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By: Theresa Yarbrough
Founder/Director Georgia Cannabis Industry Alliance (GA CIA)
September 7, 2025

As the U.S. prepares to reschedule marijuana from Schedule I to Schedule III under the Controlled Substances Act, a critical—but often overlooked—component of the new regulatory landscape is already in place: the DEA’s selection of eight bulk manufacturing licensees for cannabis research. These federally registered entities form the backbone of the legal supply chain for research-grade cannabis and are positioned to become the exclusive domestic sources for FDA drug development once Schedule III is enacted.

Not Common Knowledge

The fact that the DEA has already issued eight bulk manufacturing licenses for cannabis research is publicly available but not widely known. It’s buried in federal registries and ethics filings, not broadcast in mainstream media. Most people—even within the cannabis industry—don’t realize that:

• These 8 entities form a closed-loop supply chain for federally sanctioned cannabis.

• They are poised to become the exclusive domestic sources for FDA drug development once Schedule III is enacted.

• This effectively locks out legacy growers, community cultivators, and independent researchers from the pharmaceutical pipeline.

So while the information is accessible, it’s not part of the public discourse. That’s why this article is so important—it names what’s been quietly structured behind the scenes.

Tied to Post-Rescheduling

This licensing framework becomes strategically relevant only if marijuana is rescheduled to Schedule III under the Controlled Substances Act. That shift:

• Recognizes marijuana’s medical value

• Places it under FDA oversight

• Requires federally compliant sourcing for clinical trials and drug development

In that context, the DEA-licensed manufacturers become the only legal suppliers for pharmaceutical cannabis. Their role is minor under Schedule I, but central under Schedule III

The Eight DEA-Registered Cannabis Manufacturers

The DEA has granted bulk manufacturing licenses to the following organizations:

• National Center for Natural Products Research (University of Mississippi)

• Groff NA

• Biopharmaceutical Research Company LLC

• Hemplex LLC

• Irvine Labs

• Maridose LLC

• Royal Emerald Pharmaceuticals

• Scottsdale Research Institute

These manufacturers are authorized to produce cannabis for federally approved research and clinical trials. Their designation by the DEA gives them a unique advantage in the emerging pharmaceutical cannabis market, particularly under Schedule III, which would require FDA oversight and federally compliant sourcing.

Licensing Cost

The DEA does not publicly list a fixed fee for bulk manufacturing registration specific to cannabis, but based on the DEA Diversion Control Division, the general registration fee for bulk manufacturers of Schedule I substances is approximately $3,047 per year. However, this fee is just the surface—applicants often incur significant additional costs related to:

• Facility upgrades to meet DEA security standards

• Legal and regulatory consulting

• Compliance audits and documentation

• GMP (Good Manufacturing Practice) certification prep

For most applicants, the true cost of becoming a DEA-licensed cannabis manufacturer likely exceeds six figures, especially when factoring in infrastructure and legal readiness.

Licensing Guidelines

According to the DEA’s final rule published in the Federal Register and codified in 21 CFR Part 1318, applicants must meet several stringent criteria:

1. Application Requirements

• Submit DEA Form 225 (Manufacturer Registration)

• Provide detailed descriptions of cultivation methods, security protocols, and diversion controls

• Include a bona fide supply agreement with a registered researcher or manufacturer

2. Public Interest Determination

The DEA Administrator must determine that the registration is:

• Consistent with the public interest, based on factors like prior compliance, experience, and demand

• Aligned with U.S. treaty obligations under the Single Convention on Narcotic Drugs

3. Security and Recordkeeping

• Facilities must meet physical security standards (e.g., surveillance, restricted access)

• Registrants must maintain detailed records of all cannabis production, inventory, and transfers

• Subject to DEA inspections and audits

4. Limited Approval Window

The DEA opened the application window following its 2020 rule change, but approvals were limited and selective. The eight registrants were chosen over several years, with little transparency about why certain applicants were accepted over others.

Strategic Implication

This wasn’t an open-access process. It was a curated selection, favoring entities with:

• Existing pharmaceutical infrastructure

• Legal teams fluent in federal compliance

• Prior relationships with DEA or federal research institutions

Legacy growers and MSOs were effectively excluded by design, not just by cost.

This pre-selection creates a significant bottleneck: legacy growers, community cultivators, and state-licensed operators are excluded from the federally recognized supply chain. Once Schedule III is enacted, these eight registrants will hold a privileged position in the cannabis economy, controlling access to clinical trials, drug development, and export markets. Pharmaceutical companies are already initiating partnerships with these manufacturers, securing early access to compliant supply and positioning themselves for rapid scale-up.

Strategic Key Implications 

• Limited Access: Only eight entities are currently authorized, creating a bottleneck in supply and limiting participation from independent or legacy growers.

