Section 812 - Schedules of controlled substances

71 Analyses of this statute by attorneys

  1. Big Brother Cancels Trip, Court Says Not So Fast My Friend

    Bradley Arant Boult Cummings LLPNovember 20, 2023

    ion can’t be dismissed. The Ninth Circuit’s order did not tell the DEA what decision to reach. And the chance for the DEA to reconsider (and rewrite) its determination could certainly result in a more robust denial from the DEA – one that would be more defensible by critics of rescheduling.It, however, certainly keeps the petition to reschedule alive. So, yes, we’re telling you there’s a chance.Given that our modest blog began as an update exclusively on the cannabis plant, we would be remiss not to direct you to our posts on recent efforts by the Biden administration to consider the rescheduling or de-scheduling of cannabis. If the psychedelic industry can learn anything from the cannabis industry, it’s that the implications of rescheduling could be huge but that the trip can be long.The DEA’s Five-Part Test – Will It Hold Up?Since the 90s, the DEA has utilized a five-part test for determining whether a drug has a “currently accepted medical use” and should be rescheduled pursuant to 21 U.S.C. §812(b)(2)(B). Under the test, a drug is considered to have a “currently acceptable medical use” if it meets five elements:The drug’s chemistry is known and reproducible;There are adequate safety studies;There are adequate and well-controlled studies proving efficacy;The drug is accepted by qualified experts; andThe scientific evidence is widely available.(Though it would be fair of you to do so, Budding Trends readers shouldn’t confuse the DEA’s five-part test with the eight-part test utilized by the U.S. Department of Health and Human Services (HHS)).One could infer from the DEA’s denial letter that its position is that a drug must meet the five-part test to be rescheduled, but as noted by the Ninth Circuit, the DEA didn’t explicitly say so. And the DEA’s position on that remains to be seen.The Ninth Circuit in Aggarwal made clear that it was not deciding whether the DEA’s five-part test is a lawful interpretation of 21 U.S.C. 812(b)(2)(B). We expect that proponents of change will challenge the t

  2. Half-Baked: An Overview of Current Cannabinoid Laws & Regulations

    Butler Snow LLPCaroline LovelessDecember 9, 2022

    gov/data-and-reports/marijuana-data/marijuana-sales-reports; see also Colorado Department of Revenue, Marijuana Tax Reports, https://cdor.colorado.gov/data-and-reports/marijuana-data/marijuana-tax-reports (Tax revenue comes from the state sales tax (2.9%) on marijuana sold in stores, the state retail marijuana sales tax (15%) on retail marijuana sold in stores, and the state retail marijuana excise tax (15%) on wholesale sales/transfers of retail marijuana). Nevada Department of Revenue Cannabis Tax Revenue, Excise Tax and Taxable Sales FY 2022, (Aug. 25, 2022), https://tax.nv.gov/uploadedFiles/taxnvgov/Content/TaxLibrary/NV-Cannabis-Revenue-FY22(5).pdf?n=2150.Id. Mike Sill, Forbes Business Council, The Future of the CBD Industry in 2022 and Beyond, (Oct. 21, 2021), https://www.forbes.com/sites/forbesbusinesscouncil/2021/10/21/the-future-of-the-cbd-industry-in-2022-and-beyond/?sh=3a0d2f1525fd.Id. “Up in Smoke,” the title of Cheech & Chong’s first film (1978). 21 U.S.C. § 801, et seq. 21 U.S.C. § 812. 21 U.S.C. § 812. 21 U.S.C. § 841, et seq. David Ogden, Deputy Attorney General, U.S. Department of Justice, Memorandum for Selected U.S. Attorneys:Investigations and Prosecutions in States Authorizing the Medical Use of Marijuana (Oct. 19, 2009)(confirming that the DOJ remained committed to the enforcement of the CSA in all states); James M. Cole, Deputy Attorney General, U.S. Department of Justice, Memorandum for US Attorneys:Guidance Regarding the Ogden Memo in Jurisdictions Seeking to Authorize Marijuana for Medical Use 1-2 (June 29, 2011)(expressing DOJ’s position that the Ogden Memo was not intended to shield from federal enforcement action and prosecution marijuana-related cultivation and distribution for medical use or lower-level marijuana related crimes being prosecuted by state law); James M. Cole, Deputy Attorney General, U.S. Department of Justice, Memorandum for All United States Attorneys, Guidance regarding Marijuana Enforcement (August 29, 2013). James M. Cole, Deputy

