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dea and cbd

As explained in the Final Rule, the creation of this new drug code was primarily intended to give DEA more precise accounting to assist the agency in carrying out its obligations to provide certain reports required by U.S. treaty obligations. Because the Final Rule did not add any substance to the schedules that was not already controlled, and did not change the schedule of any substance, it was not a scheduling action under 21 U.S.C. §§ 811 and 812.

The new drug code is a subset of what has always been included in the CSA definition of marijuana. By creating a new drug code for marijuana extract, the Final Rule divides into more descriptive pieces the materials, compounds, mixtures, and preparations that fall within the CSA definition of marijuana. Both drug code 7360 (marijuana) and new drug code 7350 (marijuana extract) are limited to that which falls within the CSA definition of marijuana.

Note regarding this rule – In light of questions that the Drug Enforcement Administration has received from members of the public following the publication of the Final Rule establishing a new Controlled Substance Code Number (drug code) for marijuana extract, DEA makes the following clarification:

Clarification of the New Drug Code (7350) for Marijuana Extract

Because recent public inquiries that DEA has received following the publication of the Final Rule suggest there may be some misunderstanding about the source of cannabinoids in the cannabis plant, we also note the following botanical considerations. As the scientific literature indicates, cannabinoids, such as tetrahydrocannabinols (THC), cannabinols (CBN) and cannabidiols (CBD), are found in the parts of the cannabis plant that fall within the CSA definition of marijuana, such as the flowering tops, resin, and leaves. 2 According to the scientific literature, cannabinoids are not found in the parts of the cannabis plant that are excluded from the CSA definition of marijuana, except for trace amounts (typically, only parts per million) 3 that may be found where small quantities of resin adhere to the surface of seeds and mature stalk. 4 Thus, based on the scientific literature, it is not practical to produce extracts that contain more than trace amounts of cannabinoids using only the parts of the cannabis plant that are excluded from the CSA definition of marijuana, such as oil from the seeds. The industrial processes used to clean cannabis seeds and produce seed oil would likely further diminish any trace amounts of cannabinoids that end up in the finished product. However, as indicated above, if a product, such as oil from cannabis seeds, consisted solely of parts of the cannabis plant excluded from the CSA definition of marijuana, such product would not be included in the new drug code (7350) or in the drug code for marijuana (7360), even if it contained trace amounts of cannabinoids. 5

Some critics, however, assert that the DEA’s interim rule may negatively impact cannabis processing. Critically, the rule does not allow for products containing more than .3% THC at any stage of the processing. This means that processors that inadvertently create products with more than .3% THC would be in possession of a schedule I substance, even if those products were later diluted or destroyed.

The DEA’s rule also removes CBD-based drugs approved by the Food and Drug Administration from Schedule V of the CSA. The DEA took a similar position in April 2020, when it removed the FDA-approved CBD epilepsy medication Epidolex from Schedule V status.

The Drug Enforcement Administration has released interim final rules regarding hemp and CBD products, to bring the agency into compliance with the 2018 Farm Bill.

While the DEA stated that public comment on the proposed rule is “unnecessary in this instance” because the agency is merely conforming to new law, it will be accepting public comment through October 20 th .

The rules revise the definition of THC and marijuana extracts under the Controlled Substances Act to exclude substances considered legal hemp. Under the 2018 farm bill, legal hemp is defined as those products containing less than .3% THC.

While the federal government has taken efforts to legalize hemp and CBD products in recent years, the DEA’s regulation may have a chilling effect on cannabis processing. The coming months are likely to see refinement of these rules, and other existing regulations, as businesses grapple with the complex and everchanging requirements of the cannabis industry.