Allay Consulting’s June Newsletter: An Overview of Oregon’s Proposed Psilocybin Rules
An Overview of Oregon’s Proposed Psilocybin Rules
The beginning of 2023 will be a huge step to the US’s legalized psilocybin industry! Oregon Psilocybin Services (OPS), a new section housed within the Oregon Health Authority, will begin accepting license applications January 2, 2023. Oregon’s legalization and implementation of regulations will take 3 years all together – several years may seem too long for the legalized psilocybin roll out, but better late than never. This should give the department plenty of time to draft, edit, edit some more, then implement the nation’s first regulatory framework for psilocybin.
The Oregon Health Authority (OHA), Public Health Division, has released their proposed psilocybin rules. These rules are necessary to execute the Oregon Psilocybin Services Act. The proposed rules began with how the adoption of the rules can impact racial equity, fiscal/economic impact, and the cost of compliance. The proposed rules include standards for the types of licenses, types of psilocybin products, cultivation and production standards, health & safety expectations for workers and end consumers, training curriculum requirements, product testing and more. The proposed regulations have plenty of information, and Allay Consulting is here to look further into the licensing and manufacturing requirements within the proposed regulations.
- Manufacturer License – Allows the licensee to manufacture, plant, grow, cultivate (indoor only), harvest, produce, prepare, propagate, package and label psilocybin mushrooms. Manufacturing licenses has three endorsement types: (a) Fungi cultivation, (b) Psilocybin extraction; and (c) Edible psilocybin production.
- Service Center License – Allows the licensee establishment to administer psilocybin sessions and further support during the session. Under this license, the recipient individual receives their psilocybin and associated therapy during the experience. The service center will provide preparation to the individual – followed by administration – then integration.
- Facilitator License – Allows individuals to conduct psilocybin services at the licensed service center.
- Laboratory Testing License – Allows facilities to test psilocybin products. Products must be tested for microbiological contaminants, pesticides, other contaminants, solvents/residual solvents, and psilocybin concentration.
Manufacturing Allowances and Restrictions
Species Allowance: There is a limitation on allowed species under the proposed regulations. The noted allowed species only allows Psilocybe Cubensis. The proposed regs further states, “Psilocybe Cubensis has been recommended as a safe species of fungi, and it is the only species allowed under the rules”. Psilocybe Cubensis is the most psychedelic mushroom species. Don’t fret, there are plenty (hundreds) of strains that fall under the Psilocybe Cubensis species.
Cultivation Restrictions: Manufacturer licensees are prohibited from using manure and wood chips. Manufacturers may not produce psilocybin by using genetically modified organisms such as bacteria and producing psilocybin by chemical synthesis. Also, manufacture licensees are prohibited from applying pesticides to fungi or the fungi growing medium.
Manufacturer Requirements: Manufacturing licensees must use food grade equipment and other product touching surfaces. These product touching surfaces must be easily cleanable and safe to use in sanitary operations. Psilocybin products must have an assigned process lot and harvest lot unique ID number that are stored in a locked area. All process and harvest lot numbers must be entered into Oregon’s Psilocybin Tracking System. Similar to cannabis regulations, licensees cannot produce, transfer, sell, product that appeals to minors, products modeled after non-psilocybin products primarily consumed by minors/in the shape of animals/vehicle/person/
Manufacturing Method Limitations: The proposed regulations places limitations on extraction methods to include water, vegetable glycerin, acetic acids, ethanol and methanol as solvents in extraction. Other solvents are prohibited; specifically noting that denatured alcohol is not allowed. The proposed regs include further restrictions regarding pressure and heat – a manufacturer may not apply pressure or heat over 140ᴼF when manufacturing psilocybin extracts.
Restrictions on Adulterants: The drafted regulations state, “a licensee may not add to psilocybin products any chemical, drug, plant, or substance that has the effect of altering potency, intoxicating effect, duration of effect, toxicity, or potential for excessive use, including but not limited to monoamine oxidase inhibitors (MAOI’s), beverage alcohol or cannabis. A psilocybin product that has added chemicals, drugs, plants, or substances that alter the potency, intoxicating effect, duration of effect, toxicity or addictiveness is considered adulterated.”
Methods of use: OHA has placed limitations on the type of psilocybin products allowed to include only orally ingestible products. Other methods such as transdermal patches, inhalers, nasal sprays, suppositories, and injections, are prohibited
Manufacturing Extraction Safety Measures: The licensee must have adequate ventilation controlling all sources of ignition where flammable vapors that may be present, only use potable water if using water extraction method, install eye wash stations and emergency shower when working with solvents, must provide personal protective equipment, and the licensee must train their staff on the safety of extraction.
Manufacturing Records and other Documentation: To no surprise, it’s proposed that manufacturer licensees are required to keep records of the following but not limited to: manufacturing instructions, ingredients, procedure, solvent (use & handling), procedures for conducting necessary safety checks prior to commencing production, cleaning and sanitation, procedures for preventing growth of pathogenic organisms/toxin formations, proper disposal of any waste, emergency procedures in case of fire, chemical spill, or other emergencies. Requiring basic cGMP principles will result in more compliant products – which benefits both the industry (decreases liability) and the end consumer (decrease in safety issues and increase in quality!).
Required Testing: Similar to state level cannabis testing requirements, the proposed regulations include testing for psilocybin. Below include the proposed testing requirements.
- Speciation Testing – ensuring the psilocybin derived from the Psilocybe Cubensis species
- Potency Testing – concentration (potency) of psilocybin and psilocin in the product
- Solvent Testing – methanol or acetic acid solvents are used to manufacture psilocybin extract, a manufacturer must order tests for these solvents
- Pesticide Testing – Upon written request by the Authority
- Contaminate Testing – Upon written request by the Authority
- Heavy Metals Testing – Upon written request by the Authority
Unfortunately, these regulations are now closed to public comment. The Oregon Psilocybin Services Section will begin accepting applications for licensure on January 2, 2023. Until then, the Oregon Psilocybin Services Section is in a development period, working to build the nation’s first regulatory framework for psilocybin services. If you have any questions, comments or would like to join one of the Psilocybin Advisory Board Meetings, visit OHA’s Website for more information, or reach out to inquire using the information below.
Email Inquiries: OHA.Psilocybin@dhsoha.state.
General Information Line: 971-341-1713
Need Support with Compliance Training?
No matter the industry, a key to success for any company is ensuring compliance! Allay’s compliance services work one-on-one with your company to create a realistic Quality Management System that is unique to your company’s production needs while also meeting local, state, and federal regulatory requirements.
Contact Allay Consulting to learn more about implementing a quality management system, written documentation, facility compliance, certification readiness, and employee education!
Contact Us Today!
Learn how cannabis consulting can help move your business forward.