  3. Two-Thirds of States Recognize Medical Use of Marijuana: DEA Disagrees

    Womble Bond DickinsonAl WindhamDecember 16, 2020

    On May 21, 2020, Suzanne Sisley and multiple U.S. veterans petitioned the Ninth Circuit Court of Appeals for review of the Drug Enforcement Administration (DEA)’s final determination, denying a rulemaking petition, filed by two California residents in January 2020, to reschedule marijuana, currently a Schedule I drug. Rather than conduct a “fresh” analysis of the January petition, the DEA substantiated its denial by recycling a 2016 order denying petitions brought by the Governors of Rhode Island and Washington, and reasserting its 1992 interpretation of the Controlled Substances Act (CSA) for determining whether a drug has a “currently accepted medical use in treatment in the United States.” 21 U.S.C. § 812(b)(1)(B).Sisley seeks judicial review of several issues, primarily challenging: DEA’s final determination that marijuana must be placed in either Schedule I or II because of DEA’s determination that marijuana has no currently accepted medical use and that there is a lack of accepted safety even under medical supervision.Sisley argues, among other things, that CSA § 812(b)(1)(B) “contemplates an agency attentive to the shifting winds of medical opinion and ready to adjust the schedules annually to ensure federal law never falls out of step with the medical profession…Rather than effectuate these purposes, DEA’s rigid approach renders it blind to current evidence of medical practice. Denial on conclusions drawn years earlier…no longer measures ‘currently accepted medical use’”.Sisley also asserts that “[m]arijuana has an accepted medical use in treatment in the United States because the States — a primary source of authority for determining acceptable medical uses for drugs — have accepted it.

  4. The Cannabis Paradox: Clarifying the Confusing Legality of Delta-8, THC-O, THCV, and Synthetically Derived THC

    Stark & StarkMarch 9, 2023

    nabidiol). Prior to 2019, both marijuana and hemp were lumped together as “marihuana/marijuana” and classified as a federally prohibited Schedule 1 drug under the Controlled Substances Act (“CSA”).That changed with the passage of the 2018 Agricultural Improvement Act (the “Farm Bill”), which effectively removed “hemp” from the definition of “marijuana” in the CSA. The Farm Bill defined “hemp” as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 [THC] concentration of not more than 0.3 percent on a dry weight basis.” See 7 U.S.C. § 1639o(1). Therefore, the difference between federally-illegal marijuana and federally-legal hemp is the THC content, with the threshold divider being 0.3% THC potency. Thus, while Schedule 1 prohibits “tetrahydrocannabinols [THC],” it provides an exception for “tetrahydrocannabinols in hemp.” See 21 U.S.C. § 812 sched. I(c)(17). Furthermore, the DEA has recognized that “any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. [§] 1639o” is exempt from federal prohibition. See 21 C.F.R. § 1308.11(d)(31)(ii); see also 21 C.F.R. § 1308.11(d)(58) (defining “Marihuana Extract” to include only cannabinoid extracts with greater than 0.3 percent delta-9 THC).Simply put, any extracts or derivatives derived from hemp that contain no more than 0.3% delta-9 THC are federally permissible. Enter delta-8 THC. Delta-8 THC is one of the cannabinoids naturally occurring in the cannabis plant but is not found in significant amounts; it can nevertheless be manufactured in concentrated amounts from CBD. CBD can be converted to delta-8 in a lab through a relatively simple isomerization process involving reacting CBD with solvent-acid solutions at high heat. Despite the simplicity (or as a result of), not all delta-8 THC is equal, and attention to solvents, acid

