Imported Prescription Medications

The safest manner for you and your family to receive drugs is through the collaboration between your physician and your pharmacist. Any method that removes that interaction with your prescribing physician and your pharmacist is a safety concern. Their cooperative efforts help you achieve improved outcomes in your prescription drug use.

As the practice becomes more common, purchasing drugs from other countries raises serious issues. In the interest of medical safety, it is important to consider the pertinent information and cautions concerning the importation of prescription medications for personal use.

Purchasing prescription drugs from other countries is illegal. However, the Food and Drug Administration does permit certain restricted allowances for importing prescription drugs for personal use. These allowances and other things to consider when contemplating such a purchase are listed below:

Importation of Medications:

The practice of importing foreign versions of U.S.-approved prescription medications from Canada and other countries is becoming increasingly common as U.S. citizens import these medications to save money. While the FDA does make some allowances for personal use, they are also against the dangers of bypassing the federal regulations enacted for your safety. Before choosing to purchase prescription medications from outside the United States, keep these considerations in mind:

  • When obtaining medications from both inside and outside the U.S., pharmacists are unable to check for dangerous drug interactions.
  • Purchasing medications without visiting a health care provider (such as purchasing via the internet) bypasses an important step in the health care process. Without being seen and evaluated, the patient cannot be assured that this medication is the most appropriate, effective, safe, and convenient treatment for the patient’s affliction.
  • Medications obtained from another country may not have the same labeling requirements as in the United States.
  • These medications may be dispensed from an unlicensed pharmacy; some pharmacies in Canada are selling medications in the U.S. without being licensed in their own provinces.
  • A common myth is that all medications sold from Canada are manufactured in the same plants as medications sold from the U.S. This is not true. Some medications may originate in the same U.S. manufacturing plant, but many originate in Canada and are not subject to United States regulations and standards. And, if any of these Canadian companies sell medications only to U.S. citizens and not to any Canadian citizens, they may be bypassing the Canadian regulations as well.
  • These medications may not have achieved the same standards for safety and efficacy as those regulated in the U.S.
  • These medications may not have been manufactured using the same good manufacturing practices that are regulated in the U.S.
  • There is no assurance that these medications have been stored in proper conditions to avoid degradation or contamination.

FDA Allowances:

If you still choose to import prescription medications from outside the United States, be aware that FDA inspectors are allowed to use “enforcement discretion” to permit the importation of certain unapproved prescription medications for personal use, but that discretion includes these stipulations:

  • The product is for personal use (90 day supply or less).
  • The intended use is for a serious condition for which effective treatment may not be available domestically.
  • There is no known commercialization or promotion to U.S. residents by those involved in the distribution of the product.
  • The product does not represent an unreasonable risk.
  • The individual seeking to import affirms in writing that it is for the patient’s own use and give the name of the U.S. physician caring for them or that the therapy is a continuation of therapy begun by a foreign physician.