Update on the USP CBD Monograph

The USP republished the proposed new USP Monograph on Cannabidiol (CBD) in Pharmacopeial Forum (PF) 51(3). The revised draft is open for comment until 31 July 2025.

Background

Because there is currently no existing USP monograph for CBD, a new monograph is being proposed. However, the previous proposal that appeared in PF 50(3) [May–June 2024] has been canceled and is replaced with the new proposal. This proposed monograph aims to provide specifications for highly purified Cannabidiol (CBD) from Cannabis sativa. CBD obtained from synthetic routes of production could result in different impurity profiles. The proposal does not include specifications for synthetically derived CBD. Compared to the previous version, and on the basis of comments received, a limit of total unspecified impurities (max. 0.50%) has been added to the test for Organic Impurities.

The proposed USP CBD Monograph was first published in PF 48(1) and then, following the comments received, published in PF 50(3) in a revised version. In addition, the new USP draft chapter entitled <1568> Quality Considerations for Cannabis and Cannabis-Derived Products for Clinical Research was republished for comment in PF 51(3).

In contrast to the European Pharmacopoeia (Ph. Eur.), the USP does still not include official monographs on Cannabis Flower and CBD.

More information is available at USPs Proposal Status/Commentary website and in the Pharmacopeial Forum (PF).