  5. President Biden's Cannabis Scheduling Directive Is a Game Changer

    Vicente Sederberg LLPOctober 24, 2022

    ver, these takes are badly misinformed. President Biden’s scheduling directive is enormously important. In fact, if permitted to run its course, it could revolutionize federal drug control law to a far greater degree than any of the many pending cannabis legalization bills. Don’t believe me? Keep reading.Unlike pending legislative proposals, which target cannabis specifically, President Biden has directed the Executive Branch to initiate an administrative process that can only remove cannabis from schedule I by reinterpreting the statutory requirements that have kept it in schedule I for years. And whatever new interpretations the Administration announces in this cannabis proceeding will apply with equal force to all substances under the Controlled Substances Act.An example will make the point clear. Imagine that President Biden’s scheduling directive results in cannabis being moved to schedule II. For that to happen, DEA and FDA would have to abandon their long-held interpretation of 21 U.S.C. 812(b)(1)(B)—the provision of the Controlled Substances Act that requires DEA to place substances with high abuse potential and “no currently accepted medical use in treatment in the United States” in schedule I. For decades, DEA and FDA have insisted that a substance has a “currently accepted medical use” only if it is approved by FDA for interstate marketing as a drug or meets DEA’s five-part test designed to mirror that test. Under that standard, state laws recognizing cannabis’s medical utility and the real-world evidence of physicians across the country recommending cannabis to patients “in treatment in the United States” is categorically irrelevant to cannabis’s schedule I status under the Controlled Substances Act.If DEA and FDA were to announce a change to that standard through the scheduling review President Biden has set in motion—one recognizing that widespread state acceptance of a substance’s medical utility as proof of “currently accepted medical use,” for example—that new standard w

  6. House Approves Amendment Shielding State-Authorized Cannabis Activities

    Hyman, Phelps & McNamara, P.C.Larry K. HouckAugust 6, 2020

    But marijuana remains a schedule I controlled substance federally. 21 U.S.C. § 812(c)(10). Schedule I substances under the federal Controlled Substances Act (“CSA”) have a high potential for abuse, have no currently accepted medical use in treatment in the U.S. and lack accepted safety under medical supervision. 21 U.S.C. § 812(b)(1).

  7. Liability for Medical Clinics in New Jersey Who Prohibit Medical Cannabis Use on Site – Not So Fast

    Goldberg SegallaAdam R. DolanFebruary 28, 2020

    Under federal law, marijuana is a Schedule I controlled substance.[1]The Controlled Substances Act (CSA), placed marijuana in is most restrictive category, Schedule I. It further defined marijuana as a drug with a high potential for abuse, no currently accepted medical use for treatment, and lacking acceptable safety uses even under medical supervision. 21 U.S.C. Section 812(b)(1).In 2010, New Jersey enacted the Compassionate Use Medical Marijuana Act which decriminalized the possession of a certain amount of marijuana for medical use by qualifying patients.

  8. N.J. Court Requires Reimbursement For Marijuana Use As Part Of Workers’ Compensation Case

    Roetzel & AndressJonathan MillerJanuary 24, 2020

    Under federal law, marijuana is a Schedule I controlled substance. See 21 U.S.C. § 812(c), Schedule I(c)(10); 21 C.F.R. § 1308.11, Schedule I(d)(23), (31). The Controlled Substances Act (“CSA”), passed in 1970, placed marijuana in Schedule I, the most restrictive of categories, defining it as a drug with a high potential for abuse, no currently accepted medical use for treatment, and lacking acceptable safety uses even under medical supervision.

  9. Important Legislative and Regulatory Changes Impacting the Commercialization of Cannabis, Hemp, and CBD

    Wilson Sonsini Goodrich & RosatiCharles AndresFebruary 7, 2019

    Claims 1-13 were challenged in an inter partes review, and claims 1 and 2 were found to be unpatentable.23,24 While it is noteworthy that claims 1-2 were shown to be unpatentable, it is equally noteworthy that claims 3-13 remained patentable.Conclusion Federal and state law on hemp, cannabis, and CBD continue to evolve in a fast-paced, and not-always-predictable, fashion. It is recommended that companies operating in these areas consult counsel early and often to understand and minimize the risk of running afoul of federal and state laws, and regulatory agencies.1 "FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy," FDA Press Release; available at: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611046.htm.2Id.3Id.4 21 U.S.C. § 812(b)(1)(A)-(C).5 83 Fed. Reg. 48950 (Sept. 28, 2018); available at: https://www.govinfo.gov/content/pkg/FR-2018-09-28/pdf/2018-21121.pdf.6 21 U.S.C. § 812(b)(5)(A)-(C).7 83 Fed. Reg.

  10. Florida’s New Law Changes Physician Responsibilities for Opioid Dispensing

    Foley & Lardner LLPJana Kolarik AndersonJune 14, 2018

    This requirement does not apply when prescribing or dispensing a nonopioid controlled substance listed in Schedule V of [Florida Statutes (“F.S.”) section] 893.03 or 21 U.S.C. 812.” [2] Failure to comply with the consulting requirement can result in a non-disciplinary citation for the first offense, and disciplinary action under F.S. section 456.