[Federal Register Volume 68, Number 176 (Thursday, September 11, 2003)]
[Proposed Rules]
[Pages 53529-53532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23169]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 68, No. 176 / Thursday, September 11, 2003 / 
Proposed Rules  

[[Page 53529]]



DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

[Docket No. DEA-192P]
RIN 1117-AA56


Exemption From Import/Export Requirements for Personal Medical 
Use

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Controlled Substances Import and Export Act (CSI&EA) 
authorizes the Drug Enforcement Administration (DEA) to accommodate 
travelers who have a legitimate medical need for controlled substances 
during their journey. The CSI&EA allows DEA to issue a regulation 
exempting travelers from application of the CSI&EA requirements 
regarding importation and exportation of controlled substances. Such a 
regulation has existed since the CSI&EA came into effect in 1971. 
However, in recent years, Congress became aware that this regulation 
was being exploited by some individuals as a means of bringing 
controlled substances into the United States for illicit use. For this 
reason, Congress amended the CSI&EA in 1998 to place additional 
restrictions on the importation of controlled substances for personal 
use.
    In this document, DEA is proposing to amend its regulations to 
expressly incorporate the restrictions on personal use importation 
imposed by Congress in 1998 and to expand upon those restrictions to 
curtail diversion that has continued even after the 1998 congressional 
amendment. Specifically, DEA is proposing to limit to 50 dosage units 
the total amount of controlled substances that a United States resident 
may bring into the United States for legitimate personal medical use 
when returning from travel abroad.

DATES: Comments must be postmarked by November 10, 2003.

ADDRESSES: Comments should be submitted to the Deputy Administrator, 
Drug Enforcement Administration, Washington, DC 20537, Attention: DEA 
Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION: 

What Does This Rule Accomplish and by What Authority Is It Being 
Issued?

Background

    The CSI&EA (21 U.S.C. 951 et seq.) prohibits the importation of 
controlled substances into the United States, and the exportation of 
controlled substances from the United States, except as authorized by 
the Act. 21 U.S.C. 952, 953, 957, 960. In general, only persons who are 
registered with DEA to import or export controlled substances may do 
so. Id. In addition, depending on the schedule of the controlled 
substance being imported or exported, the CSI&EA requires the 
appropriate permit, notification, or declaration, as specified in the 
DEA regulations. Id.; 21 CFR 1312.11-1312.30. These requirements are 
necessary and appropriate to ensure that international shipments of 
controlled substances are limited to that which is necessary to meet 
the medical, scientific, and other legitimate needs of the country of 
destination and to prevent diversion of dangerous drugs into illicit 
channels. In addition, these requirements are necessary to meet United 
States obligations to control drugs of abuse in accordance with 
international treaties to which the United States is a party, including 
the Single Convention on Narcotic Drugs, 1961 (Single Convention), and 
the Convention on Psychotropic Substances, 1971 (Psychotropic 
Convention).
    The CSI&EA makes a limited allowance, however, for travelers 
entering and departing the United States who have a legitimate medical 
need for controlled substances during their journey. As set forth in 21 
U.S.C. 956, the Administrator of DEA \1\ may, by regulation, exempt an 
individual traveler from application of the CSI&EA requirements 
regarding importation and exportation of controlled substances where 
such traveler possesses a controlled substance (except a substance in 
Schedule I) for the traveler's personal medical use, provided the 
controlled substance was obtained lawfully and the traveler makes the 
appropriate declaration or notification to the United States Customs 
Service, as specified in the DEA regulation. Such regulation has been 
in place since the CSI&EA was enacted in 1970. The regulation currently 
appears in 21 CFR 1301.26.
---------------------------------------------------------------------------

    \1\ The Attorney General has delegated to the Administrator of 
DEA functions vested in the Attorney General by the CSA. 28 CFR 
0.100.
---------------------------------------------------------------------------

