Regulation of Medicine
FAQs about Importing Prescription Drugs
August 18, 2016
What Are the Risks and What Do Physicians and Their Patients Need to Know?
Patients hoping to save money on prescription medications may consider importing these drugs from other countries. They should be aware that this is illegal except in limited circumstances. Importing drugs from outside the U.S. can also be risky, even when they appear to come from “safe” Canadian suppliers.
What is the law regarding drug imports? The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, effectiveness, and security of drugs. Foreign companies that produce or prepare drugs to be imported into the U.S. must be registered, and it is the importer’s obligation to show the imported drugs have been approved by the FDA. An unapproved drug includes any foreign-made version of a U.S.-approved drug that has not received FDA approval. The law allows only drug manufacturers, not individuals, to import prescription drugs that were not originally produced in the U.S. into this country. There is an exception for emergency use.
Are there exceptions when patients acquire drugs for personal use? The FDA has developed guidance for FDA personnel titled “Coverage of Personal Importations”1 where it may refrain from taking legal action when drugs are imported illegally in the following circumstances:
- When the intended use is appropriately identified; the use is not for treatment of a serious condition; and the product is not known to represent a significant health risk; and
- When the intended use of the unapproved drug is for a serious condition for which an effective treatment may not be available domestically; the drug is not promoted commercially in the U.S.; the drug does not present an unreasonable risk; and the person seeking to import the drug affirms in writing that the drug is for the patient’s own use (generally no more than a three-month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment which began in a foreign country.
What are the risks of using imported drugs?
- Drugs may not have been manufactured using quality assurance procedures for safety.
- Drugs may not have been stored safely or may be outdated.
- Ingredients, even if legal in foreign countries, may not meet U.S. standards for safety and effectiveness.
- Drugs may have dangerous contaminants, especially those originating from third world countries.
- Some drugs bearing the name of a U.S.-approved product may be counterfeit.
- Labeling may be in a language the patient doesn’t understand and may not accurately reflect precautions or side effects.
Even drugs from supposedly safe Canadian Internet sites may pose a risk. An FDA operation in 2005 found that, of nearly 4,000 imported pharmaceutical parcels examined, 43 percent had been ordered from “Canadian” Internet pharmacies.2 Only 15 percent of the drugs actually originated in Canada. The remaining 85 percent were manufactured in 27 different countries. Recommendations
Patients purchasing medications online should make sure the site requires a prescription and has a pharmacist available for questions. Patients should buy only from licensed pharmacies located in the U.S.
The National Association of Boards of Pharmacy has a program to certify online pharmacies. It lists Internet pharmacies that comply with state licensing and survey requirements, and follow recommended safe practices. It also lists online pharmacy sites that are not recommended. This information is accessible at www.nabp.net/programs/consumer-protection/buying-medicine-online.
1 “Coverage of Personal Importations” Food and Drug Administration, http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179266.htm 2 “FDA Operation Reveals Many Drugs Promoted as ‘Canadian’ Products Really Originate from Other Countries” FDA News Release, December 16, 2005
Created by MagMutual from materials provided by COPIC as part of MagMutual and COPIC’s alliance to improve patient safety and quality of care for all of our PolicyOwners.
The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.