schedule 5 drugs cbdDecember 15, 2021
The following Schedule III, IV, and V non-narcotic controlled substances have been specifically designated by the Administrator of the Drug Enforcement Administration as requiring import and export permits pursuant to sections 201(d)(1), 1002(b)(2), and 1003(e)(3) of the Act (21 U.S.C. 811(d)(1), 952(b)(2), and 953(e)(3)):
This action does not have federalism implications warranting the application of Executive Order 13132. This action does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications warranting the application of Executive Order 13175. The action does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
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Although the text of section 811(d)(1) thus overrides the normal APA considerations, it is notable that the APA itself contains a provision that would have a similar effect. As set forth in 21 U.S.C. 553(a)(1), the section of the APA governing rulemaking does not apply to a “foreign affairs function of the United States.” An order issued under section 811(d)(1) may be considered a foreign affairs function of the United States because it is for the express purpose of ensuring that the Start Printed Page 48953 United States carries out its obligations under an international treaty.
5. There are numerous isomers of cannabidiol, which will be referred to here collectively as “CBD.”
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7. The provisions of federal law relating to the import and export of controlled substances—those found in 21 U.S.C. 951 through 971—are more precisely referred to as the Controlled Substances Import and Export Act (CSIEA). However, federal courts and DEA often use the term “CSA” to refer collectively to all provisions from 21 U.S.C. 801 through 971 and, for ease of exposition, this document will do likewise.
Kathy L. Federico, Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
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Authority: 21 U.S.C. 811, 812, 871(b), 956(b) unless otherwise noted.
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3. The drug Marinol was approved by the FDA in 1985. Marinol contains a synthetic form of dronabinol (an isomer of tetrahydrocannabinol) and thus is not made from the cannabis plant.
(b) 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 percent (w/w) residual tetrahydrocannabinols.
(i) Control the drug in schedule II, which will automatically require an Start Printed Page 48952 import/export permit under existing provisions of the CSA and DEA regulations or.
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1. The authority citation for part 1308 continues to read as follows:
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It should also be noted that the schedules of the Single Convention operate somewhat differently than the schedules of the CSA. Unlike the CSA, the Single Convention imposes additional restrictions on drugs listed in Schedule IV that go beyond those applicable to drugs listed in Schedule I. All drugs in Schedule IV of the Single Convention are also in Schedule I of the Convention. Cannabis and cannabis resin are among the drugs listed in Schedule IV of the Single Convention.
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The President of the United States manages the operations of the Executive branch of Government through Executive orders.
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4. The text of the Single Convention capitalizes schedules ( e.g., “Schedule I”). In contrast, the text of the CSA generally refers to schedules in lower case. This document will follow this approach of using capitalization or lower case depending on whether the schedule is under the Single Convention or the CSA.
Authority: 21 U.S.C. 821, 871(b), 952, 953, 954, 957, 958.
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Combination products with less than 15 milligrams of hydrocodone per dosage unit (Vicodin)
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The DEA has moved cannabidiol (CBD) drugs (prescription products) with a THC content below .01% to a Schedule 5 (V) drug, provided the drug has been approved by the FDA. This was prompted by the FDA’s approval of Epidolex, a drug intended to be used for rare forms of epilepsy. This means that medical cannabis facilities will not be able to distribute these types of CBD products and that they will instead have to go through a physician/prescription process like any other prescription product.
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Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. Some examples of Schedule V drugs are:
Cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC)
Thompson Coburn advises clients on state laws governing the business of cannabis to facilitate compliance with those state laws. Federal laws concerning cannabis currently conflict with state laws in states that have legalized cannabis or possession of cannabis. Although federal enforcement policy may at times defer to these states’ laws and not enforce conflicting federal laws, interested businesses and individuals should be aware that compliance with state law in no way assures compliance with federal law, and there is a risk that conflicting federal laws may be enforced in the future. In addition to this Cannabis-specific note, readers should review Thompson Coburn’s Conditions of Use / Disclaimers page containing other important information.
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Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence. Schedule III drugs abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV. Some examples of Schedule III drugs are:
Although the cannabis industry sees this as move towards rescheduling cannabis or even possibly de-scheduling cannabis, the future of cannabis in the eyes of the FDA and DEA remains at risk. This rescheduling is a fairly limited move by the DEA, and, as it did when denying the rescheduling petitions for cannabis in the past, signals that the DEA is still only prepared to follow the FDA’s lead on cannabis.
Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. Some examples of Schedule II drugs are:
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The DEA has five schedules for drugs. Each schedule takes into account the drug’s acceptable medical use and the potential for abuse or dependency. The more acceptable the drug and lower the potential for abuse or dependency, the less restrictive the scheduling will be. Drugs scheduled as a Schedule 1 (I) have no accepted medical use and have the highest potential for abuse. Schedule 5 drugs are those with the lowest potential for abuse but that may contain very limited quantities of certain narcotics or, in the case of Epidolex, THC.
Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are:
The DEA describes the schedules as follows:
Products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine)
Schedule IV drugs, substances, or chemicals are defined as drugs with a low potential for abuse and low risk of dependence. Some examples of Schedule IV drugs are:
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