Oregon Psilocybin Manufacturer License

The Oregon Psilocybin Manufacturer License is a required certification for businesses and individuals looking to the cultivation and production of psilocybin under the Oregon psilocybin program. The license authorizes the licensee to cultivate (indoor) or process natural psilocybin products. The psilocybin manufacturer license is issued by the Oregon Health Authority (OHA). Any individual or entity intending to legally grow, extract, or process psilocybin for use in Oregon must obtain this license.

Requirements for Oregon Psilocybin Manufacturer License

Anyone seeking an Oregon psilocybin manufacturer license in Oregon must meet the following conditions:

Be aged 21 years older
Obtain a Land Use Compatibility Statement (LUCS) form signed by your local city or county authority, confirming that the property complies with local land use and zoning codes.
Secure written permission from the property owner for the intended use of the facility where they intend to set up (if they do not own the property)
Prepare and submit a Premises Plan
Obtain an Oregon Department of Agriculture Food Safety License if they are applying for an Edible or Extract endorsement
Successfully pass a criminal background check
Complete and pass a site inspection during the licensing process

How to Get a Psilocybin Manufacturer License in Oregon

You may apply for an Oregon psilocybin manufacturer license in the following way:

Understand Legal Requirements: Before submitting an application, it is important to review the relevant laws and regulations, including the statutory requirements outlined in ORS 475A and Chapter 333-333 of the Oregon Administrative Rules, to ensure compliance with licensing obligations.
Choose Endorsements: Decide which endorsements you want to apply for, as these will define the specific activities your license will cover. Examples include endorsements for fungi cultivation, psilocybin edible production, or psilocybin extraction.
Obtain a Land Use Compatibility Statement (LUCS): Before submitting your application, schedule a visit or contact your local city or county jurisdiction in order to complete an OPS Land Use Compatibility Statement (LUCS).

This document confirms that the proposed property aligns with local land use and zoning requirements. Your local jurisdiction will review and approve the LUCS, with a response required within 21 days of your request.
Complete the Property Permission Form: If you are not the owner of the property where you intend to operate, you must submit an OPS Property Permission Form signed by the property owner. This form verifies that the owner understands and agrees to the proposed use of the property for psilocybin manufacturing.
Prepare a Premises Plan and Scaled Floor Plan: Develop a scaled floor plan and a detailed premises plan of the proposed licensed location. Ensure your documentation aligns with the guidance provided in the General OPS Premises Plan Checklist and the OPS Manufacturing Premises Plan Checklist.
Gather Application Materials: Collect all required materials for your application. This includes proof of age (21 or older), social equity documentation, and additional forms for legal entity applicants if applicable. For guidance on creating a social equity plan, see the OPS Social Equity Plan Resources available on the Oregon government website.
Submit the License Application: Create an account on the OPS Training Program, Licensing, and Compliance (TLC) system on the Oregon psilocybin website. Begin your online application, or if you prefer a paper application, contact the OPS Licensing Program at (971) 673-0304 or via email at licensing.psilocybin@oha.oregon.gov.
Complete a Criminal Background Check: Once your psilocybin license application is submitted, follow the instructions provided by OPS to complete the required criminal background check. You may use the OPS Background Check Process handout for preparation.
Pay the Application Fee: You will be required to pay a non-refundable application fee of $500. Once payment is processed, OPS will begin reviewing your application and notify you by mail about the next steps.
Site Inspection: Here, Next, OPS staff will visit your proposed site for inspection to ensure that the location complies with all rule and statute requirements. You may use the Inspection Orientation for Manufacturer Applicants to prepare for this review.
Pay the Annual License Fee: Upon approval of your application, you will be required to pay an annual license fee of $10,000. Qualified applicants, such as veterans or individuals receiving certain government benefits, may be eligible for a reduced fee of $5,000. Applicants who are part of a legal entity or applying as a group may qualify for a discounted license fee provided that all individual applicants within the entity meet the eligibility criteria outlined in OAR 333-333-4060.