• Regulatory Exclusivity: These registrants are positioned to dominate the supply chain for any cannabis-based drug development, clinical trials, and exports.

• Policy Leverage: Their federal status allows them to align with pharmaceutical companies and influence future regulatory frameworks.

Strategic Summary

This licensing structure raises concerns about market consolidation, exclusion of community-based cultivators, and the long-term control of cannabis research and development by a small group of federally sanctioned actors.

1. Exclusion from the FDA Supply Chain

Multi-state operators (MSOs) like Trulieve are not among the DEA’s licensed manufacturers. This means they cannot legally supply cannabis for FDA-approved clinical trials or drug development. If Schedule III is enacted, their products will remain outside the federally recognized pharmaceutical pipeline unless they secure partnerships or pursue DEA licensure themselves.

2. Pressure to Partner or Pivot

To remain competitive, MSOs may need to:

• Form strategic alliances with DEA-licensed manufacturers

• Invest in federally compliant infrastructure

• Shift product development toward FDA-compatible formulations

The DEA’s licensing framework creates a federal bottleneck:

• Only eight entities can legally supply cannabis for FDA trials

• MSOs are left operating in state silos, even as federal policy shifts

MSO’s, despite their scale and lobbying power, may find themselves locked out of the pharmaceutical cannabis economy, unless it adapts quickly.

This could require significant capital and operational restructuring, diverting resources from retail expansion and state-level advocacy.

3. Market Fragmentation and Bottlenecking

The DEA’s licensing framework creates a two-tiered system:

• DEA-licensed manufacturers with access to federal drug channels

• State-licensed MSOs operating in siloed, non-FDA markets

Even large MSOs like Trulieve, despite their scale and lobbying power, may find themselves locked out of the pharmaceutical cannabis economy unless they adapt quickly.

4. Regulatory Uncertainty

Even with Schedule III, marijuana remains federally controlled. MSOs must navigate:

• Conflicting state and federal rules

• Unclear pathways for integrating into FDA-regulated markets

• Potential compliance burdens if they seek DEA licensure

This creates risk, especially for companies heavily invested in state-level retail and cultivation.

Schedule III reclassification introduces new compliance burdens:

• FDA approval for medical products

• GMP manufacturing standards

• DEA recordkeeping and security protocols

MSOs must navigate conflicting state and federal rules while preparing for a more tightly regulated future. Their future in a Schedule III world depends on how fast they can adapt, align, or disrupt. The DEA’s eight cultivators aren’t just competitors—they’re gatekeepers.

MSO’s Position

MSO’s stand to benefit from Schedule III’s repeal of IRS Section 280E, which would allow them to deduct ordinary business expenses like rent, payroll, and marketing. Trulieve has invested heavily in state-level legalization efforts, particularly in Florida, and has spent over $260,000 on federal lobbying in 2025 alone.

However, without DEA licensure or strategic partnerships, Trulieve risks being excluded from the federally sanctioned cannabis supply chain. The company’s future in a Schedule III landscape depends on its ability to align with federal standards, secure compliant sourcing, and potentially collaborate with pharmaceutical entities.

That means:

• MSO’s cannot supply cannabis for federally approved clinical trials or FDA drug development.

• If Schedule III is enacted, Trulieve’s products would be ineligible for pharmaceutical pathways unless they partner with a DEA registrant or secure their own license.

This creates a two-tiered system:

• DEA-licensed cultivators = federally compliant supply

• MSOs like Trulieve = state-licensed, excluded from federal drug channels

The DEA’s eight licensed cannabis manufacturers aren’t just a regulatory footnote. They represent a structural shift that could reshape how MSOs like Trulieve operate in a post–Schedule III landscape.

Structural Parallels: DEA vs. State Licensing

What This Reveals

• Legacy growers were marginalized by state systems that prioritized control, compliance, and corporate investment.

• Now, MSOs—despite their scale and lobbying power—are being boxed out of the federally compliant supply chain unless they pivot or partner.

• In both cases, the gatekeepers were chosen before the public understood the rules, and the infrastructure was built quietly, behind closed doors.

This isn’t just exclusion. It’s a pattern of regulatory consolidation—where those closest to the plant are pushed aside in favor of those closest to power.

The DEA’s pre-selection of eight cannabis manufacturers is not just a regulatory detail—it’s a structural shift that will define access, control, and competition in the post-rescheduling cannabis economy. MSOs must now decide whether to partner, pivot, or push for inclusion. The gate has already been built. The question is who gets through it.

Conclusion

The DEA’s pre-selection of eight cannabis manufacturers for federally compliant supply mirrors how many state legislatures treated legacy growers during early legalization phases. Both moves created exclusive access points that favored well-capitalized, institutionally aligned actors while sidelining those who built the foundation.