ASPL Developments in Pharmacy Law Seminar: Drug Supply Chain Security Act Changes and Implications for Dispensers

Christopher Smith, Senior Counsel, co-presents "Drug Supply Chain Security Act Changes and Implications for Dispensers" at the American Society of Pharmacy Law (ASPL) Developments in Pharmacy Law Seminar, which runs from November 2 to 5.

The presentation will provide an overview of the enhanced drug distribution requirements under the DSCSA and DSCSA interoperable electronic exchange requirements starting in November 2023. Specifically, the presentation will discuss the transition to a fully interoperable electronic system for transaction data exchange at the drug package level and compliance requirements for dispensers. The presentation will further assess new requirements for drug product verification at the package level and identify changes that dispensers may need to comply with these requirements. Additionally, speakers will explain the actions that dispensers must take to meet new requirements regarding responses to regulatory and trading partner requests for information and tracing documentation in recall situations and suspect or illegitimate product investigations, as well as evaluating the new March 2023 FDA guidance document on suspect and illegitimate product. The presentation will further outline new statutory requirements regarding saleable returns and possible changes in government DSCSA enforcement following implementation of the 2023 changes. Finally, the presentation will list the features your pharmacy needs from a DSCSA solution provider, and list resources from the FDA and trade associations that will help ensure that your pharmacy complies with the DSCSA.

For more information, visit ASPL.org.