What Cannabis Rescheduling Means (and Doesn’t Mean) for Patients

In October 2022, the Biden administration initiated an administrative process to review cannabis’ classification as a Schedule I controlled substance. The following year, officials at the US Department of Health and Human Services issued a 250-page review calling for all botanical cannabis to be rescheduled from Schedule I to Schedule III. 

In April, acting Attorney Todd Blanche bifurcated this recommendation – ordering the immediate rescheduling of “marijuana in any form covered by a state medical marijuana license” while maintaining that “unlicensed bulk marijuana” remains classified as a Schedule I controlled substance. Separately, the Justice Department announced that the DEA would hold hearings this summer to “receive factual evidence and expert opinion” on the matter of more comprehensive federal reforms. Those hearings are scheduled to begin on June 29^th.

Here’s a look at where the rescheduling process currently stands and what it means for patients.

Is Medical Marijuana Rescheduling a Done Deal?

Not quite. Although Blanche’s final order took effect upon issuance, it remains subject to legal scrutiny. Under the administrative rescheduling process, interested parties have 30 days to challenge the order. Several parties – including the attorneys general of Indiana and Nebraska – filed suit during this window. They argue that Blanche’s order is “arbitrary, capricious, an abuse of discretion, and not in accordance with law.” These suits have been consolidated and are now before the US Court of Appeals for the D.C. Circuit. The Court will decide whether some or all of the parties have standing to bring the case. (In order to establish legal standing, plaintiffs must show the court that rescheduling will cause them to suffer from a “specific, concrete injury.”) Plaintiffs also must show that they possess a high likelihood of success “on the merits” of their challenge. If both criteria are met, the litigation can go forward – potentially delaying the upcoming DEA hearings and possibly leading to a reconsideration of the order itself.

How Significant Is Rescheduling? 

The federal government’s admission that certain cannabis products possess “accepted medical utility in the United States” validates the experiences of tens of millions of Americans, as well as those of tens of thousands of physicians – over a quarter of whom acknowledge having recommended medical cannabis to their patients. It also marks a significant shift in the governments’ posture. Historically, federal officials adamantly refused to acknowledge that cannabis possessed any legitimate therapeutic value – even going so far as to legally threaten the medical licensure of physicians who counseled their patients on the matter. (Justices on the Ninth Circuit Court of Appeals eventually determined that the federal government’s threats were unconstitutional.)

Does This Mean Patients Will Need a Prescription? 

No. Blanche’s federal rescheduling order does not explicitly designate any state-authorized cannabis product as an FDA-approved medicine, nor does it provide any regulatory pathway for the agency to expedite this designation. Consequently, nothing in the order mandates that cannabis products be distributed in licensed pharmacies or be regulated like traditional prescription drugs. Going forward, state-approved cannabis products will still be available only in state-licensed dispensaries. Patients residing in states without dispensaries will continue to lack access to state-authorized medical cannabis products. 

Will Rescheduling Impact the Price of Medical Cannabis?

The Acting AG’s final order explicitly states that “state licensees will no longer be subject to the deduction disallowance imposed by Section 280E of the Internal Revenue Code.” This means that, for the first time, state-licensed medical cannabis providers can take standard business deductions, just like traditional businesses. This policy change greatly reduces these entities’ cost of doing business and should ultimately result in lower retail prices.

What’s this Mean for Research?

Provisions in Blache’s rescheduling order also make significant changes in scientists’ ability to clinically investigate cannabis. Whereas federal regulations have historically prohibited scientists from clinically evaluating non-federally approved cannabis products, Blanche’s final order explicitly allows investigators to use either “marijuana or marijuana-derived products from a state license for use in scientific research.” This policy change will spur scientific evaluations of state-licensed, real-world products – ultimately providing greater clarity to patients regarding their safety and efficacy.

Will More Changes Be Coming Soon?

The federal government’s decision to remove cannabis from Schedule I and acknowledge it as a legitimate therapeutic agent may ultimately lead to many additional policy changes. These include the potential relaxing of employee-mandated drug testing restrictions, easing prohibitions on firearm ownership, ending restrictions on the use of medical cannabis by patients residing in public housing, and providing pathways for insurers to reimburse patients for their use of certain medical cannabis products, among other changes.

Rescheduling Is an Important Step Forward, But It’s Not the Finish Line

While the Administration’s medical cannabis rescheduling order is an important and welcome step forward, it still falls well short of the comprehensive changes necessary to provide nationwide relief to patients and it fails to harmonize state and federal marijuana policy.

Specifically, this new order does not aid patients residing in the minority of US states that do not yet regulate medical cannabis use. They will continue to have to fend for themselves. And they will continue to risk arrest and prosecution for doing so.

Further, this federal policy change provides no legal remedies for either the thousands of businesses or the millions of consumers who reside in the 24 states that have legalized marijuana for adults. To rectify this state/federal conflict, and to provide state governments with the explicit authority to establish their own adult-use cannabis regulatory policies — like they already do with alcohol — the cannabis plant and the products derived from it must be removed from the Controlled Substances Act altogether. Doing so would affirm America’s longstanding principles of federalism and appeal to Americans’ deep-rooted desires to be free from undue government intrusion into their daily lives.

Additional information on cannabis rescheduling and its implications is available from NORML’s factsheet, ‘Cannabis Rescheduling: Myths Versus Reality.’

Paul Armentano is the Deputy Director of NORML — the National Organization for the Reform of Marijuana Laws and he is the author of the book Clinical Applications for Cannabis & Cannabinoids, which has been translated and published internationally.

The information in this article and any included images or charts are for educational purposes only. This information is neither a substitute for, nor does it replace, professional legal advice or medical advice, diagnosis, or treatment. If you have any concerns or questions about laws, regulations, or your health, you should always consult with an attorney, physician or other licensed professional.