Estimated reading time: 17 minutes
Table of contents
- General Manufacturer License Requirements
- Steps to Become a Licensed Manufacturer
- How People Access Psilocybin Services in Oregon
- How Do Psilocybin Products Get to a Service Center?
- Safety and Compliance
- Closing Thoughts
- Additional Resources
- FAQs
- Consulting Services For Cannabis, Hemp, Psilocybin, and Natural Medicine
- Testimonials and Public Relations
- Latest Articles
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- Free Ebook – Start Your Own Legal Cannabis Business
In November 2020, Oregonians passed The Oregon Psilocybin Services Act (M109), which is now codified into Oregon law in ORS 475A. This statute establishes a licensing and regulatory framework for psilocybin services in Oregon. Before taking steps to become licensed, please go to the: “Training Video on ORS 475A: What is the Oregon Psilocybin Services Act?” and “What are Psilocybin Services?” to learn more. Many applicants find that consulting with a knowledgeable Psilocybin Consultant provides clarity throughout this process.
Licensed manufacturers may only cultivate or process products containing the species Psilocybe Cubensis. Synthetic psilocybin and wild harvesting of fungi are not permitted. Psilocybin products may include whole dried mushrooms, ground homogenized fungi, extracts, and edible products. Applicants for a manufacturer license will need to apply for specific endorsement types, which include fungi cultivation, psilocybin extraction, and edible psilocybin production. There is no additional cost for endorsements; however, an applicant will need to understand all requirements related to the endorsements they are planning to apply for. For expert guidance, consider reaching out to a professional in Psilocybin Consulting.
General Manufacturer License Requirements
1) Must be 21 years of age or older.
2) Must acquire a Land Use Compatibly Statement (LUCS) form, signed by local city or county, which demonstrates that the proposed use of the property is consistent with local land use and zoning codes.
3) If not the owner of the property, must acquire written permission from the property owner for proposed use.
4) Prepare a Premises Plan, which must be submitted as part of the application process.
5) If planning to apply for an Edible or Extract endorsement, an Oregon Department of Agriculture Food Safety License will be required.
6) Must pass a criminal background check.
7) Must pass a site inspection as part of the license application process.
Steps to Become a Licensed Manufacturer
- Review and understand statutory (ORS 475A) and administrative rule (OAR, Chapter 333-333) requirements related to a manufacturer license. Many applicants benefit from working with a Psilocybin Consultant who can offer insights into these regulations.
- Decide which endorsements to apply for.
- Before submitting an application, you will need to work with your local city or county jurisdiction to complete an OPS Land Use Compatibility Statement (LUCS) form which identifies an applicant name listed on the license application and demonstrates that the proposed property is in compliance with local land use and zoning requirements. Your local jurisdiction will need to review and approve the LUCS. Once you make the request, your local jurisdiction is required to respond within 21 days. For further clarification, consider engaging a Psilocybin Consulting service.
- Complete the Property Permission Form. If you are not the owner of the proposed premises, you must submit an OPS Property Permission Form that has been signed by the property owner and demonstrates that the owner understands and consents to the proposed use of the property for manufacturing psilocybin products.
- Complete a scaled floorplan and premises plan. As part of the license application process, you will need to submit a scaled floorplan of the proposed licensed premises. Please see the General OPS Premises Plan Checklist and the OPS Manufacturing Premises Plan Checklist for more information. Our Psilocybin Consultants can assist in ensuring your documentation meets all requirements.
- Prepare materials for the application process. You will need to provide proof of being 21 years of age or older. If the applicant is a legal entity, please see the Legal Entity Applicant Information Form Instructions. You will also need to submit a social equity plan. Please refer to the OPS Social Equity Plan Resources for resources that can support applicants in meeting this requirement. Expert advice from a Psilocybin Consultant can streamline this process.
- Begin your license application process with OPS. To begin an online application, account registration is required. Go to the OPS Training Program, Licensing, and Compliance (TLC) platform at: https://psilocybin.oregon.gov to access TLC and create an account. For TLC tips or to troubleshoot TLC issues, please view the OPS TLC Login and TLC Messages Guidance Document. If you are unable to complete the application online using the TLC platform and would like OPS to mail a paper application to you, please contact the OPS Licensing Program at 971-673-0304 or email licensing.psilocybin@oha.oregon.gov. Complete the criminal background check process. Once you have submitted a license application to OPS, you will be sent more information about how to complete the required background check. To prepare, please see this handout on the OPS Background Check Process. A Psilocybin Consultant can also help navigate the online process.
