This guidance addresses the compliance of dispensers that engage in transactions with first responders and the compliance of first responders with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1) related to the exchange of product tracing information (i.e., transaction information, transaction history, and transaction statements) and verification. This guidance also addresses the compliance of trading partners5 that engage in transactions with first responders with the requirement for conducting business only with authorized trading partners. The requirements related to the exchange of product tracing information took effect on July 1, 2015 for dispensers. Requirements for verification and conducting business only with authorized trading partners went into effect for all trading partners on January 1, 2015.
This guidance describes FDA’s compliance policy regarding certain requirements in section 582 of the FD&C Act for transactions with first responders. Specifically, FDA does not intend to take action against a dispenser who transfers ownership of a product6 directly to a first responder without providing product tracing information to the first responder, as required by sections 582(c)(1)(A)(ii)-(iv) and (d)(1)(A)(ii) of the FD&C Act, provided that the conditions enumerated in Section IV. A of this guidance are met. FDA also does not intend to take action 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. In addition, FDA does not intend to take action against a first responder who: (1) accepts ownership of product without first receiving the product tracing information as required by section 582(d)(1)(A)(i) of the FD&C Act and does not capture and maintain product tracing information as required by section 582(d)(1)(A)(iii) of the FD&C Act; or (2) does not comply with the dispenser requirements for verification of suspect or illegitimate product described in section 582(d)(4) of the FD&C Act. This compliance policy is in effect until further notice by FDA.