[Federal Register: June 29, 2004 (Volume 69, Number 124)]
[Notices]
[Page 38920-38922]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jn04-90]
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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