Overview of Psilocybin Licensing
With over 38 states legalizing medical marijuana, communities throughout the United States are seeing a increase in support to further expand patient access to alternative medicines such as psychedelics. In 2017, Oregon deviated from federal law as first-time possession of small amounts of psychedelics was downgraded from a Class B felony to a Class A misdemeanor. Furthering this separation of state and federal law, Oregon residents pushed for psilocybin to be an accepted form of palliative treatment through a citizen’s initiative, Measure 109. The purpose of this initiative is to allow access of psilocybin to terminally ill patients whose diagnoses have led to treatment-resistant anxiety and depression.
With the passage of Measure 109—now known as the Psilocybin Services Act, Oregon law enlists the Oregon Health Authority (“OHA”) to create and instill procedural rules and regulations of administering psilocybin. This Act allows the State of Oregon to develop a “long-term strategic plan” to ensure that psilocybin is not only affordable, but a safe therapeutic option for those suffering from mental disorders.
Timeline
- OHA Board to submit Rules & Regulations by June 30, 2022
- Draft of rules should be coming out by September 1, 2022
- Local Ordinances to determine Zoning by November 8, 2022
- ALL rules will be adopted by December 31, 2022
- Begin accepting applications for Psilocybin Business Licenses by January 2, 2023
Types of Licenses
1. Manufacturer License
This license allows a business to manufacture, plant, cultivate, grow, harvest, produce, prepare, and propagate psilocybin mushrooms. It also allows licensee to package psilocybin products and label its container.
2. Service Center License
This license will allow establishments to administer psilocybin sessions such as psilocybin therapy. To summarize, the services may include: preparation session, administrative session, and integration session. Under this license, a patient will purchase, consume, and experience the psilocybin product under the supervision of a psilocybin service facilitator.
3. Facilitator License
This license will be issued to individuals who will conduct the services detailed above. To be a facilitator, the individual must have a high school diploma, or equivalent, as well as proof of Oregon residency of 2+ years and pass a criminal background check. In addition, they must complete: (1) Training Program approved by OPS; (2) An exam administered by OPS; and (3) all other licensing requirements.
4. Testing Laboratory License
To acquire this license, an applicant must be accredited by Oregon Environmental Laboratory Accreditation Program (“ORELAP”). ORELAP is NOW accepting accepting applications for accreditation.
Eligibility Requirements
- 21 years or older
- 50% of the Manufacturing or Service Center License must be owned by residents of Oregon for 2+ years.
- No disqualifying convictions
- Ownership Limitations (cannot exceed below):
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- A person can hold up to 5 Service Center Operator Licenses
- A person can hold both a Manufacturer License and a Service Center Operator License at same/ different premises.
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- Financial Limitations:
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- No financial interest in more than 1 Psilocybin Product Manufacturer
- No financial interest in more than 5 Psilocybin Service Center Operators
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Upcoming Applications for Psilocybin Licenses
Oregon has not published the final application instructions yet, but it is expected to have a similar process to cannabis business licensing.
Expected components of the application:
- Business Plan
- Financial Plan
- Psilocybin Cultivation Plan
- Manufacturing Plan
- Security Plan
- Operating Plan
- Inventory Tracking Plan
- Quality Assurance and Control Plan
- Education Plan
- Community Impact Plan
- Standard Operating Procedures (SOPs)
With the application period fast-approaching by January of 2023, NOW is the time to work with our Team of experts to ensure you and your company are one of the first to enter into the psilocybin industry. If you are interested in pursuing a psilocybin license in Oregon, contact us to begin to put together a comprehensive and strategic business plan. Schedule an appointment here so we can discuss your options!