On February 29, 2016, the FDA published a guidance entitled “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act—Compliance Policy.” The guidance is effective immediately (starting on Tuesday, March 1) and states that the Agency will not take action against first responders failing to obtain product tracing information, as required under the Drug Supply Chain Security Act (DSCSA).
The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) was signed into law on November 27, 2013. The DSCSA sets forth critical steps to build an electronic, interoperable system to identify and trace products as they are distributed in the United States. Section 202 of the DSCSA added sections 581 and 582 to the Food, Drug, and Cosmetic (FD&C) Act, introducing various definitions and requirements for the tracing of products through the pharmaceutical distribution supply chain.
Beginning in 2015, under Section 582 certain trading partners were required “to exchange product tracing information when engaging in transactions involving certain prescription drugs.” The “trading partners” include: manufacturers, wholesale distributors, dispensers (pharmacies), and repackagers. Additionally, trading partners must now have methods for identifying suspicious and illegitimate prescription drugs.
In the new guidance published by FDA, the Agency states that it “does not intend to take action against certain trading partners and first responders as described in the guidance.” Specifically, FDA does not intend to take action against a dispenser who transfers ownership of a product directly to a first responder without providing product tracing information to the first responder, provided certain conditions are met; or, against trading partners who conduct business with a first responder that is not “authorized” as a dispenser within the meaning of section 581(2)(D) of the FD&C Act. The compliance policy outlined in the guidance, demonstrates the Agency’s attempt to reduce possible disruptions to the activities of first responders. The guidance will remain in effect until further notice by the FDA.
If you are a trading partner subject to the requirements under Section 582 of the FD&C Act, and would like assistance coming into compliance with these and other applicable regulations, please contact Ann Marie Gaitan, Esq. at 305.443.8900 or via email at [email protected].