Updated Cannabis Quality Standards, Regulation Helps Establish Its Role as Medicine

Pharmacy Times Health Systems EditionJuly 2023
Volume 12
Issue 4

Renewed focus on the potential this drug can provide patients is upon us as we continue to strive for greater and better care and treatment for patients throughout US health systems.

Public opinion regarding cannabis has changed drastically in the past 20 years. A drug that was once taboo in polite society is now legal for medical use in 38 states, 3 territories, and the District of Columbia (DC) as of April 24, 2023. It is also legal for adult nonmedical use in 23 states, 2 territories, and DC as of June 1, 2023.1

Cannabis leaves. Cannabis marijuana foliage with a purple pink tint on a black background. Large leaf of cannabis plant in purple light. Medicinal hemp: a new look at the agricultural hemp strain | Image Credit: Tsareva.pro - stock.adobe.com

Tsareva.pro - stock.adobe.com

However, this piecemeal approach to cannabis legislation has posed problems in its regulation as medicine by national organizations such as the FDA and US Pharmacopeial Convention (USP). To address this problem, earlier this year the USP proposed a new cannabis monograph to help set acceptance criteria for plant chemotypes, content of cannabinoids, microbial contamination, elemental impurities, pesticide residues, terpenes, and foreign organic matter. Shortly thereafter, the FDA released guidance for the industry on quality considerations for cannabis in clinical research. These efforts by the FDA and USP have helped to clarify that if we are using cannabis as medicine (nearly) nationwide, it must be federally regulated and standardized as such.

In the cover story on page 10, coauthors Christine Roussel, PharmD, BCOP, BCSCP; and Megan Schwartz, BS, PharmD candidate 2024, highlight points of interest within the proposed USP cannabis monograph, explaining aspects of appropriate labeling for each set of acceptance criteria. Additionally, they provide a brief overview of how the USP has regulated cannabis quality since it was first included in a USP monograph in 1851, with potency assessed using physiologic assays.

On page 18, authors Zachary (Zack) Nelson, PharmD, MPH, BCPS, BCIDP, AAHIVP; and Nicholas Kane, PharmD, discuss an updated guideline from the Society for Healthcare Epidemiology of America on Clostridioides difficile infection (CDI) in acute-care hospitals. Then, on page 30, we discuss the patient experience of medical gaslighting as it relates to CDI.

Today, as we bridge the gap between the last cannabis USP monograph of 1936 to the proposed USP monograph of 2023, renewed focus on the potential this drug can provide patients is upon us as we continue to strive for greater and better care and treatment for patients throughout US health systems.


State medical cannabis laws. National Conference of State Legislatures. Updated June 22, 2023. Accessed June 27, 2023. https://www.ncsl.org/health/state-medical-cannabis-laws#:~:text=Medical%2DUse%20Update,1%20below%20for%20additional%20information

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