    The allowance for personal use importation and exportation is 
consistent with United States treaty obligations. Article 4(a) of the 
Psychotropic Convention states: ``In respect of psychotropic substances 
other than those in Schedule I, the Parties may permit * * * the 
carrying by international travellers of small quantities of 
preparations for personal use; each Party shall be entitled, however, 
to satisfy itself that these preparations have been lawfully 
obtained.''
    The Official Commentary to the Psychotropic Convention explains the 
purpose and meaning of article 4(a): ``Paragraph (a) applies only to 
small quantities needed for personal use, i.e., to such quantities as 
the traveller may require during his journey or voyage and until he is 
able to provide himself with the medicine in question in the country of 
destination.''
    It bears emphasis that 21 U.S.C. 956 does not require DEA to permit 
any minimum amount of controlled substances to be imported or exported 
for personal medical use. Rather, consistent with article 4(a) of the 
Psychotropic Convention, Congress gave DEA permissive authority to 
issue a regulation allowing personal use importation/exportation under 
such conditions as DEA finds are necessary to prevent diversion of 
controlled substances into illicit channels and which are consistent 
with Congressional intent.
    Another critical factor is that transporting controlled substances 
across international borders entails a

[[Page 53530]]

heightened risk of diversion. Because of this inherent risk of 
diversion, United States drug control laws and international drug 
control treaties have, for most of the past century, placed paramount 
focus on international shipments of drugs of abuse. For example, the 
CSI&EA has, in general, always prohibited the commercial importation 
into the United States of controlled substances manufactured abroad, 
except where domestic production is inadequate to supply the legitimate 
medical, scientific, research, and industrial needs of the United 
States. In this manner, drug control authorities in the United States 
can maintain oversight over the handling of controlled substances from 
the point of manufacture to the point of dispensing to the ultimate 
user. Such complete oversight is essential to preventing diversion of 
controlled substances. This is precisely why Congress made the `` 
`closed' system of drug distribution'' the hallmark of the CSA.\2\
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    \2\ See House Report No. 91-1444, 1970 U.S.C.C.A.N. 4566-4572. 
``The [CSA] provides for control by the Justice Department of 
problems related to drug abuse through registration of 
manufacturers, wholesalers, retailers, and all others in the 
legitimate distribution chain, and makes transactions outside the 
legitimate distribution chain illegal.'' Id.
---------------------------------------------------------------------------

    The allowance of importation and exportation of controlled 
substances for personal medical use (first established by Congress in 
1970 and codified in 21 U.S.C. 956) was meant to strike a balance 
between the significant risk of diversion associated with the carrying 
of controlled substances across international borders and the desire to 
accommodate the legitimate medical needs of travelers during their 
actual travel between countries. Stated alternatively, the allowance 
was meant to accommodate those who have an unavoidable legitimate 
medical need to import (or export) controlled substances as a result of 
their travel. The allowance was not meant to encourage United States 
residents to travel abroad to obtain their controlled substances for 
use in this country. To encourage such obtaining of controlled 
substances abroad would be to diminish the closed system of drug 
distribution intended by Congress under the CSA.

Why Congress Amended the Law in 1998

    In 1998, Congress became concerned that 21 U.S.C. 956 and the DEA 
regulation implementing this provision were being misused by 
individuals--particularly United States residents--whose true intent 
was to divert controlled substances obtained abroad for illicit use in 
the United States (rather than to import controlled substances for 
legitimate personal medical use). Due to this concern, Congress amended 
21 U.S.C. 956 to limit to 50 dosage units the amount of a controlled 
substance that a United States resident may bring into the country 
through an international land border for personal medical use without a 
prescription. This amendment was contained in a bill entitled the 
``Controlled Substances Trafficking Prohibition Act'' (Pub. L. 105-
357), which was enacted November 10, 1998.
    The sponsor of the bill in the House of Representatives, 
Representative Chabot of Ohio, explained the purpose of the amendment 
as follows:

