ACOG continues to receive inquiries regarding the use of IUDs imported from countries outside of the United States.
The importation of prescription drugs from Canada and other countries is one of the FDA's main concerns. The FDA has found that the unregulated importation of prescription drugs from foreign countries, including Canada, poses serious health risks. Importation of medical devices, such as IUDs, is also restricted.
The Federal Food, Drug, and Cosmetic Act (Act) strictly limits the types of drugs that may be sold within and imported into the United States and who may import them. The FDA has indicated that "virtually all prescription drugs imported for personal use into the United States from Canada violate the Act because they are unapproved new drugs, labeled incorrectly, or dispensed without a valid prescription". Furthermore, the FDA has made clear that "importing a drug into the United States that is unapproved and/or does not comply with the labeling requirements and dispensing requirements in the Act is a prohibited act" that may be enjoined or prosecuted. The levonorgestrel IUD is considered by the FDA to be a drug and, as such, is subject to these proscriptions.
Both the College and the FDA continue to recommend approved IUDs as a safe and effective method of contraception. For practical assistance in helping you make these options available to patients, visit the College's Long Acting Reversible Contraception (LARC) page at: www.acog.org/goto/larc.
The following links provide more information from the FDA:
Letter to Healthcare Professionals
FDA General information regarding importing prescription drugs
Please be advised that ACOG can not provide any legal advice to ACOG members. You should consult with your own private attorney for specific advice.