[Federal Register Volume 75, Number 210 (Monday, November 1, 2010)]
[Proposed Rules]
[Pages 67054-67059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27502]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-344P]


Listing of Approved Drug Products Containing Dronabinol in 
Schedule III

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This proposed rule is issued by the Deputy Administrator of 
the Drug Enforcement Administration (DEA) to modify the listing of the 
Marinol[supreg] formulation in schedule III so that certain generic 
drug products are also included in that listing.
    Several products are currently the subject of Abbreviated New Drug 
Applications (ANDAs) under review by the U.S. Food and Drug 
Administration (FDA). Each product is a generic formulation of 
Marinol[supreg] and contains dronabinol, the (-) isomer of delta-9-
(trans)-tetrahydrocannabinol (THC), which is a schedule I controlled 
substance. Due to variations in formulation, these generic 
Marinol[supreg] products do not meet the specific conditions specified 
in the current schedule III listing.
    This proposed action expands the schedule III listing to include 
formulations having naturally-derived dronabinol and products 
encapsulated in hard gelatin capsules. This would have the effect of 
transferring the FDA-approved versions of such generic Marinol[supreg] 
products from schedule I to schedule III.

DATES: Written comments must be postmarked and electronic comments must 
be submitted on or before January 3, 2011. Commenters should be aware 
that the electronic Federal Docket Management System will not accept 
comments after midnight Eastern Time on the last day of the comment 
period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-344'' on all written and electronic correspondence. 
Written comments sent via regular or express

[[Page 67055]]

mail should be sent to the Drug Enforcement Administration, Attention: 
DEA Federal Register Representative/ODL, 8701 Morrissette Drive, 
Springfield, VA 22152. Comments may be sent to DEA by sending an 
electronic message to <a href="/cdn-cgi/l/email-protection#701415115e141906150203191f1e5e001f1c191309300503141f1a5e171f06"><span class="__cf_email__" data-cfemail="cca8a9ade2a8a5baa9bebfa5a3a2e2bca3a0a5afb58cb9bfa8a3a6e2aba3ba">[email protected]</span></a>. Comments may also 
be sent electronically through http://www.regulations.gov using the 
electronic comment form provided on that site. An electronic copy of 
this document is also available at the http://www.regulations.gov Web 
site. DEA will accept attachments to electronic comments in Microsoft 
Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not 
accept any file formats other than those specifically listed here.
    Please note that DEA is requesting that electronic comments be 
submitted before midnight Eastern Time on the day the comment period 
closes because http://www.regulations.gov terminates the public's 
ability to submit comments at midnight Eastern Time on the day the 
comment period closes. Commenters in time zones other than Eastern Time 
may want to consider this so that their electronic comments are 
received. All comments sent via regular or express mail will be 
considered timely if postmarked on the day the comment period closes.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, 
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug 
Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 
22152, Telephone (202) 307-7183.

SUPPLEMENTARY INFORMATION: 
    Posting of Public Comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at http://www.regulations.gov and in the Drug 
Enforcement Administration's public docket. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the DEA's public docket file. Please note that the Freedom of 
Information Act applies to all comments received. If you wish to 
inspect the agency's public docket file in person by appointment, 
please see the FOR FURTHER INFORMATION CONTACT paragraph.

