[Federal Register Volume 64, Number 127 (Friday, July 2, 1999)]
[Rules and Regulations]
[Pages 35928-35930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16833]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1308, 1312
[DEA-180F]
Schedules of Controlled Substances: Rescheduling of the Food and
Drug Administration Approved Product Containing Synthetic Dronabinol
[(-)- 9-(trans)-Tetrahydrocannabinol] in Sesame Oil
and Encapsulated in Soft Gelatin Capsules From Schedule II to Schedule
III
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: This is a final rule of the Deputy Administrator of the Drug
Enforcement Administration (DEA) transferring a drug between schedules
of the Controlled Substances Act (CSA) pursuant to 21 U.S.C. 811. With
the issuance of this final rule, the Deputy Administrator transfers
from schedule II to schedule III of the CSA the drug containing
synthetic dronabinol [(-)- 9-(trans)-
tetrahydrocannabinol] in sesame oil and encapsulated in soft gelatin
capsules in a product approved by the Food and Drug Administration
(FDA). This rule also designates this drug as a schedule III non-
narcotic substance requiring an import/export permit. As a result of
this rule, the regulatory controls and criminal sanctions of schedule
III will be applicable to the manufacture, distribution, importation
and exportation of this drug.
EFFECTIVE DATE: July 2, 1999.
FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and
Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, 202-307-7183.
SUPPLEMENTARY INFORMATION:
Background
Dronabinol is the United States Adopted Name (USAN) for the (-)-
isomer of 9-(trans)-tetrahydrocannabinol [(-)-
9-(trans)-THC], which is believed to be the major
psychoactive component of Cannibas sativa L. (marijuana). On May 31,
1985, FDA approved for marketing the product Marinol --which
contains synthetic dronabinol in sesame oil and encapsulated in soft
gelatin capsules--for the treatment of nausea and vomiting associated
with cancer chemotherapy. Following this FDA approval, DEA issued a
final rule on May 13, 1986, transferring FDA-approved products of the
same formulation as Marinol from schedule I to schedule II
of the CSA in accordance with 21 U.S.C. 811(a). (For simplicity within
this document, the term ``Marinol '' will be used hereafter
to refer to Marinol and any other products, which may by
approved by FDA in the future, that have the same formulation as
Marinol .) The 1986 rescheduling of Marinol was
based on a medical and scientific evaluation and scheduling
recommendation from the Assistant Secretary for Health in accordance
with 21 U.S.C. 811(b). The transfer of Marinol to schedule
II did not affect the CSA classification of pure dronabinol, which--as
a tetrahydrocannabinol with no currently accepted medical use in
treatment in the United States--remains a schedule I controlled
substance. On December 22, 1992, FDA expanded Marinol 's
indications to include the treatment of anorexia associated with weight
loss in patients with AIDS.
The Petition To Reschedule Marinol
On February 3, 1995, UNIMED Pharmaceuticals, Inc. petitioned the
Administrator of DEA to transfer Marinol from schedule II
to schedule III. In response to this petition, and in view of
supplemental information that UNIMED provided to DEA on December 11,
1996, DEA had to determine whether this proposed rescheduling of
Marinol would comport with United States obligations under
the Convention on Psychotropic Substances, 1971 (Psychotropic
Convention). See 21 U.S.C. 811(d). Under the Psychotropic Convention,
dronabinol and all dronabinol-containing products, such as
Marinol, are listed in schedule II. As a result, the United
States is obligated under the Psychotropic Convention to impose certain
restrictions on the export and import of Marinol. DEA has
concluded that, in order for the United States to continue to meet its
obligations under the Psychotropic Convention, DEA will continue to
require import and export permits for international transactions
involving Marinol, even though Marinol will be
transferred to schedule III of the CSA. (As set forth below, to
accomplish this, DEA is hereby amending 21 CFR 1312.30 to require
import and export permits for international transactions involving
Marinol.)
After determining that Marinol could be transferred to
schedule III while maintaining the controls required by the
Psychotropic Convention, and after gathering the necessary data, on
August 7, 1997, DEA requested from the Acting Assistant Secretary for
Health, Department of Health and Human Services (DHHS), a scientific
and medical evaluation, and recommendation, as to whether
Marinol should be rescheduled, in accordance with 21 U.S.C.
811(b).
