Revised German Cannabis Monograph

Ph. Eur., USP and other Pharmacopoeias - Live Online Training

Recommendation

17/18 September 2024

Ph. Eur., USP and other Pharmacopoeias - Live Online Training
Dealing with different compendial methods

A revised German Cannabis Flower Monograph has been announced to be published in the German Pharmacopoeia (Deutsches Arzneibuch, DAB). The announcement by the German Federal Institute for Drugs and Medical Devices (BfArM) dated 26 April 2024 was published in the Federal Gazette ("Bundesanzeiger") on 14 May 2024.

The revison relates to the correction of the wording for the content calculation (formula) in the assay of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) resulting from the content of the corresponding acids.

The amended and revised German Pharmacopoeia will be valid from 1 October 2024. The new version is called ‘Deutsches Arzneibuch 2024 (DAB 2024)’ and can be obtained from the German publisher "Deutscher Apotheker Verlag".

The European Pharmacopoeia (Ph. Eur.) meanwhile contains an official Cannabis Flower monograph, which will be implemented on 1 July 2024. It is expected that the German Cannabis Flower monograph will be removed from the DAB once a valid official German translation of the Ph. Eur. Cannabis Flower monograph becomes available.