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Chairman Greenwood,
Ranking Member Deutsch, and other members of the Subcommittee, I would like to
thank you for the opportunity to address this Subcommittee regarding current
federal law and DEA regulations which allow for the importation of controlled
substances under the personal medical use exemption. Mr. Chairman, on behalf of
Administrator Marshall, I would like to thank the Subcommittee for its interest
and support in assisting the Drug Enforcement Administration (DEA) to carry out
our mission of enforcing the Nation's drug laws.
The United States is
a party to two international treaties which control the international trade in
licit narcotic and psychotropic substances: the United Nations Single Convention
on Narcotics (1961) and the United Nations Convention on Psychotropic Substances
(1971). The DEA is designated as the U.S. competent authority for ensuring that
the United States meets its obligations under these treaties. A critical
obligation is DEA's regulation and control of the import and export of licit
narcotic and psychotropic substances.
The U.S. law
pertaining to licit controlled substances is contained in the Controlled
Substances Act of 1970 (CSA). Enforcement of the CSA is the responsibility of
the DEA. The Food and Drug Administration (FDA) also plays a critical role with
regard to controlled substances. As the federal authority for regulating all
controlled and non-controlled prescription drugs from a health and safety
perspective, the FDA 's authority is contained in the Food, Drug and Cosmetic
Act (FDCA). Thus, controlled substances are subject to regulation by both the
FDA and the DEA. Together, the FDCA and the CSA provide a framework to protect
the health and safety of the American public, and collaboratively, DEA and FDA
strive for consistent application of federal laws. Additionally, the United
States Customs Service is responsible for enforcing the import and export
provisions of the CSA at U.S. land borders.
The CSA contains a
personal medical use exemption to allow international travelers, both U.S.
citizens and others, to enter and leave the U.S. with controlled substances for
their legitimate personal medical use. Specifically,
Section 956(a) of
the CSA, entitled "Exemption Authority, Individual Possessing Controlled
Substance," states that the "Attorney General may by regulation exempt from
sections 952(a) and (b), 953, 954 and 955 of this title any individual who has a
controlled substance (except substances in Schedule I) in his possession for his
personal medical use, or for administration to an animal accompanying him, if he
lawfully obtained such substance and he makes a declaration (or gives such other
notification) as the Attorney General may by regulation require."
This exemption is
consistent with the 1971 Convention on Psychotropic Substances. Article 4 (a) of
the Convention states, with respect to psychotropic substances other than those
in Schedule I, 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 treaty explains the purpose
of this provision: "[This provision] 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 destinationYIn view of the express
provision that each Party (i.e. the countries of transit and destination) is
entitled to satisfy itself that the preparations have been lawfully obtained, it
would be useful to require the traveller to carry a medical prescription or in
cases in which the prescription is withheld by the pharmacist, a duplicate or
satisfactory copy of the prescription showing that the preparations have been
lawfully acquired."
Clearly, the treaty
seeks to provide a means to allow international travelers to carry personal use
quantities of controlled substance medications while visiting foreign countries.
The CSA exemption does the same; however, neither the treaty nor U.S. statutes
permit controlled substances to be imported under the personal medical use
provision via overnight courier, unaccompanied baggage, parcel service, U.S. or
international mail. Nor does the exemption permit one person to enter or depart
the U.S. with controlled substances intended for the personal medical use of
another person.
As set forth in the
DEA regulation on this issue, 21 CFR Section 1301.26, anyone who seeks to import
a controlled substance for personal medical use must satisfy all of the
following requirements:
(a) The controlled
substance is in the original container in which it was dispensed to the
individual; and
(b) The individual
makes a declaration to an appropriate official of the U.S. Customs Service
stating:
1) The controlled
substance is possessed for his/her personal use, or for an animal accompanying
him/her;
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 does not appear on
the label, the name and address of the pharmacy or practitioner who dispensed
the substance and the prescription number, if any; and
(c) The importation
of the controlled substance for personal medical use is authorized or permitted
under other Federal laws and state law.
The "Controlled
Substances Trafficking Prohibition Act" ("the Act") (Pub. L. 105-357), was
introduced in the U.S. House of Representatives on April 1, 1998, to amend the
Personal Medical Use Exemption. It was signed into law by the President on
November 10, 1998. The Act addressed the fact that large quantities of
controlled substances were being brought into the U.S. from Mexico by
individuals misusing the exemption in order to divert pharmaceutical controlled
substances into illicit channels. The bill amended the CSA to prohibit any U.S.
resident from entering the U.S. with more than 50 dosage units of a controlled
substance through a land border crossing with Mexico or Canada unless they
demonstrate that they posses a valid prescription for the substance, issued by a
properly licensed U.S. physician. This does not mean that any U.S.
resident may enter the United States with up to 50 dosage units of a particular
controlled substance "no questions asked." Rather, the resident must
satisfy all the requirements set forth in 21 CFR 1301.26. States may impose
additional requirements as well.
For example, if
there is evidence that the drugs are not for legitimate personal medical use
(e.g., the same person has made repeated attempts over a short time period to
import new packages of controlled substances for claimed personal medical use;
or the person has a variety of different controlled substances under
circumstances that are indicative of diversion), the importation does not comply
either with ' 956(a)(1) nor the DEA regulations and must, therefore, be
disallowed.
Furthermore, the
requirement specified in 21 CFR 1301.26(c) B that the importation for personal
medical use is authorized or permitted under other Federal laws and state law B
must be satisfied regardless whether the person importing is a U.S. resident
with no more than 50 dosage units of a controlled substance. For example, if a
person were seeking to import a particular controlled substance for personal
medical use, and the Food and Drug Administration advised the United States
Customs Service that importation of the drug should be disallowed under the
Food, Drug, and Cosmetic Act, the importation would not comply with 21 CFR
1301.26(c) and would have to be denied.
In the same way,
if a person sought to import a controlled substance for purported personal
medical use when entering the United States in a border state that prohibits
either the importation or possession of the controlled substance, such
importation must be disallowed under 21 CFR 1301.26(c).
Since the passage of
the Act, DEA has received information from the United States Customs Service
that indicates that individuals are circumventing provisions of the Personal
Medical Use Exemption by making repeated trips across the border to obtain
controlled substances. We are currently considering ways of addressing this
problem, such as amending DEA's regulations to provide the clarity and guidance
that the Customs Service needs to develop a clear, concise and enforceable
policy for its inspectors at the Nation' s land borders.
Before concluding, I would like
to thank my colleagues at the Food and Drug Administration, the United States
Customs Service, and the Office of National Drug Control Policy for their
cooperation in addressing this very important issue. Finally, Mr. Chairman, I
thank you and the members of this Subcommittee for the opportunity to comment on
this topic. I look forward to addressing any questions that you may have at the
appropriate time.
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