DEA to hopefully change CBD scheduling within 90 days.
The US Food and Drug Administration announced Monday June 25, 2018 the approval of the first cannabis based prescription medication.
The medicine is called Epidiolex and is a plant-derived oral solution of cannabidiol (CBD). CBD is a chemical component of marijuana that does not cause intoxication or a euphoric high. The London based GW Pharmaceuticals plc, is expecting another significant decision where the US Drug Enforcement Administration (DEA) reclassifies CBD.
This could unlock the opportunity to other marijuana-derived medications as well as ease restrictions on other cannabis research.
Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components.
Over the past decade, we’ve seen a growing interest in the development of therapies derived from marijuana and its components. Proponents of “medical marijuana” advertised its uses for a wide number of medical conditions, such as cancer, multiple sclerosis, post-traumatic stress disorder and anxiety – just to name a few of the touted conditions. The FDA has been supportive of research in this area for many years. But marijuana is a Schedule I compound with known risks. Research to demonstrate that marijuana or its components could be safe and effective in the treatment of medical disorders should be held to the same standard as other drug compounds. And certainly it should not be held to a lower standard, as some proponents would suggest. The FDA has an active program to assist drug developers who want to investigate marijuana or its components through properly controlled clinical trials, to demonstrate the potential for safe and effective uses.
Today, the FDA approved a purified form of the drug cannabidiol (CBD). This is one of more than 80 active chemicals in marijuana. The new product was approved to treat seizures associated with two rare, severe forms of epilepsy in patients two years of age and older.
This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies. This new treatment provides new options for patients.
This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.
So today, in addition to celebrating this scientific achievement and the medical advance that it represents for these patients and their families, we should also reflect on the path that made this possible. It’s a path that’s available to other product developers who want to bring forth marijuana-derived products through appropriate drug development programs.
That pathway includes a robust clinical development program, along with careful review through the FDA’s drug approval process. This is the most appropriate way to bring these treatments to patients. This process also includes a review of the purity of a new drug and manufacturing controls. Before a high-quality drug can be developed, evaluated, and eventually approved by the FDA; it’s critical that the necessary work is done to identify drugs of potential medical benefit and conduct rigorous scientific research through adequate and well-controlled clinical trials. This is true for all drugs, including ones derived from plant materials, like marijuana. And the FDA remains committed to collaborating with federal and state agencies, researchers and product developers on advancing this type of important and conscientious work.
This research process – from early development through preclinical and clinical research – gives us a comprehensive understanding of a new drug. That includes an understanding of whether the new product is safe and effective for treating a particular medical condition, what the proper dosage is and for what populations it is safe and effective, how the new compound could interact with other drugs, or whether the new drug has side effects or other safety concerns.
This work also helps product developers identify the appropriate dosage needed to achieve the desired therapeutic effect while minimizing toxicity and risk. Taken in totality, the scientific evidence generated by these studies forms the basis of the FDA’s evaluation of benefit versus risk. And it’s because of this careful, scientific and evidence-based evaluation by the FDA that health care providers can rely on having a quality product that delivers a consistent, uniform dose of an effective medication that is able to deliver a predictable treatment to patients. This is especially important when considering treatment for serious medical conditions that will be utilized in the clinical care of patients who may have any number of health vulnerabilities. The purified form of the drug CBD approved today by the FDA has been shown to meet these rigorous standards.
Research on the therapeutic effects of marijuana and its components involves a number of federal agencies in addition to the FDA, including the National Institute on Drug Abuse, part of the National Institutes of Health, and the Drug Enforcement Administration.
The FDA has taken several specific steps to support this research.
We meet regularly with researchers as they plan and carry out their trials. We have also formed a Botanicals Team that provides scientific expertise on botanical issues for researchers developing drugs derived from plants, such as marijuana. That team published guidance for industry on clinical studies involving botanical drugs, as well as quality controls for lot-to-lot consistency. In recent years, the agency also has recommended to the DEA the approval of several hundred Schedule I research protocol licenses for research on marijuana or its constituent compounds.
Additionally, the FDA also works with companies to provide patients access to experimental therapies while clinical trials are ongoing through expanded access provisions. These approaches help protect patients while also allowing for the collection of data necessary to support the FDA approval of safe and effective therapies for use in the broader population. Through this process, hundreds of children were able to get access to investigational CBD products while this product was being studied.
Drugs derived from marijuana also are eligible for several programs that are intended to facilitate and expedite development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions. Much of the work we’ve done to encourage research in this area has led to the approval action we took today.
The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels. However, we remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims.
The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. The FDA has taken recent actions against companies distributing unapproved CBD products. These products have been marketed in a variety of formulations, such as oil drops, capsules, syrups, teas, and topical lotions and creams. These companies have claimed that various CBD products could be used to treat or cure serious diseases such as cancer with no scientific evidence to support such claims. We’ll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims. We’re especially concerned when these products are marketed for serious or life threatening diseases, where the illegal promotion of an unproven compound could discourage a patient from seeking other therapies that have proven benefits.
