Psilocybin Regulation & Compliance

Overview

The emerging psilocybin/psychedelic therapy market is estimated to be worth $6.9 billion by 2027. Entrepreneurs interested in seizing market share and providing cutting edge treatments in this sector must stay abreast of new laws and standards as well as audits by inspectors as they develop their processes for regulating this industry.

Currently, only the state of Oregon has legalized possession and sale of psilocybin mushrooms, and the state is currently undergoing a 2-year period with the OHA (Oregon Health Authority) to develop a program for medical administration of this substance.

Given the wording of “Measure 109” in Oregon, the regulatory framework surrounding medicinal applications of psilocybin products will be very similar to the medical cannabis industry. The goals of this measure are to provide psilocybin therapy for those in need, while preventing access to unqualified individuals, and having a plan to prevent product diversion.

Ongoing Efforts

Looking forward to the upcoming election cycle, there are a number of psilocybin and psychedelic therapy initiatives being developed at the state level, most notably California’s Psilocybin Initiative 2022. This initiative, like Oregon, lays out a medical framework for the cultivation, manufacturing, and retail sales of products and applications of therapies for both psychological and spiritual uses. California is not alone. Forbes magazine has noted bipartisan support for these new psilocybin research projects and therapies even in majority Republican states such as Florida.

Compliance Requirements

Aside from the legal code surrounding access to these products and therapies, the cultivation of mushrooms requires clean and sterile media, and regular in-house testing for mold/mildew and other contaminants which can occur during the propagation or drying/handling process. Third-party testing will be required by the state for consumer safety. SOPs for sanitization, security, packaging, testing, waste disposal, QAQC, employee training and more will all be necessary to demonstrate to regulators that an operator is prepared to produce according to state guidelines.

The remaining state legal code focuses on the safe and therapeutic administration of these substances by qualified professionals, and safety for clients undergoing treatments.  So, the final phase of compliance would be ensuring that companies are following state and federal guidelines for allowing only qualified medical professionals to administer therapies using psilocybin products, as well as maintaining the appropriate licensing and professional accreditations.

Partner with Seasoned Industry Experts

Given that this emerging market is being developed along much the same lines as the medical cannabis market, it makes sense to partner with industry experts who are experienced at securing licensing, developing business plans, and maintaining compliant operations. This market is developing quickly across the nation, and businesses who want to succeed in a continually evolving landscape will want to begin planning their strategy early, with an understanding of what timeline and trajectory they wish to take within the industry. Is the plan to become an industry leader or to be a locally owned sustainable enterprise? What avenues are there for potential expansion or exit within such a new industry? The compliance experts at CannaBeSecure can answer all of these questions and more to help your business build a winning model, from start-up to exit, that will last through whatever your company’s ultimate goals are.

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