Track and trace: FDA clarifies transactions with first responders

APhA updates checklist for pharmacies

On February 29, 2016—one day before FDA’s March 1, 2016, Drug Supply Chain Security Act (the track-and-trace law) enforcement deadline—FDA released a guidance document stating that the agency would not take action against trading partners who transfer ownership of a product directly to a first responder without providing product tracing information to the first responder provided that certain conditions are met.

Under the guidance, trading partners, such as pharmacies, transferring ownership of products to first responders must capture and maintain the product tracing information for such transactions for at least 6 years and must provide such product tracing information to the first responder or HHS Secretary, if requested, not less than 2 business days after receiving the request or in such other reasonable time, based on the circumstances of the request. 

The policy is effective until further notice from FDA. As of March 1, pharmacies were required to only accept product if the previous owner provides the “3Ts” (transaction history, transaction information, and a transaction statement) and pharmacies are required to capture and maintain the 3Ts for 6 years from the date of the transaction.

APhA’s Government Affairs team has posted an updated track-and-trace checklist for pharmacies on