[Federal Register Volume 69, Number 177 (Tuesday, September 14, 2004)]
[Rules and Regulations]
[Pages 55343-55347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-20628]



[[Page 55343]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

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


Exemption From Import/Export Requirements for Personal Medical 
Use

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

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration (DEA) is amending its 
regulations to expressly incorporate the restrictions on personal use 
importation imposed by Congress in 1998 and to expand upon those 
restrictions to curtail the diversion that has continued even after the 
1998 congressional amendment. Specifically, DEA is limiting 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 at any location 
and by any means. This regulation will help prevent importation of 
controlled substances for unlawful use while still accommodating 
travelers who have a legitimate medical need for controlled substances 
during their journey.

EFFECTIVE DATE: October 14, 2004.

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: DEA published a Notice of Proposed 
Rulemaking (NPRM) in the Federal Register on September 11, 2003 (68 FR 
53529), proposing to amend its regulations to incorporate restrictions 
on personal use importation of controlled substances imposed by 
Congress in 1998 and expand upon those restrictions as Congress 
contemplated to curtail continued diversion. In 1998, Congress amended 
a provision of the Controlled Substances Import and Export Act (CSI&EA) 
(21 U.S.C. 956) to limit to 50 dosage units the amount of a controlled 
substance that a United States resident \1\ may bring into the country 
through an international land border for personal medical use without a 
prescription. Congress took this action because it had become aware 
that many individuals were exploiting the regulation that implements 21 
U.S.C. 956(a) as a means of bringing controlled substances into the 
United States for illicit use. Because the law, even after the 
amendment made by Congress in 1998, continues to be used by many for 
diversion of controlled substances, and because Congress envisioned 
that DEA would fine tune the law over time, DEA is expanding upon the 
1998 restrictions to limit to a combined total of 50 dosage units all 
controlled substances that a United States resident may bring into the 
United States for legitimate personal medical use when returning from 
travel abroad. The rule being finalized here applies 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). This rule does not allow United 
States residents to travel to a foreign country for the sole purpose of 
obtaining controlled substances to bring to the United States. Further, 
as DEA stated in a Notice published in the Federal Register June 29, 
2004: ``The personal medical use exemption does not apply to the 
shipment of controlled substances into the United States from a foreign 
country, regardless of whether the individual receiving the shipment 
possesses a valid prescription issued by a United States practitioner 
for the controlled substances, and regardless of the fact that those 
controlled substances are intended for the personal medical use of an 
individual.'' (69 FR 38922).
---------------------------------------------------------------------------

    \1\ For purposes of this rule, a United States resident is a 
person whose residence (i.e., place of general abode--meaning one's 
principal, actual dwelling place in fact, without regard to intent) 
is in the United States.
---------------------------------------------------------------------------

Background

    The CSI&EA 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 \2\ 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 Bureau of Customs and 
Border Protection (CBP).\3\ These requirements are specified in 21 CFR 
1301.26 and have been part of the regulations since the CSI&EA was 
enacted in 1970.
---------------------------------------------------------------------------

    \2\ The Attorney General has delegated to the Administrator of 
DEA functions vested in the Attorney General by the CSA. 28 CFR 
0.100.
    \3\ Effective March 1, 2003, the United States Customs Service 
underwent organizational changes under the Homeland Security Act of 
2002. As a result of this reorganization, travelers entering or 
departing the United States with controlled substances will be 
required to make the appropriate declaration or notification 
referenced in 21 CFR 1301.26 to the appropriate official from the 
Bureau of Customs and Border Protection (CBP).
---------------------------------------------------------------------------

    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.''