Today’s approval demonstrates our commitment to the scientific process and working with product developers to bring marijuana-based products to market. We remain committed to our gold standard for product development and review. Such a process ensures that any new therapies from marijuana and its constituents are safe, effective and manufactured to a high and consistent quality. And most importantly, that these products have been proven safe and effective for patients.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Information was relayed to me regarding a DEA statement about CBD
(paraphrasing and embellishing for your entertainment).
– Check this article out on the internet. The DEA said it was OK. They are not going to bust people or enforce the law for CBD or that stuff. We won…You can do it. Spread the word.
So I asked…what did I win, what can I do and do you actually believe things you read on the internet? The conversation ended there.
BTW – Regarding all this medical marijuana and anything related to it… After a personal experience with the “laws” that can be twisted into a required narrative… my catch phrase is…“You can…But you can’t”.
So it goes…
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DEA Internal Directive Regarding the Presence of Cannabinoids in Products and Materials Made from the Cannabis Plant
(May 22, 2018)
The Ninth Circuit enjoined enforcement of what is now 21 C.F.R. § 1308.11(d)(31) (drug code 7370) with respect to products that are excluded from the definition of marijuana in the Controlled Substances Act (CSA). DEA thus does not enforce that provision as to such products.
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I call BS…
So…Is anyone seeing it the way I am? I am sure you law hawks are…right?!! I keep reading it over and I see the same ball of confusion that’s always regurgitated by law makers that allows one to step into the trap and when the trap is triggered, they compound their advantage by throwing more charges upon you just to increase their odds of winning. With almost unlimited funds and time, prosecutors have the upper hand and winning is everything no matter the cost…except for the accused, their family and the rest of life’s burdens.
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Whoah there self…bring it back to the subject of this article.
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OK here is what I am talking about and I will break it down highlighting the important parts. I have limited time because I have to get back to work…after all…I am just the copy boy.
Note: (From here on OPINIONS, observations and definitions to words or stuff you should focus on will be in red text. There will also be underlined items to pay attention to.)
The news goes…
DEA Internal Directive Regarding the Presence of Cannabinoids in Products and Materials Made from the Cannabis Plant
(May 22, 2018)
In 2004, the U.S. Court of Appeals for the Ninth Circuit enjoined(v. for a court to order that someone either do a specific act, cease a course of conduct or be prohibited from committing a certain act. ) DEA from enforcing certain regulations (from enforcing certain regulations) with respect to tetrahydrocannabinols (THC).
See Hemp Industries Ass’n v. DEA, 357 F.3d 1012 (9th Cir. 2004).
The government did not seek Supreme Court review of that decision. In response to various inquiries, DEA hereby issues to DEA personnel the following internal directive on how to carry out their duties in light of the Ninth Circuit’s decision.
The Ninth Circuit enjoined enforcement of what is now 21 C.F.R. § 1308.11(d)(31) (drug code 7370) with respect to products that are excluded from the definition of marijuana in the Controlled Substances Act (products that are excluded from the definition of marijuana in the Controlled Substances Act ) (CSA). DEA thus does not enforce that provision as to such products (DEA thus does not enforce that provision as to such products).
Consistent with the Ninth Circuit’s decision, DEA does not enforce 21 C.F.R. § 1308.35.
Products and materials that are made from the cannabis plant and which fall outside the CSA definition of marijuana (such as sterilized seeds, oil or cake made from the seeds, and mature stalks) are not controlled under the CSA. Such products may accordingly be sold and otherwise distributed throughout the United States without restriction under the CSA or its implementing regulations. The mere presence of cannabinoids is not itself dispositive(adj1: directed toward or effecting a disposition (as of a case) [an endless variety of …pretrial motions “Robert Shaw-Meadow”] 2: relating to a disposition of property [ words in a will] 3: providing a final resolution (as of an issue) : having control over an outcome [ of the question]as to whether a substance is within the scope of the CSA; the dispositive question is whether the substance falls within the CSA definition of marijuana (falls within the CSA definition of marijuana).
OK…BEFORE WE LOOK AT AN UPDATED CODE…LET US CHECK THE DEFINITION OF MARIJUANA IN THE CONTROLLED SUBSTANCE ACT….Keep in mind that it is a Schedule 1 drug.
Title 21 United States Code (USC) Controlled Substances Act
802. Definitions
(15) The term “manufacture” means the production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice. The term “manufacturer” means a person who manufactures a drug or other substance.
(16) The term “marihuana” means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.
Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.
What? Read it slowly again and be ready to come back to it to read again. Is it or isn’t it?
