EXCLUSIVE: Expert Advice On How To Become Compliant Psychedelics Cultivator And Manufacturer

What can businesses and clients expect from psychedelic-assisted therapies (PAT)? What are state regulations looking like from a for-profit perspective and what does it take to provide safe, effective and compliant treatments?

Benzinga spoke with Kim Stuck, founder and CEO of Allay Consulting about these issues. (See conversation’s Part 1.)

The national compliance strategy and services provider works at the consultancy level providing certifications to facilitate working out ethical dilemmas. Services include Gap analysis audits, writing their SOPs, training staff, and assuring everything in the facility is certified followed by calling a certifying body, which does the audit and eventually hands out the certification. 

Getting Compliant-Ready

Allay aims to serve clients owning psilocybin cultivation and manufacturing facilities. Stuck views providing potential services for the therapeutic centers’ “storefronts” - a sort of small dispensary holding the doses to be taken in-clinic provided by facilitators.

As state regulations “aren't really set in stone yet,” she foresees several issues will go back and forth for a few years as was the case with cannabis.

The firm has several clients working with psilocybin, which are moving toward application and are concerned with health and safety. “It's a fungus. There can be mold, all kinds of toxins, as we know it pulls a lot of things from the soil like heavy metals, bringing about much potential contamination.”

For that reason, whether making gummies, capsules, tinctures or growing psilocybin mushrooms, the smart thing to target is the GACP. The “Good Cultivation and Harvesting Practices for Medicinal Plants” certification, Stuck explains, is like a good agricultural practices certification and exists in other mushroom and plant realms too. 

Being certified as a facility compliant with the classic Good Manufacturing Practices (GMP), a reportedly similar certification, also accounts for doing the right thing. “You're following, essentially, FDA rules; so it's definitely above and beyond.”

While working mostly with internationally validated federal GACP in cultivation and GMP in manufacturing, Allay also helps clients prepare the ISO9001 certification through its accredited certifying body. 

“Those are the kinds of certifications you need to sell on Amazon AMZN. As an investor, having those certifications means a lot of risk mitigation, ”concerning safety and quality assurance." 

See Also: New Clinical MDMA And Psilocybin Batches Head To Flourishing Psychedelics Market

Stuck sees the industry going in that direction. “We had so many cannabis companies go through us to get GMP certification and then more people coming because now they won't buy their ingredients that are not GMP-certified, so they're losing clients. It’s the industry that’s driving that requirement -which happened in wholesale food as well.”

Both GMP and GACP are based on the U.S. Department of Agriculture and the FDA. “So if you have one of those certifications and somebody gets involved on a federal level, you're going to be fine. You're not going to be shut down, which is really peace of mind for most of our clients,” Stuck told Benzinga. 

And having such certifications are key, she says, as eventually, it will become federally legal.

“It’s just a matter of time. And it's nice now to let my clients sleep better at night, knowing that they are making safe products and they're doing everything that they're supposed to do to make sure their consumers are both happy and safe,” Stuck said. 

Photo courtesy of Kim Stuck.