybin Rules: Licensed Premise Requirements
- Oregon Proposed Psilocybin Rules: Service Centers
- Oregon Proposed Psilocybin Rules: Facilitators, Sessions, Dosing
- Oregon Proposed Psilocybin Rules: Tracking, Advertising, Prohibited Conduct
Much of what we covered in those posts remains in place. Not everything, though. In conjunction with the rules drop, OHA released a Letter to the Public (“Letter”) and a Hearings Officer Report (“Report”), which summarize feedback the Authority received during the recent public comment period. These missives also explain some of the rationale for OHA’s final body of work.
Interestingly, OHA reports that it “received over 200 written comments and six hours of comments” last month following its last release of draft rules. At first blush those numbers may feel significant, but given the novelty of the program, its diversity of interested parties and its scope, they are far from overwhelming. This appears consistent with: 1) the phenomenon of interested parties having strong opinions about controlled substances programs (and government programs more generally), but declining to contribute to the record, and 2) the fact that the regulated psilocybin industry in Oregon will be smaller than many people initially expected.
I encourage interested parties to review the Letter and the Report. The Letter categorizes topics of interest into four main categories: 1) equity and access, 2) public health and safety, 3) operational flexibilities and 4) affordability. The Report is more granular on all of these issues, using a “call and response” type format to summarize key public comments and OHA’s responses thereto. Below are the highlights for me.
Some things changed; others not
Microdosing. OHA isn’t going to use the “microdose” term, but the Authority will allow that practice. These rules create a new tier of administration sessions for subperceptual doses, which is welcome news to many. As written, for anything at 2.5mg or less, the minimum session will last an hour; after that, subsequent sessions are required to last 30 minutes.
Outside parties in administration sessions. Still not allowed. Facilitators and clients only.
License fees. Many people (including yours truly) have argued that fees are too high, especially for facilitators. OHA isn’t going to bend on this. That’s not surprising, from the perspective that the program’s fiscal forecast is already looking grim, and OHA must demonstrate sustainability going into the 2023-2025 budget biennium.
Emergency services. I and others noted that the draft rules were problematic as to the requirement that facilitators and license representatives immediately call emergency services in certain circumstances. The rules have been amended to require service centers to adopt procedures for client emergencies, and to take mitigation steps prior to contacting emergency services.
Client data and privacy. Another hot button topic. The draft rules limited client rights to confidentiality and privacy only “while receiving psilocybin services.” The final rules amend the definition of “de-identified” data and clients are now allowed to opt-out of allowing their de-identified data to be shared, entirely.
Outdoor group sessions. The proposed requirement that a service center provide an indoor area for participants in outdoor sessions is removed, based on impracticality.
Background checks for licensees. Clarifications were made here. Big picture, anyone identified as an “applicant” on an initial worker permit or license application will be required to undergo a criminal background check and fitness determination. For renewal applications, checks “may be required… at regular intervals determined by the Authority.”
Co-location with cannabis businesses. OHA received comments that psilocybin operations should be allowed to co-locate with cannabis businesses, and also that they should not. The draft rules haven’t changed here: a psilocybin business can be located on the same property as a cannabis business, but the businesses’ footprints on that property cannot overlap.
How to apply for an Oregon psilocybin license?
We have probably received more questions on how to apply than anything else in the past month or two. As of the writing of this post (December 27), applications still aren’t posted on the OHA site and the portal is not open. That should change this week. Keep checking.
We expect to work with quite a few clients beginning next week on getting these applications submitted. From our discussions with OHA, the Authority still expects the first service centers to open by summer. For that to happen, psilocybin manufacturers and testing labs would obviously have to be up and running.
If you are looking to become a licensee or otherwise participate in the regulated Oregon psilocybin program, give us a call. In the meantime, check out our expansive coverage for participants in this pioneering program here.
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