Would you like to win a psilocybin testing laboratory license in Oregon and be one of the first in this potentially expanding wellness and healthcare medical market? Final rules have been posted and as of January 2, 2023, the application period is open.
So, don’t wait. The process will be highly competitive and involve hundreds of hours of technical writing. Our license consultants are here to help! We have over 10 years of success with the cannabis market and now, the burgeoning market for psilocybin services. Reach out to us!
We can make it simpler for you to move quickly to get accredited to obtain a license in this first-ever legal Oregon market. We’ll help you gain contracts with licensed manufacturers so that you can better utilize your testing laboratory license to make profit to sustain your business.
Below, I’ve provided a summary I hope you find helpful – a step-by-step guide to obtain a psilocybin testing license in Oregon.
Guide on How to Win an Oregon Psilocybin Testing Laboratory License
Enlist our Oregon psilocybin business consultants who will directly manage your testing lab application to best get it approved by the OHA.
Step 1 – Read the Rules and Regulations
The first step to opening a psilocybin testing laboratory in Oregon is to read through these rules and regulations. Be aware that laboratories performing testing of psilocybin products must first be accredited by Oregon Environmental Laboratory Accreditation Program (ORELAP) before they can apply to be licensed to test psilocybin products (and only psilocybin products from a licensed manufacturer).
Once your lab receives accreditation by ORELAP, you can move forward with your psilocybin laboratory license application. To do so, make sure you are prepared and have read the following rules and regulations:
- Oregon statute ORS 475A establishes the licensing and regulatory framework for psilocybin services.
- Oregon administrative rule OAR 333-333 requires psilocybin products to be tested to confirm the presence of psilcoybe cubensis, as well as tested for potency.
- The Oregon Psilocybin Services section of Oregon Health Authority (OHA)’s Prevention and Wellness Public Health Division is responsible for setting up and regulating the new program.
Once you’ve studied these laws, you will better understand the application process, operational requirements, and the overall framework.
The next step is to determine if you are eligible to apply for a psilocybin testing laboratory license in Oregon.
Step 2 – Determine eligibility
First of all, prospective psilocybin businesses that want to apply to test products must do the following:
- Register for a username in the ORELAP Data Input and Edit (ODIE) system.
- File initial application for accreditation.
- After ORELAP reviews and invoices your application, pay the invoice and arrange for an onsite inspection.
- Meet other applicable requirements as determined appropriate by ORELAP rules.
Also, heed the following:
- Must be 21 years of age or older.
- All of your owners must pass a criminal background check.
- None of your owners/partners may exceed the ownership limitations.
- At least 50% of your applying entity partnership/ownership interests must be held by residents of Oregon who’ve lived in the State for at least 2 years. Please note that this requirement ends in 2025.
If you are not sure of your eligibility, or want to know how your entity can become eligible, contact our psilocybin license consultants.
Step 3 – Engage an Oregon Psilocybin Testing Laboratory Consultant
We understand that reading several hundred pages of laws can be both daunting and time-consuming. For this reason, the next step is to bring in a professional. We’ve already thoroughly examined the rules for you!
Allow our psilocybin consultants in Oregon to manage your entire application for you from start to finish, making sure you are submitting the best application possible.
We have one of the highest success rates in the cannabis and alternative plants/medical caretaking industry for winning licenses (90.12%). We have already helped entrepreneurs start cannabis testing laboratories across the globe and are well-prepared to apply our licensing experience to this new legal market for psilocybin product testing.
Step 4 – Develop a Business Plan for Your Psilocybin Testing Laboratory
At this stage, it’s a good idea to craft a business plan for your Oregon psilocybin testing laboratory. A solid business plan will help you understand the market, what return to expect on investment, start-up costs, types of equipment, timelines, and more. And, you can gauge what makes your work processes flow more smoothly.
Additionally, if you’re still raising capital, a good psilocybin laboratory business plan will help attract investors. Use your business plan to help you raise capital for your psilocybin laboratory business.
You will incur costs pre-licensure and post-licensure. For instance, you may incur costs from the following sources during pre-licensure: real estate and architectural designs, attorneys, consulting, marketing, and more.
A strong business plan is key to the success of your psilocybin testing license application in Oregon.
Step 5 – Build a Team
If you do not have a team formed yet, it’s a good idea to start recruiting a team of experienced scientists in psilocybin testing or related fields.
You’ll need a team of experienced analytical testing scientists for two main reasons:
- To develop psilocybin testing standard operating procedures (SOPs); and
- To score higher on your Oregon testing laboratory license application.
For the specific requirements for analytical testing, please see further below.
Would you like help with recruiting a team for your Oregon psilocybin testing laboratory license application? Quantum 9 has a deep network of analytical chemists and scientists. Reach out today to learn about our talent acquisition services.
Step 6 – Raise Capital
Keep in mind, you must obtain your location and equipment before applying for an Oregon psilocybin testing laboratory license because ORELAP will arrange for an onsite inspection to determine your laboratory’s compliance to the accreditation rules and the 2016 (TNI) Standards.
As exciting as it is, starting a psilocybin business in Oregon can be a costly endeavor. It will be less so if you anticipate for costs well in your business plan, and start raising the capital now.
Essential base start-up costs for a testing lab will include at the bare minimum:
- Installed and operable laboratory testing equipment and associated supplies,
- Development of psilocybin testing procedures (SOPs), and
- Facility site in an appropriately zoned location in a municipality which has opted in to allow licensed psilocybin businesses in their jurisdiction.