- Pay a $500 application fee. OPS will review your application as quickly as possible after the payment has cleared. You will want to monitor your email inbox for messages about next steps. OPS staff will need to visit your proposed location and perform a site inspection to ensure your premises is compliant with statute and rule requirements. Please refer to the Inspection Orientation for Manufacturer Applicants to ensure that you are prepared for the site inspection. Consider speaking with a Psilocybin Consultant to ensure you are well-prepared for the inspection.
- Pay the annual license fee of $10,000. If you are approved for licensure, you will be required to pay an annual license fee of $10,000. Individual applicants who are veterans, receiving Supplemental Security Income, receiving food stamp benefits, or are enrolled in the Oregon Health Plan may qualify for a reduced annual licensure fee of $5,000. If applicants are part of a legal entity or there are more than one individual applicants, they may be eligible for a reduced license fee if every individual applicant within the entity meets requirements for reduced fees in OAR 333-333-4060. More information can be found in administrative rules.
How People Access Psilocybin Services in Oregon
Individuals are able to access psilocybin services for any reason. A prescription or referral from a medical or clinical provider is not required. Clients must be 21 years of age or older and participate in at least one preparation session with a licensed facilitator before they consume psilocybin during an administration session at a licensed service center.
1) Schedule a Session: A person interested in accessing psilocybin services will contact licensed service centers for information about psilocybin services. Once they find a service center that fits their needs, the potential client will schedule a preparation session with a licensed facilitator associated with the licensed service center they choose to work with. The OPS Licensee Directory includes contact information for service centers that have consented to being listed. Potential clients may also verify if a service center has a valid license by using the Search for License or Permit Status tool. A Psilocybin Consultant can help clarify these steps if needed.
2) Preparation Session: The client meets with a licensed facilitator for a preparation session and completes required forms (including: client information, bill of rights, informed consent, safety and support plan, transportation plan, and accessibility). A licensed facilitator determines whether they can provide services to the client, and the client determines whether they want to move forward with an administration session. How People Access Psilocybin Services in Oregon
3) Administration Session: The administration session takes place at a licensed service center. The client buys psilocybin products from a licensed service center and consumes psilocybin at the beginning of their administration session. The client remains at the service center with the licensed facilitator until they are ready to be released from the session. For group administration sessions, a minimal client-facilitator ratio is required. Within 72 hours after the session, the licensed facilitator contacts the client to check on them. An optional integration session is offered.
4) Integration Session: If the client chooses to take part in an optional integration session, they may review their safety and support plan or request referrals for community resources, peer support networks, and other resources at that time. Professional guidance from a Psilocybin Consultant may enhance the integration process.
How Do Psilocybin Products Get to a Service Center?
1) Psilocybin products are cultivated, produced, and/or processed by a licensed manufacturer and tracked in a product tracking system.
2) Psilocybin products are tested by a licensed laboratory that is accredited by the Oregon Environmental Laboratory Accreditation Program (ORELAP). Test results are entered into the product tracking system.
3) Psilocybin products are sold or transferred from a licensed manufacturer to a licensed service center and tracked in the product tracking system.
Safety and Compliance
OPS will investigate complaints, incidents, or concerns related to safety issues or statute and rule violations that occur on licensed premises and during the provision of psilocybin services. Once we receive a complaint, OPS will determine if there are potential violations of ORS 475A or OAR 333-333 and whether the Oregon Health Authority is the agency with jurisdiction to take further action. Oregon Psilocybin Services will only investigate violations of ORS 475A or ORS 333-333. Complaints related to criminal activity are a matter for law enforcement. Complaints are subject to public disclosure under Oregon’s Public Records Law. If a complainant is concerned about their privacy or safety, OPS will make effort to keep their identity confidential to the extent permitted by law.
During an investigation, OPS will conduct interviews with the complainant, witnesses, and licensees involved. If needed, we will also interview clients. OPS will request all relevant records and any security camera footage, if available. If statute or rule violations are discovered and there is enough evidence to prove the violation, the licensee will be issued a notice of a proposed administrative action that proposes some disciplinary licensing action and/or civil penalty. Administrative sanctions depend on the severity of violation and may include restriction of a license, civil penalties, or suspension or revocation of a license. A licensee will have between 20-30 days to request a hearing, depending on what the proposed sanction is. If requested, the hearing would be conducted by an Administrative Law Judge (ALJ). After the hearing, the ALJ would issue their proposed order and then OHA would issue a final order. For more information on categories of OPS’s administrative violations, please reference OAR 333-333-6200.