Background

    The DEA has received four petitions from companies that have 
products that are currently the subject of ANDAs under review by the 
FDA. Each product is a generic formulation of Marinol[supreg] and 
contains dronabinol, the (-) isomer of delta-9-(trans)-
tetrahydrocannabinol (THC), which is a schedule I controlled substance. 
These petitions each requests amendments to Controlled Substances Act 
(CSA) regulations that would have the effect of transferring the 
proposed generic Marinol[supreg] product from schedule I to schedule 
III.
    At present, the only formulation containing dronabinol that is in a 
schedule other than schedule I is the following, as set forth in 21 CFR 
1308.13(g)(1) as schedule III:
    ``Dronabinol (synthetic) in sesame oil and encapsulated in a soft 
gelatin capsule in a U.S. Food and Drug Administration approved 
product.''
    While the petitioners cite that their generic products are 
bioequivalent to Marinol[supreg], their products do not meet schedule 
III current definition provided above. Therefore, these firms have 
requested that 21 CFR 1308.13(g)(1) be expanded to include: (1) Both 
naturally-derived or synthetically produced dronabinol; and (2) both 
hard or soft gelatin capsules.
    In response to these petitions, DEA prepared several scheduling 
review documents based upon petitioner-provided data. On June 22, 2007, 
and August 15, 2007, these analyses were submitted to the Department of 
Health and Human Services (DHHS) with requests for scientific and 
medical evaluation and scheduling recommendations. The submissions to 
DHHS also requested that they consider (1) whether dronabinol extracted 
from Cannabis sativa (i.e. naturally-derived), is identical to 
synthetically-produced dronabinol found in Marinol[supreg]; and (2) 
whether a formulation encapsulated in hard gelatin capsules, instead of 
soft gelatin capsules, changes a product's abuse potential.
    On March 17, 2010, and June 1, 2010, the Assistant Secretary for 
Health, DHHS, sent the Deputy Administrator of DEA scientific and 
medical evaluations and letters recommending that FDA-approved drug 
products containing dronabinol (both naturally-derived or synthetic) in 
sesame oil in a gelatin capsule (either hard or soft gelatin) be placed 
into schedule III of the CSA. Enclosed with the March 17, 2010, letter, 
was a document prepared by the FDA entitled, ``Basis for the 
Recommendation to Control FDA-Approved Drug Products Containing 
Synthetic Dronabinol in Sesame Oil in a Hard Gelatin Capsule to 
Schedule III of the Controlled Substances Act.'' The June 1, 2010, 
letter included a document entitled, ``Basis for the Recommendation to 
Reschedule FDA-Approved Drug Products Containing Naturally-Derived 
Dronabinol in Sesame Oil in a Gelatin Capsule to Schedule III of the 
Controlled Substances Act.'' These documents contained a review of the 
factors which the CSA requires the Secretary to consider 21 U.S.C. 
811(b).
    Therefore, in this rulemaking, DEA is proposing that 21 CFR 
1308.13(g)(1) be modified to include generic equivalents of 
Marinol[supreg] which are (1) both synthetic or naturally-derived 
dronabinol; and/or (2) hard or soft gelatin capsules.

Background Regarding Dronabinol

    Dronabinol is a name of a particular isomer of a class of chemicals 
known as tetrahydrocannabinols (THC). Specifically, dronabinol is the 
United States Adopted Name (USAN) for the (-)-isomer of [Delta]\9\-
(trans)-tetrahydrocannabinol [(-)-[Delta]\9\-(trans)-THC], which is 
believed to be the major psychoactive component of the cannabis plant 
(marijuana).
    THC, as a general category, is listed in schedule I of the CSA,\1\ 
while

[[Page 67056]]