Keep this in mind from above…(The DEA thus does not enforce that provision as to such products under 21 C.F.R. § 1308.35)
PART 1308 — SCHEDULES OF CONTROLLED SUBSTANCES
EXEMPT CANNABIS PLANT MATERIAL, AND PRODUCTS MADE THEREFROM, THAT CONTAIN TETRAHYDROCANNABINOLS
1308.35 Exemption of certain cannabis plant material, and products made therefrom, that contain tetrahydrocannabinols.
(a) Any processed plant material or animal feed mixture containing any amount of tetrahydrocannabinols (THC) that is both:
(1) Made from any portion of a plant of the genus Cannabis excluded from the definition of marijuana under the Act [i.e., the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination] and (2) Not used, or intended for use, for human consumption (Not used, or intended for use, for human consumption), has been exempted by the Administrator from the application of the Act and this chapter.
(b) As used in this section, the following terms shall have the meanings specified:
(1) The term processed plant material means cannabis plant material that has been subject to industrial processes, or mixed with other ingredients, such that it cannot readily be converted into any form that can be used for human consumption.
(2) The term animal feed mixture means sterilized cannabis seeds mixed with other ingredients (not derived from the cannabis plant) in a formulation that is designed, marketed, and distributed for animal consumption (and not for human consumption).
(3) The term used for human consumption means either:
(i) Ingested orally or (ii) Applied by any means such that THC enters the human body.
(4) The term intended for use for human consumption means any of the following:
(i) Designed by the manufacturer for human consumption; (ii) Marketed for human consumption; or (iii) Distributed, exported, or imported, with the intent that it be used for human consumption.
(c) In any proceeding arising under the Act or this chapter, the burden of going forward with the evidence that a material, compound, mixture, or preparation containing THC is exempt from control pursuant to this section shall be upon the person claiming such exemption, as set forth in section 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). In order to meet this burden with respect to a product or plant material that has not been expressly exempted from control by the Administrator pursuant to Sec. 1308.23, the person claiming the exemption must present rigorous scientific evidence, including well-documented scientific studies by experts trained and qualified to evaluate the effects of drugs on humans.
The way I interpret it is…If you are not human the DEA will not enforce it or really if it is not made for human consumption as defined above. So Hemp Oil / CBD / Soap / Lotion / Hemp Beer / Soda /etc… Are they legal or an illegal Schedule 1 possession
But wait…you say there is no THC in those products…the burden is on you to scientifically prove it and of course…
The DEA States – \1\ Although it might be theoretically possible to produce a CBD extract that contains absolutely no amounts of other cannabinoids, the DEA is not aware of any industrially-utilized methods that have achieved this result.
OK Define Cannabinoids (the new way)
(58) Marihuana Extract–7350
“Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.”
Still a Schedule 1 drug…………..
§1308.11 Schedule I.
(a) Schedule I shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the DEA Controlled Substances Code Number set forth opposite it.
(b) Opiates. Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, whenever the existence of such isomers, esters, ethers and salts is possible within the specific chemical designation (for purposes of paragraph (b)(34) only, the term isomer includes the optical and geometric isomers):
Which brings us to the new drug code for Marijuana Extract .
The United Nations Conventions on international drug control treats extracts from the cannabis plant somewhat differently than marihuana or tetrahydrocannabinols. The creation of a new drug code in the DEA regulations for marihuana extracts will allow for more appropriate accounting of such materials consistent with treaty provisions.
Establishment of a New Drug Code for Marihuana Extract
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
SUMMARY: The Drug Enforcement Administration is creating a new Administration Controlled Substances Code Number for “Marihuana Extract.” This code number will allow DEA and DEA-registered entities to track quantities of this material separately from quantities of marihuana. This, in turn, will aid in complying with relevant treaty provisions.
Under international drug control treaties administered by the United Nations, some differences exist between the regulatory controls pertaining to marihuana extract versus those for marihuana and tetrahydrocannabinols. The DEA has previously established separate code numbers for marihuana and for tetrahydrocannabinols, but not for marihuana extract. To better track these materials and comply with treaty provisions, DEA is creating a separate code number for marihuana extract with the following definition: “Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.” Extracts of marihuana will continue to be treated as Schedule I controlled substances.
DATES: Effective: January 13, 2017.
Read on – Specifically the comments
SUPPLEMENTARY INFORMATION:
Background
As provided in 21 CFR 1308.03, each controlled substance or basic class thereof is assigned a four digit Administration Controlled Substance Code Number (“Code number” or “drug code”) that is used to track quantities of the controlled substance imported and exported to and from the United States. Additionally, the DEA uses these code numbers in establishing aggregate production quotas for basic classes of controlled substances listed in Schedules I and II as required by 21 U.S.C. 826.
