On December 2, 2013, the Food and Drug Administration (FDA) issued a press release announcing that the Drug Quality and Security Act (DQSA) was signed into law, requiring tracking and tracing systems, licensing, and reporting for pharmaceuticals to be implemented by manufacturers, drug wholesalers, repackagers and dispensers.
 
According to the release, “The development of the system will be phased in with new requirements over a 10-year period. These requirements will include placing unique product identifiers on individual drug packages and providing product and transaction information at each sale with lot level information, in paper or electronic format.”
 
Once fully implemented, the system will:

• Enable verification of the legitimacy of the drug product identifier down to the package level;
• Enhance detection and notification of illegitimate products in the drug supply chain; and
• Facilitate more efficient recalls of drug products.

Key features of the plan include:

• Product Identification- Manufactures are required to add unique product ID  to certain prescriptions
• Product Tracing- Manufacturers, Drug Wholesalers, Repackagers and Dispensers are required to provide tracking steps of the product
• Product Verification- Manufacturers, Drug Wholesalers, Repackagers and Dispensers need to establish systems and processes to verify the product ID
• Detection and Response- Manufacturers, Drug Wholesalers, Repackagers and Dispensers need to quarantine and investigate counterfeit, unapproved, or potentially dangerous drugs
• Notification- Manufacturers, Drug Wholesalers, Repackagers and Dispensers need to notify FDA and stakeholders
• Wholesaler Licensing- FDA will develop new standards for drug wholesalers. Wholesaler Drug distributors need to report licensing status
• Third Party Logistics Providers- Need to obtain federal or state license if providing storage or logistical operations in regards to drugs

 FDA is currently working on a schedule for implementation, as well as guidance documents and pilot programs.
 
The press release can be accessed here