[Federal Register Volume 62, Number 21 (Friday, January 31, 1997)] [Rules and Regulations] [Pages 4644-4646] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-2352] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1311 [DEA Number 146I] RIN 1117-AA38 Exemption From Import and Export Requirements for Personal Medical Use; Interpretation Regarding Effect of State Law and Federal Laws AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Final rule; interpretation of existing regulations. ----------------------------------------------------------------------- SUMMARY: Current DEA regulations provide an exemption from certain provisions of the Controlled Substances Import Export Act (CSIEA) regarding personal use quantities of certain controlled substances. DEA is amending the language of the exemption to incorporate an existing provision that controlled substances for personal use may be imported only to the extent that such importation is authorized or permitted under other Federal laws or state law. Recent occurrences have demonstrated that the exemption is being improperly promoted and used as a means to import controlled substances for abuse purposes in violation of other Federal laws and state law. This action will prevent misinterpretation of the circumstances under which the exemption applies. EFFECTIVE DATE: January 31, 1997. FOR FURTHER INFORMATION CONTACT: G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, D.C. 20537, Telephone (202) 307-7297. SUPPLEMENTARY INFORMATION: The CSIEA provides in 21 U.S.C. 956(a) that the Attorney General may, by regulation, exempt an individual who has a controlled substance for personal medical use from the import/export requirements of 21 U.S.C. 952-955. Pursuant to title 21, Code of Federal Regulations (CFR), 1311.27, individuals may enter or depart the United States with a controlled substance in Schedules II, III, IV, or V, that they have lawfully obtained for personal medical use, provided that the controlled substance is in the original container in which it was dispensed and the appropriate declaration is made to the United States (U.S.) Customs Service. However, the exemption must be read within the context of the existing requirements of 21 CFR 1307.02, which states that nothing in DEA's regulations can be construed as authorizing or permitting any person to do any act that is not authorized or permitted under other Federal or state laws. DEA, the U.S. Customs Service, and independent sources have found that the personal medical use exemption found in 21 CFR 1311.27 is being promoted and exploited as a means to import controlled substances for purposes of trafficking and abuse. Especially troubling is the fact that controlled substances that are not approved for marketing or distribution in the United States are being imported in this manner for trafficking and abuse purposes in amounts that represent a danger to the public health and safety. [[Page 4645]] The Internet and the news media contain numerous references to the personal use exemption found in Section 1311.27 as a means to import drugs from Mexico that are not readily available here in the United States. The Internet messages provide advice on how to use the exemption to obtain drugs and get them through U.S. Customs, including one message that provides specific details on how to act and what to say regarding the personal use exemption when bringing the drugs through U.S. Customs. These messages are incorrect and misleading because they do not acknowledge that the exemption applies only to the extent that the importation is allowed under other Federal laws and state law. DEA is concerned with, and will be addressing in a separate rulemaking action, the misuse of the personal use exemption for the general purpose of importing controlled substances for abuse and trafficking purposes. However, the present concern is the misconception that Section 1311.27 permits the importation of controlled substances regardless of prohibitions that may be found in other Federal or state laws. A case in point involves flunitrazepam, which is manufactured in certain foreign countries under various brand names, including Rohypnol. Rohypnol is not approved under the Federal Food, Drug, and Cosmetic Act (FDCA) for use in the United States and the FDCA prohibits the importation of the drug. Despite this, large amounts of the drug were being imported by individuals under the personal medical use exemption. DEA has received reports from law enforcement authorities in numerous states, including Alabama, Arkansas, Georgia, Louisiana, Tennessee and Indiana, regarding the trafficking in and seizure of flunitrazepam (Rohypnol) that had originally been imported from Mexico. DEA itself has engaged in a significant number of seizures of the product throughout the country. As part of its investigation of these problems, DEA conducted a study of U.S. Customs drug declaration records at one border crossing point in Laredo, Texas. During a three week period in July of 1995, 1679 declarations for prescription drugs were filed. Of