[Federal Register Volume 62, Number 21 (Friday, January 31, 1997)]
[Rules and Regulations]
[Pages 4644-4646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2352]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1311
[DEA Number 146I]
RIN 1117-AA38
Exemption From Import and Export Requirements for Personal
Medical Use; Interpretation Regarding Effect of State Law and Federal
Laws
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule; interpretation of existing regulations.
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SUMMARY: Current DEA regulations provide an exemption from certain
provisions of the Controlled Substances Import Export Act (CSIEA)
regarding personal use quantities of certain controlled substances. DEA
is amending the language of the exemption to incorporate an existing
provision that controlled substances for personal use may be imported
only to the extent that such importation is authorized or permitted
under other Federal laws or state law. Recent occurrences have
demonstrated that the exemption is being improperly promoted and used
as a means to import controlled substances for abuse purposes in
violation of other Federal laws and state law. This action will prevent
misinterpretation of the circumstances under which the exemption
applies.
EFFECTIVE DATE: January 31, 1997.
FOR FURTHER INFORMATION CONTACT:
G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of
Diversion Control, Drug Enforcement Administration, Washington, D.C.
20537, Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION: The CSIEA provides in 21 U.S.C. 956(a) that
the Attorney General may, by regulation, exempt an individual who has a
controlled substance for personal medical use from the import/export
requirements of 21 U.S.C. 952-955. Pursuant to title 21, Code of
Federal Regulations (CFR), 1311.27, individuals may enter or depart the
United States with a controlled substance in Schedules II, III, IV, or
V, that they have lawfully obtained for personal medical use, provided
that the controlled substance is in the original container in which it
was dispensed and the appropriate declaration is made to the United
States (U.S.) Customs Service. However, the exemption must be read
within the context of the existing requirements of 21 CFR 1307.02,
which states that nothing in DEA's regulations can be construed as
authorizing or permitting any person to do any act that is not
authorized or permitted under other Federal or state laws.
DEA, the U.S. Customs Service, and independent sources have found
that the personal medical use exemption found in 21 CFR 1311.27 is
being promoted and exploited as a means to import controlled substances
for purposes of trafficking and abuse. Especially troubling is the fact
that controlled substances that are not approved for marketing or
distribution in the United States are being imported in this manner for
trafficking and abuse purposes in amounts that represent a danger to
the public health and safety.
[[Page 4645]]
The Internet and the news media contain numerous references to the
personal use exemption found in Section 1311.27 as a means to import
drugs from Mexico that are not readily available here in the United
States. The Internet messages provide advice on how to use the
exemption to obtain drugs and get them through U.S. Customs, including
one message that provides specific details on how to act and what to
say regarding the personal use exemption when bringing the drugs
through U.S. Customs. These messages are incorrect and misleading
because they do not acknowledge that the exemption applies only to the
extent that the importation is allowed under other Federal laws and
state law.
DEA is concerned with, and will be addressing in a separate
rulemaking action, the misuse of the personal use exemption for the
general purpose of importing controlled substances for abuse and
trafficking purposes. However, the present concern is the misconception
that Section 1311.27 permits the importation of controlled substances
regardless of prohibitions that may be found in other Federal or state
laws. A case in point involves flunitrazepam, which is manufactured in
certain foreign countries under various brand names, including
Rohypnol. Rohypnol is not approved under the Federal Food, Drug, and
Cosmetic Act (FDCA) for use in the United States and the FDCA prohibits
the importation of the drug. Despite this, large amounts of the drug
were being imported by individuals under the personal medical use
exemption.
DEA has received reports from law enforcement authorities in
numerous states, including Alabama, Arkansas, Georgia, Louisiana,
Tennessee and Indiana, regarding the trafficking in and seizure of
flunitrazepam (Rohypnol) that had originally been imported from Mexico.
DEA itself has engaged in a significant number of seizures of the
product throughout the country.
