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Consumer Focus

Safety Tips On Importing Prescription Medications

Pharmacists are concerned about patients' safety with medications. The collaboration between physicians and pharmacists in initiating drug therapies is the safest manner for you and your family to receive drugs. Any distribution of drugs that removes interaction with your prescribing physician and your pharmacist is a safety concern. The cooperative efforts between your physician and your pharmacist achieve improved outcomes in the use of prescription drugs. As the practice becomes more common, purchasing drugs from other countries raises serious issues. Pertinent information and cautions concerning importing prescription medications for personal use must be considered in the interest of medication safety.

Purchasing prescription drugs from other countries is considered an illegal practice. Following are tips to consider when contemplating such a purchase. In addition, the Food and Drug Administration (FDA) permits restricted allowances for the personal importation of certain unapproved prescription drugs. These allowances are listed below.

Importation of Medications:

Importing medications for personal use from other countries is considered an illegal practice. The FDA does not permit the importation of foreign versions of U.S. approved medications. This practice is becoming more and more common, as U.S. citizens are importing prescription medications from Canada or other countries to save money.

  • When a patient is getting some medicines from the U.S. and others from a pharmacy outside the country, there is no pharmacist checking for drug interactions.
  • If a medication is purchased without a visit to a health care provider (i.e., via the internet), an important step is bypassed. This can be very dangerous because it is necessary to be seen and evaluated for prescription medications to assure that a drug is appropriate, effective, safe and convenient for the patient.
  • The medications may not have the same labeling required on medications in the U.S.
  • There is no assurance that these medications are being dispensed by a licensed pharmacy in Canada; some pharmacies in Canada that are selling medications in the U.S. are not licensed in their own provinces.
  • There is a belief that the medications in Canada are manufactured in the same manufacturing plants as those in the United States. This may or may not be true. And if a Canadian company is only selling medications to the U.S. and not to any Canadian citizens, they would be bypassing all regulations by the Canadian government 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 inspectors are allowed to use "enforcement discretion to permit the importation of certain unapproved prescription medication for personal use," which 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 the name of the U.S. physician caring for them or that the therapy is a continuation of therapy begun by a foreign physician.