Page 17476 Federal Register / Vol.51, No. 92 / Tuesday, May 13,
1986 / Rules and Regulations
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
Schedules of Controlled Substances: Rescheduling of Synthetic Dronabinol in Sesame
Oil and Encapsulated in Soft Gelatin Capsules From Schedule I to Schedule II; Statement
of Policy
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Final Rule and Statement of Policy.
SUMMARY: This final rule is issued by the Administrator
of the Drug Enforcement Administration (DEA) to transfer U.S. Food and Drug Administration
(FDA) approved drug products that consist of synthetic dronabinol in sesame oil
encapsulated in soft gelatin capsules from Schedule I into Schedule II of the Controlled
Substances Act (CSA). Dronabinol is the synthetic equivalent of the isomer of delta-9-tetrahydrocannabinol
(THC) which is the principal psychoactive substance in Cannabis sativa L.,
marijuana. This action is based on a finding that U.S. Food and Drug Administration
approved drug products which contain dronabinol fit the statutory criteria for inclusion
in Schedule II of the CSA. As a result of this rule, the regulatory controls and
criminal sanctions of Schedule II of the CSA will apply to the manufacture, distribution,
importation and exportation of dronabinol pharmaceutical products. This rule does
not affect the Schedule I status of any other substance, mixture or preparation
which is currently included in 21 CFR 1308.11(d)(21), Tetrahydrocannabinols. The
Administrator herein also issues a statement of policy regarding review, under the
public interest criteria of 21 U.S.C. 823(f) and 824(a)(4), of the DEA registrations
of practitioners who distribute or dispense dronabinol for purposes at variance
with the FDA approved indications for use of the approved product. A notice is published
elsewhere in this isue of the Federal Register that withdraws the
proposed rule entitled Changes in Protocol Requirements for Researchers and Prescription
Requirements for Practitioners (50 FR 42184-42186, October 18, 1985).
EFFECTIVE DATE: May 13, 1986.
FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug
Control Section, Office of Diversion Control, Drug Enforcement Administration, Washington,
DC 20537. Telephone: (202) 633-1366.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic
control, Narcotics, Prescription drugs.
A proposed rule was published in the Federal Register
on October 18, 1985 (50 FR 42186-42187), proposing that dronabinol in sesame oil
and encapsulated in soft gelatin capsules in a drug product approved by the U.S.
Food and Drug Administration be transferred from Schedule I to Schedule II of the
Controlled Substances Act (21 U.S.C. 801 et seq.). Concurrently, a proposal was
published which proposed changes in protocol requirements for researchers and prescription
requirements for practitioners (50 FR 42184-42186). Interested persons were given
until November 18, 1985, to submit comments or objections regarding each of the
proposals.
Thirteen individuals or organizations availed themselves
of the opportunity to comment, object or request an administrative hearing, Two
organizations, Cannabis Corporation of America and National Organization for the
Reform of Marijuana Laws (NORML), requested hearings. Both requests for hearings
were subsequently withdrawn. Comments or objections were submitted by or on behalf
of the following: Alliance for Cannabis Therapeutics, American College of Neuropsychopharmacology,
American Medical Association, American Pharmaceutical Association, Arkansas Department
of Health, Committee on Problems of Drug Dependence, Inc., Mr. Ansis M. Helmanis,
the law offices of Kleinfeld, Kaplan and Becker, Marcos A. S. Lima, M.D., H. G.
Pars Pharmaceutical Laboratories and the Pharmaceutical Manufacturers Association.
Having considered the comments and objections presented
by the above listed parties, the requirements of the Controlled Substances Act and
the Convention on Psychotropic Substances (T.I.A.S. 9725, July 15, 1980), the Administrator
has decided (a) to proceed with the rescheduling of dronabinol as proposed at 50
FR 42186-42187 and (b) to issue a statement of policy regarding review of the distribution
or dispensing of dronabinol by practitioner registrants which deviates from approved
medical use to insure compliance with the obligations of the United States as a
signatory to the Convention on Psychotropic Substances. The previously proposed
regulations relating to dronabinol are withdrawn elsewhere in this issue of the
Federal Register.