How to Prepare an OPS Social Equity Plan

Every Oregon Psilocybin Service license applicant (including manufacturers, service centers, facilitators, and laboratories) is required, per OAR 333-333-4020, to create a social equity plan before they may be issued a psilocybin license under the Oregon Psilocybin Program.

According to state law, a social equity plan is required to ensure that Oregon psilocybin licensees acknowledge the disproportionate harm caused to certain communities in the state by systemic inequities and how they intend to address such inequities in the operation of their psilocybin businesses.

Per the OPS Social Equity Plan document on the Oregon Health Authority website, a social equity plan must contain the following:
A definition of justice, equity, diversity, and inclusion principles and how the business intends to apply them in practices and policies:
A definition of the Justice, Equity, Diversity, and Inclusion (JEDI) principles that are meaningful to them and their role as an OPS licensee. They may also include commitments to these principles.

Additionally, applicants must explain how these principles will be incorporated into their policies and practices, acknowledging both challenges and opportunities. This can include:
Aligning policies with Healthier Together Oregon goals.
Efforts to increase diversity in ownership, management, and employment within the psilocybin industry.
Workforce training and investments in JEDI initiatives.
Plans to serve priority populations and collaborate with community leaders or organizations to improve accessibility.
An identification of at least one objective performance measure that the psilocybin business intends to use to evaluate the social equity plan: To assess the effectiveness of a Social Equity Plan, applicants must establish clear objective performance measures with defined data collection methods. These measures help track progress and identify areas for improvement in JEDI efforts.

Key requirements include:

Setting specific annual goals tied to JEDI principles.
Identifying at least one measurable goal and a method for tracking progress.
Ensuring goals follow the JEDI-SMART framework - Specific, Measurable, Achievable, Relevant, and Time-bound.

The Oregon Psilocybin Program allows social equity plans to be flexible by not restricting plans to only those listed in the social equity plan resource. Goals and performance measures are also provided as guidance and not set in stone. The OHA advises applicants to propose alternative initiatives that align with their goals and develop their own measurable objectives. Note that the objectives set must be based on data that can be collected and accurately reported during annual license renewal processes.

Social equity plans under the Oregon psilocybin program have no specific size or page requirements, and applicants are encouraged to ensure their plans are clear, concise, and actionable. When renewing their license, licensees will be required to provide evidence of how their plan has been implemented and evaluated. Failure to meet the administrative rule requirements through the Annual Social Equity Evaluation Report may result in non-renewal of the license.

How to Apply for a Psilocybin Manufacturer License in Oregon

You may apply for an Oregon psilocybin manufacturer license online or by mail. To apply online, you must visit the OPS Training program, Licensing, and Compliance (TLC) system to complete the process. To use the TLC, you must first create an account on the platform. The OPS TLC Login Guidance document provides assistance to applicants on creating an account on the TLC system, logging into the platform, and troubleshooting potential issues.

Applicants who prefer paper applications and intend to obtain the paper forms from the OPS may contact the licensing program at (971) 673-0304 or by email at licensing.psilocybin@oha.oregon.gov.

The following are forms that will be required in the application process:

Other documents that may assist in your application process include the following:

How Much Does a Psilocybin Manufacturer License Cost in Oregon?

The cost of a psilocybin manufacturer license in Oregon includes a $500 application fee and an annual license fee of $10,000. Some applicants, such as veterans or individuals receiving specific government benefits, may qualify for a reduced annual fee of $5,000.

How to Renew an Oregon Psilocybin Manufacturer License

An Oregon psilocybin license must be renewed annually. According to the provisions of OAR 333-333-4250, a psilocybin manufacturer license in Oregon must be renewed at least 60 days prior to the expiration date of the license. Current licensees who timely submit their renewal applications are allowed to continue operating on their expired licenses until the OPS is able to process their renewal application. However, licenses who fail to timely submit their Oregon psilocybin manufacturer license renewal applications are prohibited from continuing business operations on expired licenses.

