FDA says rules on prescription drug tracking will take effect in December

FDA says rules on prescription drug tracking will take effect in December

[JURIST] The US Food and Drug Administration [official website] said Friday that new rules [press release] requiring wholesalers to be able to track prescription drugs will take effect in December. The rules stem from the Prescription Drug Marketing Act of 1987 [summary], a law aimed at combating drug counterfeiting [FDA backgrounder]. The FDA has so far been unable to fully enforce this law due to a lack of practical means to do so. Certain regulations requiring distributors to document the "pedigree" of drug products [draft compliance policy guide] had been delayed due to a concern about their impact on small wholesalers, but in a report [text] Friday, the FDA said that "it can no longer justify not implementing these regulations." The advent of radio frequency identification tags technology (RFID) [Wikipedia backgrounder] now allows wholesalers to more effectively and efficiently track individual bottles.

According to the World Health Organization [official website], counterfeiting involves between 8 and 10 percent of all drugs sold. FDA acting Commissioner Dr. Andrew C. von Eschenbach [official profile] has said that the use of RFID tags will help to reduce the risk that these counterfeit drugs will enter the US market. The New York Times has more.