Oregon Psilocybin Services - Manufacturer License

• Manufacturer License Printable Application
• Individual Applicant Information Form
• Legal Entity Applicant Information Form
• Premises Plan Checklist (General)
• Manufacturing Premises Plan Checklist
  
• Property Owner Consent for Manufacturing Psilocybin
  

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 Location Request

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 

To request to add or remove an endorsement, manufacturers must submit a completed Request to Change Manufacturer Endorsement(s) and all required documents.
 Request to Change Manufacturer Endorsement(s)

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:

• Overview of the Background Check Process
• Conviction Reporting Guide
  

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: 

OPS Social Equity Evaluation Report Guidance for Licensees 

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	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 Food Safety Information

Learn more about psilocybin products and food safety:

• Psilocybin Products and Food Safety
  
• Psilocybin Products and Food Safety (Spanish)
  

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

Weights and Measures (Spanish) 

Site Inspection Information

Learn more about site inspections:

Inspection Orientation for Manufacturer Applicants