Guidelines for Attendees Travelling with Medications, including a Controlled Substance, to the AIDS 2012 Conference
In order to help make entry into the United States (U.S.) as smooth as possible, AIDS 2012 Conference attendees who are travelling to the U.S. carrying medications, including controlled substances, should comply with the following guidelines:
The U.S. Federal Food, Drug and Cosmetic Act (FD&C Act) defines U.S. Food and Drug Administration (FDA) legal authority over medications. While the FD&C Act generally prohibits the importation of foreign medications into the United States, FDA recognizes there are certain circumstances under which a foreign citizen needs to continue treatment with a foreign-made medication while visiting the U.S. FDA created the Personal Importation Policy (PIP) to address such circumstances and exercise its enforcement discretion to allow importation of medications otherwise in violation of the FD&C Act. FDA considers several factors when deciding to allow the importation of medication under the PIP, including:
- The medication is for use for a serious condition for which effective treatment is not available in the U.S.;
- There is no commercialization or promotion of the medication to U.S. residents;
- The medication is considered not to represent an unreasonable health risk to the patient;
- The individual importing the medication verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the medication is for the continuation of treatment began in a foreign country; and
- Generally, not more than a 3-month supply of the medication is imported.
More information on the Personal Drug Importation may be found at http://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm.
For additional questions regarding the personal importation of medications, please contact Denise Penn at CDERDrugSupplyChainIntegrity@fda.hhs.gov.
The U.S. Drug Enforcement Administration (DEA) has legal authority over controlled substances, as defined in the Controlled Substances Act, Title 21 U.S.C. (United States Code), and Title 21 CFR (Code of Federal Regulations). Attendees travelling to the U.S., per 21 CFR § 1301.26 must:
- Have their controlled substance in the original container in which it was dispensed to the attendee—not in a pill organizer—with a label attached that lists the trade or chemical name of the substance.* A link to the list of controlled substances can be found here. Attendees should be aware that 21 CFR § 1301.26 applies to controlled substances in schedules II, III, IV, and V. Please refer to the link for information on Schedule I controlled substances.
- Declare their controlled substances to an official of the United States Customs and Border Protection, stating it is for their personal medical use upon arrival in the United States.*
The following recommendations are highly encouraged with respect to controlled substances:
- Attendees should not pack the controlled substance in checked baggage. They should carry the controlled substance on their person or in their handbag.*
- Attendees should not bring more than the amount of controlled substance needed during their travel.
- Attendees should print and carry a copy of regulation 21 CFR§ 1301.26 with them for border entry.
*The FDA highly recommends that this action be taken for every medication imported into the U.S. (whether a controlled substance or not). Additionally, participants should carry evidence, such as a foreign prescription, to show that the medication is for continuation of treatment began in the country where it was purchased.
For additional questions regarding the importation of controlled substances into the U.S., please contact Mr. Mark Via, (202) 307-8294 or Stephen.M.Via@usdoj.gov or contact Mara Nakagawa-Harwood at or call + 1 202 594 6114 (from 18 to 27 July 2012).