Counterfeit and diverted drugs are a growing problem not only in the US drug distribution supply chain but also in similar drug distribution supply chains the world over. These systems are being infiltrated by a growing trend in the illegal trade of pharmaceuticals, the result of activities of unscrupulous drug wholesalers, rogue Internet sites, foreign pharmacies, and organized criminal elements, all of which are motivated by huge profits. Efforts must be taken and new paradigms implemented on many fronts that will ultimately lead to maintaining the integrity of drug products and their packaging, securing the movement and safety of drug products as they travel through the US drug distribution supply chain. In addition, enhancing regulatory oversight and enforcement, increasing penalties for counterfeiters and drug diverters, advocating and pursuing heightened vigilance and awareness of counterfeit and diverted drugs, and increasing international collaboration are avenues that will aid in combating drug diversion and counterfeiting. This article will address several topics pertaining to drug wholesale distribution practices and how avenues for counterfeit and diverted drugs can permeate this process, notably through the secondary or shadow or gray drug market. Discussion will also highlight the emergence of Florida's drug pedigree laws and what were the goals to be obtained through enhanced legislative and enforcement action since 2003, coupled with the current state of these pedigree laws today as a result of action emanating from the 2006 Florida legislature (notably House bills HB371 and HB1540). Trends and developments in these major areas will be reviewed, with some analysis rendered noting strengths and areas of remaining weakness that require additional attention in the ongoing battle to stem the tide of drug diversion and counterfeiting, both nationally and within the state of Florida.
Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review
