[Federal Register Volume 69, Number 124 (Tuesday, June 29, 2004)]
[Notices]
[Pages 38920-38922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14716]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-245N]


Importing Controlled Substances From Canada and Other Foreign 
Countries

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice.

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SUMMARY: On April 27, 2001, the Drug Enforcement Administration (DEA) 
published a notice in the Federal Register (66 FR 21181) to provide 
guidance to prescribers, pharmacists, law enforcement authorities, 
regulatory authorities, and the public concerning the application of 
current laws and regulations as they relate to the use of the Internet 
for dispensing, purchasing, or importing controlled substances. Since 
publication of that notice, DEA has noted increasing numbers of both 
Internet Web sites and ``brick and mortar businesses'' claiming to be 
able to assist individual consumers in purchasing prescription 
medications, including controlled substances, from Canada and other 
foreign countries. This document reiterates current Federal law and DEA 
regulations pertaining to the importation of controlled substances from 
foreign countries. Persons who have controlled substances sent from 
other countries into the United States violate Federal law unless those 
persons are registered with DEA as importers of controlled substances 
and have received from DEA an import permit.

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:

Introduction

    Recently, the Drug Enforcement Administration (DEA) has noted 
increasing public interest in, and use of, both Internet Web sites and 
``brick and mortar businesses'' claiming to be able to assist 
individual citizens in having their prescriptions filled at pharmacies 
in foreign countries and mailed to them in the United States. For 
purposes of this document, DEA uses the term ``brick and mortar 
businesses'' to refer to physical storefront locations of a business 
having direct contact with customers. It has been DEA's experience that 
the vast majority of such prescriptions are for drugs for treatment of 
such conditions as high blood pressure or cholesterol, arthritis pain, 
diabetes, infections, etc., which are not controlled substances; of all 
prescriptions issued each year, approximately 89% are for non-
controlled substances and 11% are for controlled substances. DEA is 
concerned solely with the 11% of controlled substances prescriptions. 
(Controlled substances are those prescription medications which, among 
other factors, have the potential for abuse, which may lead to physical 
or psychological dependency.) The remaining 89% of prescriptions that 
do not involve controlled substances are not the subject of this notice 
or any requirement under the Controlled Substances Act or the 
Controlled Substances Import and Export Act.

Background

    DEA administers the Controlled Substances Act and the Controlled 
Substances Import and Export Act (herein jointly called the CSA) which 
together form the basis for laws governing the manufacture, 
distribution, dispensing, importation and exportation of controlled 
substances. These laws may be found in Title 21, United States Code 
(U.S.C.), Sections 801-971. Regulations implementing these laws are 
found in Title 21, Code of Federal Regulations (CFR), Parts 1300 to 
1316. Together, the CSA and its implementing regulations provide the 
framework for DEA to ensure adequate supplies of controlled substances 
for the legitimate medical, scientific, research, and industrial needs 
of the United States, while preventing the diversion of those 
controlled substances.
    To do this, the CSA creates a ``closed system of drug 
distribution'' which requires DEA to register manufacturers, 
distributors, dispensers, importers, and exporters of controlled 
substances within the legitimate distribution chain, and makes 
transactions outside the legitimate distribution chain illegal.
    The CSA provides that any person who causes controlled substances 
to be brought into the United States by any means--including causing 
items to be sent from other countries to the United States by mail or 
private shipping company--has imported controlled substances into the 
United States and is subject to criminal penalties (21 U.S.C. 951, 952, 
960). Except as authorized by law, no person may import a controlled 
substance into the United States unless such person is registered with 
DEA and has obtained the appropriate permit or authorization from DEA 
to engage in such importation (21 U.S.C. 957). Illegal importation of 
controlled substances into the United States is a felony that may 
result in imprisonment and fines (21 U.S.C. 960).
    On April 27, 2001, DEA published a notice in the Federal Register 
(66 FR 21181) to provide guidance to prescribers, pharmacists, law 
enforcement authorities, regulatory authorities, and the public 
concerning the application of current laws and regulations as they 
relate to the use of the Internet for dispensing, purchasing, or 
importing controlled substances. Since publication of that notice, DEA 
has noted increasing numbers of both Internet web sites and ``brick and 
mortar'' businesses claiming to be able to assist individual consumers 
in purchasing prescription medications, including controlled 
substances, from Canada and other foreign countries. This document 
reiterates current Federal law and DEA regulations pertaining to the 
importation of controlled substances from foreign countries.

