On August 21st the U.S. Drug Enforcement Administration (DEA) proposed amendments to the Controlled Substance Act (CSA) for hemp and CBD. On August 26th they announced changes to facilitate and expand scientific and medical research for marijuana in the United States. The amendments modify enforcement by the DEA protocols for compliance with the current 2018 Farm Bill laws. Among the amendments are updates to the definitions of THC and marihuana extract. Removal of CBD from Schedule V status. Removal of import and export controls over hemp and it’s derivatives. Finally, adding grants for research licenses to applicants in the cannabis community.
Proposed Changes To Enforcement
The amendments to conform with the Farm Bill are meant to conform DEA regulations with the CSA rules that have already taken effect. There are no additional requirements to any regulations. There should be no additional costs as a result of the compliance changes.
- It modifies 21 CFR 1308.11(d)(31) by adding language stating that the definition of “Tetrahydrocannabinols” does not include “any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639 o.”
- It removes from control in schedule V under 21 CFR 1308.15(f) a “drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1% (w/w) residual tetrahydrocannabinols.”
- It also removes the import and export controls described in 21 CFR 1312.30(b) over those same substances.
- It modifies 21 CFR 1308.11(d)(58) by stating that the definition of “Marihuana Extract” is limited to extracts “containing greater than 0.3 percent delta-9-tetrahydrocannabinol on a dry weight basis.”
October is the deadline for comments on the regulations via mail and online.
Steps to Improve Access to Marijuana Research
Additionally, new DEA cannabis announcements indicate a review of the research programs. New regulations to govern the marijuana growers program for scientific and medical research will be submitted soon. The new rules will ensure that the DEA can evaluate the applications and conform the program to relevant laws. As usual, the process will provide applicants and the general public with an opportunity to comment on the regulations.
The “DEA is making progress in the program to register additional marijuana growers for federally authorized research, and will work with other relevant federal agencies to expedite the necessary next steps,” said DEA Acting Administrator Uttam Dhillon. “We support additional research into marijuana and its components, and we believe registering more growers will result in researchers having access to a wider variety for study.”