Closing Thoughts
Our team is dedicated to providing comprehensive psilocybin licensing support, facility design, and full business support services to the regulated community. For expert guidance tailored to your specific needs, schedule a complimentary call with our Oregon Psilocybin Consulting team today.
Additional Resources
FAQs
What is psilocybin?
Psilocybin is a naturally occurring psychedelic compound found in over 200 species of mushrooms. For centuries, Indigenous and tribal communities have used psilocybin for spiritual, ceremonial, and other purposes. Regulated psilocybin services are now legally available in Oregon, and a professional Psilocybin Consultant can help you understand this evolving field. Note that psilocybin remains a Schedule I substance under the Federal Controlled Substances Act
Schedule I substance under the Federal Controlled Substances Act.
What are the benefits of psilocybin?
Research suggests psilocybin may help address depression, anxiety, trauma, and addiction. Studies have also found it can increase spiritual well-being. To learn more about the research on psilocybin benefits and risks, see the Scientific Literature Review and Cultural and Anthropological Information. These publications are available in English and Spanish. Engaging with a Psilocybin Consultant can further clarify these benefits.
What are psilocybin services?
In Oregon, “psilocybin services” refers to preparation, administration, and integration sessions provided by a licensed facilitator. The psilocybin products consumed must be cultivated or produced by a licensed psilocybin manufacturer, tested by a licensed laboratory, and may only be provided to a client by a licensed psilocybin service center during an administration session. Clients must remain at a licensed service center for the duration of the administration session. Clients must be age 21 or older. Clients do not need a prescription or medical referral and they do not need to be Oregon residents.
How does an individual access Psilocybin Services?
1) Schedule a Session: A person interested in accessing psilocybin services will contact licensed service centers for information about psilocybin services. Once they find a service center that fits their needs, the potential client will schedule a preparation session with a licensed facilitator associated with the licensed service center they choose to work with. The OPS Licensee Directory includes contact information for service centers that have consented to being listed. Potential clients may also verify if a service center has a valid license by using the Search for License or Permit Status tool. For personalized assistance, a Psilocybin Consultant can offer expert advice.
2) Preparation Session: The client meets with a licensed facilitator for a preparation session and completes required forms (including: client information, bill of rights,
informed consent, safety and support plan, transportation plan, and accessibility). A licensed facilitator determines whether they can provide services to the client, and the client determines whether they want to move forward with an administration session.
3) Administration Session: The administration session takes place at a licensed service center. The client buys psilocybin products from a licensed service center and
consumes psilocybin at the beginning of their administration session. The client remains at the service center with the licensed facilitator until they are ready to be released from the session. For group administration sessions, a minimal client-facilitator ratio is required. Within 72 hours after the session, the licensed facilitator
contacts the client to check on them. An optional integration session is offered.
4) Integration Session: If the client chooses to take part in an optional integration session, they may review their safety and support plan or request referrals for community resources, peer support networks, and other resources at that time. A Psilocybin Consultant can help integrate the experience effectively.
How do I apply online for a Psilocybin Manufacturer license in Oregon?
The Oregon Psilocybin Services (OPS) – Training program, Licensing, and Compliance (TLC) system is an online platform where applicants can apply for training program curriculum approval, psilocybin licenses, and worker permits, as well as enter product tracking requirements under ORS 475A and OAR 333-333. The TLC system is also a communications platform for messaging the OPS Licensing and Compliance teams.
Only applicants and licensees can access the TLC system. Please refer to the OPS TLC Login Guidance to guide you through creating a TLC account, logging into the system and troubleshooting TLC issues. For added support, a Psilocybin Consultant can assist with navigating the application process.
What additional forms are required to apply for a Psilocybin Manufacturer license in Oregon?
Individual Applicant Information Form
Legal Entity Applicant Information Form
Premises Plan Checklist (General)
Manufacturing Premises Plan Checklist
Property Owner Consent for Manufacturing Psilocybin
Can I apply for a Psilocybin Manufacturer license in Oregon by mail?
If you are unable to complete the application online using the TLC platform and would like OPS to mail a paper application to you, please contact the OPS Licensing Program at 971-673-0304 or email licensing.psilocybin@oha.oregon.gov.
Additional required forms:
Property Owner Consent for Manufacturing Psilocybin
Individual Applicant Information Form
Legal Entity Applicant Information Form
Premises Plan Checklist (General)
Manufacturing Premises Plan Checklist
How often do I need to renew my Oregon Manufacturer license?