[[Page 55344]]

    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 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.\4\
---------------------------------------------------------------------------

    \4\ 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 an appropriate 
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 carry lawfully obtained controlled 
substances acquired for legitimate personal medical use during the 
course of travel). 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. * * *

144 Cong. Rec. H6903-01, H6904 (August 3, 1998).

Discussion of Comments

    DEA received two comments in response to the Notice of Proposed 
Rulemaking published in the Federal Register on September 11, 2003 (68 
FR 53529). One commenter disagreed with the proposed rulemaking and the 
other commenter supported the proposed rulemaking with additional 
requirements. Both commenters were individual citizens.
    One commenter stated that DEA ``was interpreting the [1998] 
amendment incorrectly and changing the meaning of 50 dosage units'' by 
limiting 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.
    The 1998 amendment to the CSI&EA limited the amount of a controlled 
substance a United States resident could bring into the country through 
an international land border for personal medical use without a 
prescription to a maximum (not a minimum) of 50 dosage units of the 
controlled substance. During the hearings preceding enactment of the 
amendment, Senator Leahy stated that the 1998 amendment to the CSI&EA 
was ``only a stopgap measure.'' (144 Cong. Rec. S. 12680-04, 12681 
(October 20, 1998)). Senator Leahy explained: ``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.'' He 
directed ``the Department of Justice [DEA by delegation of authority] 
to study the problems and to pass regulations that are more finely 
tuned to address those problems'' (id.). By this final rule DEA is 
carrying out its obligations in the manner that Senator Leahy 
suggested--by reevaluating the situation following passage of the 1998 
amendment and issuing more fine-tuned regulations to better achieve 
Congress' goal of minimizing the exploitation of the law for purposes 
of diversion.
    The second commenter supported the proposed rulemaking, but did not 
consider it restrictive enough. The commenter proposed a dual 
approach--not permitting any controlled substance to enter the United 
States without a ``U.S. prescription'' and also limiting the amount of 
controlled substances imported. The commenter would base the amount of 
controlled substance allowed on its schedule (50 dosage units for 
Schedule II; 100 dosage units for Schedule III; 150 dosage units for 
Schedule IV, and 200 dosage units for Schedule V).
    DEA believes that limiting the personal medical use allowance to 
those who obtained controlled substances pursuant to prescriptions 
issued by

[[Page 55345]]

United States practitioners is too restrictive and inconsistent with 
the purpose of the law, which is to accommodate travelers' legitimate 
medical needs for controlled substances, or those of an animal 
accompanying them, during the course of their travel. There are 
instances when United States travelers may legitimately need to see a 
foreign doctor and be given a controlled substance by the foreign 
doctor and thus would not have a prescription issued by a practitioner 
in the United States. Under such circumstances, according to the 
commenter's proposal, the returning United States residents would have 
these controlled substances confiscated upon entry into the United 
States, even if the travelers still have a legitimate need for the 
medications until they can see their own doctors.
    The commenter also suggested allowing a greater quantity of 
controlled substances in a lower schedule to be imported than in a 
higher one because they have a lower potential for abuse. The 
importation of any controlled substance for personal medical use is 
based on medical need and not on the schedule of the controlled 
substance. Only necessary controlled substances are allowed to be 
imported. This suggested requirement would also become confusing and 
time-consuming for the Bureau of Customs and Border Protection to 
enforce given the large number of controlled substances that exist and 
the number of travelers entering and leaving the United States.

Final Rule Expands Current Requirements for Personal Use Importation

    This final rule expands upon, but does not eliminate, the 
requirements currently in effect as a result of Congress' 1998 
amendment to 21 U.S.C. 956.
    Under the current regulation, 21 CFR 1301.26, any individual may 
enter or depart the United States 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 Bureau of Customs and Border Protection 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; * * *

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.
    This final rule specifies 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 United States traveler seeks 
to import for personal medical use (rather than up to 50 dosage units 
of each of a variety of controlled substances).\5\
---------------------------------------------------------------------------

    \5\ For purposes of this rule, a dosage unit is the basic unit 
used to quantify the amount to be taken in normal usage (i.e., 
tablet, capsule, or teaspoonful (5 ml)).
---------------------------------------------------------------------------

    DEA believes that this approach strikes an appropriate balance 
between the need to prevent diversion of controlled substances for 
illicit purposes and the legitimate medical needs of United States 
residents to lawfully carry controlled substances for a legitimate 
medical purpose during the course of their travel. To reiterate, the 
purpose of the international treaties, Federal law, and this regulation 
is to permit travelers to carry, on their person, small quantities of 
controlled substances, lawfully obtained in a foreign country for 
legitimate medical use, until the traveler is able to obtain the 
medicine in question in the country of destination. As noted above, 
Congress intended when it revised the law in 1998 that DEA would 
implement additional restrictions as warranted to prevent any continued 
misuse of the law for illicit purposes. Restricting to 50 dosage units 
the total number of all controlled substances that may be imported by 
United States residents who legitimately obtained the controlled 
substances abroad fits within this Congressional mandate.
    To promote uniform enforcement, this final rule applies 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).

