CBD oil: now available at your local pharmacy

The Royal Decree of 11 June 2015 prohibits the delivery of preparations containing tetrahydrocannabinolen (THC).

Because cannabidiol (CBD) may be contaminated with a trace amount of THC, until recently CBD-based preparations were completely out of the question.

The Federal Agency for Medicines and Health Products (FAMHP) now interprets, by means of its circular of 16 July 2019, the Royal Decree of 11 June 2015 in the sense that pharmaceutical preparations based on CBD are permitted.

In its circular, the FAMHP provides criteria on the basis of which a pharmacist can determine whether a pharmaceutical raw material contaminated with THC can be used in a preparation.

The reference point is the limit dose for THC in food and the FAMHP is looking to the scientific committee of the Federal Agency for the Safety of the Food Chain (FASFC) that has set thresholds for the limit dose of THC in food of animal origin (i.e. for animals fed with hemp or hemp derivatives).

The use of raw materials such as CBD with trace amounts of THC for pharmaceutical preparations is acceptable if the maximum dosage set by the FAMHP is not exceeded (i.e. if the patient's exposure to THC does not exceed 1 microgram per kg body weight per day).

Preparations based on CBD can only be delivered on prescription. Free sale remains prohibited.

 

CORBUS ADVOCATEN specializes in all aspects of the ever-growing market for cultivation and distribution of cannabis intended for medicinal and scientific purposes.

For more information on this topic, please contact Anton Buntinx (anton.buntinx@corbus.be).

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