With just days before the deadline, it's time for a recap of the DSCSA provisions that are already in effect, and those that start in November 27. Read on for a quick overview!
At present, all pharmaceutical trading partners must:
These will be enforced by FDA and state regulators, with violations incurring seizure, injunction, criminal fines and penalties, and other measures. Trading partners may also set their own penalties or incentives around compliance; regardless, noncompliance can cause serious damage to a company's reputation.
Soon, the set of requirements known as “Section 582(g)(1)”, “package-level”, or “enhanced security" go into effect.
As of November 27, 2023, all pharmaceutical trading partners must:
As the FDA has noted, these requirements can be satisfied by Electronic Product Code Information Services (EPCIS) files with accurate product identifiers for each package. Exchanging serialized data in EPCIS enables package-level tracing.
It's important to note that the FDA has clarified an often misunderstood statement on the stabilization period.
In August, the administration announced that it “does not intend to take action to enforce” 582(g)(1) until November 27, 2024. However, it then detailed its intentions in a statement, uncharacteristically underlined for emphasis in the original:
"This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements."
The FDA’s stabilization period is not enforcement discretion, meaning that businesses are at risk of regulatory enforcement actions if they aren't complying with current requirements, or if they're stopping or slowing their compliance with 582 (g)(1).
Trading partners are expected to continue using current methods to handle transaction data while they begin to stabilize and make their systems fully interoperable for “accurate, secure, and timely electronic data exchange.”
In short, FDA still expects trading partners to have systems and processes in place to meet their requirements as of November 27, 2023. If you're not there yet, now's the time to ask for help!