Explanation Regarding Controlled Substances

    Medications which can be purchased without a prescription are over 
the counter medications. Drugs which may only be obtained pursuant to a 
practitioner's order are prescription medications. Many drugs and 
medications which have potential for abuse are controlled substances. 
Most drugs requiring a prescription from a physician or other 
practitioner are not controlled substances. The CSA and its 
implementing regulations assign controlled substances to one of five 
``schedules.'' These substances are placed in a schedule based on, 
among other factors, their potential for abuse, which may lead to 
physical or psychological dependency. Schedule I substances have no 
accepted medical use for treatment in the United States and are not 
available by prescription. Schedule II controlled substances have a 
high potential for abuse and a currently accepted medical use in 
treatment in the United States or a currently accepted medical use with 
severe restrictions. The substances in each successive schedule have a 
lower potential for abuse and dependency relative to the higher 
schedules.

[[Page 38921]]

Schedule II, III, IV and V controlled substances may be dispensed by, 
or pursuant to, the lawful order of a practitioner acting in the usual 
course of professional practice for a legitimate medical purpose. 
Practitioners include, but are not limited to, doctors, dentists, 
veterinarians, and, where authorized by an appropriate state authority, 
physician assistants and advance practice nurses. Controlled substances 
include narcotics (pain relievers), stimulants, depressants, 
hallucinogens, and anabolic steroids. A listing of controlled 
substances can be found in 21 CFR Part 1308. Examples of controlled 
substances may also be found at the Diversion Control Program Web site: 
http://www.deadiversion.usdoj.gov. A few examples are shown below.

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             Schedule                 Example of Controlled Substances
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Schedule I........................  Heroin, marijuana,
                                     methylenedioxymethamphetamine
                                     (MDMA; Ecstasy).
Schedule II.......................  Amphetamine, codeine, fentanyl
                                     (Duragesic[reg]), hydromorphone
                                     (Dilaudid[reg]), meperidine
                                     (Demerol[reg]), methadone
                                     (Dolophine[reg]), methylphenidate
                                     (Ritalin[reg], Metadate ER[reg],
                                     Concerta[reg]), morphine, oxycodone
                                     (Percodan[reg], Tylox[reg],
                                     OxyContin[reg]).
Schedule III......................  Anabolic steroids (Anadrol[reg],
                                     Depo-Testosterone[reg],
                                     Dianabol[reg]), phendimetrazine
                                     (Prelu-2[reg]), acetaminophen with
                                     codeine, hydrocodone/acetaminophen
                                     (Lorcet[reg], Vicodin[reg]).
Schedule IV.......................  Alprazolam (Xanax[reg]), diazepam
                                     (Valium[reg]), lorazepam
                                     (Ativan[reg]), phentermine
                                     (Fastin[reg], Ionamin[reg], Adipex-
                                     P[reg]).
Schedule V........................  Some cough preparations that contain
                                     a limited amount of codeine.
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Basic Requirements for Prescribing and Dispensing Controlled Substances

    Only practitioners who are authorized to prescribe controlled 
substances by the state in which they are licensed, are registered with 
DEA, and are acting in the usual course of their professional practice 
for a legitimate medical purpose may prescribe controlled substances. 
Pharmacies filling prescriptions for controlled substances must be 
licensed to dispense controlled substances by the state(s) in which 
they operate and also be registered with DEA. A prescription not issued 
for a legitimate medical purpose and not in the usual course of 
professional practice (or not for legitimate and authorized research) 
is not valid.

Importing Controlled Substances into the United States

    Federal law and DEA regulations prohibit any person or entity from 
importing any controlled substance into the United States unless that 
person or entity is registered with DEA and specifically authorized by 
DEA to import the controlled substances (21 U.S.C. 952 and 957). 
Controlled substances may only be imported into the United States for 
medical and scientific purposes or other legitimate purposes (21 U.S.C. 
952). Controlled substances may only be imported pursuant to a permit 
or declaration, as applicable, obtained from DEA (21 U.S.C. 952, 21 CFR 
1312.11). As with all other registered handlers of controlled 
substances, importers of controlled substances must provide effective 
controls and procedures to guard against the theft and diversion of 
controlled substances (21 CFR 1301.71). Such security includes, 
depending on the schedule of the controlled substance, a vault, safe, 
cage or other secure storage facility (21 CFR 1301.72). The regulations 
specify the construction of each storage facility to adequately secure 
these controlled substances. Such storage facility, regardless of its 
type, must be alarmed, and the alarm system, upon attempted 
unauthorized entry, must transmit a signal directly to a central 
protection company or a local or state police agency which has a legal 
duty to respond, or a 24-hour control station operated by the importer 
(21 CFR 1301.72). As with other registered handlers of controlled 
substances, importers must design and operate a system to disclose 
suspicious orders (21 CFR 1301.74(b)), and must file reports regarding 
the theft or significant loss of controlled substances with DEA (21 CFR 
1301.74(c)). As with other registered handlers of controlled 
substances, importers must maintain records regarding controlled 
substances imported, received, sold, delivered or destroyed (21 CFR 
1304.21, 1304.22(d)). Finally, importers must take a periodic 
inventory, at least biennially, of all controlled substances on hand 
(21 CFR 1304.03, 1304.11(e)(4)).
    Illegal importation of controlled substances is a felony that may 
result in imprisonment and fines (21 U.S.C. 960).

