Federal Legislation Takes Aim at Prescription Counterfeits, Illegal Internet Drug Distribution

Originally published in the April 2012 NABP Newsletter

In 2011, counterfeit pharmaceuticals made up the largest portion of seized items in the Consumer Safety and Technology category, at 28% when ranked by domestic value, as reported by United States Customs and Border Protection. Through its own research, NABP has identified 3,845 Web sites selling drugs that have not been tested or approved by the US Food and Drug Administration and are illegal to sell in the US. Further, of the 8,789 Web sites reviewed by the NABP Internet Drug Outlet Identification program, 96.21% are operating out of compliance with pharmacy laws and practice standards established in the US to protect public health. In addition, NABP has found that of those 8,456 Not Recommended Web sites, 86% sell prescription medication without requiring a valid prescription.

With documented reports of US victims harmed by counterfeit drugs ordered online, and thousands of packages shipped from overseas direct to consumers, federal lawmakers are considering several pieces of legislation developed to address the issue from various angles. Two bills specifically target the distribution of medications online – one, targeting sites that sell noncontrolled substances without requiring valid prescriptions, and the other targeting sites that peddle counterfeit drugs online. Three other bills currently under consideration by Congress are much broader in scope, aiming to clamp down on all counterfeited and pirated goods entering the US via the Internet. With the fate of these bills still unfolding in Congress, understanding the mechanisms proposed by each and how they may take shape if passed and implemented is of interest to all stakeholders, including boards of pharmacy, concerned about the health and safety of consumers who order medications online and the security of the US prescription drug supply chain.

The full article (PDF) is available on the NABP Web site.