Laura M. Nagel
Deputy Assistant Administrator
Office of Diversion Control
Drug Enforcement Administration
House Committee on Energy and Commerce Subcommittee on Oversight and Investigations
June 7, 2001
Note: This document may not reflect changes made in actual delivery.
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 US 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 US 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 US land borders.
The CSA contains a personal medical use exemption to allow international travelers, both US citizens and others, to enter and leave the US 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 destination...In 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 US statutes permit controlled substances to be imported under the personal medical use provision via overnight courier, unaccompanied baggage, parcel service, US or international mail. Nor does the exemption permit one person to enter or depart the US 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 US 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 US 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 US 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 US resident from entering the US 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 US physician. This does not mean that any US 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) - that the importation for personal medical use is authorized or permitted under other Federal laws and state law - must be satisfied regardless whether the person importing is a US 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.