Drug Enforcement Administration, Department of Justice.
With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance lisdexamfetamine, including its salts, isomers and salts of isomers into schedule II of the Controlled Substances Act (CSA). As a result of this rule, the regulatory controls and criminal sanctions of schedule II will be applicable to the manufacture, distribution, dispensing, importation and exportation of lisdexamfetamine and products containing lisdexamfetamine.
June 4, 2007.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD, Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, (202) 307-7183.End Further Info End Preamble Start Supplemental Information
Lisdexamfetamine is a central nervous system stimulant drug. On February 23, 2007, the Food and Drug Administration (FDA) approved lisdexamfetamine for marketing under the trade name Vyvanse TM. Lisdexamfetamine will be marketed as a prescription drug product for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Lisdexamfetamine is an amide ester conjugate comprised of the amino acid L-lysine covalently bound to the amino group of d-amphetamine. The chemical name of its dimesylate salt form is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenethyl]hexanamide dimethanesulfonate (CAS number 608137-32-3). Lisdexamfetamine per se is pharmacologically inactive and its effects are due to its in vivo metabolic conversion to d-amphetamine.
Lisdexamfetamine is a new molecular entity and has not been marketed in the United States or other countries. Therefore, there has been no evidence of diversion, abuse, or law enforcement encounters involving lisdexamfetamine.
On November 14, 2006, the Assistant Secretary for Health, Department of Health and Human Services (DHHS), sent the Deputy Administrator of DEA a scientific and medical evaluation and a letter recommending that lisdexamfetamine be placed into schedule II of the CSA. Enclosed with the November 14, 2006, letter was a document prepared by the FDA entitled, “Basis for the Recommendation for Control of Lisdexamfetamine in Schedule II of the Controlled Substances Act (CSA).” The document contained a review of the factors which the CSA requires the Secretary to consider (21 U.S.C. 811(b)).
After a review of the available data, including the scientific and medical evaluation and the scheduling recommendation received from DHHS, the Deputy Administrator of the DEA, in a February 22, 2007, Notice of Proposed Rulemaking (72 FR 7945), proposed placement of lisdexamfetamine into schedule II of the CSA. The proposed rule provided an opportunity for all interested persons to submit their written comments to be postmarked and electronic comments be sent on or before March 26, 2007.
The DEA received two comments in response to the Notice of Proposed Rulemaking. One commenter stated that monthly visits to obtain refills for Concerta ®—like drugs used in children are very expensive and the law needs to be changed. DEA notes that statutory requirements for schedule II drugs do not permit prescription refills. DEA does not regulate the size of each prescription or the frequency of medical visits; these matters are within the purview of prescribing physician. DEA has no authority regarding either the cost of medical care or the cost of the medications a prescribing practitioner may prescribe. Another commenter requested the name of the company that filed the New Drug Application for lisdexamfetamine in order to obtain standard analytical reference material and/or analytical data from the company. This comment is not relevant to the present scheduling action.
Scheduling of Lisdexamfetamine
Relying on the scientific and medical evaluation and the recommendation of the Acting Assistant Secretary for Health, received in accordance with section 201(b) of the Act (21 U.S.C. 811(b)), and the independent review of the available data by DEA, and after a review of the comments received in response to the Notice of Proposed Rulemaking, the Deputy Administrator of DEA, pursuant to sections 201(a) and 201(b) of the Act (21 U.S.C. 811(a) and 811(b)), finds that: Start Printed Page 24533
(1) Lisdexamfetamine has a high potential for abuse;
(2) Lisdexamfetamine has a currently accepted medical use in treatment in the United States; and
(3) Abuse of lisdexamfetamine may lead to severe psychological or physical dependence.
