E7-18524. Designation of Oripavine as a Basic Class of Controlled Substance

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Final Rule.

SUMMARY:

This is a final rule issued by the Drug Enforcement Administration (DEA) designating oripavine (3-O-demethylthebaine or 6,7,8,14-tetradehydro-4,5-alpha-epoxy-6-methoxy-17-methylmorphinan-3-ol) as a basic class in schedule II of the Controlled Substances Act (CSA). Although oripavine was not previously listed in schedule II of the CSA, it has been controlled in the United States as a derivative of thebaine and, as such, is controlled as a schedule II controlled substance which includes “Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate.” Oripavine is a derivative of thebaine, a natural constituent of opium, hence oripavine has been and continues to be, by virtue of the definition of “narcotic drug”, a schedule II controlled substance. International control of oripavine in schedule I of the 1961 Single Convention on Narcotic Drugs (1961 Convention) during the 50th session of the Commission on Narcotic Drugs (CND) in 2007 prompted the DEA to specifically designate oripavine as a basic class of controlled substance in schedule II of the CSA.

DATES:

Effective September 24, 2007.

FOR FURTHER INFORMATION CONTACT:

Christine A. Sannerud, Ph.D., Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, by e-mail, [e-mail] or by fax, [phone].

SUPPLEMENTARY INFORMATION:

Oripavine Control

Oripavine (3-O-demethylthebaine or 6,7,8,14-tetradehydro-4,5-alpha-epoxy-6-methoxy-17-methylmorphinan-3-ol) is the international non-proprietary name for a chemical substance which is chemically similar to thebaine. It is a phenanthrene alkaloid contained in various species of the genus Papaver and is a major metabolite of thebaine. Although oripavine was not previously listed in schedule II of the CSA, it has been controlled in the United States as a derivative of thebaine and, as such, is controlled under 21 U.S.C. 812(c) Schedule II (a)(1) which includes “Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate.” Oripavine is a derivative of thebaine, a natural constituent of opium, hence oripavine has been and continues to be, by virtue of the definition of “narcotic drug”, a schedule II controlled substance (21 U.S.C. 802(17)(A); 21 CFR 1308.12(b)(1)(17)). Oripavine is easily converted into thebaine and thebaine, in turn, is convertible into morphine and morphine derivatives. Both thebaine and morphine are opiates and are controlled under schedule I of the 1961 Single Convention on Narcotic Drugs (1961 Convention): Morphine for its abuse potential and thebaine for its convertibility into morphine derivatives.

DEA's Authority To Control Oripavine

This order is prompted by a letter dated June 27, 2007, in which the United States Government was informed by the Secretary-General of the United Nations that oripavine has been added to schedule I of the 1961 Convention. This letter was prompted by a decision at the 50th session of the CND in March 2007 to schedule oripavine under schedule I of the 1961 Convention. As a signatory Member State to the 1961 Convention, the United States is obligated to control oripavine under national drug control legislation, i.e., the Controlled Substances Act (CSA).

Oripavine is currently controlled domestically in 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 remain applicable to oripavine. Drugs controlled in schedule II of the CSA satisfy the requirements of schedule I control under the 1961 Convention.

This action has the net effect of listing oripavine as a basic class of controlled substance in schedule II. This action will allow DEA to establish an aggregate production quota and grant individual manufacturing and procurement quotas to DEA registered manufacturers of oripavine who had previously been granted individual quotas for such purposes under the basic class of thebaine.

Regulatory Certifications

Administrative Procedure Act

The Administrative Procedure Act (APA) generally requires agencies to publish a notice of proposed rulemaking and allow for a period of public comment prior to implementing new rules. The APA also provides, however, that agencies can be excepted from these requirements when “the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(B).

DEA has concluded that “good cause” exists to promulgate this rule as a final rule rather than a proposed rule in order to be in compliance with international treaty obligations to control oripavine under the CSA, as a basic class of controlled substance in schedule II. Furthermore, DEA concludes that this procedure is unnecessary since oripavine is already subject to domestic control under schedule II as a derivative of thebaine and no additional requirements are being imposed through this action. Since DEA is without authority to revise this rule based on public comments, DEA finds that notice and opportunity for comment are unnecessary under the APA. 5 U.S.C. 553(b)(B).

Further, the APA permits an agency to make a rule effective upon the date of publication if the agency makes a finding of good cause which is published with the rule (5 U.S.C. 553(d)(3)). As oripavine is already subject to domestic control under schedule II and no additional requirements are being imposed through this action, DEA believes that delaying the effective date of this rule could cause confusion regarding the regulatory status of oripavine. Oripavine is currently controlled as a schedule II controlled substance, and this level of control does not change with this rulemaking. Accordingly, DEA finds that good cause exists to justify an immediate effective date.

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. 601-612). At present, there are less than ten DEA registrants that are impacted by this rule. Additionally, DEA notes that these same entities currently meet the regulatory responsibilities under the CSA for schedule II as it pertains to this substance due to oripavine's control as a thebaine derivative prior to this action.

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).

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.

Executive Order 13132 Federalism

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

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 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.

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 the United States-based companies to compete with foreign-based companies in domestic and export markets.

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—SCHEDULES OF CONTROLLED SUBSTANCES

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 revising the table in paragraph (b)(1) to read as follows:

§ 1308.12

Schedule II.

* * * * *

(b) * * *

(1) * * *

(i) Codeine	9050
(ii) Dihydroetorphine	9334
(iii) Ethylmorphine	9190
(iv) Etorphine hydrochloride	9059
(v) Granulated opium	9640
(vi) Hydrocodone	9193
(vii) Hydromorphone	9150
(viii) Metopon	9260
(ix) Morphine	9300
(x) Opium extracts	9610
(xi) Opium fluid	9620
(xii) Oripavine	9335
(xiii) Oxycodone	9143
(xiv) Oxymorphone	9652
(xv) Powdered opium	9639
(xvi) Raw opium	9600
(xvii) Thebaine	9333
(xviii) Tincture of opium	9630

* * * * *

Dated: September 13, 2007.

Michele M. Leonhart,

Deputy Administrator.