2010-6176. 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: [phone].

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 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

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.