Consistent with the Controlled Substances Act (CSA), the schedules contained in DEA regulations include marihuana (drug code 7360) in Schedule I. 21 CFR 1308.11(d)(23). This listing includes (unless specifically excepted or unless listed in another schedule) any material, compound, mixture, or preparation, which contains any quantity of the substance, or which contains any of its salts, isomers, and salts of isomers that are possible within the specific chemical designation. Because the definition of marihuana in 21 U.S.C. 802(16) includes both derivatives and preparations of marihuana, the DEA until now has used drug code 7360 for extracts of marihuana.
This final rule finalizes a July 5, 2011, Notice of Proposed Rulemaking (76 FR 39039) in which the DEA proposed that a new drug code 7350 be used for extracts of marihuana.
Why a New Code Number Is Needed
The United Nations Conventions on international drug control treats extracts from the cannabis plant somewhat differently than marihuana or tetrahydrocannabinols. The creation of a new drug code in the DEA regulations for marihuana extracts will allow for more appropriate accounting of such materials consistent with treaty provisions.
The Single Convention on Narcotic Drugs, 1961 (“Single Convention”) and the 1971 Convention on Psychotropic Substances (“Psychotropic Convention”) provide for the international control of marihuana constituents. Many of the CSA’s provisions were drafted to comply with these Conventions. The CSA includes schemes of drug scheduling and procedures for adding, removing, and transferring drugs among the schedules that are similar, in some ways, to those in the Single Convention. With respect to those drugs that are subject to control under the Single Convention, the CSA mandates that DEA control such drugs in a manner that will ensure the United States meets its obligations under the Single Convention. 21 U.S.C. 811(d)(1).
Somewhat similar to the CSA, the Single Convention lists substances in four schedules. However, under the Single Convention, the drugs that are subject to the most stringent controls are in Schedule IV. Another difference between the CSA and the Single Convention is that, under the latter, a drug can be listed in more than one schedule. Cannabis and cannabis resin are listed in both Schedule IV and Schedule I of the Single Convention. Schedule I controls under the Single Convention include: Requirements for import and export authorization, licensing of manufacturers/distributors, recordkeeping requirements, a requirement for prescriptions for medical use, annual estimate of needs, quotas, annual statistical reporting, and a requirement that use be limited to medical and scientific purposes. Schedule II of the Single Convention is similar in controls to Schedule I with a few exceptions, and Schedule III is less restrictive. All substances listed in Schedule IV are also listed in Schedule I under the Single Convention in order to encompass the requirements mentioned above. In addition, as indicated, the Single Convention imposes certain heightened measures of control with respect to Schedule IV drugs. The placing of a drug into both Schedule I and Schedule IV, therefore imposes the most stringent controls under the Single Convention. Although cannabis and cannabis resin are listed in Schedules I and IV of the Single Convention, cannabis extracts are listed only in Schedule I.
Read these…
Comments
In response to the July 5, 2011, Notice of Proposed Rulemaking (76 FR 39039), the DEA received six submissions from five commenters. Three of the comments raised issues relating to the medical use or legality of marihuana/cannabis; these comments were not germane to the issues addressed by this rulemaking. A fourth comment was merely a clarification of a comment previously submitted.
One comment requested clarification of whether the new drug code will be applicable to cannabidiol (CBD), if it is not combined with cannabinols.
DEA response: For practical purposes, all extracts that contain CBD will also contain at least small amounts of other cannabinoids. \1\ However, if it were possible to produce from the cannabis plant an extract that contained only CBD and no other cannabinoids, such an extract would fall within the new drug code 7350. In view of this comment, the regulatory text accompanying new drug code 7350 has been modified slightly to make clear that it includes cannabis extracts that contain only one cannabinoid.
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\1\ Although it might be theoretically possible to produce a CBD extract that contains absolutely no amounts of other cannabinoids, the DEA is not aware of any industrially-utilized methods that have achieved this result.
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Another comment from a pharmaceutical firm currently involved in cannabinoid research and product development praised DEA’s efforts to establish a new drug code for marihuana extracts as a means to more accurately reflect the activities of scientific research and provide more consistent adherence to the requirements of the Single Convention. However, the comment expressed concerns that the proposed definition for the new drug code (i.e. “meaning extracts that have been derived from any plant of the genus Cannabis and which contain cannabinols and cannabidiols”) is too narrow. The comment suggested that the broader term “cannabinoids” be substituted for “cannabinols and cannabidiols.” The comment pointed out that other constituents of the marihuana plant may have therapeutic potential. The comment further clarified that the broader term “cannabinoid” includes both cannabinol-type compounds and cannabidiol-type compounds, as well as cannabichromene-type compounds, cannabigerol-type compounds, and other categories of compounds.
DEA response:DEA agrees with the commenter that the term “cannabinoid” would provide for a broader definition of marihuana extract; however, use of the term “cannabinoid” necessitates that the DEA clarify that the new marihuana extract category (drug code 7350) is not intended to include “cannabis resin” as defined in the U.N. Single Convention.
