Oregon Psilocybin Laboratory License

An Oregon psilocybin laboratory license authorizes a testing facility to offer psilocybin products tests in the state. Any laboratory that performs testing of psilocybin products in the state, as required in Section 475A.590 of the Oregon Revised Statutes (ORS), needs a psilocybin laboratory license to operate legally. The state’s Health Authority (OHA), through the Oregon Psilocybin Services (OPS), issues the psilocybin laboratory license.

Requirements for Oregon Psilocybin Laboratory License

The following are the requirements for a psilocybin laboratory license in Oregon:

The applicant must be 21 years or older
The applicant must pass a criminal background check
The facility must be accredited by the Oregon Environmental Laboratory Accreditation Program (ORELAP)
As part of the license application program, the applicant must pass a site inspection

How to Get a Psilocybin Laboratory License in Oregon

The steps involved in applying for an Oregon psilocybin drug laboratory license are outlined below:

Review and Understand OPS Laboratory License Requirements - These requirements are outlined in Section 333-333 of the Oregon Administrative Rule (ORA) and Section 475A of the state’s Revised Statutes (ORS)
Be Accredited by the ORELAP - Become accredited through the state’s Environmental Laboratory Accreditation Program (ORELAP)
Submit a Scaled Floor Plan and Premises Plan - Complete this plan for the proposed licensed premises and submit it to the OPS
Prepare the Documents Required for the Application Process - As part of the application process, prepare and submit a Social Equity Plan
Initiate the Licence Application Process - Start the application process with the Oregon Psilocybin Services. This may be done online or by mail
Complete the Required Criminal Background Check Process - Submit to this process after submitting a psilocybin license application
Pay the Application Fee - Pay the license application fee, and once the payment clears, the OPS will deploy their personnel to inspect the proposed laboratory for psilocybin
Pay the Annual License Fee - Once the license is approved, the applicant is required to pay a $10,0000 annual license fee

How to Prepare an OPS Social Equity Plan

As part of the application process for an Oregon psilocybin license, a laboratory, service center, manufacturer, or facilitator license applicant must submit a Social Equity Plan with Oregon Psilocybin Services (OPS). A Social Equity Plan for Psilocybin provides license applicants the opportunity to state how they intend to address inequities in their business practice in communities that have been disproportionately ill-treated by systemic inequities. The plan should include the applicant’s clear commitments to social equity and how they intend to integrate such commitments into their business operations.

Typically, a Social Equity Plan for an Oregon psilocybin licensure must describe the following:

Application of diversity, justice, equity, and inclusion principles to the licensee’s internal policies and practices
Objective performance measures that will assist the licensee in evaluating their Social Equity Plan

How to Apply for a Psilocybin Laboratory License in Oregon

Interested persons may apply for a psilocybin laboratory license in Oregon through any of the following application methods:

Online Application - The following steps are required to apply for an Oregon psilocybin laboratory license online:
Open the OPS Training Program, Licensing, and Compliance system (TLC). Create a new account if using the system for the first time
Login to TLC, select the Laboratory dashboard tab and click the “Apply” button
Provide all required information in the application area
While completing the online form, provide information about any previous psilocybin license or permit
Identify all individuals and legal entities who are applicants and provide information about them. Each individual applicant is required to complete an Individual Applicant Information Form, while a Legal Entity Applicant Information Form is completed for applicants who are legal entities. If a person within a legal entity is identified as an applicant in the application process, include them as an individual applicant
Upload the completed Individual Applicant Information Form and photo ID on the individual applicant information page for an individual applicant and the completed Legal Entity Applicant Information Form for a legal entity
Upload a copy of the ORELAP accreditation with the license application
Upload a copy of the premises plan with the online application
Upload a Social Equity Plan
Pay the applicable non-refundable application fee (can be paid by mail, in person, or online)
Review the application details, confirm and attest to all the statements, enter your signature, and submit the application

The Oregon Health Authority (OHA) provides a detailed Guide for Online Psilocybin Laboratory License Application Process.