dronabinol contained in the product Marinol[supreg] is listed 
separately in schedule III. Any other formulation containing dronabinol 
(or any other isomer of THC), that does not meet the definition 
provided in 21 CFR 1308.13(g)(1), remains a schedule I controlled 
substance.\2\
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    \1\ 21 U.S.C. 812(c), Schedule I(c)(17). Schedule I contains 
those controlled substances with ``no currently accepted medical use 
in treatment in the United States'' and ``a lack of accepted safety 
for use * * * under medical supervision.'' 21 U.S.C. 812(b)(1).
    \2\ The introductory language to schedule I(c) states that any 
material, compound, mixture, or preparation that contains any of the 
substances listed in schedule I(c) (including 
``tetrahydrocannabinols'') is a schedule I controlled substance 
``[u]nless specifically excepted or unless listed in another 
schedule.'' The only material, compound, mixture, or preparation 
that contains THC but is listed in another schedule is the 
Marinol[supreg] formulation, which is listed in schedule III.
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    The current wording of the Marinol[supreg] formulation in schedule 
III (21 CFR 1308.13(g)(1)) was added to the DEA regulations in 1986, 
when the substance was transferred from schedule I to schedule II after 
the FDA approved Marinol[supreg] for marketing.\3\ The wording of this 
listing was not specific to Marinol[supreg] and thereby could include 
any generic product meeting that description that might be approved by 
the FDA in the future. However, at the time the regulation was 
promulgated, DEA did not anticipate the possibility that a generic 
formulation could be developed that did not fit precisely the wording 
of the listing that currently appears in schedule III.
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    \3\ 51 FR 17476 (May 13, 1986). DEA subsequently transferred the 
FDA-approved Marinol[supreg] formulation from schedule II to 
schedule III. 64 FR 35928 (July 2, 1999).
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    Recently, firms have submitted to FDA ANDAs for their proposed 
generic versions of Marinol[supreg]. As these ANDAs remain pending with 
the FDA, the precise nature of these formulations is not available for 
public disclosure. However, these formulations might differ from the 
Marinol[supreg] formulation currently listed in schedule III. 
Nonetheless, the firms that have submitted the ANDAs assert that their 
formulations would meet the approval requirements under 21 U.S.C. 
355(j), because, among other things, they have the same active 
ingredient, strength, dosage form, and route of administration as 
Marinol[supreg], and are bioequivalent to Marinol[supreg].
    Products are bioequivalent if there is no significant difference in 
the rate and extent to which the active ingredient or active moiety 
becomes available at the site of drug action 21 CFR 320.1. There is no 
requirement under 21 U.S.C. 355(j), or FDA's implementing regulations, 
that solid oral dosage forms such as capsules that are proposed for 
approval in ANDAs contain the same inactive ingredients as the listed 
drug referenced. The generic drug, therefore, would not fall within the 
scope of the current regulation. This situation, in which a generic 
version of a drug would not necessarily fall within the schedule for 
the referenced listed drug, is unique among the CSA schedules in the 
following respect. The Marinol[supreg] formulation listed in schedule 
III is the only listing in the schedules that has the effect of 
excluding potential generic versions of the brand name formulation.\4\ 
As indicated above, this came about because DEA did not anticipate that 
other drug products could be approved by FDA that did not fit the 
description that was included in the schedules. Moreover, Congress 
structured the CSA so that there would be no distinction--for 
scheduling purposes--between brand name drug products and their generic 
equivalents. The rule being proposed here would ensure that this aspect 
of the CSA holds true for generic drug products approved under 21 
U.S.C. 355(j) that reference Marinol[supreg] as the listed drug.
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    \4\ Generally, substances are listed in the CSA schedules based 
on their chemical classification, rather than any drug product 
formulation in which they might appear. Because of this, there have 
been no other situations in which a slight variation between the 
brand name drug formulation and the generic drug formulation was 
consequential for scheduling purposes.
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    In addition, 21 U.S.C. 355(j)(2)(C) permits applicants to petition 
FDA for approval of an ANDA for a drug product that may differ from the 
listed drug in certain specified ways, if clinical studies are not 
necessary to establish the safety and effectiveness of the drug 
product. Among the types of differences permitted is a change in dosage 
form, or manner in which the active ingredient is produced.
    This proposed rule would amend the description in schedule III [21 
CFR 1308.13(g)(1)] to include products referencing Marinol[supreg] that 
are either (1) naturally derived or synthetic; or (2) in hard or soft 
gelatin capsules, as long as the formulations otherwise meet the 
approval requirements in 21 U.S.C. 355(j).

The CSA Scheduling Structure

    To understand the legal justification for the rule being proposed 
here, the scheduling scheme established by Congress under the CSA must 
first be considered. One court has succinctly summarized this scheme as 
follows:

