Complexities Arise as We Progress Toward the DSCSA Final Implementation Landmark

With the complexities and nuances of the Drug Supply Chain Security Act (DSCSA) approaching the 10-year landmark, many health care professionals working in hospital pharmacy facilities may have questions regarding the transition to full implementation of the DSCSA. However, although the 10-year mark is reached on November 27, 2023, the deadline for implementation was recently extended to November 27, 2024. Currently, the transition from pre– to post–November 27, 2024, comes with notable differences.

Jay Gilbreath, PharmD, MPA, discusses some key changes to FDA requirements post–November 27, 2024, in this issue’s cover story on page 12. Gilbreath explains that the DSCSA, which was established to address supply chain security, helps facilities develop systems to support attention being focused on the possibility of suspect (and potentially illegitimate) products entering the pharmacy through security breaches in the supply chain. Additionally, the DSCSA puts in place requirements that will make it mandatory to be ready to provide necessary information to a regulatory body requesting tracking and tracing information. These issues are key to ensure patient safety and drug quality when providing patients with medications.

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On page 40, authors Jaclyn M. Jaskowiak, PharmD, BCPS, BCSCP; Sam Martinez, PharmD, BCOP, BCPS; Stephanie Truong, PharmD, BCPS; Han Dinh, PharmD, BCPS; and Mitchell Vitale, PharmD, discuss challenges that can occur in USP <797> personnel competency evaluations at a multisite institution. According to the authors, these challenges can be addressed through implementing a training program, such as the program implemented by the authors’ organization at the University of California San Diego Health.

Addressing the financial savings of biosimilars on page 22, author Jim Lichauer, PharmD, BCPS, FASHP, discusses a collaborative exercise that reduced expenditure by approximately $40 million across 16 institutions, or close to $3 million per site on average for the 14 sites that achieved improvements. On page 24, authors Camlyn Masuda, PharmD, BCACP, CDCES; Rosalind Wong, PharmD candidate; and Chase Ibia, PharmD candidate, focus in on insulin biosimilars in particular and address some common patient questions that can arise pertaining to insulin biosimilar classification.

As we approach November 27, 2024, new regulations and updates may arise for health system pharmacies to be aware of to remain compliant. Pharmacy Times Health-System Edition will continue to keep you informed as these occur.