Legal Information from FPIC, DCMS Vendor of Choice

Importing Medications from Foreign Countries

By Cliff Rapp, LHRM, Vice President Risk Management

Since medications imported from foreign countries are not subject to the Food and Drug Administration (FDA) oversight and monitoring, they may lack the quality controls that ensure drug safety. Physicians are cautioned against participating in patients' endeavors to obtain medications from foreign countries, despite claims of potential monetary savings.

Safety Concerns

The FDA cannot ensure the safety of drugs purchased from foreign sources. Medications may lack quality controls in all aspects - manufacturing, packaging and labeling, handling, dispensing, and monitoring outcome. Imported medications may not even contain the same ingredients as products approved by the FDA. They may be manufactured, packaged, and stored under unsanitary conditions. Drugs may not be labeled properly, may contain harmful ingredients, may not be tamper-resistant or tamper-evident, and may contain different dosing than the FDA-approved counterpart. All of these aspects create the potential for adverse reactions to imported medications and may make it difficult for physicians to safely manage their patient's medication regime.

Potential Problems

• Dangerous drug interactions or side effects due to drug contamination.
• Inadequate treatment due to counterfeit, sub-potent or super-potent products, or inert ingredients.
• Lack of information may make it difficult to monitor the patient's response to medication and/or treat adverse reactions.
• No recourse in the event of adverse reaction - seller is beyond consumer's reach, seller may have required release of liability prior to selling - since not under FDA jurisdiction.

Legal Issues

• Illegal under Food, Drug, & Cosmetic Act to import unapproved, misbranded, adulterated and foreign versions of US approved medications into the US.
• Illegal for anyone, other than drug's manufacturer, to re-import a prescription drug originally manufactured in US.

Risk Management Guidelines

• Obtain and update patient's medication history - determine if patient is taking medications that are imported.
• Encourage patients to use one pharmacist as a means to help prevent drug interactions when combining medications. One pharmacist will maintain a current medication profile listing all medications prescribed from any and all prescribers - increasing detection and prevention of potential problems.
• Inform patients of the risks of obtaining drugs from foreign sources.
• Pursue financial considerations and alternatives when prescribing medications.  Many pharmaceutical companies offer drug assistance programs.

Florida's Response

Florida Board of Medicine: Although there is no specific law or ruling on the matter, the Florida Board of Medicine is opposed to physicians assisting patients to obtain medications from Canada or other foreign sources. The board does not believe that it is the best practice of medicine. 

Florida Medical Association: The FMA Legal Department has issued the following statement regarding prescriptions written by a Florida physician to be filled in Canada:

"Canadian law does not allow a Canadian pharmacist to fill a prescription written by a physician licensed only in the United States. A Canadian physician must issue the prescription (in fact, the Canadian province may require that the physician be licensed in that province.) Some Canadian physicians have been signing off en masse on US issued prescriptions that are being brought into Canada to be filled, but Canadian medical authorities have started investigating the Canadian physicians who are doing this without an adequate examination of the patient. While it is not illegal for a Florida physician to write a prescription that the patient is going to have filled in Canada, Florida physicians should refrain from giving any advice on the matter to their patients."

Florida Statutes: FS 465.0197(2) require that an Internet pharmacy must obtain a permit in order to dispense medications to persons in Florida.

Florida Board of Pharmacy: The Florida Board of Pharmacy's opinion is that any business enterprise in the State of Florida which offers services to the public by which members of the public may be induced to utilize the services of a non-registered, non-Florida resident pharmacy to fill prescriptions are unlawful and will subject the persons and entities involved to criminal and civil penalties. (Florida Administrative Code 456.0156)

Although patients may be desperate to obtain cheaper sources of medications, there are risks associated with imported medications. Physicians should be alert to the potential problems associated with using imported medications and the increased exposure to malpractice claims as a result.

Information in this article does not establish a standard of care, nor is it a substitute for legal advice. The information and suggestions contained here are generalized and may not apply to all practice situations. FPIC recommends you obtain legal advice from a qualified attorney for a more specific application to your practice. This information should be used as a reference guide only.