    This important initiative [the amendment to 21 U.S.C. 956] will 
close a loophole in Federal law that allows dangerous drugs, 
particularly drugs used in connection with date rape, to be legally 
imported into the United States.
    Federal, State and local law enforcement agencies have raised 
serious concerns about the trafficking of controlled substances from 
Mexico. Right now uppers, downers, hallucinogens and date rape drugs 
similar to Rohypnol may be easily obtained from so-called health 
care providers or pharmacists in Mexico with no documentation of 
medical need whatsoever.
    According to DEA, these drugs are frequently resold illegally in 
the United States. This situation is especially dangerous because 
these powerful drugs may be used in connection with date rapes. 
While Rohypnol, the most well-known date rape drug, has been banned 
in the U.S., it is still being used to rape young women, and many 
other dangerous controlled substances have taken its place. Jane 
Maxwell, director of the Texas Commission on Alcohol and Drug Abuse, 
says that this loophole continues to allow date rape drugs to cross 
the border.
    For example, the drug Rivotril is everywhere, according to 
Maxwell, and is now being used by juveniles, just as Rohypnol has 
been used. A 1996 study documented the controlled substance drug 
trafficking problems along the U.S.-Mexico border. The study found 
that in just one year at the Laredo border crossing over 60,000 drug 
products were brought into the U.S. by more than 24,000 people. All 
of the top 15 drug products, which represented 94 percent of the 
total quantity of declared drugs, were controlled substances. These 
dangerous drugs, classified as prescription tranquilizers, 
stimulants and narcotic analgesics, are potentially addictive and 
subject to abuse. Specifically, Valium was declared by 70 percent of 
the people, with the average person bringing in 237 tablets. 
Rohypnol was brought in by 43 percent of those who declared their 
prescription medication. Over a full year that means that over 4 
million doses of Valium and almost 1.5 million doses of Rohypnol 
were brought in at one single border crossing.
    The median age for those who declared Valium and Rohypnol is 24 
and 26 years old respectively. The large quantity of dangerous drugs 
passing through a single border crossing underscores the seriousness 
of the problem. The quantity and types of pills discovered also back 
up DEA's view that these drugs are being used for illegal purposes.
    While this problem is most notable in communities along the 
U.S.-Mexico border, it impacts communities well outside the 
Southwest. The study in Laredo found that residents from 39 States 
crossed the border and returned to the United States with a variety 
of drug products.
    Around the country, prescription drug abuse is a growing 
problem, especially among our youth. The purity and low price of 
prescription drug pills makes them an attractive alternative to 
traditional street drugs. At a recent Subcommittee on Crime hearing 
on date rape drugs, experts testified that GHB, Rohypnol and other 
date rape drugs are rapidly becoming the drug of choice in various 
communities and among the different types of users, particularly 
among teenagers.
    Mr. Speaker, this legislation will help close the loophole which 
allows these dangerous drugs into our communities.

144 Cong. Rec. H 6903-01, H6904 (August 3, 1998).

Will the Proposed Rule Eliminate Any of the Current Requirements for 
Personal Use Importation?

    The proposed rule will expand upon, but not eliminate, the 
requirements currently in effect as a result of Congress's 1998 
amendment to 21 U.S.C. 956. The current requirements are as follows:
    Under 21 CFR 1301.26, any individual may enter or depart the U.S. 
with a controlled substance listed in Schedule II, III, IV, or V, which 
he/she has lawfully obtained for his/her personal medical use, or for 
administration to an animal accompanying him/her, provided that the 
following conditions are met:

    (a) The controlled substance is in the original container in 
which it was dispensed to the individual; and
    (b) The individual makes a declaration to an appropriate 
official of the U.S. Customs Service stating:
    (1) That the controlled substance is possessed for his/her 
personal use, or for an animal accompanying him/her; and
    (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 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.

[[Page 53531]]

21 CFR 1301.26.
    The 1998 amendments to the CSI&EA made by Congress added 
restrictions that are in addition to the foregoing requirements in the 
DEA regulations. These amendments are contained in 21 U.S.C. 956(a)(2). 
This subsection provides that, where a United States resident is 
returning to this country through a land border (i.e., returning by 
land from Mexico or Canada), and such person seeks to bring into the 
country a controlled substance obtained abroad for personal medical use 
(not obtained pursuant to a prescription issued by a DEA registrant), 
such person may bring in no more than 50 dosage units of the controlled 
substance.
    The rule proposed here would specify that the 50-dosage-unit limit 
mandated by Congress under 956(a)(2) applies to the combined total of 
all controlled substances that the returning traveler seeks to import 
for personal medical use (rather than up to 50 dosage units of each of 
a variety of controlled substances). [A dosage unit is considered by 
DEA to be the basic unit used to quantify the amount to be taken in 
normal usage (i.e., tablet, capsule, milliliter, or teaspoon).] This 
limitation applies whether or not the controlled substances were 
obtained using a prescription issued by a DEA-registered practitioner.
    The rule, as proposed here, would also be applied to all United 
States residents who return to the United States at any location and by 
any means (not just travelers returning to the United States through a 
land border with Canada or Mexico). The United States Customs Service 
has advised DEA that it would be beneficial to have the rule written in 
a manner that is applied uniformly at all United States border 
checkpoints.