    The [CSA] sets forth initial schedules of drugs and controlled 
substances in 21 U.S.C. 812(c). However, Congress established 
procedures for adding or removing substances from the schedules 
(control or decontrol), or to transfer a drug or substance between 
schedules (reschedule). 21 U.S.C. 811(a). This responsibility is 
assigned to the Attorney General in consultation with the Secretary 
of Health and Human Services (``HHS'') Id. Sec. 811(b). The Attorney 
General has delegated his functions to the Administrator of the DEA 
28 CFR 0.100(b). Current schedules are published at 21 CFR 1308.11-
1308.15.
    There are three methods by which the DEA may initiate rulemaking 
proceedings to revise the schedules: (1) By the DEA's own motion; 
(2) at the request of DHHS; (3) on the petition of any interested 
party. 21 U.S.C. 811(a);
    21 CFR 1308.43(a). Before initiating rulemaking proceedings, the 
DEA must request a scientific and medical evaluation from DHHS and a 
scheduling recommendation. The statute requires the DEA and DHHS to 
consider eight factors with respect to the drug or controlled 
substance. 21 U.S.C. 811(b), (c).
    These factors are:
    (1) Its actual or relative potential for abuse.
    (2) Scientific evidence of its pharmacological effect, if known.
    (3) The state of current scientific knowledge regarding the drug 
or other substance.
    (4) Its history and current pattern of abuse.
    (5) The scope, duration, and significance of abuse.
    (6) What, if any, risk there is to the public health.
    (7) Its psychic or physiological dependence liability.
    (8) Whether the substance is an immediate precursor of a 
substance already controlled under this subchapter.
    Although the recommendations of DHHS are binding on the DEA as 
to scientific and medical considerations involved in the eight-
factor test, the ultimate decision as to whether to initiate 
rulemaking proceedings to reschedule a controlled substance is made 
by the DEA.\5\
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    \5\ See id. Sec. 811(a), (b).
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    Gettman v. DEA, 290 F.3d 430, 432 (DC Cir. 2002).

    The FDA plays an important role within DHHS in the development of 
the DHHS scientific and medical determinations that bear on eight-
factor analyses referred to above (required under section 811(c) for 
scheduling decisions). Thus, when it comes to newly developed drug 
products that contain controlled substances, FDA makes scientific and 
medical determinations for purposes of both the Food Drug and Cosmetic 
Act (in connection with decisions on whether to approve drugs for 
marketing) and the CSA (in connection with scheduling decisions). As 
explained below, the eight-factor analysis can be expected to yield the 
same conclusions with respect to a brand name drug product and certain 
generic drugs referencing that product that meet the approval 
requirements under 21 U.S.C. 355(j).

[[Page 67057]]

