March 23, 2016

FDA Releases Guidance on DSCSA Requirements and First Responders

The Food and Drug Administration (FDA) has released final industry guidance on the agency’s compliance policy regarding certain requirements in the Federal Food, Drug, and Cosmetic Act for trading partners engaged in transactions with first responders. On March 1, 2016, lot-level product tracing (i.e., transaction history, information and statement (TH, TI, TS)) took effect for dispensers (i.e., pharmacies). Through the issuance of this guidance, the FDA has signaled it does not intend to take action against these trading partners or first responders for non-compliance. This action was taken to minimize possible disruptions to the distribution pharmaceuticals at the emergency response level. The new compliance policy is in effect until further notice.

Key Takeaways:

• The FDA does not intend to take action against a dispenser who transfers ownership of product directly to a first responder where the dispenser does not provide the first responder with product tracing information.
• This new compliance policy does not extend to the requirements that manufacturers, wholesale distributors and repackagers provide product tracing information to dispensers.
• This compliance policy does not extend to transactions in which dispensers must provide the subsequent owner with product tracing information, including transaction history.

Other recent posts to FDA website on traceability and licensure:

FDA recently posted documents regarding the preemption aspects of the DSCSA including a summary of a fall meeting with state authorities on pharmaceutical wholesaler and 3PL licensure. The agency was tasked by Congress to develop federal licensure standards for these entities that provide a “floor” and “ceiling” for states.

Congressional intent was clear that states are to follow the federal guidance, and HIDA and HDMA submitted joint recommendations to FDA to inform their regulatory process. FDA is working on drafting the proposed licensure regulation and HIDA will provide detailed analysis and work with members in developing comments.

• A summary of the FDA-State meeting on licensure: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/UCM487249.pdf
• A set of Q&As, primarily on tracing preemption: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm487301.htm