Five Things to Know About The Proposed Psilocybin Products Rules
This past February 2022, the Oregon Health Authority (OHA) published draft Psilocybin Products Rules. As a reminder, OHA’s Psilocybin Services Section is tasked with implementing Measure 109 (2020): The Oregon Psilocybin Services Act. (More information on Measure 109 and Oregon Psilocybin Services is available here.)
Below is my list of five things you should know about the proposed Psilocybin Products Rules. While these rules are most relevant to those interested in manufacturing psilocybin, I encourage anyone interested in this groundbreaking area of law to have a look and to participate in this democratic process. There will be a public comment period on these rules from April 1-22, and public hearings via Zoom will be held on April 18 and 21. (Learn more about the comment period and public hearings here.)
1. There are three endorsement types.
A psilocybin manufacturer can only own hold one license, but may hold up to three endorsement types:
- Fungi cultivation
- Psilocybin extraction
- Edible psilocybin production
2. No GMOs, chemical synthesis, or other foods.
Manufacturers may only work with the fungi species Psilocybe cubensis on premises. The proposed rules also prohibit manufacturers from using GMOs, producing psilocybin through chemical synthesis, using dung or wood chips in the cultivation and production of psilocybin products, and producing non-psilocybin foods. The State Pesticide Control Act (ORS 634) would also apply to all psilocybin manufacturers.
3. No location restrictions.
Measure 109 includes geographic restrictions on where psilocybin service centers may be located, but not psilocybin manufacturers. This makes sense: fungi grow (cultivation) in more or less the dark, and extraction and edibles are subject to other state regulations. For example, the Oregon Structural Specialty Code would apply to psilocybin extraction that uses methanol or ethanol, and any premises were edibles are produced would be subject to ODA food-establishment license requirements (see OAR 603, divisions 21, 24-25, and 28).
4. Well-organized policies and procedures are a MUST.
Manufacturers engaged in extraction or making edibles would need to develop standard P&Ps (policies and procedures) covering all aspects of their operations, including:
- instructions and ingredients for each psilocybin product
- procedures for making homogenous lots
- safety and emergency procedures
- procedures for disposing of any unwanted solvents or other products from extract
- cleaning and sanitization procedures
- storage procedures for any solvents or other permitted chemicals used
5. Oral products only.
All psilocybin products must be designed to be consumed orally. All other means of transmission (e.g., transdermal patches, inhalers, sprays, injections) would be prohibited.
If you are interested in Oregon psilocybin’s program, we encourage you to attend the hearings on April 18th and 21st on proposed psilocybin product rules and to continue to monitor the Green Light Law Blog for updates.
You can contact Ramsey Chamie at info@gl-lg.com or 503-488-5424.
