[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