FDA Addresses Counterfeiting
In October, FDA issued its interim report containing options for a multipronged approach to combat counterfeit drugs.
The report recognized that although drug counterfeiters are more sophisticated and better organized than before, there are many technologies that can help to prevent counterfeit drug threats. These include the use of authentication and track-and-trace technologies. Bar codes and radio-frequency identification, for instance, can be used in the drug product, labeling, or packaging.
According to the report, counterfeit drugs are most likely to be introduced during a drug distribution process involving multiple wholesalers. Many drugs in the distribution system are also repackaged, which "may destroy anti- counterfeiting measures used in the original packaging and labeling of the drug. It may also provide a point of entry for expired, adulterated, or counterfeit drugs into the distribution system because they may be repackaged in a way that makes them appear to be legitimate products." Finally, counterfeit product could be mixed with authentic drugs during repackaging and distributed to the end-user.
The report also concluded that many prescription drugs do not use tamper-evident features, allowing the original packaging to be reused for counterfeit product.
After considering input from various groups and individuals, FDA recommended adopting one or more options concerning the use of technology to deter counterfeiters. These included packaging all dosage form drugs in unit-of-use packaging at the point of manufacture, using tamper-evident packaging with labeling that notes the tamper-evident feature, and incorporating at least two types of anti-counterfeiting technologies into packaging and labeling.
FDA's final report is due in early 2004.