Oregon is the first state in the U.S. to create a regulatory framework for psilocybin services. Starting January 2, 2023, applicants can apply for various psilocybin-related operational licenses, including psilocybin manufacturer licenses.
Background
The Oregon Psilocybin Services Act
The Oregon Psilocybin Services Act Ballot Measure 109 (M109) is also known as the Oregon Psilocybin Services Act. It was voted into law by Oregonians in November 2020 and codified in Oregon Revised Statutes in ORS 475A. M109 directs Oregon Health Authority (“Oregon Health Authority” or “OHA”) to license and regulate psilocybin products and the provision of psilocybin services.
The Oregon Psilocybin Services and Rule-making
The two-year development period for psilocybin services is from January 1, 2021, to December 31, 2022. During this time Oregon Psilocybin Services (OPS) is working with the Oregon Psilocybin Advisory Board and rule-making advisory committees (RACs) to make rules for psilocybin products and services. All rules must be in place by December 31, 2022. The section will begin taking license applications on Jan. 2, 2023.
This post is based on rules (Chapter 333, Division 333) related to products and testing which were finalized and adopted in May 2022. The remaining rules related to licensing manufacturers are still in draft form, open to revision following the public comment period. The final regulations in their entirety, are expected to be adopted by December 30, 2022.
This post will be updated with any pertinent information as the rules are finalized and adopted.
What can Licensed Psilocybin Manufacturers Produce?
The Oregon Psilocybin Services (OPS) regulations allow psilocybin manufacturers to produce and sell the following types of psilocybin products:
- Fungi (Psilocybe cubensis ONLY)
- Extracted psilocybin products
- Edible psilocybin products
Psilocybin manufacturers can only produce and sell psilocybin products if they have received an endorsement from the Oregon Health Authority for that particular category of product.
Applying for Psilocybin Manufacturing Endorsement(s)
An applicant for a psilocybin manufacturer license must request an endorsement upon submission of an initial application. Manufacturer licensees may also request to add or remove an endorsement at any time following successful licensure.
To apply for an endorsement, an applicant or licensee must submit a (yet to be released) form prescribed by the Oregon Health Authority that identifies the proposed endorsement.
Multiple Psilocybin Manufacturer Endorsements
Oregon Health Authority will allow each psilocybin manufacturer licensee to hold multiple endorsements. Requesting multiple endorsements does not affect the license fee. Requests made post-licensure will also not require additional fees.
Denial and Revocation of Existing Endorsements
Per the regulations, the Oregon Health Authority may deny a manufacturer’s request for an endorsement or revoke an existing endorsement if the manufacturer cannot or does not comply with the regulations. If OHA denies or revokes approval, the processor has a right to a hearing under ORS chapter 183.
Manufacturer Endorsements and Allowable Psilocybin Product Types
As psilocybin manufacturers are only allowed to produce those psilocybin products for which they hold an endorsement, it is important to understand the different types of products permitted under each endorsement. It is also crucial to note that psilocybin products not included in the regulations are prohibited and can not be legally manufactured, nor possessed by any licensee.
Fungi Cultivation Endorsement
The Oregon Psilocybin Services (OPS) regulations allow manufacturer licensees with a fungi cultivation endorsement to produce:
- Whole Fungi
Whole Fungi refers to dried fruiting bodies (spore producing organs i.e. mushrooms) of Psilocybe cubensis, or portions thereof, that have not been homogenized. - Mycelium
Mycelium in this context means the fungal threads or hyphae of Psilocybe cubensis. - Homogenized Fungi
Homogenized fungi consists of dried fruiting bodies or mycelium that have been mixed by powdering or other techniques which uniformly distribute psilocybin throughout the product. Homogenized products may contain inactive ingredients such as binders, dilutants, and carrying agents.
It is critical to note that manufacturer licensees with fungi cultivation endorsements are only permitted to cultivate and possess fruiting bodies of the species Psilocybe cubensis on the licensed premises. Licensed premises should also not have mycelium or spores of any species other than Psilocybe cubensis, even if the other species are capable of producing psilocybin.
Other Regulations
Manufacturers with a fungi cultivation endorsement may produce fungi in aquatic environments in addition to any substrates and growing mediums allowed by these rules. A manufacturer with a fungi cultivation endorsement must completely dry all fungi before transferring the product to another licensee.
Psilocybin Extraction Endorsement
A manufacturer with a psilocybin extraction endorsement may produce psilocybin extract. The following solvents are allowed:
Permitted Solvents for Psilocybin Extraction
A manufacturer with a psilocybin extraction endorsement in Oregon may use only water, vegetable glycerin, acetic acid, ethanol, and methanol as solvents in extraction.
Prohibited Solvents for Psilocybin Extraction
A manufacturer with a psilocybin extraction endorsement may not use denatured alcohol. All other solvents not explicitly mentioned in the regulations are also prohibited.
Oregon Structural Specialty Code and Oregon Fire Code Compliance
If using methanol or ethanol in the extraction process, a manufacturer must process psilocybin extracts in a room with equipment, including all electrical installations that meet the requirements of the Oregon Structural Specialty Code, related Oregon Specialty Codes, and the Oregon Fire Code.
Other Regulations
A manufacturer with a psilocybin extraction endorsement may not apply pressure or heat over 140 degrees Fahrenheit when manufacturing psilocybin extracts.
Edible Psilocybin Production Endorsement
A manufacturer with an edible psilocybin production endorsement is allowed to produce edible psilocybin products.
Licensed Oregon Department of Agriculture Premises
If a manufacturer with a psilocybin extraction endorsement produces a psilocybin extract that will be used in an edible psilocybin product, the manufacturer’s licensed premises must be licensed by the Oregon Department of Agriculture (ODA) as a food establishment and must comply with applicable provisions of OAR chapter 603, division 21, division 24, division 25 and division 28.
It is important to note that manufacturers with an edible psilocybin production endorsement may not use a psilocybin product to produce edible psilocybin products unless that psilocybin product was processed or cultivated in a compliant, ODA-licensed food establishment.
Conclusion
This blog is not a complete list of the compliance requirements for psilocybin manufacturer licensees in Oregon. There are other adopted regulations– including creating standard policies and procedures, and various measures to ensure the safety of workers– which are required for psilocybin extraction and edible psilocybin product endorsements.
As mentioned earlier in the post, the final Oregon Psilocybin Services (OPS) regulations are expected to be adopted by December 30, 2022. We will update this post with any pertinent information as the rules are finalized and adopted.
If you are interested in obtaining a psilocybin manufacturing license in Oregon, please contact the psychedelic law attorneys at Rogoway Law.