Purchasing Controlled Substances From Foreign Countries

    DEA has become aware of both ``brick and mortar businesses'' and 
Internet sites within the United States which claim that they are able 
to have United States consumers' prescriptions filled in Canada or 
other foreign countries, or are able to facilitate a United States 
consumer's acquisition of prescription medications from pharmacies in 
Canada or other foreign countries. These stores and Internet sites 
accomplish this in a number of ways. Some stores or Internet sites send 
prescriptions issued by United States practitioners to Canadian 
companies which then have Canadian practitioners write equivalent 
prescriptions for Canadian medications. Some companies simply mail the 
United States prescriptions to Canadian pharmacies which fill the 
prescriptions based on the United States prescriptions only.
    Some Internet sites do not require a prescription, but instead 
require the consumer to complete a questionnaire to receive a desired 
medication. These sites claim the questionnaire is evaluated by a 
physician and a prescription is written, if appropriate, based on the 
information provided in the questionnaire. Some foreign Internet sites 
claim they can legally sell controlled substances to consumers within 
the United States. Many of these sites require United States patients 
to waive their right to take legal action if a medication error occurs. 
Still other Internet sites sell listings of foreign Internet pharmacies 
which these sites claim will sell prescription medications without 
prescriptions.
    It is illegal for a United States consumer or business to have 
controlled substances shipped to the United States from a foreign 
country unless the person receiving the controlled substances is 
registered with DEA as an importer or researcher and is in compliance 
with 21 U.S.C. 952 and 957 and 21 CFR Part 1312. Importers must comply 
with recordkeeping and reporting requirements regarding the controlled 
substances they import.
    The acquisition of a controlled substance from a foreign country by 
any person other than a DEA-registered importer or researcher is a 
violation of the Controlled Substances Act. Therefore, United States 
pharmacies which fill prescriptions for controlled substances by 
obtaining those controlled substances from Canada, or any other

[[Page 38922]]

foreign country, are in violation of the Controlled Substances Act, 
regardless of whether the consumer possesses a legitimate prescription 
issued by a United States practitioner in the usual course of their 
professional practice. Likewise, consumers are also in violation of the 
Controlled Substances Act if they have prescriptions for controlled 
substances filled in foreign countries and shipped to the United 
States.

Personal Medical Use Exemption

    The CSA contains a ``personal medical use'' exemption (21 U.S.C. 
956; 21 CFR 1301.26) which makes a limited allowance for travelers 
entering and departing the United States who have a legitimate medical 
need for controlled substances during their journey. Under this 
exemption, United States residents who travel to foreign countries and 
non-United States residents who travel to the United States may carry 
controlled substances on their person for their legitimate personal 
medical use. DEA published a Notice of Proposed Rulemaking in the 
Federal Register on September 11, 2003 addressing the personal medical 
use exemption (68 FR 53529).
    The ``personal medical use'' exemption only applies to individual 
travelers who themselves are entering or departing the United States 
who require controlled substances. 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. As stated previously, 
purchasing controlled substances from a foreign country or from a 
foreign Internet site and having them shipped to a business or 
individual within the United States is not permitted by the ``personal 
medical use'' exemption. Such purchases and shipments are considered 
``imports'' under the Controlled Substances Act even if the substances 
are for personal use. Unless the business or individual within the 
United States receiving the shipment is registered as an importer with 
DEA and is in compliance with the requirements of Federal law and DEA 
regulations, such shipments are illegal and subject to seizure.

Conclusion

    The Controlled Substances Act prohibits persons from importing 
controlled substances into the United States unless those persons are 
registered with DEA to do so. Persons importing controlled substances 
into the United States without being properly registered to do so are 
in violation of the CSA and are subject to prosecution for violation of 
Federal drug laws.

    Dated: May 24, 2004.
William J. Walker,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 04-14716 Filed 6-28-04; 8:45 am]
BILLING CODE 4410-09-P