Rules - 2010
[Federal Register: March 23, 2010 (Volume 75, Number 55)]
[Rules and Regulations]
[Page 13678-13679]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23mr10-12]
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.
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.
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
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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