Pharmacist’s Role Expands in the Era of Cannabis Rescheduling

Medical marijuana is defined as cannabis that contains no more than 0.3% tetrahydrocannabinol (THC).¹ The FDA recommended that the US Drug Enforcement Administration (DEA) move medical marijuana from Schedule I to Schedule III.² This determination was based on the FDA’s evaluation of abuse potential, dependency, and accepted medical use for marijuana. If the DEA approves this move, medical marijuana will join other medications containing the synthetic psychoactive compound THC, which are dronabinol (Marinol [Schedule III] and Syndros [Schedule II]) and nabilone (Cesamet [Schedule II]).³

Rescheduling cannabis empowers pharmacists to lead in patient care by evaluating safety, interactions, and formulations while providing education. | Image Credit: HubbardSteve - stock.adobe.com

A key difference is that cannabis plants can have diverse genotypes and phenotypes and contain varying concentrations of major (cannabidiol [CBD] and THC) and minor (cannabinol, cannabigerol, etc) cannabinoids. There are many questions about what rescheduling would mean. First, what types of cannabis will be available to patients? Secondly, how and where will the natural cannabis products be available? There are 2 likely tracks.

First, a pharmaceutical company could submit an investigational new drug (IND) application for a product with fixed concentrations of cannabinoids to the FDA for approval.⁴ The government could also implement 21 CFR § 1306.26, under which pharmacists may obtain and dispense tested and quantified material.⁵ The IND route would require clinical trials and typically takes longer than a decade for a product to be available to the community.⁴ Following 21 CFR § 1306.26 would only require increased pharmacist education and training on obtaining proper products, possibly compounding, and instructing pharmacists how to dose these products safely. Regardless of the track, once it is legally decided how and where the product will be obtained, pharmacists will be at the forefront of assessing the risks and benefits of cannabis use.

Much is already known about the risks of cannabis use, with THC known to cause tachycardia, sedation, euphoria, anxiety, and hallucinations; CBD is associated with drowsiness, reduced appetite, nausea/vomiting, and liver abnormalities.^6,7 Cannabinoids are also metabolized in the liver by many enzymes, including CYP2C9, CYP3A4, and CYP2C19.⁸ A pharmacist’s assessment of the patient’s pharmacogenomics and concomitant medications can determine whether the use of cannabis might be problematic.⁸ The patient’s other disease states should also be evaluated for risk. For example, a 2025 meta-analysis shows that using cannabis increases the risk of having secondary heart attacks, stroke, and cardiovascular death.^9,10 Furthermore, there is the potential of developing cannabis use disorder.¹¹ Pharmacists can reduce this risk by minimizing exposure and monitoring for problematic symptoms with the continued use of cannabis.

If rescheduled, pharmacists will also need to focus on how patients can use cannabis. The plant’s makeup varies widely regarding concentrations of THC, CBD, and other minor cannabinoids. Due to the lack of randomized clinical trials, a pharmacist’s assessment will be based upon how cannabinoid pharmacology impacts pathophysiology vs reliance on evidence-based guidelines. The FDA’s report to the DEA stated there is good evidence of the possible utility for personalizing treatment plans to treat nausea and vomiting secondary to chemotherapy, pain, and appetite disorders.² Potential rescheduling would provide more real-world evidence for the risks and benefits of cannabis as more clinicians ensure the timely resolution of symptoms and medication adherence.^12,13 Furthermore, after rescheduling, there will likely be more cannabis products made into tablets, inhalers, smoking devices, topical creams, sublingual drops, etc.¹⁴ A pharmacist can help patients decide the best formulation to address their condition.

With rescheduling, pharmacists have the opportunity to seize the knowledge, skill, and compassion to step up for the community and become the experts in medical cannabis use.

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REFERENCES

1. Hemp Production and the 2018 Farm Bill, testimony before the US Senate Committee on Agriculture, Nutrition, and Forestry (July 25, 2019) (statement of Amy Abernethy, MD, PhD, principal deputy commissioner, Office of the Commissioner, US Food and Drug Administration). Accessed July 1, 2025. https://www.fda.gov/news-events/congressional-testimony/hemp-production-and-2018-farm-bill-07252019

2. US Department of Health and Human Services. Basis for the Recommendation to Reschedule Marijuana Into Schedule III of the Controlled Substances Act. August 29, 2023. Accessed July 1, 2025. https://www.dea.gov/sites/default/files/2024-05/2016-17954-HHS.pdf

3. Cannabis (marijuana) and cannabinoids: what you need to know. National Center for Complementary and Integrative Health. Updated November 2019. Accessed July 1, 2025. https://www.nccih.nih.gov/health/cannabis-marijuana-and-cannabinoids-what-you-need-to-know

4. Investigational new drug (IND) application. FDA. November 18, 2024. Accessed July 1, 2025. https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application

5. Dispensing without prescription. 21 CFR §1306.26 (2025).

6. Stella N. THC and CBD: similarities and differences between siblings. Neuron. 2023;111(3):302-327. doi:10.1016/j.neuron.2022.12.022

7. Epidiolex. Prescribing information. Greenwich Biosciences; 2018. Accessed July 8, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf

8. Nasrin S, Watson CJW, Perez-Paramo YX, Lazarus P. Cannabinoid metabolites as inhibitors of major hepatic CYP450 enzymes, with implications for cannabis-drug interactions. Drug Metab Dispos. 2021;49(12):1070-1080. doi:10.1124/dmd.121.000442

9. Chetty K, Lavoie A, Deghani P. A literature review of cannabis and myocardial infarction—what clinicians may not be aware of. CJC Open. 2020;3(1):12-21. doi:10.1016/j.cjco.2020.09.001

10. Storck W, Elbaz M, Vindis C, Déguilhem A, Lapeyre-Mestre M, Jouanjus E. Cardiovascular risk associated with the use of cannabis and cannabinoids: a systematic review and meta-analysis. Heart. Published online June 17, 2025. doi:10.1136/heartjnl-2024-325429.

11. Patel J, Marwaha R. Cannabis Use Disorder. In: StatPearls. StatPearls Publishing; 2024. Accessed July 8, 2025. https://www.ncbi.nlm.nih.gov/books/NBK538131/

12. Troyer J, Tanco K. Review of the use of medicinal cannabis products in palliative care. Cancers (Basel). 2024;16(7):1412. doi:10.3390/cancers16071412

13. Possible benefits of cannabis for people with cancer. American Cancer Society. Updated November 11, 2024. Accessed July 1, 2025. https://www.cancer.org/cancer/managing-cancer/treatment-types/complementary-and-integrative-medicine/marijuana-and-cancer/benefits-of-cannabis.html

14. Stella B, Baratta F, Della Pepa C, Arpicco S, Gastaldi D, Dosio F. Cannabinoid formulations and delivery systems: current and future options to treat pain. Drugs. 2021;81(13):1513-1557. doi:10.1007/s40265-021-01579-x

15. Todaro B. Cannabinoids in the treatment of chemotherapy-induced nausea and vomiting. J Natl Compr Canc Netw. 2012;10(4):487-492. doi:10.6004/jnccn.2012.0048