On September 11, 1998, the Acting Assistant Secretary for Health
sent to DEA a letter recommending that Marinol be
transferred from schedule II to schedule III of the CSA. Enclosed with
the September 11, 1998, letter was a document prepared by the FDA
entitled ``Basis for the Recommendation for Rescheduling
Marinol Capsules from schedule II to schedule III of the
Controlled Substances Act (CSA).'' In this document, the FDA defines
the Marinol product as ``an FDA-approved drug product
containing synthetically produced dronabinol dissolved in sesame oil
and encapsulated in soft
[[Page 35929]]
gelatin capsules (2.5 mg, 5 mg, and 10 mg per dosage unit).'' The
document contained a review of the factors which the CSA requires the
Secretary to consider, which are set forth in 21 U.S.C. 811(c).
The Proposed Rule
On November 7, 1998, the then-Acting Deputy Administrator of DEA
published a notice of proposed rule making in the Federal Register (63
FR 59751), proposing to transfer Marinol from schedule II
to schedule III of the CSA. The proposed rule was based on the DHHS
scientific and medical evaluation and scheduling recommendation and
DEA's independent evaluation. Also under the proposed rule, 21 CFR
1312.30 would be amended to include Marinol as a schedule
III non-narcotic controlled substance specifically designated as
requiring import and export permits pursuant to 21 U.S.C. 952(b)(2) and
953(e)(3). As discussed above, this proposed amendment to 21 CFR
1312.30 is necessary for the United States to continue to meet its
obligations under the Psychotropic Convention. The notice of proposed
rule provided an opportunity for all interested persons to submit their
comments, objections, or requests for hearing in writing to DEA on or
before December 7, 1998.
Comments From the Public
DEA received comments regarding the proposed rule from ten persons.
Nine of the commenters supported the proposed rule. One commenter
objected to the proposed rule and requested a hearing thereon. The
comments are briefly summarized below.
The nine commenters who supported the proposed rule included
organizations, physicians, and one individual. Eight of the nine
commenters who supported the proposed rule expressed the opinion that
Marinol is a safe and effective alternative to smoking
marijuana for treatment of nausea and loss of appetite and has low
abuse potential.
One commenter who supported the proposed rule expressed the view
that the rescheduling of Marinol should not serve as a
substitute for making marijuana legally available for medical use. This
commenter stated that it supported the use of marijuana for medical
purposes and, therefore, wished to emphasize that the proposed rule
affected the CSA status of Marinol--not that of marijuana,
which remains a schedule I controlled substance.
The one commenter who objected to the proposed rule, and requested
a hearing thereon, asserted that Marinol should not be
transferred to schedule III unless and until marijuana and all other
THC-containing drugs are simultaneously and likewise rescheduled. This
commenter asserted that Marinol has the same potential for
abuse as marijuana and all other THC-containing drugs. This commenter
agreed with the proposed rule that Marinol's potential for
abuse is less than the ``high potential for abuse'' commensurate with
schedules I and II of the CSA. Accordingly, this commenter agreed that
Marinol should be transferred to a less restrictive
schedule than schedule II. However, this commenter disagreed with what
would be the resultant status of Marinol vis-a-vis
marijuana and THC if the NPRM becomes final: Marinol would
be in schedule III while marijuana and THC would remain in schedule I.
This commenter asserted that the CSA prohibited transferring
Marinol to a less restrictive schedule unless marijuana and
all THC-containing drugs are simultaneously transferred to the same
schedule. DEA has determined that this commenter's objections are based
on a misinterpretation of the CSA, which can be addressed, as a matter
of law, without conducting a fact-finding hearing. Accordingly, as this
commenter presented no material issues of fact, DEA denied this
commenter's request for a hearing.
Findings
Relying on the scientific and medical evaluation and scheduling
recommendations of the Assistant Secretary for Health, and based on
DEA's independent review thereof, the Deputy Administrator of the DEA,
pursuant to 21 U.S.C. 811(a) and 811(b), finds that:
(1) Based on information now available, Marinol has a
potential for abuse less than the drugs or other substances in
schedules I and II.
(2) Marinol is a FDA-approved drug product and has a
currently accepted medical use in treatment in the United States; and
(3) Abuse of Marinol may lead to moderate of low
physical dependence or high psychological dependence.
Rescheduling Action
Based on the above findings, the Deputy Administrator of the DEA
concludes that Marinol should be transferred from schedule
II to schedule III. Schedule III regulations will, among other things,
allow five prescription refills in six months and lessen record keeping
requirements and distribution restrictions. The schedule III control of
Marinol will become effective July 2, 1999, except that
certain regulatory provisions governing registrants who handle Marinol
will take effect as indicated below. In the event that the regulations
impose special hardships on the registrants, the DEA will entertain any
justified request for an extension of time to comply with the schedule
III regulations regarding Marinol. The applicable
regulations are as follows.
1. Registration. Any person who manufactures, distributes,
dispenses, imports or exports Marinol or who engages in
research or conducts instructional activities with Marinol,
or who proposes to engage in such activities, must be registered to
conduct such activities in accordance with part 1301 of Title 21 of the
Code of Federal Regulations.
