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Designation of Oripavine as a Basic Class of Controlled Substance
FR Doc E7-18524 [Federal Register: September 24, 2007 (Volume 72, Number
184)] [Rules and Regulations] [Page 54208-54210] From the Federal Register
Online via GPO Access [wais.access.gpo.gov] [DOCID:fr24se07-4]
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.
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, ode@dea.usdoj.gov 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.
- 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:
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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