[Federal Register Volume 74, Number 166 (Friday, August 28, 2009)]
[Rules and Regulations]
[Pages 44281-44284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20768]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-329I]
RIN 1117-AB23


Schedules of Controlled Substances; Table of Excluded Nonnarcotic 
Products: Nasal Decongestant Inhalers Manufactured by Classic 
Pharmaceuticals LLC

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

ACTION: Interim rule with request for comments.

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SUMMARY: Under this Interim Rule, the Drug Enforcement Administration 
(DEA) is updating the Table of Excluded

[[Page 44282]]

Nonnarcotic Products found in 21 CFR 1308.22 to include the Nasal 
Decongestant Inhaler/Vapor Inhaler (containing 50 mg Levmetamfetamine) 
manufactured by Classic Pharmaceuticals LLC and marketed under various 
private labels (to include the ``Premier Value'' and ``Kroger'' 
labels). This nonnarcotic drug product, which may be lawfully sold over 
the counter without a prescription under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301), is excluded from provisions of the 
Controlled Substances Act (CSA) pursuant to 21 U.S.C. 811(g)(1).
    Any interested person may file comments or objections to this order 
on or before October 27, 2009. If any such comments or objections raise 
significant issues regarding any finding of fact or conclusion of law 
upon which this order is based, the Deputy Assistant Administrator 
shall immediately suspend the effectiveness of this order until he may 
reconsider the application in light of the comments or objections 
filed. Thereafter, the Deputy Assistant Administrator shall reinstate, 
revoke, or amend his original order as he determines appropriate.

DATES: This rulemaking shall become effective on August 28, 2009. 
Written comments must be postmarked and electronic comments must be 
submitted on or before October 27, 2009. 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-329I'' on all written and electronic correspondence. 
Written comments sent via regular or express mail should be sent to 
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#e5818084cb818c938097968c8a8bcb958a898c869ca59096818a8fcb828a93"><span class="__cf_email__" data-cfemail="fe9a9b9fd09a97889b8c8d979190d08e9192979d87be8b8d9a9194d0999188">[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 format 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 Drug Enforcement Administration'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 paragraph.

Background

    The Controlled Substances Act (CSA) under 21 U.S.C. 811(g)(1) 
states that the Attorney General shall by regulation exclude any 
nonnarcotic drug which contains a controlled substance from the 
application of the CSA, if such drug may, under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.), be lawfully sold over the 
counter without a prescription. This authority has been delegated to 
the Administrator of DEA and redelegated to the Deputy Assistant 
Administrator of the Office of Diversion Control pursuant to 28 CFR 
0.100 and Title 28, Part 0, Appendix to Subpart R, 7(g), respectively.
    Such exclusions apply only to nonnarcotic products and are only 
granted following suitable application to the DEA per the provisions of 
21 CFR 1308.21. The current Table of Excluded Nonnarcotic Products 
found in 21 CFR 1308.22 lists those products that have been granted 
excluded status.
    Pursuant to the application process of 21 CFR 1308.21, DEA received 
application for exclusion from Classic Pharmaceuticals, LLC, the 
manufacturer of a Nasal Decongestant Inhaler/Vapor Inhaler which 
contains the schedule II controlled substance Levmetamfetamine. This 
inhaler is sold over the counter under various private labels (such as 
the ``Premier Value'' label of the Chain Drug Consortium, Boca Raton, 
Florida, and ``The Kroger'' label by The Kroger Company of Cincinnati, 
OH). Based on the application and other information received, including 
the quantitative composition of the substance and labeling and 
packaging information, DEA has determined that this product (sold under 
various private labels) may, under the Federal Food, Drug, and Cosmetic 
Act, be lawfully sold over the counter without a prescription (21 
U.S.C. 811(g)(1)).
    The Deputy Assistant Administrator finds that this product meets 
the criteria for exclusion from the CSA in accordance with 21 U.S.C. 
811(g)(1). Note that this exclusion only applies to the finished drug 
product in the form of an inhaler (in the exact formulation detailed in 
the application for exclusion), which is lawfully sold under the 
Federal Food, Drug, and Cosmetic Act. The extraction or removal of the