In other words, you first need to acquire, secure, and operate the necessary equipment to pass your site inspections and effectively conduct the required psilocybin tests in Oregon.
- Post licensure, you can expect costs to arise from some of the following potential costs: Construction and renovations, security installation, managing inventory, Staff wages and salary, marketing, and more.
Laboratory Equipment: Obtain ISO 17025 Certification
After you’ve developed your psilocybin testing procedures on your equipment, you must obtain ISO 17025 certification. You’ll need this before you can apply for your Oregon psilocybin testing laboratory license. Obtain a copy of the 2016 TNI Standard and become familiar with the requirements for accreditation.
Ensure that you will have personnel at your laboratory who meet the educational and experience qualifications for the technical director and quality assurance officer.
You must engage a third-party accreditation body to validate your procedures and quality management system (QMS) for conformation with ISO/IEC 17035 standards. Also, understand that assessments cannot be scheduled until invoices are paid, and the laboratory has qualified personnel. Be prepared to show the assessors method validation data (as described in the appropriate modules of the TNI Standard).
Finally, you don’t need to sweat these details! Work with our team to guide you through the accreditation process.
Development of Psilocybin Testing Procedures
Since you’ve just had to acquire costly equipment before being issued a license, make sure you have your SOPs in order!
Psilocybin testing laboratories in Oregon must receive accreditation under ORS 438.605 to 438.620 and meet all requirements set out by the OHA.
By now, you should be well into developing your psilocybin testing procedures, using your approved equipment.
You should be able to accurately test and determine the following, based on established procedures for determining batch sizes and for sampling psilocybin products, as well as establishing different minus standards for different varieties of psilocybin products.
The tests required should include at a minimum:
- Microbiological contaminants,
- Other contaminants,
- Heavy metals,
- Solvents or residual solvents,
- Psilocybin concentration/potency, and
- Endured accuracy of the product labeling.
Finally, make sure your Oregon psilocybin testing procedures conform to International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) general requirements for the competence of testing and calibration laboratories (ISO/IEC 17025 standards).
Would you like help with your Oregon Psilocybin License Application? Learn how our psilocybin consultants in Oregon can help you become an owner of a psilocybin testing license for your laboratory.
Step 8 – Choose a Location
After you’ve raised capital, you can begin identifying and securing a location for your Oregon psilocybin testing laboratory.
First, identify municipalities in Oregon that will allow psilocybin testing laboratories to operate in their jurisdiction. Then, determine the areas zoned for psilocybin testing labs.
Once you’ve narrowed down the options, you should contact the landlord communicate your intentions. The landowner will have to provide a letter of consent for your Oregon psilocybin testing laboratory license application (unless you provide proof of ownership for your property location). For more detailed explanations of the law requirements, don’t hesitate to contact our psilocybin licensing experts. We’re excited about the opportunities in the medical and wellness markets for licensed plant and fungi products. We’re here to help you build a psilocybin testing laboratory!
You can use this map to quickly identify the municipalities in Oregon that have opted in or out of allowing psilocybin businesses.
Step 9– Garner Local Support
Now that you’ve secured a location, the next step is to build local support for your psilocybin testing laboratory business. You’ll want support from the municipal government as well as local organizations.
The municipal government will decide whether you can operate your business in their city or not. Always make sure to build a positive relationship with your municipality.
Step 10 – Write Your Oregon Psilocybin Testing Laboratory Application
Once you’ve received your ORELAP accreditation, and have paid your $500 application fee for a psilocybin testing lab license, you are ready to continue your online application. The application consists of several detailed plans, including:
- Premises Plan, including a map or sketch for the proposed licensed premises with details as described in the administrative rules, including:
- Secure Storage
- Camera Plan with locations
- Scaled Floor Plan
- Limited access area locations
- Outdoor and indoor administration areas
- Security Plan
- Social Equity Plan
- Waste Management Plan
- Authorized Individuals Form
- ORELAP Endorsement
Let our psilocybin and marijuana consultants handle the lengthy application writing for you.
Step 11 – Pay Application Fees and Submit
Once you’ve received the ISO 17025 certification and fulfilled the application requirements noted above, the final step is to pay the application fees and submit your Oregon psilocybin testing laboratory application.
The application fee for psilocybin testing laboratory licenses in Oregon is $500. Once you pay the fees and submit your application, you will wait 2 – 6 months as Oregon reviews your psilocybin testing laboratory license application.
If your application scores higher than the rest of the applicants and complies with all of the statutory requirements, you will win a psilocybin testing license.
The caveat? If approved for licensure, you pay an annual licensure fee of $10,000. Veterans, plus those who receive social security income, and/or food stamp benefits, or who are enrolled in the Oregon Health Plan may qualify for a reduced annual licensure fee of $5,000.
Conclusions on Oregon’s Psilocybin Testing Laboratory License
Oregon’s psilocybin testing laboratory license application is a major undertaking. The application is complex and time-consuming. It also requires a significant upfront capital investment.
If you want to apply for an Oregon psilocybin testing license, please take a few minutes to learn how our testing laboratory consultants can increase your chances of winning you a license while saving you time and money. Give us a call!
- Oregon Psilocybin Services (OPS): Evaluates training programs for approval and ensures compliance with testing requirements.
- Oregon Department of Agriculture
- Psilocybin Rules Advisory Committees