FDA gives pharmacies grace period to implement 'track and trace'
- In 2013, the Drug Supply Chain Security Act (DCSA) was signed into law in order to establish a national 'trace and track' system for all drugs in order to deter counterfeiting.
- The original deadline for implementation was July 1.
- Pharmacies now have four additional months to comply with federal 'track and trace' requirements, RAPS reports.
While the goals of the DCSA are laudable, and absolutely necessary, the National Community Pharmacists Association (NCPA) has complained that complying with the FDA's law is too labor intensive to be fully accomplished by the original deadline. In order to comply with DCSA, each entity in the supply chain, including manufacturers, wholesalers, repackagers and others, have to keep track of the drug products coming in and out of their possession with a unique serial number. Doing so allows federal regulators to trace the path of the drug if there is a problem.
The FDA has recognized, however, that some pharmacies may need more time to work with their trading partners to ensure that all of the required product tracing information is captured and maintained by dispensers.
Note that although pharmacies now have until November 1 to comply with the DCSA 'track and tracer' regulations, manufacturers, wholesalers and repackagers are still being held to the July 1 deadline.
- Regulatory Affairs Professional Society FDA Gives Pharmacies Another Four Months to Comply With Track and Trace Requirements