As discussed in the NPRM, a new drug code is necessary in order to better account for these materials in accordance with treaty obligations. The Single Convention placed “cannabis” and “cannabis resin” under both Schedule I and IV of the Convention, the most stringent level of control under the Convention. While “cannabis resin” is extracted from “cannabis,” the Single Convention specifically controls “extracts” separately. Extracts of cannabis are controlled only under Schedule I of the Convention, which is a lower level of control than “cannabis resin.”
Accordingly, it is the DEA’s intent to define the term “marihuana extract” so as to exclude material referenced as “cannabis resin” under the Single Convention on Narcotics. “Cannabis resin” (regulated under the CSA as a resin of marihuana) contains a variety of “cannabinoids” and will continue to be regulated as marihuana under drug code 7360. The new drug code for marihuana extracts under 21 CFR 1308.11(d)(58) will exclude the resin. Cannabis resin and marihuana resin remain captured under the drug code for marihuana (drug code 7360), thus differentiating this material from marihuana extracts (new drug code 7350). This will maintain compliance with the Single Convention.
Final Action
After careful consideration of all comments, the DEA is hereby amending 21 CFR 1308.11(d) to include a new subparagraph (58) which creates a new code number in Schedule I as follows:
“(58) Marihuana Extract–7350
“Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.”
The creation of this new drug code in the DEA regulations for marihuana extracts allows for more appropriate accounting of such materials consistent with treaty provisions. Such marihuana extracts remain in Schedule I. Entities registered to handle marihuana (under drug code 7360) that also handle marihuana extracts, will need to apply to modify their registrations to add the new drug code 7350 to their existing DEA registrations and procure quotas specifically for drug code 7350 each year.
Bottom Line as I see it regarding CBD /Hemp…
If it was not made for human use as defined by the law the DEA will not enforce it.
DEA Internal Directive Regarding the Presence of Cannabinoids in Products and Materials Made from the Cannabis Plant
(May 22, 2018)
In 2004, the U.S. Court of Appeals for the Ninth Circuit enjoined DEA from enforcing certain regulations with respect to tetrahydrocannabinols (THC). See Hemp Industries Ass’n v. DEA, 357 F.3d 1012 (9th Cir. 2004). The government did not seek Supreme Court review of that decision. In response to various inquiries, DEA hereby issues to DEA personnel the following internal directive on how to carry out their duties in light of the Ninth Circuit’s decision.
The Ninth Circuit enjoined enforcement of what is now 21 C.F.R. § 1308.11(d)(31) (drug code 7370) with respect to products that are excluded from the definition of marijuana in the Controlled Substances Act (CSA). DEA thus does not enforce that provision as to such products.
Consistent with the Ninth Circuit’s decision, DEA does not enforce 21 C.F.R. § 1308.35.
Products and materials that are made from the cannabis plant and which fall outside the CSA definition of marijuana (such as sterilized seeds, oil or cake made from the seeds, and mature stalks) are not controlled under the CSA. Such products may accordingly be sold and otherwise distributed throughout the United States without restriction under the CSA or its implementing regulations. The mere presence of cannabinoids is not itself dispositive as to whether a substance is within the scope of the CSA; the dispositive question is whether the substance falls within the CSA definition of marijuana.
The Controlled Substances Import and Export Act incorporates the schedules of the CSA. See generally 21 U.S.C. §§ 951-971. Accordingly, any product that the U.S. Customs and Border Protection determines to be made from the cannabis plant but which falls outside the CSA definition of marijuana may be imported into the United States without restriction under the Controlled Substances Import and Export Act. The same considerations apply to exports of such products from the United States, provided further that it is lawful to import such products under the laws of the country of destination.
This directive does not address or alter DEA’s previous statements regarding the drug code for marijuana extract and regarding resin. SeeEstablishment of a New Drug Code for Marihuana Extract, 81 Fed. Reg. 90194 (Dec. 14, 2016); Clarification of the New Drug Code (7350) for Marijuana Extract. As DEA has previously explained, the drug code for marijuana extract extends no further than the CSA does, and it thus does not apply to materials outside the CSA definition of marijuana.
PART 1308 — SCHEDULES OF CONTROLLED SUBSTANCES
SCHEDULES
§1308.11 Schedule I.
(a) Schedule I shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the DEA Controlled Substances Code Number set forth opposite it.