The renewal window for Oregon psilocybin manufacturer licenses opens on the TLC portal 120 days before the license expiration date. To commence the renewal application on the TLC portal, log in to your account or profile and select the "Start Renewal" button. You will be prompted to update any information that needs modification. Before completing the renewal process, you will be required to pay a manufacturer license renewal fee of $10,000. However, individual applicants who meet certain criteria may have their renewal fee reduced to $5,000.

For more information on renewing a manufacturer license, see the Oregon psilocybin manufacturer license renewal application guide.

Preparing for Site Inspection for Psilocybin Manufacturer Licensing

OAR 333.333 mandates a site inspection for the proposed property to be used by anyone applying for an Oregon psilocybin license. A site inspection is required to observe and review the premises of a proposed site to verify that it meets all the requirements for the psilocybin license applied for.

The OPS begins a site inspection with a pre-inspection initiated on a conference call. This is done to make introductions and explain the inspection process to the application. In the process, the OPS confirms the date and time for the inspection to ensure all parties concerned are ready for it. Note that there is an equity pause during pre-inspection. This short break is provided so that either side may acknowledge and express their preferences, needs, accessibility needs, and concerns.

The site inspection begins with a review of the premises plan. To ensure your premises plan is complete, you must ensure it includes the following:

A map of the proposed premises, showing the boundaries of the premises relative to its location.
Identification of unlicensed areas in the building where the licensed premises are located, including suite numbers (if applicable)
A scaled floor plan showing all ingress and egress points
Identification of client administration areas
Identification of all residences or other unlicensed structures on the same tax lot as the premises to be licensed
Identification of areas where psilocybin products will be stored in the licensed premises
Identification of camera locations. A licensed psilocybin premises must have camera coverage for all egress and ingress points to and from indoor areas of the licensed premises, except where points are located within a client administration area. The same goes for where psilocybin products are stored or produced and where psilocybin waste is required to be stored, destroyed, or rendered unusable

In addition, the following elements must be ready before a site inspection:

Limited Access Areas: All limited access areas must be clearly identified with signage that is visible and legible from a reasonable distance. These areas may include spaces where psilocybin products or waste are stored or handled. While a limited access area does not need to be a separate room, it must be appropriately labeled. Access to these areas is restricted to licensee representatives and other authorized personnel only.
Locked and Limited Access Product Storage: Finished psilocybin products must be stored securely in one of the following: a locked enclosed area with a steel-frame door, a locked refrigerator or freezer, or a locked safe. All storage options must be located within a designated limited access area.
Locked and Compliant Waste Disposal: Psilocybin waste must be stored securely in either a locked waste receptacle or within a limited access area under the licensee's control. The waste must be rendered unfit for consumption using methods like composting or mixing with inactive substances. It must then be securely stored and either disposed of on the licensed premises or transferred to another licensee for disposal.
Operational Alarm System: Licensed premises are required to have an operational alarm system that is activated when the facility is closed for business. The system must detect unauthorized entry and activity, notify the licensee, and include two functional panic buttons.
Operational Surveillance Equipment: Surveillance equipment must be installed and cover all limited access areas, entry and exit points, psilocybin storage and production areas, and waste disposal zones. The system must allow access to view recorded footage, include the ability to print screenshots, and have a battery backup. Maintenance logs, outage logs, a list of personnel with access to the system, and daily visitor logs must be kept on-site.
Sanitary, Food-Grade Surfaces and Equipment: All equipment, counters, and surfaces used for post-harvest processing must be food-grade and non-reactive with any solvents utilized.
Endorsements: Applicants must request applicable endorsements, such as extraction or edible endorsements, during the initial application process.
Policies and Procedures for Endorsements: Licensees requesting endorsements must develop comprehensive policies and procedures specific to their endorsement activities, such as extraction or edible production.
Fire Code Compliance for Extraction Endorsements: Manufacturers using methanol or ethanol for extraction must ensure all processing areas meet fire code requirements, including compliance with the Oregon Structural Specialty Code, related Specialty Codes, and the Oregon Fire Code.
Required Equipment and Personal Protective Equipment for Extraction Endorsements: Manufacturers with extraction endorsements must provide emergency equipment, including an eye-wash station, rinse kit, and emergency shower, in all rooms where solvents other than water are used. Additionally, they must make appropriate personal protective equipment available for employees.

