Prescription Cannabinoid Medicines: How They Are Regulated

What "approved medicine" means here

In this library, approved medicine means a specific drug product that a regulator has authorized for named conditions after reviewing trial evidence. That approval applies to that product, made to a set standard, for those uses. It does not transfer to cannabis flower, hemp oils, gummies or other consumer products. For the clinical side of each drug, see approved cannabinoid medicines; for the broader contrast, see cannabis medicines vs consumer products. This page covers only regulation. Laws change and this is not legal advice; sources were read on 2026-10-22.

United States: FDA

The FDA states that it has not approved a marketing application for cannabis for the treatment of any disease or condition. [1] It has approved one cannabis-derived drug and three cannabis-related drugs:

• Epidiolex contains a purified form of cannabidiol (CBD). It is approved for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 year of age and older, and for tuberous sclerosis complex. [1]
• Marinol and Syndros contain dronabinol, a synthetic delta-9-tetrahydrocannabinol (THC). [1]
• Cesamet contains nabilone, which has a chemical structure similar to THC and is synthetically derived. [1]

The FDA says these approved products are available only with a prescription from a licensed health care provider. [1] The FDA page we read (content current as of July 16, 2024) is the source for this list; newer approvals, if any, were not checked.

United States: Drug Enforcement Administration scheduling

Approval and scheduling are separate. A Justice Department final rule effective April 28, 2026 places FDA-approved drug products containing marijuana in Schedule III, and states it is not rescheduling products previously moved out of Schedule I, with Marinol and Syndros as examples. [2] It also adds such drugs to the list of substances that may be imported or exported only under a permit. [2]

European Union: EMA

The European Medicines Agency lists Epidyolex (active substance cannabidiol) as authorized for use in the European Union, with a marketing authorization issued on 19 September 2019. [3] Its listed uses are Lennox-Gastaut syndrome or Dravet syndrome (with clobazam) from two years of age, and tuberous sclerosis complex with other epilepsy treatments from age two. [3] The EMA says it can only be obtained with a prescription and that treatment should be started and supervised by a doctor experienced in treating epilepsy. [3]

The age threshold differs between the FDA (1 year) and EMA (2 years) listings above; the label for your country governs. We did not read national medicine agencies in individual EU countries, the United Kingdom or Canada for this page.

Why a drug label does not describe consumer products

European food-safety experts make the same point from the other direction: in medicine, adverse effects are tolerated if the benefit outweighs the harm, which is not acceptable when judging CBD as a food. [4] See consumer CBD product rules.

If a prescription is involved

Questions about starting, stopping or combining a prescribed medicine belong with the prescriber. Interactions are discussed in CBD and medication interactions.