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Oregon Psilocybin Services - Manufacturer License

Manufacturer License Information

The Oregon Health Authority began accepting applications for Psilocybin Manufacturer licenses on January 2, 2023.

Learn More About a Manufacturer License:

Apply Online

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.

Ready to Apply? Click Here.

For more information about how to prepare for the application process, please read the information on this page and refer to the application guide below:

Manufacturer Application Guide for ONLINE APPLICATIONS


Additional forms for the online application process:

Apply By Mail

If you are unable to complete the application online using the TLC platform and application guide, you may print the paper application packet below. Please mail the paper copy of the application packet, along with the $500 non-refundable fee to the address listed at the end of the application packet. 

For more information, please see the MAILED application guide below.
 Manufacturer License Application Guide for MAILED APPLICATIONS

Application Packet for Mailed Applications:

Renew a 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.

For more information about completing the required annual license renewal application process, please read this Letter to OPS Licensees on Renewals and refer to the Manufacturer License Renewal Application Guide below: 

Manufacturer License Renewal Application Guide for ONLINE APPLICATIONS

Change Requests

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

Request to Surrender OPS License
To request to surrender your OPS License, service centers must submit a completed Request to Surrender OPS LIcense Form and all required documents. 

For any change requests not covered by these forms, please message the licensing team in TLC messenger with your request.

Local Government, LUCS, and Certificate of Occupancy

Learn more about local government considerations:
 Local Government Information

Land Use Compatibility Statement (LUCS):
OPS LUCS Form

Certificate of Occupancy (for extraction endorsements):
Demonstrating Flammable Extraction Compliance for Fire Code 

Background Check Information

Learn more about background checks:

Social Equity Plan Information

Learn more about social equity plans:
OPS Social Equity Plan Resources

Learn more about the required annual social equity evaluation reports: 

Oregon Department of Agriculture (ODA) Information

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)
Mushroom
Ingredient
used in
Psilocybin
Food
Product
Psilocybin
Extracts
(tinctures)
Whole
Dried
Fungi
Homogenized
Fungi
(including
tablets
and capsules)
Food
Safety
License
required:
Yes
YesYesNo
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 Food Safety Information

Learn more about psilocybin products and food safety:

ODA Weights and Measures Information

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: 
Weights and Measures

Site Inspection Information

Learn more about site inspections:

Inspection Orientation for Manufacturer Applicants

Questions? Contact:

Licensing.Psilocybin@oha.oregon.gov

1-971-673-0304