(b) Opiates. Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, whenever the existence of such isomers, esters, ethers and salts is possible within the specific chemical designation (for purposes of paragraph (b)(34) only, the term isomer includes the optical and geometric isomers):
(c) Opium derivatives. Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(1) Acetorphine
9319
(2) Acetyldihydrocodeine
9051
(3) Benzylmorphine
9052
(4) Codeine methylbromide
9070
(5) Codeine-N-Oxide
9053
(6) Cyprenorphine
9054
(7) Desomorphine
9055
(8) Dihydromorphine
9145
(9) Drotebanol
9335
(10) Etorphine (except hydrochloride salt)
9056
(11) Heroin
9200
(12) Hydromorphinol
9301
(13) Methyldesorphine
9302
(14) Methyldihydromorphine
9304
(15) Morphine methylbromide
9305
(16) Morphine methylsulfonate
9306
(17) Morphine-N-Oxide
9307
(18) Myrophine
9308
(19) Nicocodeine
9309
(20) Nicomorphine
9312
(21) Normorphine
9313
(22) Pholcodine
9314
(23) Thebacon
9315
(d) Hallucinogenic substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation (for purposes of this paragraph only, the term “isomer” includes the optical, position and geometric isomers):
(1) Alpha-ethyltryptamine
7249
Some trade or other names: etryptamine; Monase; α-ethyl-1H-indole-3-ethanamine; 3-(2-aminobutyl) indole; α-ET; and AET.
(2) 4-bromo-2,5-dimethoxy-amphetamine
7391
Some trade or other names: 4-bromo-2,5-dimethoxy-α-methylphenethylamine; 4-bromo-2,5-DMA
(3) 4-Bromo-2,5-dimethoxyphenethylamine
7392
Some trade or other names: 2-(4-bromo-2,5-dimethoxyphenyl)-1-aminoethane; alpha-desmethyl DOB; 2C-B, Nexus.
(4) 2,5-dimethoxyamphetamine
7396
Some trade or other names: 2,5-dimethoxy-α-methylphenethylamine; 2,5-DMA
Some trade or other names: 4-methoxy-α-methylphenethylamine; paramethoxyamphetamine, PMA
(8) 5-methoxy-3,4-methylenedioxy-amphetamine
7401
(9) 4-methyl-2,5-dimethoxy-amphetamine
7395
Some trade and other names: 4-methyl-2,5-dimethoxy-α-methylphenethylamine; “DOM”; and “STP”
(10) 3,4-methylenedioxy amphetamine
7400
(11) 3,4-methylenedioxymethamphetamine (MDMA)
7405
(12) 3,4-methylenedioxy-N-ethylamphetamine (also known as N-ethyl-alpha-methyl-3,4(methylenedioxy)phenethylamine, N-ethyl MDA, MDE, MDEA
7404
(13) N-hydroxy-3,4-methylenedioxyamphetamine (also known as N-hydroxy-alpha-methyl-3,4(methylenedioxy)phenethylamine, and N-hydroxy MDA
7402
(14) 3,4,5-trimethoxy amphetamine
7390
(15) 5-methoxy-N,N-dimethyltryptamine
7431
Some trade or other names: 5-methoxy-3-[2-(dimethylamino)ethyl]indole; 5-MeO-DMT
(16) Alpha-methyltryptamine (other name: AMT)
7432
(17) Bufotenine
7433
Some trade and other names: 3-(β-Dimethylaminoethyl)-5-hydroxyindole; 3-(2-dimethylaminoethyl)-5-indolol; N, N-dimethylserotonin; 5-hydroxy-N,N-dimethyltryptamine; mappine
(18) Diethyltryptamine
7434
Some trade and other names: N,N-Diethyltryptamine; DET
Some trade and other names: 7-Ethyl-6,6β,7,8,9,10,12,13-octahydro-2-methoxy-6,9-methano-5H-pyrido [1′, 2′:1,2] azepino [5,4-b] indole; Tabernanthe iboga
(22) Lysergic acid diethylamide
7315
(23) Marihuana
7360
(24) Mescaline
7381
(25) Parahexyl
7374
Some trade or other names: 3-Hexyl-1-hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]pyran; Synhexyl.
(26) Peyote
7415
Meaning all parts of the plant presently classified botanically as Lophophora williamsii Lemaire, whether growing or not, the seeds thereof, any extract from any part of such plant, and every compound, manufacture, salts, derivative, mixture, or preparation of such plant, its seeds or extracts
(Interprets 21 USC 812(c), Schedule I(c) (12))
(27) N-ethyl-3-piperidyl benzilate
7482
(28) N-methyl-3-piperidyl benzilate
7484
(29) Psilocybin
7437
(30) Psilocyn
7438
(31) Tetrahydrocannabinols
7370
Meaning tetrahydrocannabinols naturally contained in a plant of the genus Cannabis (cannabis plant), as well as synthetic equivalents of the substances contained in the cannabis plant, or in the resinous extractives of such plant, and/or synthetic substances, derivatives, and their isomers with similar chemical structure and pharmacological activity to those substances contained in the plant, such as the following:
1 cis or trans tetrahydrocannabinol, and their optical isomers
6 cis or trans tetrahydrocannabinol, and their optical isomers
3,4 cis or trans tetrahydrocannabinol, and its optical isomers
(Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions covered.)