Mail-in Application - To submit an Oregon psilocybin license application by mail, take the following steps:
Contact the OPS at (971) 673-0304 or by email and ask them to mail a paper application packet. Afterward, complete the laboratory license application packet with the required laboratory information
Provide information about any previous permit or license in the application
Identify all individuals and legal entities who are applicants in the license application. Each of the applicants should complete any of the relevant forms below:
- Individual Applicant Information Form
- Legal Entity Applicant Information Form
Designate one applicant as the primary point of contact
Prepare a copy of the ORELAP accreditation and include it in the license application
Include the premises plan and social equity plan in the application
Complete the Authorized Individuals of the Named Licensee Form to identify one or more applicants who are authorized to make certain decisions on behalf of the named licensee
Pay the required application fee (non-refundable) in person, by mail, or online
Mail the completed application packet, proof that the application fee has been paid, and all other relevant forms and required documents to the OHA at:
Oregon Health Authority - Public Health Division
Fiscal Services
RE: Oregon Psilocybin Services
P.O. Box 14260
Portland, OR 97293-0260

The OPS will review the application and initiate a criminal background check. No applicant should submit their fingerprints until the OPS asks them to do so. Once the license fee is paid and cleared and the applicant passes the criminal background check, the OPS will approve the license application and notify the applicant by email. The Psilocybin Laboratory License Application Guide For Mail Applicants provides a detailed overview of the mail application process.

How Much Does a Psilocybin Laboratory License Cost in Oregon?

An Oregon psilocybin laboratory license costs $50 (non-refundable).

How to Renew an Oregon Psilocybin Laboratory License

An Oregon psilocybin laboratory license is valid for one year from the issue date and must be renewed annually. A licensee should complete the renewal application at least 60 days before the current license expires by taking the following steps:

Log in to the existing TLC online account and navigate to “my licenses and permits”
Select the psilocybin laboratory license that needs renewal
Review the information under the “Applicant Information” tab and make changes where possible
Identify all legal entities and persons who qualify as applicants. Each individual applicant and legal entity must fill out the applicable applicant information form
Provide information about any previous OPS license or permit
In the Documents Tab, upload the annual Social Equity Evaluation Report and any reduced fee supporting documentation, if applicable
Submit the renewal application online after confirming and attesting to all statements and adding a signature
If the renewal application meets all licensing requirements, the OPS will send an email requesting the applicant to pay the annual license fee. The application status will show “Renewal Approved, pending fee payment and clearance”
Pay a non-refundable $10,000 psilocybin laboratory annual license fee online, in person, or by mail within 30 days of receiving the email from OPS
Once OPS confirms and clears payment, it will review and evaluate the application. Afterward, the applicant will be notified by email if the license renewal application is approved

Interested persons may check the Psilocybin Laboratory License Renewal Application Guide to help them navigate this process.

Preparing for Site Inspection for Psilocybin laboratory Licensing

When applying for an Oregon psilocybin laboratory license, OPS conducts a site inspection to enable it to observe and review the proposed license premises to ensure compliance with rules requirements outlined in Section 333-333 of the ORA. The license applicant should schedule adequate time for the deployed compliance specialist so they can review all the requirements. Typically, OPS will review and evaluate the following during a site inspection for psilocybin laboratory licensing in Oregon:

Limited access areas clearly marked and identified by signage
Locked and limited access product storage
Functional surveillance equipment
Operational alarm system with two panic buttons
Locked and compliant waste disposal system
Logs for surveillance maintenance, all visitors, limited access areas, and surveillance outages

Background Check for Oregon Psilocybin laboratory License

In Oregon, a psilocybin laboratory license applicant is required to submit to the OHA Background Check Unit (BCU) and pass a criminal background check. A typical criminal background check conducted by the BCU involves the following steps:

The BCU initiates the process through ORCHARDS using relevant information provided in a psilocybin laboratory license application
The license applicant will receive an email with a link to review the Authorization Statement from ORCHARDS and authorize the BCU to proceed with the background check. They will also need to answer certain questions about criminal history
After authorizing the BCU to continue with the check, the applicant will receive a letter (electronic) by email describing how to schedule an appointment with a FieldPrint vendor to submit fingerprints
The applicant visits the FieldPrint vendor to submit their fingerprints
Once the BCU determines whether the applicant constitutes a risk, it will either deny or approve the applicant