(a) Transfer of FDA Approved Dronabinol Drug Products From Schedule I to Schedule II
Having considered the comments and objections presented
by the above listed parties and based on the investigations and review of the Drug
Enforcement Administration, with attention to the obligations of the United States
under the Convention on Psychotropic Substances, and relying on the scientific and
medical evaluation and recommendation of the Assistant Secretary for Health of the
Department of Health and Human Services, acting on behalf of the Secretary of the
Department of Health and Human Services, in accordance with 21 U.S.C. 811(b), and
the Food and Drug Administration approval of a new drug application for Marinol
capsules, the Administrator of the Drug Enforcement Administration, pursuant to
the provisions of 21 U.S.C. 811(a), finds that:
1. Dronabinol (synthetic) in sesame oil and encapsulated
in soft gelatin capsules in a U.S. Food and Drug Administration approved drug product
has a high potential for abuse;
2. Dronabinol (synthetic) in sesame oil and encapsulated
in soft gelatin capsules in a U.S. Food and Drug Administration approved drug product
has a currently accepted medical use in treatment in the United States or a currently
accepted medical use with severe restrictions, and
3. Dronabinol (synthetic) in sesame oil and encapsulated
in soft gelatin capsules in a U.S. Food and Drug Administration approved drug product
may lead to severe psychological or physical dependence.
The above findings are consistent with placement of
dronabinol approved drug products into Schedule II of the CSA. The transfer of the
product from Schedule I to Schedule II is effective on May 13, 1986 with selected
implementation dates as indicated. In the event that this imposes special hardships
on any registrant, the Drug Enforcement Administration will entertain any justified
request for an extention of time to comply with the Schedule II regulations. The
applicable regulations are as follows:
1. Registration. Any person who manufactures,
distributes, delivers, imports or exports a FDA approved dronabinol drug product,
or who engages in research or conducts instructional activities with such a substance
must be registered to conduct such activities in accordance with Parts
Page 17477
1301 and 1311 of Title 21 of the Code of Federal Regulations. Any person currently
registered to handle dronabinol in Schedule I may continue activities under that
registration until approved or denied registration in Schedule II, provided such
registrant has filed an application for registration in Schedule II with DEA on
or before June 12, 1986. Any persons not currently registered and proposing to engage
in such activities may not conduct activities with the drug product until properly
registered in Schedule II.
2. Security. FDA approved dronabinol drug
products must be manufactured, distributed and stored in accordance with §§
1301.71, 1301.72(a), (c) and (d), 1301.73, 1301.74, 1301.75(b) and (c) and §
1301.76 of Title 21 of the Code of Federal Regulations. Dronabinol and all mixtures,
compounds and preparations thereof, except for dronabinol in sesame oil and encapsulated
in soft gelatin capsules in a FDA approved drug product, remain in Schedule I and
must be stored in accordance with § 1301.75(a).
3. Labeling and Packaging. All labels and
labeling for commercial containers of FDA approved dronabinol drug products must
comply with the requirements of §§ 1302.03-1302.05 and 1302.07-1302.08
of Title 21 of the Code of Federal Regulations. Current products distributed or
dispensed for approved research and labeled as Schedule I products may continue
to be distributed and dispensed until May 13, 1987.
4. Quotas. All persons required to obtain
quotas for dronabinol drug products shall submit applications pursuant to §§
1303.12 and 1303.22 of Title 21 of the Code of Federal Regulations.
5. Inventory. Every registrant required to
keep records and who possesses any quantity of FDA approved dronabinol drug product
shall take an inventory, pursuant to § 1304.04 and §§ 1304.11-1304.19
of Title 21 of the Code of Federal Regulations, of all stocks on hand as of June
12, 1986.
6. Records. All registrants required to keep
records pursuant to §§ 1304.21-1304.27 of Title 21 of the Code of Federal
Regulations shall do so regarding FDA approved dronabinol drug products.
7. Reports. All registrants required to submit
reports pursuant to §§ 1304.34-1304.37 of Title 21 of the Code of Federal
Regulations shall do so regarding FDA approved dronabinol drug products.
8. Order Forms. All registrants involved
in the distribution of dronabinol drug products shall comply with the order form
requirements of Part 1305 of Title 21 of the Code of Federal Regulations.
9. Prescriptions. FDA approved dronabinol
drug products have been approved for use in medical treatment and the drug may be
dispensed by prescription. All prescriptions for FDA approved dronabinol drug products
shall comply with §§ 1306.01-1306.06 and §§ 1306.11-1306.15
of Title 21 of the Code of Federal Regulations.
10. Importation and Exportation. All importation
and exportation of dronabinol drug products shall be in compliance with Parts 1311
and 1312 of Title 21 of the Code of Federal Regulations.
11. Criminal Liability. Any activity with
respect to FDA approved dronabinol drug products not authorized by or in violation
of the Controlled Substances Act or the Controlled Substances Import and Export
Act continues to be unlawful. The applicable penalties after May 13, 1986 shall
be those of a Schedule II substance.
12. Other. In all other respects, this order
is effective on May 13, 1986.