All psilocybin license types have a one-year term, beginning on the date the license was first issued.
To ensure license continuity, you must submit a complete renewal application at least 60 days before your license expires. See OAR 333-333-4250.
- Renewal applications that are complete, submitted according to requirements, and submitted at least 60 days before the license expires will be considered timely under OPS rules. Licensees who submit timely applications may continue to operate on an expired license if OPS is unable to process the renewal application prior to the license expiration date. Incomplete renewal applications will not be considered timely unless they are made complete at least 60 days before the license expires.
- Renewal applications that are submitted less than 60 days before the license expires will be considered untimely under OPS rules. Licensees who submit untimely applications are prohibited from continuing to operate on an expired license if OPS is unable to process the renewal application prior to the license expiration date. Licensees are prohibited from exercising license privileges on the date their license expires if OPS is unable to process their renewal application before the expiration date and the renewal application is untimely.
We encourage licensees to begin the renewal process as soon as the renewal window in TLC opens. The renewal window in TLC opens 120 days prior to your license expiration date.
How do I make changes to my Oregon Manufacturer license?
Licensees are required to use the forms below for change requests. These forms must be submitted to the OPS Licensing team through the Training program, Licensing and Compliance (TLC) system. Please attach the necessary form and any other required documents to a TLC message and send to the OPS Licensing team. For questions, please email: Licensing.Psilocybin@oha.oregon.gov
Change of Name
To request a change of name, including a change to a manufacturer’s operational name, legal entity name, or to update a legal name change of an individual licensee, manufacturers must submit a completed Change of Name Form.
Change of Licensee
Manufacturers may use this form to remove individual and legal entity licensees from their approved business structure or add applicants to the licensed business. To request a change of licensee, manufacturers must submit a completed Change of Licensee Form and all required documents.
Change of Licensee Form
Change of Manufacturer Endorsements
To request to add or remove an endorsement, manufacturers must submit a completed Request to Change Manufacturer Endorsements form and all required documents.
Request to Change Manufacturer Endorsements
Change of Location
To request a change of location of a licensed premises, manufacturers must submit a completed Change of Location Request and all required documents.
Change of Location Request
Modification of Licensed Premises
To request a modification of a licensed premises, manufacturers must submit a completed Modification of Licensed Premises request and all required documents.
Modification of Licensed Premises Request
For any change requests not covered by these forms, please message the licensing team in TLC messenger with your request. For further guidance, consider consulting with a Psilocybin Consultant who is experienced in managing regulatory changes.
Are Food Safety Licenses Required for Manufacturing Psilocybin in Oregon?
The Oregon Department of Agriculture (ODA) is responsible for regulating the production, processing, and distribution of food products in the state of Oregon. If you are considering selling, storing, or manufacturing edibles or extracts, please visit the ODA Food Safety Program webpage and reference the resources below.
The following products require a Food Establishment License:
| Product Type: | Edible Psilocybin Food Product (including beverages) | Psilocybin Extracts (tinctures) | Whole Dried Fungi | Homogenized Fungi (including tablets and capsules) |
|---|---|---|---|---|
| Food Safety License required: | Yes | Yes | No | No |
An OPS license is not required before ODA can provide onsite consultation help, review site plans, or issue a food safety license. But remember that your ODA food safety license does not mean that you may legally operate. You still must be licensed by OPS and meet all other requirements.
ODA will not be able to issue a Home (Domestic) Kitchen Processing and/or Domestic Kitchen Bakery License for the manufacturing of psilocybin products. Psilocybin edible products must be manufactured according to the same standards as manufactured foods.
ODA will not be able to issue a Home (Domestic) Kitchen Processing and/or Domestic Kitchen Bakery License for the manufacturing of psilocybin products. Psilocybin edible products must be manufactured according to the same standards as manufactured foods. For additional assistance, a Psilocybin Consultant can offer expert advice.
What are the requirements for scales used in commercial Psilocybin manufacturing in Oregon?
Scales that are used for commercial activity require a license in Oregon. All OPS manufacturers that are producing standardized packages of fungi, extracts, or edibles will be required to have a licensed commercial scale. Learn more about required scales, weights and measures:
What services are available to help me navigate licensing and secure a compliant facility?
Contact our Oregon licensing team for specialized consulting and coaching through the Psilocybin application and licensing processes. Additionally, our facility design experts will guide you through local regulations, building compliance, new construction, or retrofitting an existing space to meet local laws and regulations for a licensed Oregon Psilocybin Manufacturing Facility.
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