The ANDA Approval Process

    The Drug Price Competition and Patent Term Restoration Act of 1984 
(known as the ``Hatch-Waxman Amendments''), codified at 21 U.S.C. 355, 
360cc, and 35 U.S.C. 156, 271, 282, permits the submission of ANDAs for 
approval of generic versions of approved drug products. 21 U.S.C. 
355(j). The ANDA process shortens the time and effort needed for 
approval by, among other things, allowing the applicant to demonstrate 
its product's bioequivalence to a drug already approved under a New 
Drug Application (NDA) (the ``listed'' drug) rather than having to 
reproduce the safety and effectiveness data for that drug. If an ANDA 
applicant establishes that its proposed drug product has the same 
active ingredient, strength, dosage form, route of administration, 
labeling, and conditions of use as a listed drug, and that it is 
bioequivalent to that drug, the applicant can rely on FDA's previous 
finding that the listed drug is safe and effective [See id].\6\ Once 
approved, an ANDA sponsor may manufacture and market the generic drug 
to provide a safe, effective, and low cost alternative to the American 
public.
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    \6\ See also Approved Drug Products with Therapeutic Equivalence 
Evaluations (commonly known as the ``Orange Book''), Intro. at p. 
vi, (27th ed.).
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    The majority of drugs approved under 21 U.S.C. 355(j) are 
therapeutically equivalent to the listed drug they reference. This 
means that the generic drug and the referenced innovator drug contain 
identical amounts of the active ingredient, and are bioequivalent. 
Therapeutic equivalents can be expected to have the same clinical 
effect and safety profile when administered to patients under the 
conditions specified in the labeling.
    The key point, for purposes of the rule being proposed here, is 
that the generic drug can be substituted for the innovator drug with 
the full expectation that the generic drug will produce the same 
clinical effect and safety profile as the innovator drug. Consequently, 
for CSA scheduling purposes, the eight-factor analysis conducted by the 
FDA and DEA under 21 U.S.C. 811(c) would necessarily result in the same 
scheduling determination for an approved generic drug product as for 
the innovator drug to which the generic drug is a therapeutic 
equivalent. This is because, in conducting the eight-factor analysis, 
the FDA and DEA would be examining precisely the same medical, 
scientific, and abuse data for the generic drug product as would be 
considered for the innovator drug. The same would be true of the 
innovator drug and a drug product approved pursuant to a petition under 
21 U.S.C. 355(j)(2)(C), where the drug approved in the ANDA differs 
from the listed drug only because it is a hard gelatin capsule and the 
listed drug is a soft gelatin capsule; or the active ingredient is 
naturally-derived, rather than synthetically produced.
    As noted earlier, these considerations never previously arose for 
any other controlled substance because the regulation citing the 
Marinol[supreg] formulation is the only scheduling regulation that is 
drug product formulation-specific and thereby (inadvertently) excludes 
certain generic versions.\7\ This unintended result is not consistent 
with the structure and purposes of the CSA, which generally lists 
categories of substances in the schedules, rather than product 
formulations. Thus, by ensuring that generic versions of the 
Marinol[supreg] formulation which might be approved by the FDA in the 
future are in the same schedule as Marinol[supreg], the rule being 
proposed here would make the DEA regulations more consistent with the 
structure and purposes of the CSA.
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    \7\ When Congress enacted the CSA in 1970, it scheduled codeine 
and certain other opiates in three different schedules depending on 
their respective concentrations. See 21 U.S.C. 812(c), schedule 
II(a)(1), schedule III(d), and schedule V. However, this 
differential scheduling for opiates does not specify drug product 
formulation in a manner that would result in a generic version of an 
opiate drug product being scheduled separately from the innovator 
drug.
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    Finally, for additional clarity, the proposed rule would amend 21 
CFR 1308.13(g)(1) to change the phrase ``U.S. Food and Drug 
Administration approved product'' to ``drug product approved for 
marketing by the U.S. Food and Drug Administration.''
    On June 22, 2007, and August 15, 2007, DEA submitted scheduling 
review documents for several dronabinol generic products to the DHHS, 
and requested that DHHS provide scientific and medical evaluation and 
scheduling recommendations under the CSA. (These documents are 
available for review online at http://www.deadiversion.usdoj.gov.)
    On March 17, 2010, and June 1, 2010, the Assistant Secretary for 
Health, DHHS, sent the Deputy Administrator of DEA scientific and 
medical evaluations and letters recommending that FDA-approved drug 
products containing dronabinol (naturally-derived or synthetic) in 
sesame oil in a gelatin capsule (hard or soft) be placed into schedule 
III of the CSA. Enclosed with the March 17, 2010, letter was a document 
prepared by the FDA entitled, ``Basis for the Recommendation to Control 
FDA-Approved Drug Products Containing Synthetic Dronabinol in Sesame 
Oil in a Hard Gelatin Capsule to Schedule III of the Controlled 
Substances Act.'' The June 1, 2010 letter included a document entitled, 
``Basis for the Recommendation to Reschedule FDA-Approved Drug Products 
Containing Naturally-Derived Dronabinol in Sesame Oil in a Gelatin 
Capsule to Schedule III of the Controlled Substances Act.'' These 
documents contained a review of the factors which the CSA requires the 
Secretary to consider. 21 U.S.C. 811(b).

    Note: The DHHS scheduling recommendations of March 17, 2010, and 
June 1, 2010, are available for review online at http://www.deadiversion.usdoj.gov.

