In the prepublication version of today’s Federal Register, the U.S. Drug Enforcement Agency (DEA) issued an interim final rule (IFR) implementing conforming changes to DEA’s regulations as a result of the Agricultural Improvement Act of 2018 (i.e., the 2018 Farm Bill).

Importantly, DEA states that the interim final rule is intended to conform DEA’s regulations to the 2018 Farm Bill and does not create any additional regulatory requirements. Specifically, the interim final rule:

1. Modifies DEA’s regulation defining tetrahydrocannabinols (THC) to exclude any material, compound, mixture, or preparation that falls within the definition of “hemp;

2. Removes from Schedule V drug products in finished dosage formulations that have been approved by FDA that contains cannabidiol (CBD);

3. Removes import and export controls over drug products in finished dosage formulations that have been approved by FDA that contains CBD; and

4. Modifies DEA’s regulation defining “marihuana extracts” to clarify this definition only encompasses extracts containing greater than 0.3% THC.

DEA acknowledges that the 2018 Farm Bill did not modify the status of synthetic THC under the Controlled Substances Act, and that for synthetic THC, the THC concentration is not a determining factor of the control status. Rather, DEA states that all synthetically derived THC remains a Schedule I controlled substance.

Next steps

The interim final rule will become immediately effective upon official publication in the Federal Register. There will be a 60 day comment period.

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