Based on these findings, the Deputy Administrator of DEA concludes that lisdexamfetamine, including its salts, isomers, and salts of isomers, warrants control in schedule II of the CSA. The applicable regulations are as follows:
Registration. Any person who manufactures, distributes, dispenses, imports, exports, engages in research or conducts instructional activities with lisdexamfetamine, or who desires to manufacture, distribute, dispense, import, export, engage in instructional activities or conduct research with lisdexamfetamine, must be registered to conduct such activities in accordance with Part 1301 of Title 21 of the Code of Federal Regulations. Any person who is currently engaged in any of the above activities and is not registered with DEA must submit an application for registration on or before June 4, 2007 and may continue their activities until DEA has approved or denied that application.
Security. Lisdexamfetamine is subject to schedule II security requirements and must be manufactured, distributed and stored in accordance with §§ 1301.71, 1301.72(a), (c), and (d), 1301.73, 1301.74, 1301.75(b) and (c), 1301.76 and 1301.77 of Title 21 of the Code of Federal Regulations on or after June 4, 2007.
Labeling and Packaging. All labels and labeling for commercial containers of lisdexamfetamine must comply with requirements of §§ 1302.03-1302.07 of Title 21 of the Code of Federal Regulations on or after June 4, 2007.
Quotas. Quotas for lisdexamfetamine must be established pursuant to part 1303 of Title 21 of the Code of Federal Regulations.
Inventory. Every registrant required to keep records and who possesses any quantity of lisdexamfetamine must keep an inventory of all stocks of lisdexamfetamine on hand pursuant to §§ 1304.03, 1304.04 and 1304.11 of Title 21 of the Code of Federal Regulations on or after June 4, 2007. Every registrant who desires registration in schedule II for lisdexamfetamine must conduct an inventory of all stocks of the substance on hand at the time of registration.
Records. All registrants must keep records pursuant to §§ 1304.03, 1304.04, 1304.21, 1304.22, and 1304.23 of Title 21 of the Code of Federal Regulations on or after June 4, 2007.
Reports. All registrants required to submit reports to the Automation of Reports and Consolidated Order System (ARCOS) in accordance with § 1304.33 of Title 21 of the Code of Federal Regulations must do so for lisdexamfetamine.
Orders for Lisdexamfetamine. All registrants involved in the distribution of lisdexamfetamine must comply with the order requirements of part 1305 of Title 21 of the Code of Federal Regulations on or after June 4, 2007.
Prescriptions. All prescriptions for lisdexamfetamine or prescriptions for products containing lisdexamfetamine must be issued pursuant to 21 CFR 1306.03-1306.06 and 1306.11-1306.15.
Importation and Exportation. All importation and exportation of lisdexamfetamine must be in compliance with part 1312 of Title 21 of the Code of Federal Regulations on or after June 4, 2007.
Criminal Liability. Any activity with lisdexamfetamine not authorized by, or in violation of, the Controlled Substances Act or the Controlled Substances Import and Export Act shall be unlawful on or after June 4, 2007.
Executive Order 12866
In accordance with the provisions of the CSA (21 U.S.C. 811(a)), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of 5 U.S.C. 556 and 557 and, as such, are exempt from review by the Office of Management and Budget pursuant to Executive Order 12866, section 3(d)(1).
Regulatory Flexibility Act
The Deputy Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this final rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. Lisdexamfetamine products will be prescription drugs used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Handlers of lisdexamfetamine also handle other controlled substances used to treat ADHD which are already subject to the regulatory requirements of the CSA.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
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 in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under 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 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 costs 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.Start List of Subjects
List of Subjects in 21 CFR Part 1308End List of Subjects Start Amendment Part
Under the authority vested in the Attorney General by section 201(a) of the CSA (End Amendment Part Start Part
PART 1308—SCHEDULES OF CONTROLLED SUBSTANCESEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. Section 1308.12 is amended by adding a new paragraph (d)(5) to read as follows:End Amendment Part
(d) * * * Start Printed Page 24534
(5) Lisdexamfetamine, its salts, isomers, and salts of its isomers—1205.
Dated: April 25, 2007.
Michele M. Leonhart,
[FR Doc. E7-8421 Filed 5-2-07; 8:45 am]
BILLING CODE 4410-09-P