(b) Statement of Policy
The Administrator takes special note of the fact that
synthetic tetrahydrocannabinol in all forms, including dronabinol, remains internationally
controlled in Schedule I of the Convention on Psychotropic Substances. Under the
special obligations of the Convention, to which the United States is a party, relative
to Schedule I substances, Article 7 requires in part that parties shall "prohibit
all use except for scientific and very limited medical purposes . . ."
(emphasis added). The Administrator also notes that the official "Commentary
on the Convention on Psychotropic Substances" provides guidance to parties
in meeting this obligation consistent with national laws and policies.
The Administrator finds that the existing requirements
of Schedule II of the Controlled Substances Act can provide adequate controls and
restrictions to comply with the obligations of the Convention on Psychotropic Substances
when coupled with effective oversight and enforcement, such as provided for in the
Dangerous Drug Diversion Control Act of 1984 (part B of chapter V of Title II of
Pub. L. 98-473). The Administrator notes that experience has demonstrated that there
are medical practitioners registered to dispense Schedule II substance who abuse
that registration and prescribe or dispense Schedule II substances outside the scope
of the legitimate medical practice.
On May 31, 1985, the Food and Drug Administration
(FDA) approved the drug product, Marinol capsules, containing dronabinol for nausea
associated with cancer treatment. Considering the nature of this drug, it is reasonable
to assume that drug abusers will attempt to seek out practitioner registrants willing
to prescrible the drug for abuse purposes, under the guise of legitimate medical
practice, as frequently occurs with other Schedule II substances. DEA has encountered
practitioners who attempt to justify illegal or improper distribution or dispensing
by claiming unique knowledge of a drug's effectiveness for a broad range of
medical indications. While it is expected that legitimate structured research programs
may document additional medical indications for dronabinol, prescribing which deviates
from the recognized approved medical use must be questioned in keeping with the
United States obligations to prohibit all use except for scientific and very limited
medical purposes.
Therefore, in keeping with sound domestic drug control
policy and the United States obligations under the Convention on Psychotropic Substances,
the Administrator hereby issues this statement of policy:
Any person registered by DEA to distribute, prescribe,
administer or dispense controlled substances in Schedule II who engages in the distribution
or dispensing of dronabinol for medical indications outside the approved use associated
with cancer treatment, except within the confines of a structured and recognized
research program, may subject his or her controlled substances registration to review
under the provisions of 21 U.S.C. 823(f) and 824(a)(4) as being inconsistent with
the public interest. DEA will take action to revoke that registration if it is found
that such distribution or dispensing constitutes a threat to the public health and
safety, and in addition will pursue any criminal sanctions which may be warranted
under 21 U.S.C. 841(a)(1). See United States v. Moore,
423 U.S. 122 (1975).
The proposed rule which was published at 50 FR 42184-42186,
October 18, 1985, entitled Changes in Protocol Requirements for Researchers and
Prescription Requirements for Practitioners, is withdrawn elsewhere in this issue
of the Federal Register.
Pursuant to sections 3(c)(3) and 3(e)(2)(C) of Executive
Order 12291 (46
Page 17478
FR 13193), this statement of policy has been submitted for review by the Office
of Management and Budget. In accordance with the provisions of 21 U.S.C. 811(a),
this order to reschedule certain drug products which contain synthetic dronabinol
from Schedule I to Schedule II 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 have been exempted from the consultation
requirements of Executive Order 12291.
Pursuant to 5 U.S.C. 605(b), the Administrator certifies
that the rescheduling of formulations which contain dronabinol, as ordered herein,
will not have a significant impact upon small businesses or other entities whose
interests must be considered under the Regulatory Flexibility Act (Pub. L. 96-354,
September 19, 1980). This action will allow the marketing of a drug product which
has been approved by the FDA.
Pursuant to the authority vested in the Attorney General
by section 201(a) of the CSA [21 U.S.C. 811(a)], as redelegated to the Administrator
of the Drug Enforcement Administration by 28 CFR 0.100, and for the reasons set
forth above, the Administrator hereby orders that 21 CFR 1308.12 be amended 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).
2. 21 CFR 1308.12 is amended by redesignating the
existing paragraph (f) as paragraph (g) and by adding a new paragraph (f), reading
as follows:
§ 1308.12 Schedule II.
* * * * *
(f) Hallucinogenic substances.
(1) Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule
in a U.S. Food and Drug Administration approved drug 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]
* * * * *
Dated: May 1, 1986.
John C. Lawn,
Administrator, Drug Enforcement Administration.
[FR Doc. 86-10724 Filed 5-12-86; 8:45 am]
BILLING CODE 4410-09-M