This is the sixth and final installment in my write-up of the proposed Oregon psilocybin program rules. This post will cover product transportation and tracking, advertising, prohibited conduct, and penalties. I’ll skip waste management. As with earlier installments in this series (linked below), this post will highlight key areas and skip or skim less prominent material.
Product Transportation (333-333-8100)
The basic idea is that all movement of psilocybin inventory is controlled and tracked. Psilocybin products within a delivery vehicle must be stored in a locked, secured area, which is also temperature-controlled and out of public view. Vehicles must go straight from point A to point B, as per the manifest route. No dallying.
Manifests are printed out of the psilocybin tracking system, and the receiving licensee must verify the contents of any manifest delivery prior to recording receipt and entering any or all of those products into their own tracking system interface. Very similar to the cannabis rules.
Product Tracking (OAR 333-333-8200 – 8260)
Product tracking is covered in six separate subsections, all of which are technical and dry. All service center, manufacturer and laboratory licensees must use the psilocybin tracking system, and appoint at least one administrator. Then, everything must be tracked, always. And reconciled with inventory. Unique identification numbers must be assigned and affixed to areas containing cultivation batches, and then to products in various stages of refinement.
The Oregon Health Authority (OHA) may conduct inventory audits at any time, and any variance between the physical audit and tracking system which cannot be attributed to “normal moisture variation psilocybin products” is a violation. System-generated compliance notices may be generated, and licensees are charged with monitoring and addressing these in a timely fashion.
Prohibited Conduct; Dishonest Conduct (333-333-6000; 6030, 6040)
No surprises here. Sales and services of psilocybin can only be provided to persons 21 or older, after identification has been provided. A licensee or related party cannot at any time deny the OHA access to its licensed premises. All licensees must also retain total control over their licensed premises at all times, including inventory. Failure to do so is a “Category I” violation and may be grounds for immediate suspension or revocation of a license.
No use of intoxicating substances is allowed by a licensee or any non-client person at the premises; and no “disorderly activities” or “unlawful activities” (with respect to state law) are allowed. No delivery of psilocybin is allowed off the licensed premises; and most definitely no import or export of psilocybin– in or out of state.
Additional rules apply specifically to laboratory licensees. Like all Oregon testing labs, they must be accredited through the Oregon Environmental Laboratory Accreditation Program (ORELAP), and use equipment and testing methods approved by that program. Labs may not sample or test for manufacturers in which the laboratory licensee has a financial interest, for obvious reasons.
The rules around “dishonest conduct” are pretty short. A licensee cannot make a false statement or representation to OHA. A licensee also cannot “misrepresent any psilocybin item to a consumer, licensee or the public.” This includes misrepresentations about the contents of products, or testing results; and a big one: licensees cannot make “representations or claims that the psilocybin product has curative or therapeutic effects.”
Finally, there are prohibitions on “adulterated” psilocybin items, and damaging or removing evidence of prohibited or dishonest conduct.
Advertising Restrictions; Media, Coupons and Promotions (333-333-6100; 6110))
Oregon has the broadest speech protections in the nation (resulting in a naked bike ride, tons of strip clubs and no campaign finance restrictions). This means OHA latitude on restricting licensee advertising for the psilocybin program is relatively narrow. Still, they took a whack at it in this short section, cribbing a fair bit from OLCC and the cannabis rules.
Licensees are not allowed to make “statements that are deceptive, false or misleading.” They can’t target individuals under the age of 21 through use of cartoons and toys, or placement of billboards or other advertising media where 30% or more of the audience may be under 21. They can’t encourage activity that’s illegal under state law.
Here’s the most interesting one, though: they cannot claim that psilocybin products have curative or therapeutic effects, or “make other health claims that are not supported by the totality of publicly available scientific evidence….”. The wording continues and painstaking. I’m sure we’ll see a fair number of facilitators and service centers make claims that OHA finds objectionable under OAR 333-333-6100(1)(e).
As to “coupons and promotions”, well, I don’t know. Those topics are listed in the section title but the topics are not borne out. I can only assume this is an oversight and that OHA will land somewhere similar to where OLCC did with cannabis on discounting. Let’s see.
Suspension, Cancellation, Civil Penalties, Sanction Schedule (333-333-6200)
These draft rules adopt the a “Category I – IV” sanctions schedule that will be familiar to licensees in the Oregon cannabis program. Category I violations are the most serious and “pose the highest risk to public health and safety or make a licensee ineligible for a license.” Category IV violations are “technical in nature and inconsistent with the orderly regulation of the [psilocybin program].”
There’s a companion sanctions schedule here which lays out the fines and suspensions applicable to licensees and those with worker permits for various categories of violations. OHA did a nice job here of enumerating what might be considered “aggravating circumstances” or “mitigating circumstances” when it comes to disposition of violations and penalties.
If you’re interested in these rules and any potential changes, remember to follow the RAC process (calendar is here) and take the opportunity to submit public comment 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 Proposed Psilocybin Rules: Part 3
- Oregon Proposed Psilocybin Rules: Part 4
- Oregon Proposed Psilocybin Rules: Part 5
- 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 this Friday, 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.
The post Oregon Proposed Psilocybin Rules, Part 6: Tracking, Advertising, Prohibited Conduct appeared first on Harris Bricken Sliwoski LLP.