Does the 50-Dosage-Unit Limit Mean That a Returning Traveler May Bring 
Into the United States Up to 50 Dosage Units of Controlled Substances 
``No Questions Asked''?

    Many persons appear to be under the mistaken impression that 
Congress's 1998 amendment to 21 U.S.C. 956 was intended to allow United 
States residents to travel to Mexico or Canada, purchase controlled 
substances, then return to the United States with up to 50 dosage units 
``no questions asked.'' It is DEA's intention, through this 
publication, to end any such misconceptions. In 1998 Congress placed a 
limit of 50 dosage units on the amount of a controlled substance that 
may be imported by United States residents entering from Mexico or 
Canada; Congress did not eliminate any of the existing requirements 
established by DEA in its regulation governing personal use importation 
(21 CFR 1301.26). It remains true that all persons who wish to import 
controlled substances for personal medical use may do so only for 
legitimate personal medical use and must satisfy all of the 
requirements in 21 CFR 1301.26. The requirements found in Sec.  1301.26 
are necessary to ensure that the drugs possessed by the traveler will 
actually be used by the traveler for legitimate personal medical use; 
Congress had no intention of eliminating these appropriate safeguards 
against diversion.
    In all instances, if there is evidence that the traveler is 
attempting to bring into the United States controlled substances (in 
any amount) for other than legitimate personal medical use, the 
importation does not comport with either the statute (21 U.S.C. 956) or 
the DEA regulation (21 CFR 1301.26) and must be disallowed. The Customs 
official should, of course, take into account all facts and 
circumstances of a particular case in determining whether the traveler 
is attempting to bring in controlled substances for legitimate personal 
medical use or attempting to do so in order to divert the drugs for 
illicit use. Though neither dispositive nor exhaustive, the following 
factors may, depending on the circumstances, be indicative of 
diversion: (i) The same traveler has made repeated attempts over a 
short period of time to import controlled substances for claimed 
personal medical use; (ii) the traveler is carrying a variety of 
different controlled substances that are either contraindicated or in a 
combination that is commonly used by drug abusers.

Does the 50-Dosage-Unit Limit Apply to Foreign Travelers?

    By its express terms, Congress's 1998 amendment, which imposed the 
50-dosage-unit limit, applies only to United States residents; it does 
not apply to foreign travelers entering the United States. Likewise, 
the DEA regulation proposed here will apply only to United States 
residents.
    Having made this distinction, it must be emphasized that all 
travelers--United States residents or non-United States residents--may 
only import (or export) controlled substances for legitimate personal 
medical use and must comply fully with all of the current provisions of 
21 CFR 1301.26.

 How Does the Combined 50-Dosage-Unit Limit Contained in the Proposed 
Rule Comport With Congress's 1998 Amendment to the CSI&EA?

    On its face, the 1998 amendment to the CSI&EA (contained in 21 
U.S.C. 956(a)(2)) does not mandate that United States residents be 
allowed to bring into the United States 50 dosage units of each of a 
variety of controlled substances purchased abroad. Rather, 50 dosage 
units is the maximum amount of a controlled substance that DEA may 
permit, through regulation, to be imported for personal medical use 
without a prescription. As explained above, Congress in 1998 was 
responding to the exploitation of the personal use allowance by persons 
seeking to divert controlled substances. Congress recognized that DEA 
would continue to monitor the situation and, if necessary, modify its 
regulation to impose tighter controls. As Senator Leahy stated during 
consideration of the bill:

    Such abuses have increased dramatically in recent years, and 
there is a need to address this problem now. [The 1998 amendment] 
does this by limiting the personal use exemption in certain 
circumstances to 50 dosage units. But this is only a stopgap 
measure. What constitutes ``personal use'' is a complicated issue 
that will turn on a number of circumstances, including the nature of 
the controlled substance and the medical needs of the individual. It 
is the sort of issue that should be addressed not through single-
standard legislation but through measured regulations passed by an 
agency with the expertise in this matter. For this reason, * * * I 
[will] direct the Department of Justice to study the problems at our 
borders and to pass regulations that are more finely tuned to 
address those problems.
144 Cong. Rec. S 12680-04, 12681 (October 20, 1998).
    Indeed, recently obtained information indicates that the misuse of 
the personal use importation allowance persists even after the 1998 
amendment by Congress. Thus, revising the DEA regulations such that the 
50-dosage-unit limit enacted by Congress applies to the combined total 
of all controlled substances in the traveler's possession is a 
necessary and appropriate step to further curtail the misuse of the 
personal use importation exception. DEA will continue to monitor the 
situation to determine whether future revisions to the regulation are 
needed to maintain adequate safeguards against diversion.

