Blog Outline

Short on time? Jump to relevant sections by clicking the links below:

1. i. Psilocybin Background in Oregon
2. ii. Psilocybin Supply Chain
3. iii. Psilocybin Manufacture
4. iv. Psilocybin Testing
5. v. Licensed Psilocybin Service Centers
6. vi. Licensed Facilitators
7. vii. Our Psilocybin Attorneys in Portland, Oregon

Psilocybin Background in Oregon

Having passed Oregon’s Ballot Measure 109, codified as ORS 475A, Oregon is implementing rules for the production, testing, and consumption of consumables containing the active ingredient found in certain mushrooms: psilocybin. The Oregon Health Authority started accepting applications for the psilocybin industry on January 2, 2023.

Oregon Psilocybin Services (OPS) administers these regulatory processes. OPS will provide oversight over the production, testing, and administration of the psilocybe cubensis mushroom and associated psilocybin products. OPS will also issue licenses to the facilitators that will assist with administration of the final tested products at the licensed service centers. The manufacture, processing, and retail of psilocybin products, as well as the licensing of psilocybin services providers, is being overseen by the Oregon Health Authority Public Health Division’s Center for Health Protection.

Below are some, but not all of the requirements for those wishing to apply to become part of the Oregon psilocybin industry.

Psilocybin Supply Chain

The psilocybin product supply chain that will be regulated by the Oregon Health Authority will have three parts:

1. Psilocybin products will be cultivated, produced, and processed by licensed manufacturers.  Manufacturers will need to apply for endorsements to determine the type of production they will be eligible for.  These endorsements include the cultivation of the psilocybe cubensis mushroom, extraction of psilocybin, and production of edible psilocybin products.
2. Psilocybin products created by a licensed manufacturer will be tested by a licensed laboratory accredited by the Oregon Environmental Laboratory Accreditation Program (ORELAP), the same accreditation program for licensed adult use and medical marijuana testing laboratories. The laboratory will test for the presence of the psilocybe cubensis mushroom and the potency of the product.
3. Psilocybin products will be made available to clients through licensed service centers at designated administration areas. A licensed psilocybin services facilitator will need to be present for the three components of the session, which involve preparation, administration, and integration.

ORS 475A.250 details additional requirements for applicants of licenses. These indicate that licenses may be refused, limited, or rescinded if the applicant is determined:

1. Not to have met the education or training requirements required,
2. Has not passed a required examination,
3. Is in the habit of using alcohol, habit-forming drugs, or any controlled substances to excess,
4. Has made false statements to authority,
5. Is incompetent or physically unable to perform the management of the establishment,
6. Has a conviction that impugns the fitness and ability to carry out the licensed activities lawfully,
7. Is not of good repute and moral character,
8. Does not have a good record of compliance with required provisions under ORS 475A,
9. Does not have the proper authority to make use of the applicant’s premises,
10. Has not demonstrated financial responsibility necessary to meet requirements of the premises, or
11. Is unable to understand the laws of Oregon relating to psilocybin and ORS 475A.

Psilocybin Manufacture

A manufacturer license is needed to grow psilocybe cubensis, as well as to process psilocybin products. Psilocybin products can be whole or ground dried mushrooms, extracts, and edible products. To qualify to hold a manufacturer license, applicants must meet the following general requirements:

1. The applicant must meet the minimum age requirement of being 21 years of age or older and must have a high school diploma or equivalent.
2. At this time, 50 percent of the partnership or ownership interest of the applicant’s business must be held by one or more individuals who have been Oregon residents for two or more years. This requirement is due to end in 2025.
3. An OPS Land Use Compatibility Statement (LUCS) must be signed by the local city or county authority, which shows the proposed property usage meets local land use and zoning codes. A response is required by the jurisdictional authority within 21 days, but additional work may be required to obtain approval, so the timeline may be lengthier.
4. If the property to be used is not owned by the applicant, written permission from the property owner is required.
5. Applicant(s) must pass a criminal background check.
6. The location where manufacturing is taking place must pass a site inspection to demonstrate administrative requirements have been met.

Applicants should review ORS 475A and the administrative rules outlined in OAR, Chapter 333-333. This is a critical first step in the process to ensure that the initial requirements do not prove to be an issue in subsequent stages of the application process. For example, a manufacturing location cannot be within 1000 feet of a school, with a few specific exceptions, and there are numerous rules regarding prohibited growing mediums for the mushrooms themselves.

