With One Day Remaining Before July 1 Compliance Date, FDA Exercises Enforcement Discretion of DSCSA’s Product-Tracing Requirements for Dispensers

June 30, 2015

By Andrew J. Hull* –

Only one day before the product-tracing provisions of the Drug Supply Chain Security Act (“DSCSA”) were set to take effect for dispensers, FDA issued a Guidance Document for immediate implementation that signals FDA’s intention to delay any use of enforcement for failure to comply with the DSCSA’s two major product-tracing requirements for dispensers until November 1, 2015.  These provisions, which take effect on July 1, 2015, require that a dispenser (1) not accept ownership of a product without receiving the necessary product-tracing information (i.e., transaction history, transaction information, and transaction statement), and (2) capture and maintain such information for at least 6 years.  See FDCA § 582(d)(1)(A)(i), (iii).  The Guidance Document comes just over a week after pharmacist associations wrote a letter to FDA asking for an extension of time for compliance with these requirements (see our previous post here).

Noting that many dispensers intend to use an electronic system to capture and maintain product-tracing information, FDA recognized “that some dispensers may need additional time beyond July 1, 2015, to work with trading partners to ensure that the product tracing information required by section 582 [of the FDCA] is captured and maintained by dispensers.”  Guidance Document at 3.  While FDA does not intend to take action against dispensers who fail to receive product-tracing information upon acceptance of ownership or who fail to capture and maintain such information, it does recommend that dispensers “work with the previous owner[s] to receive this information” in order to fulfill their additional obligations under the DSCSA to identify and investigate suspect and illegitimate product.  Id. 

The Guidance Document reminds prescribers, however, that they are not completely off the hook until November 1, including when it comes to their product-tracing responsibilities.  Prescribers must still only engage in transactions with authorized trading partners, and they must ensure proper handling of suspect and illegitimate product.  Additionally, under the product-tracing requirements in section 582(d) of the FDCA, dispensers engaged in transactions with subsequent owners must still pass along the appropriate product-tracing information, effective July 1.  Guidance Document at 3; see FDCA § 582(d)(1)(A)(ii).

* Admitted only in Virginia.  Work supervised by the Firm while D.C. application pending.