Last week, the Oregon Health Authority adopted new administrative rules to govern testing and training programs for psilocybin as well as psilocybin products. These rules, as well as others that have not yet been finalized, will go into effect in January 2023, when Oregon’s therapeutic psilocybin program begins.
Earlier this year, the state published a draft of its proposed directives on psilocybin before it obtained feedback from its residents in April. According to Oregon Psilocybin Services (OPS), since then more than 200 verbal and written comments have been submitted. Consequently, last week OPS released a list of finalized rules, noting which ones had been amended.
OPS also acknowledges that, while it was a priority to ensure access to psilocybin services, the agency did not have the authority to regulate the cost of psilocybin services or products, noting that the administration costs for the work needed to be covered by licensing and application fees.
Under the regulations, licensed manufacturers of psilocybin will only be permitted to grow or possess one fungi species: psilocybe cubensis. This, Oregon Psilocybin Services noted, was to avoid the potential for animal-borne pathogens and woodlover’s paralysis, as well as the risks linked to poisonous and deadly lookalikes.
The board held its stance and declined to make any changes to this policy, even based on comments requesting that the methods of delivery for psilocybin be expanded to grow accessibility. In its letter, Oregon Psilocybin Services stated that while access to services was vital to implementation success, it wasn’t able to accommodate these requests because of the language used in the state’s Psilocybin Services Act.
The letter also explained that after conducting an evaluation, the agency determined that the measure’s text limited psilocybin products to those that can be taken orally, noting that the act’s statutory language didn’t permit the provision of psilocybin services or the consumption of psilocybin products on any other premise apart from a licensed center.
However, a number of changes, which included a modification of the facilitator training requirements and on psilocybin product testing, were made based on the comments submitted from citizens. Oregon Psilocybin Services increased the required hours for the group facilitation module and decreased the hours for the pharmacology module, noting that they had removed the in-person training requirement for key training modules.
The state is adopting the first set of rules now, about seven months before its Psilocybin Act comes into effect, in order to start accepting applications for psilocybin programs by next month. Oregon plans to conduct a second rule-making process for the remaining rules come fall.
As early adaptors such as Oregon move to implement psilocybin use for therapeutic purposes, entities such as Cybin Inc. (NYSE American: CYBN) (NEO: CYBN) have set bigger targets involving the development of psychedelic formulations, which must go through the FDA approval process so that these medicines can be prescribed throughout the country.
NOTE TO INVESTORS: The latest news and updates relating to Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) are available in the company’s newsroom at https://ibn.fm/CYBN
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