[[Page 44283]]

active ingredient (Levmetamfetamine) from the inhaler shall negate this 
exclusion and result in the possession of a schedule II controlled 
substance.
    This rulemaking adds Classic Pharmaceuticals, LLC product 
containing 50 mg Levmetamfetamine in a Nasal Decongestant Inhaler/Vapor 
Inhaler and marketed under various private labels to the list of 
excluded nonnarcotic products contained in 21 CFR 1308.22. Effective 
August 28, 2009 this product is excluded from CSA regulatory 
provisions. Any interested person may file written comments or 
objections to this order on or before October 27, 2009. If any such 
comments or objections raise significant issues regarding any finding 
of fact or conclusion of law upon which this order is based, the Deputy 
Assistant Administrator shall immediately suspend the effectiveness of 
this order until he may reconsider the application in light of the 
comments or objections filed. Thereafter, the Deputy Assistant 
Administrator shall reinstate, revoke, or amend his original order as 
he determines appropriate.

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Assistant Administrator hereby certifies that this 
rulemaking has been drafted in accordance with the Regulatory 
Flexibility Act (5 U.S.C. 601-612). This rule will not have a 
significant economic impact on a substantial number of small entities. 
This rule adds a product to the list of products excluded from the 
requirements of the CSA.

Executive Order 12866

    The Deputy Assistant Administrator certifies that this rulemaking 
has been drafted in accordance with the principles in Executive Order 
12866 Section 1(b). It has been determined that this is not ``a 
significant regulatory action.'' As discussed previously, based on the 
information received by the manufacturer of the product in question, 
DEA has determined that this product may, under the Federal Food, Drug, 
and Cosmetic Act, be lawfully sold over the counter without a 
prescription.

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 
$120,000,000 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 
Congressional Review Act/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 cost 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.

Administrative Procedure Act

    An agency may find good cause to exempt a rule from certain 
provisions of the Administrative Procedure Act (5 U.S.C. 553), 
including notice of proposed rulemaking and the opportunity for public 
comment, if it is determined to be unnecessary, impracticable, or 
contrary to the public interest. DEA finds that it is unnecessary and 
impracticable to seek public comment prior to making the exclusion of 
this nonnarcotic product from the requirements of the CSA effective. 
DEA has no discretion in its determination of whether the product may, 
under the Federal Food, Drug, and Cosmetic Act, be lawfully sold over 
the counter without a prescription.
    The Administrative Procedure Act permits an agency to make a rule 
effective upon date of publication if it is ``a substantive rule which 
grants or recognizes an exemption or relieves a restriction'' (5 U.S.C. 
553(d)(1)). Since this rule excludes a nonnarcotic drug product from 
the provisions of the CSA, DEA finds that it meets the criteria set 
forth in 5 U.S.C. 553(d)(1) for an exception to the effective date 
requirement.

List of Subjects in 21 CFR Part 1308

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

0
For the reasons set out above, 21 CFR Part 1308 is amended as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1308 continues to read as follows:

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

0
2. Section 1308.22 is amended by adding to the table, in alphabetical 
order, the product listed below:

Sec.  1308.22  Excluded substances.

* * * * *

                                          Excluded Nonnarcotic Products
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                                                                                    Controlled
           Company               Trade name       NDC code           Form           substance      (mg or mg/ml)
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Classic Pharmaceuticals LLC.  Nasal            ..............  IN..............  Levmetamfetamin           50.00
                               Decongestant                                       e (l-
                               Inhaler/Vapor                                      Desoxyephedrin
                               Inhaler.                                           e).
 
                                                  * * * * * * *
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[[Page 44284]]

    Dated: August 21, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Deputy Chief of Operations, Office of 
Diversion Control.
[FR Doc. E9-20768 Filed 8-27-09; 8:45 am]
BILLING CODE 4410-09-P


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