FDA Ends Enforcement Discretion for Dispensers While Providing New First Responder Guidance
As expected, the Food and Drug Administration (FDA) today ended its existing Drug Supply Chain Security Act (DSCSA) enforcement discretion for dispensers. While the law took effect for dispensers in July 2015, the agency had delayed enforcement in order to ensure that all pharmacies and hospitals were ready. As of today, however, every dispenser must be prepared to comply with the law.
In addition, the FDA announced new enforcement discretion for dispensers conducting transactions with first responders (such as fire/rescue and ambulance services). While the FDA guidance now clarifies that dispensers are required to generate the T3 for dispenser-to-first responder transactions, under this new enforcement discretion, the FDA does not intend to enforce DSCSA product tracing (T3) requirements for this dispenser-to-first responder sale because of potential concerns that:
- A dispenser may lack the resources to provide T3 to such a first responder.
- Some first responders may not be “authorized” dispensers under DSCSA definitions.
- Some first responders may lack the capabilities to manage T3 product tracing requirements.
The new enforcement discretion only applies provided that the dispenser generates and stores the T3 for this transaction for the first responder so that it may be made available upon request. While the FDA does not intend to enforce the requirement for the dispenser to send the T3 to the first responder, all other DSCSA requirements still apply.
This announcement is notable because it identifies a DSCSA regulatory requirement that is somewhat at odds with a common industry interpretation. There is a Transaction exemption in DSCSA basically stating that distribution of a product for emergency medical reasons is exempt from the requirements to provide T3 compliance documentation for such sold drug product. A prevailing opinion was advanced, stating that drug products sold to first responders constituted products provided for emergency reasons, and thus, this transaction was exempt. The FDA guidance now seems to confirm that this exemption did not apply to dispenser-to-first-responder transactions, requiring dispensers to generate the T3 for these transactions.
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You can download a copy of the FDA requirements for transactions with first responders.