German Pharmacopoeia Monograph for Cannabis Extracts

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

The German Federal Institute for Drugs and Medical Devices (BfArM ) announced the release of the DAB 2020 (Deutsches Arzneibuch = German Pharmacopoeia) on 5 March 2020 (published in the (German) Bundesanzeiger of 18 March 2020). The announcement lists the texts and monographs adopted by the German Pharmacopoeial Commission on 11 October 2019. According to the announcement the DAB monograph entitled "Cannabis Extract, Standardized (Cannabis extractum normatum)" will be added to the DAB 2020. The draft monograph on cannabis extract was published last year in the German "Bundesanzeiger".

Changes to the draft in 2019

As a result of the comments and remarks received on the draft monograph "Cannabis Extract, Standardized" - (BAnz. AT 06.05.2019 B6), the monograph has been revised. It is anticipated that the DAB monograph will be published as agreed in the protocol of the 62nd consultation of the DAB Committee for Pharmaceutical Biology (to be found on the BfArM website under "DAB Commission Expert Groups" (Fachausschüsse der DAB-Kommission). Thus, it is expetced that the DAB monograph will

• require a minimum of 1 % and a maximum of 25 % (m/m) for the THC content and will not contain a limit (or range) for cannabidiol (CBD).
• indicate under "Manufacture" the following:
  "The extract is prepared by an appropriate extraction process, preferably CO2 extraction. The extract obtained is refined, if necessary, and adjusted to the declared content with an inert excipient, preferably with medium-chain triglycerides. The cannabinoid acids are decarboxylated during the preparation of the extract or during drying of the herbal drug" (in addition, the requirements of the General Ph. Eur. Monograph "Herbal Drug Extracts" apply).
• include under "Tests" a limit for cannabinol (CBN) of max 2.5 percent (in the 2019 draft a maximum of 1% - similar to the flowers - was required) and contain a test on residual solvents according to Ph. Eur. Chapter 5.4.

The DAB already contains the monograph "Cannabis flowers" (Cannabis flos). The amended and revised German Pharmacopoeia will be renamed "Deutsches Arzneibuch 2020 (DAB 2020)" and will be effective as of 1 June 2020. The German Pharmacopoeia can be purchased from "Deutscher Apotheker Verlag".

In addition, the European Pharmacopeia (Ph. Eur.) is currently working on a Cannabis Monograph. However, some specific challenges for the development of the Ph. Eur. Cannabis monograph (e.g. inclusion of preparations, sample availability) have been recently discussed (please see Committee on Herbal Medicinal Products (HMPC) Minutes for the meeting on 23-25 September 2019).