As part of its investigation of these problems, DEA conducted a
study of U.S. Customs drug declaration records at one border crossing
point in Laredo, Texas. During a three week period in July of 1995,
1679 declarations for prescription drugs were filed. Of these, 796, or
47.4%, included Rohypnol. A total of 101,700 dosage units were reported
on 730 of the declarations; the remaining 66 declarations did not
specify the number of dosage units. The daily number of dosage units of
Rohypnol reported ranged from a low of 1680 to a high of 12,930, with
an average of 4843 dosage units reported per day, or, on an annualized
basis, 1,767,695 dosage units per year, at this one checkpoint. Taking
into consideration the declarations that did not specify the number of
dosage units, the annual figure could well exceed 1,900,000 dosage
units per year. These figures represent the number of dosage units per
year. These figures represent the number of dosage units of Rohypnol
reported at just one of the many border crossings between the United
States and Mexico. A separate study conducted by another source of the
top 15 drugs declared over a randomly selected 84-day period at this
border crossing, found that individuals declared a total of 338,760
dosage units of Rohypnol.
As noted earlier, flunitrazepam (Rohypnol) is not approved for
medical use in the United States. Further, there is no indication that
the manufacturer of Rohypnol or any other manufacturer of a product
containing flunitrazepam, the medical community, or any public interest
groups are actively pursuing or advocating the approval of the drug in
this country. There are other drugs available that are widely
recognized and used in treating the conditions for which flunitrazepam
might be considered. There is increasing evidence of abuse and
trafficking of flunitrazepam into the United States. There have been at
least 2000 seizures of the drug by law enforcement officials; a growing
number of reports in the national media regarding its abuse; reports of
its use to facilitate sexual assaults against unsuspecting victims; and
increasing inquiries from medical personnel for information regarding
the drug, including its properties, actions, and treatments.
In light of the exploitation of the personal medical use exemption
from the requirements of the CSIE as a means to import unapproved
controlled substances for abuse purposes and the incorrect and
misleading promotion of the exemption as an easy means to import drugs,
DEA is incorporating into 21 CFR 1311.27 the existing language in 21
CFR 1307.02. This change makes clear that the personal use exemption
applies only to those importations of controlled substances that are
authorized or permitted under other Federal laws or state law. Personal
medical use importations of controlled substances that are not
authorized or permitted under other Federal laws or state law are not
exempt from the requirements of the CSIE. Absent satisfaction of the
requirements of the CSIE, such imports are subject to seizure by U.S.
authorities.
The Deputy Assistant Administrator of the Office of Diversion
Control, Drug Enforcement Administration has determined that because
this rule addresses existing regulatory requirements and does not
impose any new requirements, general notice and comment are unnecessary
pursuant to 5 U.S.C. 553(b). This action emphasizes DEA's existing
regulatory requirements to ensure that individuals are not misled by
the language of the regulation into believing that they may engage in
activities that are inconsistent with other Federal laws or state law
and to address the incorrect and inappropriate promotion and
exploitation of the personal medical use exemption as a means to import
otherwise unavailable controlled substances for abuse purposes.
The Deputy Assistant Administrator for the Office of Diversion
Control, Drug Enforcement Administration certifies that this action
will have no significant impact upon entities whose interests must be
considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq.
This action reiterates existing regulatory requirements regarding the
personal medical use importation of controlled substances.
The Office of Management and Budget (OMB) has determined that this
is a significant regulatory action, therefore, it has been reviewed by
OMB pursuant to the requirements of Executive Order 12866.
This action has been analyzed in accordance with the principles and
criteria in E.O. 12612, and it has been determined that the proposed
rule does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
List of Subjects in 21 CFR Part 1311
Administrative practice and procedure, Drug traffic control,
Exports, Imports.
For the reasons set out above, 21 CFR Part 1311 is amended as
follows:
PART 1311--[AMENDED]
1. The authority citation for part 1311 continues to read as
follows:
Authority: 21 U.S.C. 952, 956, 957, 958, unless otherwise noted.
2. Section 1311.27 is amended by revising paragraph (b)(2) and
adding a new paragraph (c) to read as follows:
Sec. 1311.27 Exemptions for personal medical use.
* * * * *
(b) * * *
(2) The trade or chemical name and the symbol designating the
schedule of the controlled substance if it appears on the container
label, or, if such name does not appear on the label, the name
[[Page 4646]]
and address of the pharmacy or practitioner who dispensed the substance
and the prescription number, if any; and
(c) The importation of the controlled substance for personal
medical use is authorized or permitted under other Federal laws and
state law.
Dated: January 2, 1997.
Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 97-2352 Filed 1-30-97; 8:45 am]
BILLING CODE 4410-09-M
