Saving Money on Prescription Drugs

Legal Status of Canadian Prescription Drugs

Prescription drugs are among the most highly regulated commodities in our society.

In the United States, prescription drugs are certified as being safe and effective by the Food and Drug Administration (FDA). The FDA undertakes extensive scientific reviews for each new drug. In deciding whether or not to license a new drug, it makes a judgment as to whether its benefits to users outweigh its risks. When it approves a drug, it also approves the language that can be used in describing its risks and benefits. In addition, it monitors the way the drug is manufactured, and it keeps track of unexpected side effects after the drug has come to market.

In Canada, the Health Products and Food Branch of Health Canada protects its citizens in a similar manner. [The Congressional Research Service has prepared a memorandum comparing the two systems.]The FDA and its Canadian counterpart are equally reliable in protecting the health of their respective citizens, but neither agency has any authority outside its borders. The FDA prohibits the importation prescription drugs from other countries [see FDA policy statement].

However, coordination between Canada and the US may improve in the future. In November of 2003, the FDA and Health Canada signed a memorandum of understanding that, among other things, will result in procedures for dealing with cross-border issues. In addition, the US Department of Health and Human Services has the power to certify Canadian drugs as being safe and effective. It is currently considering whether or not it will do so. Toward this end, it recently created a Task Force on Drug Importation, as mandated by the Medicare Prescription Drug, Improvement and Modernization Act of 2003. The Task Force will complete its work by December 2004.

The US Food and Drug Administration (FDA) maintains that (1) Reimporting into the US prescription drugs originally manufactured in the US is a violation of the Food, Drug and Cosmetic Act; and (2) Importing medications made in other countries violates the Food, Drug and Cosmetic Act if the medicine is not approved by the FDA or if it does not meet all FDA approval requirements. To our knowledge, the US government has not stopped individual US residents from buying small amounts of prescription drugs for their own personal use, or that of a family member, and the FDA has made statements to the media that they do not plan to interfere with such small individual purchases. The FDA can choose not to stop shipments that might violate federal law, but this policy is discretionary. You may wish to read the FDA's policy on "personal use."

In isolated cases, the US Customs Service has intercepted prescriptions from Canada in the mail.

Nevertheless, several states and cities in the US have recently taken measures to help their citizens gain access to reliable sources of Canadian prescription drugs. Is it safe? There is no evidence that drugs that are certified as safe by Health Canada are unsafe in the United States. Some have argued that unaffordable drugs are neither safe nor effective. But there are other legal issues to consider.

In California, doctors, pharmacists, and pharmacies are licensed by the state. A similar system exists in each state in the US. The same goes for each province in Canada. A prescription written by your doctor in San Francisco is not a valid prescription in Vancouver. Therefore, if you decide, for example, to have your prescription filled by Granville Pharmacy in Vancouver, it will be reviewed by a pharmacist who is licensed by the province of British Columbia. Then a doctor who is licensed in British Columbia will review and rewrite the prescription. After it is filled by the pharmacist in the British-Columbia-licensed pharmacy, it will be sent to you. Ten to twenty days later, you will receive this prescription. In California, prescription drugs are defined as "dangerous drugs" by the California State Board of Pharmacy, which licenses pharmacies and pharmacists in San Francisco. The chain of custody of prescription drugs is carefully guarded by licensed entities in California. The California State Board of Pharmacy expects prescription drugs to be FDA-approved drugs that are obtained from wholesalers that are licensed in California and sold to pharmacies that are licensed in California. These pharmacies can dispense these drugs only under the supervision of pharmacists that are licensed in California. In all probability, it is quite safe to have your prescription filled in British Columbia, but you could find yourself in uncharted legal territory should a legal dispute arise from any problem.

The San Francisco Department of Public Health has not visited or inspected the pharmacies that are linked from this site, but the States of Minnesota, New Hampshire, and Wisconsin have done so and found them to be safe. The State of Minnesota has published their screening criteria on their website. The State of California, not the City of San Francisco, has regulatory power over the pharmacies used by San Franciscans. The pharmacies on this site are not licensed by the State of California.