Counterfeit drugs resemble legitimate drugs but may contain only inactive ingredients, incorrect ingredients, improper doses or be otherwise contaminated.
Counterfeiting is now widespread in the US drug market, but the FDA is investigating more cases of such activity, often involving well-organized criminal operations.
The comprehensive report highlights ways to assure that the nation's drug distribution system protects Americans from counterfeit drugs. These measures address 6 critical areas:
- Securing the actual drug product and its packaging.
- Securing the movement of the product as it travels through the US drug distribution chain
- Enhancing regulatory oversight and enforcement
- Increasing penalties for counterfeiters
- Heightening vigilance and awareness of counterfeit drugs
- And increasing international collaboration.
The report has been issued by an FDA task force which met with security experts, federal and state law enforcement officials, technology developers, manufacturers, wholesalers, retailers, consumer groups, and the general public.
The report describes specific steps that can be taken now and in the future to protect consumers from counterfeit drugs and to secure the US drug distribution system.