What Is the Meaning of ``Lawfully Obtained'' In the Context of Personal 
Use Importation?

    Both the statute (21 U.S.C. 956) and the DEA regulation (21 CFR 
1301.26) allow personal use importation only

[[Page 53532]]

where the controlled substances was ``lawfully obtained'' by the 
traveler abroad. In harmony with international drug control treaties, 
many countries, including Canada and Mexico, have laws that govern the 
prescribing and dispensing of controlled substances. For example, as is 
the case in the United States, Canadian law allows pharmacies to 
dispense controlled substances only pursuant to a prescription issued 
by a practitioner licensed to prescribe controlled substances in the 
province in which the controlled substance is dispensed.
    The traveler seeking to import into the United States controlled 
substances obtained abroad for personal medical use may only do so if 
the controlled substances were dispensed in full compliance with the 
laws of the country in which they were obtained. It is the duty of the 
individual seeking to import a controlled substance for personal 
medical use pursuant to 21 U.S.C. 956(a) and DEA's regulation to know 
and comply with the laws of the jurisdiction in which the controlled 
substance was dispensed. Additionally, compliance with the CSI&EA and 
DEA's regulation does not excuse noncompliance with other Federal laws 
and state laws that may regulate the importation of controlled 
substances.

Regulatory Certifications

Regulatory Flexibility Act

    The Administrator hereby certifies that this rulemaking has been 
drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 
605(b)), and by approving it certifies that this regulation will not 
have a significant economic impact on a substantial number of small 
entities. This proposed regulation affects only individual travelers 
and personal use quantities of controlled substances. Small businesses 
are subject to other DEA regulations for the importation and 
exportation of controlled substances, including registration, 
recordkeeping, reporting and security requirements. Businesses would 
not be using the personal use importation exemption to bring controlled 
substances into the United States. In fact, this rule could help small 
businesses as United States residents will purchase controlled 
substances from United States pharmacies rather than traveling outside 
the United States to make such purchases.

Executive Order 12866

    The Administrator further certifies that this rulemaking has been 
drafted in accordance with the principles of Executive Order 12866, 
section 1(b). This action has been determined to be a significant 
regulatory action. Therefore, this regulation has been reviewed by the 
Office of Management and Budget.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988.

Executive Order 13132

    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 of 1995

    This regulation will not result in the expenditure by State, local, 
and tribal governments in the aggregate, or by the private sector, of 
$100 million or more in any one year, and would not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    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 million or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation or on the ability of U.S.-based companies to compete with 
foreign-based companies in domestic and export markets.

List of Subjects in 21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Security measures.
    For the reasons set out above, 21 CFR Part 1301 is proposed to be 
amended as follows:

PART 1301--[AMENDED]

    1. The authority citation for 21 CFR Part 1301 is proposed to be 
amended to read as follows:

    Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 951, 
952, 953, 956, 957.

    2. Section 1301.26 is proposed to be revised to read as follows:


Sec.  1301.26  Exemptions from import or export requirements for 
personal medical use.

    Any individual who has in his/her possession a controlled substance 
listed in schedules II, III, IV, or V, which he/she has lawfully 
obtained for his/her personal medical use, or for administration to an 
animal accompanying him/her, may enter or depart the United States with 
such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C. 
952-955), provided the following conditions are met:
    (a) The controlled substance is in the original container in which 
it was dispensed to the individual; and
    (b) The individual makes a declaration to an appropriate official 
of the U.S. Customs Service stating:
    (1) That the controlled substance is possessed for his/her personal 
use, or for an animal accompanying him/her; and
    (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 and 
address of the pharmacy or practitioner who dispensed the substance and 
the prescription number.
    (c) In addition to (and not in lieu of) the foregoing requirements 
of this section, a United States resident may import into the United 
States no more than 50 dosage units combined of all such controlled 
substances in the individual's possession.

    Dated: September 4, 2003.
Karen P. Tandy,
Administrator.
[FR Doc. 03-23169 Filed 9-10-03; 8:45 am]
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