Total Limit of 50 Dosage Units for a Returning Traveler's Legitimate 
Personal Medical Use

    Many persons appear to be under the mistaken impression that 
Congress' 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). Nor did Congress preclude DEA from imposing more 
restrictive requirements by regulation. 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 
Section 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 Bureau 
of Customs and Border Protection 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

[[Page 55346]]

substances that are either contraindicated or in a combination that is 
commonly used by drug abusers.
    DEA wishes to clarify, however, that the amendment to the 
regulation being finalized here does not apply to controlled substances 
lawfully obtained by a United States resident within the United States 
for a legitimate medical purpose which the United States resident then 
carries with them during the course of their foreign travel--provided 
such traveler otherwise meets all requirements of 21 CFR 1301.26. In 
such a circumstance, because these controlled substances were lawfully 
obtained by a United States resident within the United States, it is 
appropriate not to impose the 50 dosage unit restriction when the 
traveler returns to the United States with the controlled substances in 
their original container. This is consistent with Congress' chief 
concern in enacting the 1998 amendment--to prevent persons from 
obtaining controlled substances abroad for illicit purposes in the 
United States. To ensure that this is clear, DEA is revising paragraph 
(c) of 21 CFR 1301.26 from that which was proposed to note that the 
requirements of this paragraph apply solely to controlled substances 
obtained abroad.

Foreign Travelers

    By its express terms, Congress' 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. Rather, this 
Final Rule 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. These requirements, which have been part of the CSI&EA 
implementing regulations since 1971, have not changed and are 
unaffected by this rulemaking.
    Thus, regardless of the quantity possessed, any individual, 
including a foreign traveler, possessing a Schedule II, III, IV or V 
controlled substance lawfully obtained for the individual's personal 
medical use, or for administration to an animal accompanying the 
individual, may enter the United States with the controlled substance, 
provided that the individual declares their possession of the 
controlled substance to an appropriate official of the Bureau of 
Customs and Border Protection, including the reason for possession 
(i.e., intended for the individual's personal medical use or the 
administration to an animal accompanying the individual). The 
individual must also state 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. Finally, the controlled 
substance must be in the original container in which it was dispensed 
to the individual (21 CFR 1301.26(a) and (b)).

The Combined 50 Dosage Unit Limit and Congress' 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.
    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.

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 where the controlled 
substances were ``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 carry, on their person, 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, while DEA 
has eliminated the original paragraph (c) of 21 CFR 1301.26 which 
stated: ``The importation of the controlled substance for personal 
medical use is authorized or permitted under other Federal laws and 
state law.'' as being redundant, 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. 
As 21 CFR 1307.02 states: ``Nothing in this chapter shall be construed 
as authorizing or permitting any person to do any act which such person 
is not authorized or permitted to do under other Federal laws or 
obligations under international treaties, conventions or protocols, or 
under the law of the State in which he/she desires to do such act * * 
*''.

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy 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 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

[[Page 55347]]

will purchase controlled substances from United States pharmacies 
rather than traveling outside the United States to make such purchases.

Executive Order 12866

    The Deputy 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.

0
For the reasons set out above, 21 CFR Part 1301 is amended as follows:

PART 1301--[AMENDED]

0
1. The authority citation for 21 CFR Part 1301 is revised to read as 
follows:

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


0
2. Section 1301.26 is 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 Bureau of Customs and Border Protection 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 that were obtained abroad for 
personal medical use. (For purposes of this section, a United States 
resident is a person whose residence (i.e., place of general abode--
meaning one's principal, actual dwelling place in fact, without regard 
to intent) is in the United States.) This 50 dosage unit limitation 
does not apply to controlled substances lawfully obtained in the United 
States pursuant to a prescription issued by a DEA registrant.

    Dated: September 1, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 04-20628 Filed 9-13-04; 8:45 am]
BILLING CODE 4410-09-P