(32) Ethylamine analog of phencyclidine
7455
Some trade or other names: N-ethyl-1-phenylcyclohexylamine, (1-phenylcyclohexyl)ethylamine, N-(1-phenylcyclohexyl)ethylamine, cyclohexamine, PCE
(33) Pyrrolidine analog of phencyclidine
7458
Some trade or other names: 1-(1-phenylcyclohexyl)-pyrrolidine, PCPy, PHP
(34) Thiophene analog of phencyclidine
7470
Some trade or other names: 1-[1-(2-thienyl)-cyclohexyl]-piperidine, 2-thienylanalog of phencyclidine, TPCP, TCP
Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.
(e) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(1) gamma-hydroxybutyric acid (some other names include GHB; gamma-hydroxybutyrate; 4-hydroxybutyrate; 4-hydroxybutanoic acid; sodium oxybate; sodium oxybutyrate)
2010
(2) Mecloqualone
2572
(3) Methaqualone
2565
(f) Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers:
(1) Aminorex (Some other names: aminoxaphen; 2-amino-5-phenyl-2-oxazoline; or 4,5-dihydro-5-phenly-2-oxazolamine)
1585
(2) N-Benzylpiperazine (some other names: BZP, 1-benzylpiperazine)
7493
(3) Cathinone
1235
Some trade or other names: 2-amino-1-phenyl-1-propanone, alpha-aminopropiophenone, 2-aminopropiophenone, and norephedrone
(4) Fenethylline
1503
(5) Methcathinone (Some other names: 2-(methylamino)-propiophenone; alpha-(methylamino)propiophenone; 2-(methylamino)-1-phenylpropan-1-one; alpha-N-methylaminopropiophenone; monomethylpropion; ephedrone;N-methylcathinone; methylcathinone; AL-464; AL-422; AL-463 and UR1432), its salts, optical isomers and salts of optical isomers
(8) N,N-dimethylamphetamine (also known as N,N-alpha-trimethyl-benzeneethanamine; N,N-alpha-trimethylphenethylamine)
1480
(g) Cannabimimetic agents. Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, or which contains their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(h) Temporary listing of substances subject to emergency scheduling. Any material, compound, mixture or preparation which contains any quantity of the following substances:
(1) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: MAB-CHMINACA; ADB-CHMINACA)
7032
(2) N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: Butyryl fentanyl)
9822)
(3) N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-phenylpropionamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: beta-hydroxythiofentanyl)
9836
(4) 3,4-Dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: U-47700)
9547
(5) N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: Furanyl fentanyl)
9834
(6) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F-ADB; 5F-MDMB-PINACA)
7034
(7) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F-AMB)
7033
(8) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: 5F-APINACA, 5F-AKB48)
7049
(9) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: ADB-FUBINACA)
7010
(10) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: MDMB-CHMICA, MMB-CHMINACA)
7042
(11) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: MDMB-FUBINACA)
7020
(12) [Reserved]
(13) N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: 4-fluoroisobutyryl fentanyl, para-fluoroisobutyryl fentanyl)
9824
(14) N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: acryl fentanyl, acryloylfentanyl)
9811
(15) [Reserved]
(16) [Reserved]
(17) [Reserved]
(18) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate, its optical, positional, and geometric isomers, salts and salts of isomers (Other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA)
7021
(19) N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: ortho-fluorofentanyl, 2-fluorofentanyl)
9816
(20) N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: tetrahydrofuranyl fentanyl)
9843
(21) 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: methoxyacetyl fentanyl)
9825
(22) N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: cyclopropyl fentanyl)
9845
(23) N-(1-phenethylpiperidin-4-yl)-N-phenylpentanamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: Valeryl fentanyl)
9840
(24) N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: para-fluorobutyryl fentanyl)
9823
(25) N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-yl)butyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: para-methoxybutyryl fentanyl)
9837
(26) N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: para-chloroisobutyryl fentanyl)
9826
(27) N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: isobutyryl fentanyl)
9827
(28) N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: cyclopentyl fentanyl)
9847
(29) N-(2-fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: Ocfentanil)
9838
(30) Fentanyl-related substances, their isomers, esters, ethers, salts and salts of isomers, esters and ethers
9850
(i) Fentanyl-related substance means any substance not otherwise listed under another Administration Controlled Substance Code Number, and for which no exemption or approval is in effect under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], that is structurally related to fentanyl by one or more of the following modifications:
(A) Replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle;
(B) Substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
(C) Substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro groups;
(D) Replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle; and/or
(E) Replacement of the N-propionyl group by another acyl group.
(ii) This definition includes, but is not limited to, the following substances:
(A)-(B) [Reserved]
[39 FR 22141, June 20, 1974]
Editorial Note: For Federal Register citations affecting §1308.11, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.
