[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