2. Security. Marinol must be manufactured, distributed
and stored in accordance with Secs. 1301.71, 1301.72(b), (c), and (d),
1301.73, 1301.74, 1301.75(b) and (c) and 1301.76 of Title 21 of the
Code of Federal Regulations.
3. Labeling and Packaging. All commercial containers of
Marinol, which are packaged on or after January 3, 2000
must have the appropriate Schedule III labeling as required by
Secs. 1302.03-1302.07 of Title 21 of the Code of Federal Regulations.
Commercial containers of Marinol packaged before January 3,
2000. After April 3, 2000, all commercial containers of Marinol must
bear the CIII labels as specified in Secs. 1302.03-1302.07 of Title 21
of the Code of Federal Regulations.
4. Inventory. Registrants possessing Marinol are
required to take inventories pursuant to Secs. 1304.03, 1304.04 and
1304.11 of Title 21 of the Code of Federal Regulations.
5. Records. All registrants must keep records pursuant to
Secs. 1304.03, 1304.04 and 1304.21-1304.23 of Title 21 of the Code of
Federal Regulations.
6. Prescriptions. All prescriptions for Marinol are to
be issued pursuant to Secs. 1306.03-1306.06 and 1306.21-1306.26 of
Title 21 of the Code of Federal Regulations. All prescriptions for
Marinol issued on or after July 2, 1999, if authorized for
refilling, shall as of that date be limited to five refills and shall
not be refilled after January 2, 2000.
7. Importation and Exportation. Due to its international control
status, import and export permits for Marinol will be
required in accordance with 21 CFR 1312.30. All importation and
exportation of Marinol shall be in compliance with part
1312 of Title 21 of the CFR.
8. Criminal Liability. Any activity with Marinol not
authorized by, or in violation of, the CSA or the Controlled
[[Page 35930]]
Substances Import and Export Act shall continue to be unlawful.
In accordance with the provisions of the CSA (21 U.S.C. 811(a)),
this action is a formal rule making ``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
(E.O.) 12866, section 3(d)(1). 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.
Marinol is a prescription drug used to treat nausea due to
cancer chemotherapy and AIDS wasting. Handlers of Marinol
are likely to handle other controlled substances used to treat cancer
or AIDS which are already subject to the regulatory requirements of the
CSA. Further, placement of Marinol in schedule III of the
CSA will mean a significant decrease in the regulatory requirements for
persons handling Marinol.
This rule will not result in the expenditure by 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.
This rule is not a major rule as defined by section 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 United States-based companies to
compete with foreign-based companies in domestic and export markets.
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. 12612, it is
determined that this rule, if finalized, will not have sufficient
federalism implications to warrant the preparation of a Federalism
Assessment.
List of Subjects
21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Narcotics, Prescription drugs.
21 CFR Part 1312
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Narcotics, Reporting requirements.
Under the authority vested in the Attorney General by section
201(a) of the CSA (21 U.S.C. 811(a)), 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, the Deputy Administrator hereby amends 21 CFR parts 1308 and
1312 as follows:
PART 1308--[AMENDED]
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.
Sec. 1308.12 [Amended]
2. Section 1308.12 is amended by removing paragraph (f)(1) and
redesignating the existing paragraph (f)(2) as (f)(1).
3. Section 1308.13 is amended by adding a new paragraph (g) to read
as follows:
Sec. 1308.13 Schedule III.
* * * * *
(g) Hallucinogenic substances.
(1) Dronabinol (synthetic) in sesame oil and encapsulated in a
soft gelatin capsule in a U.S. Food and Drug Administration approved
product--7369.
[Some other names for dronabinol: (6aR-trans)-6a,7,8,10a-tetrahydro-
6,6,9-trimethyl-3-pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)-delta-9-
(trans)-tetrahydrocannabinol]
(2) [Reserved]
PART 1312--[AMENDED]
1. The authority citation for part 1312 continues to read as
follows:
Authority: 21 U.S.C. 952, 953, 954, 957, 958.
2. Section 1312.30 is amended by adding a new paragraph (a) and
reserving paragraph (b) to read as follows:
Sec. 1312.30 Schedule III, IV and V non-narcotic controlled substances
requiring an import and export permit.
* * * * *
(a) Dronabinol (synthetic) in sesame oil and encapsulated in a soft
gelatin capsule in a U.S. Food and Drug Administration approved
product.
(b) [Reserved]
Dated: June 28, 1999.
Donnie R. Marshall,
Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 99-16833 Filed 7-1-99; 8:45 am]
BILLING CODE 4410-09-M