    The factors considered by the Assistant Secretary of Health and DEA 
with respect to these products were:
    (1) Its actual or relative potential for abuse;
    (2) Scientific evidence of its pharmacological effects;
    (3) The state of current scientific knowledge regarding the drug;
    (4) Its history and current pattern of abuse;
    (5) The scope, duration, and significance of abuse;
    (6) What, if any, risk there is to the public health;
    (7) Its psychic or physiological dependence liability; and
    (8) Whether the substance is an immediate precursor of a substance 
already controlled under this subchapter. 21 U.S.C. 811(c).
    The DHHS scheduling recommendation of March 17, 2010, concluded 
that drug products containing synthetic dronabinol in sesame oil and 
encapsulated in a hard gelatin capsule, have a similar potential for 
abuse as Marinol[supreg]. ``These products contain the same Active 
Pharmaceutical Ingredient (API), have similar chemistry and 
pharmacokinetics and have similar formulations in sesame oil.'' FDA and 
National Institute on Drug Abuse (NIDA), after reviewing the available 
information conclude ``that drug products approved for marketing by FDA 
that contain synthetic dronabinol in sesame oil in a hard gelatin 
capsule be controlled in Schedule III of the CSA.''
    The DHHS scheduling recommendation of June 1, 2010, concluded that 
drug products that contain naturally-derived dronabinol in sesame oil 
and in a gelatin capsule, have a similar potential for abuse as 
Marinol[supreg]. FDA and NIDA, after reviewing the available 
information, concluded ``that drug products approved

[[Page 67058]]

for marketing by FDA that contain naturally-derived dronabinol in 
sesame oil in a gelatin capsule should be rescheduled to Schedule III 
of the CSA.''
    Based on the recommendations of the Assistant Secretary for Health, 
received in accordance with section 201(b) of the Act [21 U.S.C. 
811(b)], and the independent review of the available data by DEA, the 
Deputy Administrator of DEA, pursuant to sections 201(a) and 201(b) of 
the Act [21 U.S.C. 811(a) and 811(b)], finds that FDA-approved generic 
dronabinol products, both naturally-derived or synthetically produced, 
in sesame oil and encapsulated in both hard gelatin or soft gelatin 
capsules meet the criteria for placement in schedule III set in 21 
U.S.C. 812(b), as follows:

A. The Drug or Other Substance Has a Potential for Abuse Less Than the 
Drugs or Other Substances in Schedule II

    FDA-approved generic drug products that contain dronabinol (both 
naturally-derived or synthetically produced) in sesame oil in a gelatin 
capsule (both hard or soft gelatin) and reference Marinol[supreg], have 
a similar potential for abuse as Marinol[supreg], a schedule III drug 
product and have similar chemistry and pharmacokinetics as similar 
formulations in sesame oil.

B. The Drug or Other Substance Has a Currently Accepted Medical Use in 
Treatment in the United States

    Marinol[supreg] was initially approved by FDA in 1985. When drug 
products that reference Marinol[supreg] receive FDA approval, they will 
have a currently accepted medical use in the United States.

C. Abuse of the Drug or Other Substance May Lead to Moderate or Low 
Physical Dependence or Psychological Dependence and Such Dependence 
Would Be Less Than the Drugs or Other Substances in Schedule II

    The withdrawal syndrome associated with dronabinol, the API in 
Marinol[supreg], produces symptoms in humans such as restlessness, 
irritability, mild agitation, anxiety, anger, insomnia, sleep EEG 
disturbances, nausea, decreased appetite, and decreased weight. Since a 
withdrawal syndrome is indicative of physical dependence, it is 
reasonable to conclude that generic dronabinol products (both 
naturally-derived or synthetically produced, and in hard or soft 
gelatin capsules) in sesame oil, will also produce physical dependence 
similar to those produced by Marinol[supreg].
    Therefore, in this rulemaking, DEA is proposing that 21 CFR 
1308.13(g)(1) be modified to include generic equivalents of 
Marinol[supreg] which are (1) naturally-derived or synthetically 
produced dronabinol; and/or (2) hard or soft gelatin capsules. These 
products, once approved by FDA, shall meet the criteria for inclusion 
in schedule III of the CSA.

