Schedule II Control of Dihydroetorphine Under the Controlled Substances Act (CSA)

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Final rule.

SUMMARY:

This is a final rule issued by the DEA that dihydroetorphine (7,8-dihydro-7α-[1-(R)-hydroxy-1-methylbutyl]-6,14-endo-ethanotetrahydrooripavine) is a Schedule II controlled substance. Although dihydroetorphine is not specifically listed in Schedule II of the Controlled Substances Act (CSA), it is a derivative of thebaine and as such is controlled under 21 U.S.C. 812 Schedule II(a)(1) which includes “Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate.” Dihydroetorphine is a derivative of thebaine, a natural constituent of opium, hence dihydroetorphine is, by virtue of 21 U.S.C. 812 and 21 CFR Part 1308.12(b)(1)(16), a Schedule II controlled substance. International control of dihydroetorphine in Schedule I of the Single Convention on Narcotic Drugs, 1961 in 1998 prompted the DEA to specifically list dihydroetorphine as a controlled substance in Schedule II of the CSA.

EFFECTIVE DATE:

November 17, 2000.

FOR FURTHER INFORMATION OR QUOTA REQUESTS CONTACT:

Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, (202) 307-7183.

SUPPLEMENTARY INFORMATION:

What Is Dihydroetorphine and Why Is It Controlled?

Dihydroetorphine is the international non-proprietary name for a chemical substance which is chemically similar to etorphine. It is an opiate-like substance that is 3-4 order of magnitude (1000 to 10,000 times) more potent than morphine but with a shorter duration of action. The effects of dihydroetorphine and its psychological dependence liability are similar to those produced by heroin. Animal studies demonstrate that it is a highly potent analgesic with effects that begin within 15 minutes of administration and the effects last from 60-90 minutes. Dihydroetorphine was registered in China in December of 1992 for the relief of acute severe pain. However, abuse of dihydroetorphine began soon after it was marketed in China in 1992. Dihydroetorphine is not marketed or used medically in the United States. As a thebaine derivative, dihydroetorphine is controlled in Schedule II of the CSA in the United States.

Under What Authority Is Dihydroetorphine Controlled?

This order is prompted by a letter dated November 11, 1998, in which the United States Government was informed by the Secretary-General of the United Nations that dihydroetorphine has been added to Schedule I of the Single Convention on Narcotic Drugs, 1961 (1961 Convention). As a signatory Member State to the 1961 Convention, the United States is obligated to control dihydroetorphine under national drug control legislation, i.e., the CSA. Dihydroetorphine is currently controlled under Schedule II of the CSA as a thebaine derivative, and as such, all regulations and criminal sanctions applicable to Schedule II substances have been and are applicable to dihydroetorphine. Schedule II control under the CSA satisfies the requirements of Schedule II control under the 1961 Convention.

Executive Order 12866

This regulation has been drafted and reviewed in accordance with Executive Order 12866, Section 1(b), Principles of Regulation. DEA has determined that this rule is not a significant regulatory action under Executive Order 12866, Section 3(f), Regulatory Planning and Review, and accordingly this rule has not been reviewed by the Office of Management and Budget.

Executive Order 12988—Civil Justice Reform

This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988.

Regulatory Flexibility Act

This action will not have a significant economic impact on a substantial number of entities whose interests must be considered under the Regulatory Flexibility Act (5 U.S.C. 601, et seq.). This action provides notification of control of dihydroetorphine in Schedule II of the CSA in order to comply with international treaty obligations. Although dihydroetorphine was not specifically listed in the CSA as a controlled substance, it was already controlled in Schedule II of the CSA as a derivative of thebaine.

Unfunded Mandate Reform Act

This rule will not result in the expenditure of state, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996

This rule is not a major rule as defined by § 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. 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 the United States-based companies to compete with foreign-based companies in domestic and export markets.

Executive Order 13132 Federalism

This rule will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with E.O. 13132, it is determined that this rule will not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

Plain English

The DEA makes every effort to write clearly. If you have suggestions as to how to improve the clarity of this regulation please contact Patricia M. Good, Chief, Policy and Liaison Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, phone (202) 307-7297.

List of Subjects in 21 CFR Part 1308

• Administrative practice and procedure
• Drug traffic control
• Narcotics
• Prescription drugs

Under the authority vested in the Attorney General by Section 201(d)(1) of the CSA [21 U.S.C. 811(d)(1)], and delegated to the Administrator of the DEA by the Department of Justice regulations (28 CFR 0.100) and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, Appendix to Subpart R, Section 12, the Deputy Administrator hereby amends 21 CFR part 1308 as follows:

PART 1308—[AMENDED]

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

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

2. Section 1308.12 is amended by redesignating paragraphs (b)(1)(8) through (b)(1)(16) as (b)(1)(9) through (b)(1)(17) and adding a new paragraph (b)(1)(8) to read as follows: