FDA Compliance Policy: Requirements for Transactions with First Responders Under the FD&C Act


As FDA’s Track-and-Trace Requirements go Into Effect, the Agency Issues a New Guidance for Trading Partners Engaged in Transactions with First Responders

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.

Background

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law. Section 202 of the DSCSA added Sections 581 and 582 to the Food, Drug, and Cosmetic (FD&C) Act, “which set forth new 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.” In addition, these trading partners must also have systems in place to support the verification of suspicious and illegitimate products.

The “trading partners” bound by these requirements include:

  • Manufacturers
  • Wholesale distributors
  • Dispensers
  • Repackagers

New Guidance

On Monday, February 29, the FDA published its compliance policy regarding transactions between dispensers and first responders involving product tracing information.

Transactions between dispensers and first responders can be challenging when it comes to exchanging product tracing information, conducting business only with authorized trading partners, and having verification systems in place. FDA is aware and understanding of these difficulties. As such, “FDA does not intend to take action against certain trading partners and first responders as described in the guidance.” The compliance policy outlined in the guidance, which is effective until further notice by the FDA, demonstrates the Agency’s attempt to reduce possible disruptions to the activities of first responders.

FDA’s previous “compliance policy regarding the provisions to provide, capture, and maintain product tracing information” expired on March 1, 2016. Due to the time sensitive nature of the information being presented, the guidance was published without prior public comment, which the Agency stated was unfeasible or inappropriate. Another reason that the guidance was published without public involvement is because it contains “information pertaining to compliance with certain statutory requirements” that were in effect at the time.

Despite the fact that the guidance is effective immediately, it is still subject to comment and the FDA “is particularly interested in comments related to the scope of this guidance.” The Agency has stated that it will consider any comments that it receives, and that the scope of the enforcement policy may be revised as appropriate and necessary.

Are you a “trading partner” subject to the requirements under Section 582 of the FD&C Act? We can help you ensure compliance with these and all other applicable FDA regulations. To learn more about our services and how we can help you, contact us today.