Effective Date Notes: At 82 FR 20544, May 3, 2017, §1308.11 was amended by adding (h)(16), effective May 3, 2017, until May 3, 2019. At 82 FR 47974, Oct. 16, 2017, §1308.11 was amended by redesignating (h)(16) as paragraph (h)(13).
At 82 FR 32457, July 14, 2017, §1308.11 was amended by adding (h)(17), effective July 14, 2017, until July 15, 2019. At 82 FR 47974, Oct. 16, 2017, §1308.11 was amended by redesignating (h)(17) as paragraph (h)(14).
At 82 FR 49508, Oct. 26, 2017, §1308.11 was amended by adding reserved paragraphs (h)(15) through (h)(18) and (h)(19), (20) and (21), effective Oct. 26, 2017,, through Oct. 28, 2019.
At 82 FR 51558, Nov. 3, 2017, §1308.11 was amended by adding paragraph (h)(18), effective Nov. 3, 2017, through Nov. 4, 2019.
At 83 FR 472, Jan. 4, 2018, §1308.11 was amended by adding paragraph (h)(22), effective Jan. 4, 2018. through Jan. 4, 2020.
At 83 FR 4584, Feb. 1, 2018, §1308.11 was amended by adding paragraphs (h)(23) through (h)(29), effective Feb. 1, 2018 through Feb. 1, 2020.
At 83 FR 5191, Feb. 6, 2018, §1308.11 was amended by adding paragraph (h)(3), effective Feb. 6, 2018, through Feb. 6, 2020.
At 83 FR 10368, Mar. 9, 2018, §1308.11 was amended by revising paragraphs (h)(23) and (h)(29), effective Mar. 9, 2018, through Feb. 1, 2020.
PART 1308 — SCHEDULES OF CONTROLLED SUBSTANCES
EXEMPT CANNABIS PLANT MATERIAL, AND PRODUCTS MADE THEREFROM, THAT CONTAIN TETRAHYDROCANNABINOLS
1308.35 Exemption of certain cannabis plant material, and products made therefrom, that contain tetrahydrocannabinols.
(a) Any processed plant material or animal feed mixture containing any amount of tetrahydrocannabinols (THC) that is both:
(1) Made from any portion of a plant of the genus Cannabis excluded from the definition of marijuana under the Act [i.e., the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination] and (2) Not used, or intended for use, for human consumption, has been exempted by the Administrator from the application of the Act and this chapter.
(b) As used in this section, the following terms shall have the meanings specified:
(1) The term processed plant material means cannabis plant material that has been subject to industrial processes, or mixed with other ingredients, such that it cannot readily be converted into any form that can be used for human consumption.
(2) The term animal feed mixture means sterilized cannabis seeds mixed with other ingredients (not derived from the cannabis plant) in a formulation that is designed, marketed, and distributed for animal consumption (and not for human consumption).
(3) The term used for human consumption means either:
(i) Ingested orally or (ii) Applied by any means such that THC enters the human body.
(4) The term intended for use for human consumption means any of the following:
(i) Designed by the manufacturer for human consumption; (ii) Marketed for human consumption; or (iii) Distributed, exported, or imported, with the intent that it be used for human consumption.
(c) In any proceeding arising under the Act or this chapter, the burden of going forward with the evidence that a material, compound, mixture, or preparation containing THC is exempt from control pursuant to this section shall be upon the person claiming such exemption, as set forth in section 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). In order to meet this burden with respect to a product or plant material that has not been expressly exempted from control by the Administrator pursuant to Sec. 1308.23, the person claiming the exemption must present rigorous scientific evidence, including well-documented scientific studies by experts trained and qualified to evaluate the effects of drugs on humans.
Cannabidiol (“CBD”) and Industrial Hemp (“Hemp”) Products
Michigan – Based on the statutory definitions related to “marihuana” found in the Michigan Public Health Code (Act 368 of 1978), the Michigan Medical Marihuana Act (MMMA), and the Medical Marihuana Facilities Licensing Act (MMFLA), any extracts of marihuana or extracts of the marihuana plant will continue to be treated as marihuana.
The possession, purchase, or sale of marihuana or any marihuana product – including CBD – must be done in compliance with the MMMA and MMFLA.
The cannabis plant has over 100 cannabinoids – one of which is cannabidiol (CBD). Cannabinoids are most abundant in the flowering tops, resin, and leaves of the cannabis plant and are not found in parts of the cannabis plant that are excluded from the definition of marihuana, except for trace amounts – typically, only parts per million – that may be found where small quantities of resin adhere to the surface of seeds and mature stalk, not within the seeds nor the mature stalk. If cannabidiol is found on the seeds or stalks, it is found only as a result of contact with the resin produced by the cannabis plant.
