July 24, 2026 By Jesse Harlan Alderman , Michael McQueeny
While the medical marijuana rescheduling order made clear that the Drug Enforcement Agency (“DEA”) would prioritize the review of medical marijuana applications submitted during the first sixty (60) days of the application window, we are watching now the details and process of that review come into picture.
DEA field offices have kicked off inspections, not just in medical-only states, but also now in states with both medical and adult-use licensed businesses. While this process, at times, can differ depending on the individual field offices involved, many common themes have emerged by virtue of the questions asked, information requested, and physical inspections of facilities to date. Moreover, this process also reveals the initial scope of federal oversight as it relates to existing DEA regulatory requirements, and how those requirements differ, complement, and/or layer on top of the state-based controls forming the core of this regulated industry.
With this background as a guide, Foley Hoag’s national cannabis team has developed a set of documents identifying emerging best practices, including as it relates to DEA-specific checklists and SOPS identifying corresponding federal regulatory requirements and overlays. Please reach out if we can help prepare your team for DEA inspection and assist in crafting responses to written responses for information.
Below are some key takeaways:
- DEA application review is being delegated to regional offices;
- Most applicants in medical-only states have received outreach from a regional office;
- Most – but not all – applicants in dual-use states have not yet received outreach from the DEA;
- Sequence of inspections.
- Initial outreach and requests for additional documentation, including, but not limited to:
- Corporate structure and beneficial ownership;
- SOPs;
- Information on persons with responsibility;
- Patient verification;
- Site control;
- Security protocols, equipment and design; and
- Background checks and employee screening.
- Inspections.
- Post-Inspection Follow-Up.
- Initial outreach and requests for additional documentation, including, but not limited to:
While DEA has not yet opened a specific window for production, distribution and other applicants aside from dispensaries, DEA has identified that medical-marijuana cultivators and producers may utilize the existing DEA Form 225 to apply. Specifically, the DEA has noted that “[i]n the coming weeks, an updated ‘medical marijuana manufacturer,’ ‘medical marijuana bulk manufacturer (grower/cultivator)’, ‘Medical Marijuana Analytical Lab’, and ‘Medical Marijuana Distributor’ application will be available specifically for handling Schedule III medical marijuana and posted on DEA Diversion’s Registration Page.” However, the promise of these applications opening “in the coming weeks,” has already been promised (and not delivered) for several weeks. With that in mind, DEA has made clear that medical marijuana applicants may submit for manufacturing and/or distribution utilizing the existing Form 225, noting that “[i]f you have already submitted your application . . . . we will be in contact with you shortly to continue processing your application – there is no need to reapply.” For those that may not have applied for their registrations related to their medical marijuana cultivation and/or manufacturing facilities, the use of the Form 225 raises additional compliance and application related questions, which Foley Hoag has been working with applicants in addressing and resolving.
The preceding is largely good news in that the DEA process is unfolding without much incident. And it’s good news too that the DEA review process includes questions very familiar to all operators because they are the same state regulators have been asking for years. That being said, preparation for these inspections and a clear understanding of DEA regulations that may be overlayed on state requirements is a core compliance consideration, and only promises to aid in the swift processing of each DEA registration application. We continue to monitor all developments in the medical cannabis DEA registration process with an eye also on the broader rescheduling hearings.