Note that the duration of an inspection depends on the size and complexity of the facility, but it is generally expected to take around three hours.

Background Check for Oregon Psilocybin Manufacturer License

According to ORS 475A.255, the OHA may require fingerprints of any individual listed on a psilocybin license application. Hence, the OHA conducts a criminal background check when an applicant applies for a psilocybin license, worker permit, or renewal. The OHA BCU (Background Check Unit) and the Oregon Department of Human Services (ODHS) perform criminal records checks for OPS licensing and worker permits.

The background check process typically follows this process:

Submission of Personal Information: By submitting a license application, the applicant provides the required information for the OPS to begin the background check process. The information required includes the applicant's legal name, prior names and aliases, date of birth, Social Security number, email address, phone number, physical address, mailing address, and residential history outside of Oregon in the previous five years.
After submitting the application, the licensing team begins the criminal background check via the Oregon Criminal History and Abuse Records Data System (ORCHARDS). The applicant receives an email with a link to review and authorize the background check. Authorization is required before the process begins, and the applicant must also provide answers to questions about their criminal history.
Fingerprinting: Once the applicant reviews and agrees to the Authorization Statement, they will get an electronic letter via email with instructions for scheduling an appointment with a FieldPrint vendor. The letter includes details about the process and a link to schedule an appointment at a local FieldPrint vendor, available in any U.S. state where the applicant resides. The applicant may proceed to complete the fingerprinting at the chosen FieldPrint location.
Review by Background Check Unit (BCU): The background check will review an applicant's criminal history. However, under ORS 475A.250, certain prior convictions are excluded from consideration:
Manufacture of Psilocybin or Marijuana: Convictions are not considered if they occurred two or more years before the application date and the individual has only one prior conviction for such offenses.
Possession of Controlled Substances or Marijuana Items: Convictions are not considered if they occurred two or more years before the application date or if the individual has only one prior conviction for possession.

For other criminal convictions or crime-related issues, the Background Check Unit (BCU) will conduct an additional "weighing test" to evaluate the circumstances. In the weighing test, the BCY will obtain additional information from the applicant to weigh the pros and cons of crime-related conditions and criminal convictions. The unit will consider several factors to evaluate whether the applicant is a risk to the emotional, physical, or financial well-being of vulnerable persons. The BCU's weighing test flyer provides more information on the weighing test.
Eligibility Determination: The BCU assesses whether the applicant presents a risk and will approve or deny their application accordingly. If restrictions on the applicant’s duties or work environment can mitigate risks to vulnerable individuals, BCU may issue a restricted approval. In cases where an application is denied or granted restricted approval, the applicant retains the right to request a hearing to challenge or review the decision.

Note that OPS does not have access to the applicant's criminal history or weighing test information. The OPS only receives BCU's final determination and issues a permit or license based on that decision. For more information on the background check process, see the Background Check Process Overview guidance document or call the OHA at (971) 673-0304.

Do You Need a Food Safety License as a Psilocybin Manufacturer in Oregon?

Licensed psilocybin manufacturers in Oregon may only cultivate or process psilocybin products containing the Psilocybe cubensis species, such as whole-dried fungi and homogenized fungi. Synthetic psilocybin and wild harvesting of fungi are not permitted under this license.

Any psilocybin manufacturer licensee who intends to cultivate fungi or manufacture psilocybin edible products or extracts in Oregon must obtain a Food Safety License from the Oregon Department of Agriculture (ODA) in addition to your Oregon Psilocybin Services (OPS) license. Under the Oregon Psilocybin Program, there are specific endorsements for psilocybin extraction, edible psilocybin production, and fungi cultivation.

Endorsements are available at no additional cost; however, applicants must familiarize themselves with all relevant requirements before applying for an endorsement.