Applicants should complete all of the pre-licensing requirements needed for the proposed manufacturing facility in advance of the application. The LUCS form, showing the proposed site is in compliance with land use and zoning requirements, is a primary prerequisite. A detailed property outline is also required. For applicants who are not the property owner, the landlord must also sign the OPS Property Permission Form, showing they understand and consent to the site’s intended use. Applicants must also submit a Social Equity Plan.

Endorsements are required to engage in specific parts of the manufacturing process, such as fungi cultivation, psilocybin extraction, and edible psilocybin production. An application fee of $500 will allow applicants to apply for multiple endorsements with just one initial fee. Additional endorsements may be sought after the initial application is submitted without any additional fees. Annual fees for approved applications are $10,000, though veterans, social security or food stamp benefit recipients, or Oregon Health Plan enrollees may qualify for a reduced fee.

Psilocybin Testing

Licensed psilocybin testing laboratory applicants must meet general requirements similar to those for manufacturers. The major difference in the psilocybin testing licensure process is the necessity of successfully passing the Oregon Environmental Laboratory Accreditation Program (ORELAP). This assessment will be determined based upon the accreditation rules and the 2016 (TNI) Standards. Applicants must register in the ORELAP Data Input and Edit (ODIE) system. The application will receive an invoice that must be paid before the onsite assessment is administered by ORELAP. If a certificate of accreditation is awarded, it must be renewed annually, with onsite assessments taking place every two years following the initial accreditation. As with other application types, applicants must submit a Social Equity Plan and detailed property outline.

Once the above listed requirements have been completed, an applicant can begin the license application process with OPS on the OPS Testing Laboratory License site. A $500 application fee is required. Once the fee and license application have been submitted, the applicant will be provided instructions on completing the background check process. The OPS team will also need to perform a site inspection to verify compliance with statute and administrative rule requirements. Psilocybin testing laboratories are subject to the same annual licensing fees.

Licensed Psilocybin Service Centers

Psilocybin products produced by licensed psilocybin manufacturers may only be consumed at licensed service centers. Licensed psilocybin service center applicants must meet the same codified general requirements as manufacturers and licensees, with a few differences, including the desired site being at least 1000 feet from a school. As with other application types, the next step will involve working with the local city or county to complete the OPS Land Use Compatibility Statement (LUCS). Service centers can be of any size so long as they meet all requirements set forth in the statutory and administrative rules. Outdoor administration areas are also permitted. A restroom is required, as well as secure facilities for holding client possessions during the sessions. A social equity plan will also need to be submitted.

Once the prerequisites have been completed, the applicant may begin the application process at the OPS Service Center Operator License site with a $500 fee, and an additional site inspection will take place. At this point, the applicant will receive information on how to complete the OPS Background Check Process as well. As before, licensed psilocybin service centers have similar annual fees.

Licensed Facilitators

The administration of psilocybin products may only be done with the assistance of a licensed facilitator in a licensed service center. Psilocybin products may not be taken off-site. There are three components to the service process, which begin with a preparation session, proceed to an administration session, and may be followed by an integration session.

The preparation session involves the use of a client intake process. The client must give informed consent and review the client’s bill of rights, which must be posted at licensed service centers. Safety and support planning, with a discussion on transportation arrangements, are required. A discussion with a licensed facilitator will also need to take place.

The administration session is where the actual consumption of psilocybin products takes place. An optional integration session will be offered following the administration session. Integration sessions will offer the client an opportunity to receive referrals to community resources and peer-support networks.

To be a licensed psilocybin facilitator, applicants must meet the following general requirements:

1. The applicant must meet the minimum age requirement of being 21 years of age or older and must have a high school diploma or equivalent.
2. At this time, applicants must be an Oregon resident. This requirement is due to end in 2025.
3. Applicants must pass a criminal background check.
4. Applicants must complete a training program approved by OPS before they apply.
5. An examination administered by OPS must be successfully completed.

The first step is to complete a training program that has been approved by OPS and pass the examination administered by your chosen training program. Tuition for these programs can be in the range of $10,000. The application process will require proof of age, education, and residence. Applicants must also submit a social equity plan and complete an OPS criminal background check.

Once the facilitator application has been submitted, the applicant must take the OPS Facilitator Exam and receive a score of 75% or greater. If necessary, applicants are allowed to retake the exam until they receive a passing score. There is a $150 application fee for the OPS application. Upon approval, an annual fee of $2,000 is required in most cases.

If you have questions about the licensed psilocybin application process or are considering joining the industry, please contact our psilocybin attorneys at Navigate Law Group.