Drugs
Importing Prescription Drugs
FDA's Main Concern: Patient Safety
FDA cannot ensure the safety and effectiveness of products that are not FDA-approved and come from unknown sources and foreign locations, or that may not have been manufactured under proper conditions. These unknowns put patient’s health at risk if they cannot be sure of the products identity, purity, and source. For these reasons, FDA recommends only obtaining medicines from legal sources in the U.S.
Resources for Consumers
FDA Operation Reveals Many Drugs Promoted as "Canadian" Products Really Originate From Other Countries Educational Resources: Buying Medicine From Outside the United States Questions and Answers on Importing Beef or Pork Insulin for Personal Use Travelers Alert
Importation of Prescription Medicines/DrugsFDA Finds Consumers Continue to Buy Potentially Risky Drugs Over the Internet FDA Alerts Consumers to Unsafe, Misrepresented Drugs Purchased Over the Internet FDA Public Health Advisory, January 2006: Consumers Filling U.S. Prescriptions Abroad May Get the Wrong Active Ingredient Because of Confusing Drug Names FDA Consumer Safety Alert: Don't buy these drugs over the Internet or from foreign sources - More FDA Information on Counterfeit Drugs and Importing Prescription Drugs
Regulatory Actions
FDA Takes Action Against Company for Illegal Importation of Unapproved, Potentially Unsafe Drugs FDA Test Results of Prescription Drugs from Bogus Canadian Website Show All Products Are Fake and Substandard Recent FDA/U.S. Customs Import Blitz Exams Continue to Reveal Potentially Dangerous Illegally Imported Drug Shipments Rx Depot Agrees in Consent Decree to Cease Importing Unapproved Drugs from Canada FDA Talk Paper: Court Halts Illegal Importation of Prescription Drugs
Regulatory Policy
FDA - HPFB
FDA and Health Canada Agree to Share Information About Therapeutic ProductsStatement on Vermont's Lawsuit on Importing Prescription Drugs from Canada Import Program Overview Overview of FDA's Import Program HHS Task Force on Drug Importation Regulatory Procedures Manual
Letters to State and Local Officials
The following are reprints of official communication that occurred between the FDA and State and Local officials. Also included are reprints of testimony given by FDA. These documents have not been changed from their original form and all of the included links are not functional. Please contact the FDA Web staff at webmail@oc.fda.gov to request additional information.
- 08/14/2008
Hawaii: Governor Linda Lingle - 02/06/2008
Minnesota: Mayor Don Ness - 03/17/2006
Washington Department of Health: Director Steven Saxe - 11/08/2005
Maryland: County Executive Douglas Duncan - 10/14/2005
Oregon: Governor Theodore R. Kulongoski - 07/27/2005
Texas: Attorney General Greg Abbott - 06/17/2005
Texas: Governor Rick Perry - 05/20/2005
Nevada: Governor Kenny Guinn - 01/28/2005
Rhode Island: Attorney General Patrick C. Lynch - 08/20/2004
Washington DC: Mayor Anthony Williams - 08/04/2004
Massachusetts: Mayor Thomas M. Menino - 07/22/2004
Wisconsin: Governor Jim Doyle - 07/01/2004
Rhode Island: Governor Donald L. Carcieri - 04/20/2004
New Hampshire: Pharmacists Association, Rick Potter - 04/05/2004
North Carolina: Caldwell County Manager, Bobby White - 03/31/2004
New Hampshire: Governor Craig Benson - 02/23/2004
Minnesota: Governor Tim Pawlenty - 11/06/2003
Illinois: Special Advocates Ram Kamath and Scott McKibbon - 08/25/2003
California: Deputy Attorney General Gregory Gonot
Testimony
The following are reprints of official communication that occurred between the FDA and State and Local officials. Also included are reprints of testimony given by FDA. These documents have not been changed from their original form and all of the included links are not functional. Please contact the FDA Web staff at webmail@oc.fda.gov to request additional information.
- 03/07/2007
Policy Implications of Importing Drugs in the United States Randall W. Lutter, Ph.D., before the Senate Committee on Commerce, Science, and Transportation, Subcommittee on interstate Commerce, Trade, and Tourism - 04/20/2006
FDA Statement Before the Nevada State Board of Pharmacy FDA submits testimony on issues relating to the Nevada State Board of Pharmacy licensing Canadian pharmacies for importation of prescription medications - 07/22/2004
Importation of Prescription Drugs
John M. Taylor, III, before the Senate Committee on Governmental Affairs, Permanent Subcommittee on Investigations - 07/14/2004
Importation of Prescription Drugs
William K. Hubbard, before the Subcommittees on Health Care and International Trade, Senate Committee on Finance - 04/27/2004
Importation of Pharmaceutical Products - 06/12/2003
Safety of Prescription Drugs From Foreign Sources William K. Hubbard, before the House Committee on Government Reform, Subcommittee on Human Rights and Wellness