[Federal Register Volume 75, Number 55 (Tuesday, March 23, 2010)]
[Rules and Regulations]
[Pages 13678-13679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6176]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-329F]
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: Final rule.

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SUMMARY: Under this Final Rule, the Drug Enforcement Administration 
(DEA) is updating the Table of Excluded 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, is 
excluded from provisions of the Controlled Substances Act (CSA) 
pursuant to 21 U.S.C. 811(g)(1).

DATES: This rulemaking shall become effective on March 23, 2010.

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: On August 28, 2009, the DEA published an 
interim rule with request for comments [74 FR 44281]. This interim rule 
updated the Table of Excluded 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 et seq.), is excluded from provisions of the Controlled Substances 
Act (CSA) pursuant to 21 U.S.C. 811(g)(1).

Comments Received

    DEA did not receive any comments to its interim rule published 
August 28, 2009, regarding this exemption. Therefore, DEA is issuing 
this rulemaking to finalize the interim rule without change.

Background

    The CSA, specifically 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

[[Page 13679]]

of the Chain Drug Consortium, Boca Raton, Florida, and ``The Kroger'' 
label by The Kroger Company of Cincinnati, Ohio). 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 
active ingredient (Levmetamfetamine) from the inhaler shall negate this 
exclusion and, depending on the circumstances, result in the possession 
or manufacture of a schedule II controlled substance.
    This rulemaking finalizes the addition of 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. 
Therefore, this product is excluded from CSA regulatory provisions 
pursuant to 21 U.S.C. 811(g)(1).

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

    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, and as this rule finalizes an interim rule 
already in effect excluding this product from CSA regulatory control, 
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
The Interim Rule with Request for Comments amending part 1308 of title 
21, Code of Federal Regulations, published in the Federal Register 
August 28, 2009, at 74 FR 44281, is hereby adopted as a final rule 
without change.

    Dated: March 16, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2010-6176 Filed 3-22-10; 8:45 am]
BILLING CODE 4410-09-P