According to the U.S. Food and Drug Administration (FDA), illegal pharmacies, black market pharmaceutical rings, and other drug dealers have been arrested for violating the Federal Food, Drug, and Cosmetic Act (FFDCA).  Under the FFDCA, the interstate shipment, including importation, of any prescription drug that does not have the approval of the FDA is illegal.  Drugs sold in the U.S. must have proper labeling and have been manufactured at FDA registered facilities.  Drugs obtained from facilities not approved by the FDA do not have the same guarantee that it was shipped, handled, and stored under conditions meeting the U.S. standards.

However, the FDA realizes that under certain circumstances, importing prescription medications for personal use should be permitted.  Drug importation is okay under the following circumstances:

• if the treatment is for a serious condition and not available in the U.S.;
• the product is not considered a reasonable risk;
• the patient affirms in writing the drug is for personal use and states the U.S. licensed prescribing doctor's contact information;
• the prescription is limited to a three-month supply or less;
• and there is no known commercially available product in the U.S.

The FDA reports potential health risks associated with imported drugs are quality assurance; counterfeit potential; presence of untested substances; risks associated with unsupervised use; labeling and language issues; and lack of information regarding possible side effects.   For more information regarding the safety concerns of imported drugs, you can visit www.fda.gov.

As previously mentioned, some lawmakers are stepping forward once again and offering legislation to help lower the cost of prescription drugs.  In the House, Representative Rahm Emanuel (IL-5) and Representative Jo Ann Emerson (MO-8) introduced H.R. 380, titled the Pharmaceutical Market Access and Drug Safety Act.   Sen. Byron Dorgan (ND) and Sen. Olympia Snowe (ME), introduced a companion bill, S. 242, in the Senate.  If signed into law, this legislation would allow prescription drugs to be imported from FDA-approved and registered Canadian pharmacies.  The facilities would be inspected regularly, and U.S. licensed pharmacists and wholesalers could import FDA-approved medications and pass along savings to customers.

To learn more about this legislation, or to find out if your Member of Congress is a co-sponsor, visit www.tscl.org.

July 2007