these, 796, or 47.4%, included Rohypnol. A total of 101,700 dosage units were reported on 730 of the declarations; the remaining 66 declarations did not specify the number of dosage units. The daily number of dosage units of Rohypnol reported ranged from a low of 1680 to a high of 12,930, with an average of 4843 dosage units reported per day, or, on an annualized basis, 1,767,695 dosage units per year, at this one checkpoint. Taking into consideration the declarations that did not specify the number of dosage units, the annual figure could well exceed 1,900,000 dosage units per year. These figures represent the number of dosage units per year. These figures represent the number of dosage units of Rohypnol reported at just one of the many border crossings between the United States and Mexico. A separate study conducted by another source of the top 15 drugs declared over a randomly selected 84-day period at this border crossing, found that individuals declared a total of 338,760 dosage units of Rohypnol. As noted earlier, flunitrazepam (Rohypnol) is not approved for medical use in the United States. Further, there is no indication that the manufacturer of Rohypnol or any other manufacturer of a product containing flunitrazepam, the medical community, or any public interest groups are actively pursuing or advocating the approval of the drug in this country. There are other drugs available that are widely recognized and used in treating the conditions for which flunitrazepam might be considered. There is increasing evidence of abuse and trafficking of flunitrazepam into the United States. There have been at least 2000 seizures of the drug by law enforcement officials; a growing number of reports in the national media regarding its abuse; reports of its use to facilitate sexual assaults against unsuspecting victims; and increasing inquiries from medical personnel for information regarding the drug, including its properties, actions, and treatments. In light of the exploitation of the personal medical use exemption from the requirements of the CSIE as a means to import unapproved controlled substances for abuse purposes and the incorrect and misleading promotion of the exemption as an easy means to import drugs, DEA is incorporating into 21 CFR 1311.27 the existing language in 21 CFR 1307.02. This change makes clear that the personal use exemption applies only to those importations of controlled substances that are authorized or permitted under other Federal laws or state law. Personal medical use importations of controlled substances that are not authorized or permitted under other Federal laws or state law are not exempt from the requirements of the CSIE. Absent satisfaction of the requirements of the CSIE, such imports are subject to seizure by U.S. authorities. The Deputy Assistant Administrator of the Office of Diversion Control, Drug Enforcement Administration has determined that because this rule addresses existing regulatory requirements and does not impose any new requirements, general notice and comment are unnecessary pursuant to 5 U.S.C. 553(b). This action emphasizes DEA's existing regulatory requirements to ensure that individuals are not misled by the language of the regulation into believing that they may engage in activities that are inconsistent with other Federal laws or state law and to address the incorrect and inappropriate promotion and exploitation of the personal medical use exemption as a means to import otherwise unavailable controlled substances for abuse purposes. The Deputy Assistant Administrator for the Office of Diversion Control, Drug Enforcement Administration certifies that this action will have no significant impact upon entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This action reiterates existing regulatory requirements regarding the personal medical use importation of controlled substances. The Office of Management and Budget (OMB) has determined that this is a significant regulatory action, therefore, it has been reviewed by OMB pursuant to the requirements of Executive Order 12866. This action has been analyzed in accordance with the principles and criteria in E.O. 12612, and it has been determined that the proposed rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. List of Subjects in 21 CFR Part 1311 Administrative practice and procedure, Drug traffic control, Exports, Imports. For the reasons set out above, 21 CFR Part 1311 is amended as follows: PART 1311--[AMENDED] 1. The authority citation for part 1311 continues to read as follows: Authority: 21 U.S.C. 952, 956, 957, 958, unless otherwise noted. 2. Section 1311.27 is amended by revising paragraph (b)(2) and adding a new paragraph (c) to read as follows: Sec. 1311.27 Exemptions for personal medical use. * * * * * (b) * * * (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 [[Page 4646]] 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. Dated: January 2, 1997. Gene R. Haislip, Deputy Assistant Administrator, Office of Diversion Control. [FR Doc. 97-2352 Filed 1-30-97; 8:45 am] BILLING CODE 4410-09-M