Comments and Requests for Hearing

    In accordance with the provisions of the CSA (21 U.S.C. 811(a)), 
this action is a formal rulemaking ``on the record after opportunity 
for a hearing.'' Such proceedings are conducted pursuant to the 
provisions of the Administrative Procedure Act 5 U.S.C. 556 and 557. 
All persons are invited to submit their comments or objections with 
regard to this proposal. Requests for a hearing may be submitted by 
interested persons and must conform to the requirements of 21 CFR 
1308.44 and 1316.47. The request should state, with particularity, the 
issues concerning which the person desires to be heard and the 
requestor's interest in the proceeding. Only interested persons, 
defined in the regulations as those ``adversely affected or aggrieved 
by any rule or proposed rule issuable pursuant to section 201 of the 
Act (21 U.S.C. 811),'' may request a hearing 21 CFR 1308.42. Please 
note that DEA may grant a hearing only ``for the purpose of receiving 
factual evidence and expert opinion regarding the issues involved in 
the issuance, amendment or repeal of a rule issuable'' pursuant to 21 
U.S.C. 811(a). All correspondence regarding this matter should be 
submitted to the DEA using the address information provided above.

Regulatory Certifications

Executive Order 12866

    In accordance with the provisions of the CSA [21 U.S.C. 811(a)], 
this action is a formal rulemaking ``on the record after opportunity 
for a hearing.'' Such proceedings are conducted pursuant to the 
provisions of 5 U.S.C. 556 and 557 and, as such, are exempt from review 
by the Office of Management and Budget pursuant to Executive Order 
12866, section 3(d)(1).

Regulatory Flexibility Act

    The Deputy Administrator hereby certifies that this rulemaking has 
been drafted in accordance with the Regulatory Flexibility Act (5 
U.S.C. 601-612), has reviewed this regulation, and by approving it 
certifies that this regulation will not have a significant economic 
impact on a substantial number of small entities. DEA is hereby 
proposing to modify the listing of the Marinol[supreg] formulation in 
schedule III so that certain generic drug products are also included in 
that listing.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform.

Executive Order 13132

    This rulemaking does not preempt or modify any provision of state 
law; nor does it impose enforcement responsibilities on any state; nor 
does it diminish the power of any state to enforce its own laws. 
Accordingly, this rulemaking does not have federalism implications 
warranting the application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by state, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$126,000,000 or more (adjusted for inflation) in any one year, and will 
not significantly or uniquely affect small governments. Therefore, no 
actions were deemed necessary under the provisions of the Unfunded 
Mandates Reform Act of 1995.

Congressional Review Act

    This rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act). This rule will not result in an annual 
effect on the economy of $100,000,000 or more; a major increase in 
costs or prices: or significant adverse effects on competition, 
employment, investment, productivity, innovation, or on the ability of 
United States-based companies to compete with foreign based companies 
in domestic and export markets.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Narcotics, Prescription drugs.

    Pursuant to the authority vested in the Attorney General under 
sections 201, 202, and 501(b) of the CSA (21 U.S.C. 811, 812, and 
871(b)), delegated to the Administrator and Deputy Administrator 
pursuant to section 501(a) (21 U.S.C. 871(a)) and as specified in 28 
CFR 0.100 and 0.104, and appendix to subpart R, sec. 12, the Deputy 
Administrator hereby orders that Title 21 of the Code of Federal 
Regulations, part 1308, is proposed to be amended as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

    1. The authority citation for 21 CFR part 1308 continues to read as 
follows:


[[Page 67059]]


    Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.

    2. Section 1308.13 is amended by revising paragraph (g) to read as 
follows:


Sec.  1308.13  Schedule III.

* * * * *
    (g) Hallucinogenic substances. (1)(i) Dronabinol in sesame oil and 
encapsulated in a gelatin capsule in a drug product approved for 
marketing by the U.S. Food and Drug Administration (FDA)--7369.
    (ii) Any drug product in hard or soft gelatin capsule form 
containing natural dronabinol (derived from the cannabis plant) or 
synthetic dronabinol (produced from synthetic materials) in sesame oil, 
for which an abbreviated new drug application (ANDA) has been approved 
by the FDA under section 505(j) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)) which references as its listed drug the drug 
product referred to in the preceding paragraph (g)(1)(i) of this 
section--7369.

    Note to paragraph (g)(1): Some other names for dronabinol: (6a 
R-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6 H-dibenzo 
[b,d]pyran-1-ol] or (-)-delta-9-(trans)-tetrahydrocannabinol]

    (2) [Reserved]
* * * * *

    Dated: October 19, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-27502 Filed 10-29-10; 8:45 am]
BILLING CODE 4410-09-P


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