[Federal Register Volume 73, Number 189 (Monday, September 29, 2008)]
[Proposed Rules]
[Pages 56533-56534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-22839]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-308W]


Technical Amendment to Listing in Schedule III of Approved Drug 
Products Containing Tetrahydrocannabinols; Withdrawal of Proposed Rule

AGENCY: Drug Enforcement Administration (DEA), Department of Justice

ACTION: Withdrawal of proposed rule.

-----------------------------------------------------------------------

SUMMARY: DEA is withdrawing a proposed rule that was published in the 
Federal Register on September 24, 2007 (72 FR 54226) and is terminating 
the rulemaking. The proposed rule would have revised the DEA 
regulations with respect to the listing in schedule III of a synthetic 
isomer of tetrahydrocannabinols (THC) contained in a specific 
formulation of a drug product approved by the U.S. Food and Drug 
Administration (FDA). Specifically, the proposed rule would have 
revised the DEA regulation so that it would also include generic drug 
products approved by the FDA under section 505(j) of the Food, Drug, 
and Cosmetic Act (FDCA) (21 U.S.C. 355) that cite the drug product 
currently listed in schedule III as the reference listed drug. In view 
of the comments DEA received in response to the proposed rule, DEA has 
decided--in lieu of finalizing the proposed rule--to proceed with the 
process set out in 21 U.S.C. 811 for transferring each such generic 
drug individually to schedule III.

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: 
    Under the Controlled Substances Act (CSA), the schedules of 
controlled substances are published on an updated basis in the DEA 
regulations. 21 U.S.C. 812(a), (c) and n.1. Currently, one of the 
substances listed in schedule III is the following: ``Dronabinol 
(synthetic) in sesame oil and encapsulated in a soft gelatin capsule in 
a U.S. Food and Drug Administration [FDA] approved product.'' 21 CFR 
1308.13(g)(1). This describes the drug product marketed under the brand 
name Marinol. As explained in the Notice of Proposed Rulemaking (NPRM) 
(72 FR 54226), it is possible that generic versions of Marinol could be 
approved by the FDA yet not fit within the same schedule III listing as 
Marinol. The proposed rule was intended to correct this situation so 
that certain generic versions of Marinol that might be approved by the 
FDA in the future would be in the same schedule as Marinol.
    During the comment period, DEA received comments from nine entities 
(firms, organizations, and one individual). Six of the nine commenters 
expressed support for the proposed rule,\1\ two opposed it, and one 
stated both that it was ``a good idea'' and ``not a good idea.'' \2\ 
One of the commenters that opposed the rule asserted that the rule was 
not in conformity with the CSA. Specifically, this commenter asserted 
that, to achieve the intended result of the rule (transferring to 
schedule III any future FDA-approved generic versions of Marinol that 
do not fit within the current wording of 21 CFR 1308.13(g)(1)), DEA 
must engage in formal rescheduling action, following the procedures set 
forth in 21 U.S.C. 811. Under these procedures, DEA requests from the 
Department of Health and Human Services (HHS) a scientific and medical 
evaluation and scheduling recommendation, with DEA and HHS being 
required to consider the eight factors set forth in 21 U.S.C. 
811(b).\3\ In addition, both of the commenters that objected to the 
proposed rule asserted that the unique formulation of Marinol (that 
which meets the current wording of 21 CFR 1308.13(g)(1)) prevents the 
drug from having the ``high potential for abuse'' commensurate with 
controlled substances in schedules I and II. Further, these commenters 
asserted, generic versions of Marinol that might be approved by the FDA 
in the future cannot be assumed to have the same potential for abuse as 
Marinol if they were to differ from Marinol in their formulations or 
routes of administration. Based on these considerations, one of the 
objecting commenters asked that DEA withdraw the proposed rule or, in 
the alternative, grant an administrative hearing to address the issues 
raised in its objections.
---------------------------------------------------------------------------

    \1\ Three of the commenters that supported the rule also said, 
in somewhat different ways, that the proposed rule should go 
further--for example, by also transferring marijuana and/or its 
derivatives out of schedule I or by granting a pending application 
by a person seeking to become registered to manufacture marijuana.
    \2\ This commenter suggested that all forms of THC should either 
be in schedule I or schedule III, but that FDA-approved formulations 
containing THC should not be listed separately from illicit forms of 
the drug.
    \3\ For a discussion of the formal rescheduling procedures under 
the CSA, see Gettman v. DEA, 290 F.3d at 430, 432 (D.C. Cir. 2002).
---------------------------------------------------------------------------

    In the NPRM (in the preamble to the proposed rule), DEA addressed 
the foregoing legal and factual issues raised by the objecting 
commenters. Having considered the comments, DEA continues to believe 
that the proposed rule is legally permissible within the structure of 
the CSA, for the reasons set forth in the NPRM. In addition, having 
obtained the input and concurrence of the FDA during the development of 
the proposed rule, DEA believes that the proposed rule accurately 
reflects the relevant legal considerations under the FDCA and further 
that it is grounded in sound scientific considerations. It should also 
be noted that two of the commenters that supported the rule agreed with 
DEA regarding the core legal and factual issues raised by those 
commenters that objected to the rule. Nonetheless, DEA must consider 
what would likely be the practical realities of going forward with the 
proposed rule at this time.
    First, if DEA were to grant the objecting commenter's request for a 
hearing, the administrative proceedings within the agency would likely 
take at least two years to complete, taking into account the time to 
conduct the hearing presided over by an administrative law judge (ALJ), 
the issuance by the ALJ of a recommended decision, and the

[[Page 56534]]

issuance by the Deputy Administrator of a final order. Thereafter, if 
DEA were to finalize the proposed rule, any person aggrieved by the 
final rule would be permitted to seek review in the United States Court 
of Appeals. It can never be automatically assumed that the Court of 
Appeals will uphold a challenge to an agency rule. Thus, it is 
conceivable that going forward toward finalizing the proposed rule at 
this time could result in years of litigation followed by no final rule 
that actually takes effect.
    Given these considerations, DEA believes that the most sound 
approach from this point forward is to withdraw the proposed rule and 
proceed instead with a continuation of the formal rescheduling 
procedures set forth in 21 U.S.C. 811 that are already underway for 
each of the proposed generic versions of Marinol affected by the 
proposed rule (those for which the sponsor has submitted to FDA an 
abbreviated new drug application referencing Marinol but which fall 
outside the current wording of 21 CFR 1308.13(g)(1)). For each such 
product, where the proposed marketer has petitioned DEA to initiate 
rulemaking proceedings to transfer the product into schedule III, DEA 
has already--prior to the publication of the NPRM--forwarded the 
petition to FDA for a scheduling evaluation in accordance with the 
procedures set forth in 21 U.S.C. 811(b).
    Thus, the net result of the withdrawal of this proposed rule is 
that FDA and DEA will continue with the ongoing scheduling evaluations 
and any resultant rescheduling proceedings for each of the individual 
proposed generic versions of Marinol, rather than attempting to 
reschedule all of them simultaneously through the issuance of this 
proposed rule. DEA believes the former approach, as compared to the 
latter, is most likely to result in such rescheduling becoming 
effective in the shortest period of time.

    Dated: September 18, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-22839 Filed 9-26-08; 8:45 am]
BILLING CODE 4410-09-P