[Federal Register Volume 72, Number 184 (Monday, September 24, 2007)]
[Rules and Regulations]
[Pages 54208-54210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18524]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-309F]


Designation of Oripavine as a Basic Class of Controlled Substance

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final Rule.

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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, [email protected] or by fax, (202) 
353-1263.

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

[[Page 54209]]

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.


0
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

0
1. The authority citation for part 1308 continues to read as follows:

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


0
2. Section 1308.12 is amended by revising the table in paragraph (b)(1) 
to read as follows:


Sec.  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
 

* * * * *


[[Page 54210]]


    Dated: September 13, 2007.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E7-18524 Filed 9-21-07; 8:45 am]
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