20039
Federal Register
/Vol. 66, No. 75/Wednesday, April 18, 2001/Notices
3
A controlled substance in schedule II must haveeither
‘‘
a currently accepted medical use intreatment in the United States or a currentlyaccepted medical use with severe restrictions.
’’
21USC 812(b)(2)(B).
must have a
‘‘
currently accepted medical usein treatment in the United States.
’’
3
Id.
Thisis why the CSA allows practitioners toprescribe only those controlled substancesthat are listed in schedules II through V. 21USC 829. Drugs listed in schedule I, bycontrast, may not be prescribed for patientuse; they may only be dispensed bypractitioners who are conducting FDA-approved research and have obtained aschedule I research registration from DEA. 21USC 823(f); 21 CFR 5.10(a)(9), 1301.18,1301.32.That schedule I controlled substances arecharacterized by a lack of accepted medicaluse was recently reiterated by Congress,when it declared, in a provision entitled,
‘‘
NOT LEGALIZING MARIJUANA FORMEDICINAL USE
’’
:It is the sense of the Congress that
—
(1) certain drugs are listed on Schedule Iof the Controlled Substances Act if they havea high potential for abuse, lack any currentlyaccepted medical use in treatment, and areunsafe, even under medical supervision;(2) the consequences of illegal use of Schedule I drugs are well documented,particularly with regard to physical health,highway safety, and criminal activity;(3) pursuant to section 401 of theControlled Substances Act, it is illegal tomanufacture, distribute, or dispensemarijuana, heroin, LSD, and more than 100other Schedule I drugs;(4) pursuant to section 505 of the FederalFood, Drug and Cosmetic Act, before anydrug can be approved as a medication in theUnited States, it must meet extensivescientific and medical standards established by the Food and Drug Administration toensure it is safe and effective;(5)
marijuana and other Schedule I drugshave not been approved by the Food and Drug Administration to treat any disease or condition.
* * * * *
Pub. L. No. 105
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277, Div. F., 112 Stat. 2681
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760 to 2681
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761 (1998) (emphasis added).Thus, when it comes to a drug that iscurrently listed in schedule I, if it isundisputed that such drug has no currentlyaccepted medical use in treatment in theUnited States and a lack of accepted safetyfor use under medical supervision, and it isfurther undisputed that the drug has at leastsome potential for abuse sufficient to warrantcontrol under the CSA, the drug must remainin schedule I. In such circumstances,placement of the drug in schedules II throughV would conflict with the CSA since suchdrug would not meet the criterion of
‘‘
acurrently accepted medical use in treatmentin the United States.
’’
21 USC 812(b).Therefore, even if one were to assume,theoretically, that your assertions aboutmarijuana
’
s potential for abuse were correct(
i.e.,
that marijuana had some potential forabuse but less than the
‘‘
high potential forabuse
’’
commensurate with schedules I andII), marijuana would not meet the criteria forplacement in schedules III through V since ithas no currently accepted medical use intreatment in the United States
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adetermination that is reaffirmed by HHS inthe attached medical and scientificevaluation.For the foregoing reasons, your petition toreschedule marijuana cannot be grantedunder the CSA and is, therefore, denied.Sincerely,Donnie R. Marshall,
Administrator.
Attachments.
Department of Health and Human Services,
Office of the Secretary, Office of the PublicHealth and Science, Assistant Secretary forHealth, Surgeon General, Washington, D.C.20201. January 17, 2001.Mr. Donnie R. Marshall,
Deputy Administrator, Drug Enforcement Administration, Washington, D.C. 20537.
Dear Mr. Marshall: In response to yourrequest dated December 17, 1997, andpursuant to the Controlled Substances Act(CSA), 21 U.S.C.
§
811 (b), (c), and (f), theDepartment of Health and Human Services(DHHS) recommends that marijuana ***continue to be subject to control underSchedule I. *** Marijuana and thetetrahydrocannabinols are currentlycontrolled under Schedule I of the CSA.Marijuana continues to meet the three criteriafor placing a substance in Schedule I of theCSA under 21 U.S.C. 812(b)(1). As discussedin the attached analysis, marijuana has a highpotential for abuse, has no currently acceptedmedical use in treatment in the UnitedStates, and has a lack of accepted safety foruse under medical supervision. Accordingly,HHS recommends that marijuana ***continue to be subject to control underSchedule I of the CSA.You will find enclosed two documentsprepared by FDA
’
s Controlled SubstanceStaff that are the bases for therecommendations.Sincerely yours,David Satcher,
Assistant Secretary for Health and SurgeonGeneral.
Enclosure.
Basis for the Recommendation forMaintaining Marijuana in Schedule I of the Controlled Substances Act
A. Background
On July 10, 1995, Mr. Jon Gettmansubmitted a petition to the DrugEnforcement Administration (DEA)requesting that proceedings be initiatedto repeal the rules and regulations thatplace marijuana and thetetrahydrocannabinols in Schedule I of the Controlled Substances Act (CSA)and dronabinol and nabilone inSchedule II of the CSA. The petitioncontends that evidence of abusepotential is insufficient for eachsubstance or class of substances to becontrolled in Schedule I or II of theCSA. In December 1997, the DEAAdministrator requested that theDepartment of Health and HumanServices (DHHS) develop scientific andmedical evaluations andrecommendations as to the properscheduling of the substances at issue,pursuant to 21 U.S.C. 811(b).This document responds to theportion of the petition that concernsmarijuana ***.In accordance with 21 U.S.C. 811(b),the DEA has gathered information, andthe Secretary of DHHS has consideredeight factors in a scientific and medicalevaluation, to determine how toschedule and control marijuana(Cannabis sativa) under the CSA. Theeight factors are: actual or relativepotential for abuse, scientific evidenceof pharmacological effects, scientificknowledge about the drug or substancein general, history and current patternsof abuse, the scope and duration andsignificance of abuse, the risk (if any) topublic health, psychic or physiologicdependence liability, and whether thesubstance is an immediate precursor of a substance that is already controlled. If appropriate, the Secretary must alsomake three findings
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related to asubstance
’
s abuse potential, legitimatemedical use, and safety or dependenceliability
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and then a recommendation.This evaluation presents scientific andmedical knowledge under the eightfactors, findings in the three requiredareas, and a recommendation.Administrative responsibilities forevaluating a substance for control underthe CSA are performed by the Food andDrug Administration (FDA), with theconcurrence of the National Institute onDrug Abuse (NIDA), as described in theMemorandum of Understanding (MOU)of March 8, 1985 (50 FR 9518
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20).Pursuant to 21 U.S.C. 811(c), the eightfactors pertaining to the scheduling of marijuana are considered below. Theweight of the scientific and medicalevidence considered under these factorssupports the three findings that: (1)Marijuana has a high potential forabuse, (2) marijuana has no currentlyaccepted medical use in treatment in theUnited States, and (3) there is a lack of accepted evidence about the safety of using marijuana under medicalsupervision.
B. Evaluating Marijuana Under theEight Factors
This section presents scientific andmedical knowledge about marijuanaunder the eight required factors.
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