505(b)(2) Therapeutics: Practice Considerations
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505(b)(2) Therapeutics: Practice Considerations
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Presented at: Specialty Pharmaceutical Summit 2025 SPS Puerto Rico
Summit Directors:
Jorge J. Garcia, PharmD, MS, MHA, MBA, FACCC, FACHE | Baptist Health South Florida
Bhavesh Shah, RPh, BCOP | Boston Medical Center
505(b)(2) Therapeutics: Practice Considerations
Moderator: Jorge J. Garcia, PharmD, MS, MHA, MBA, FACCC, FACHE| Baptist Health South Florida
Panel: Héctor J. Hernández, PharmD, RPh, MPH, CSP | Special Care Pharmacy Services, Kenny Gonzalez Rivera,PharmD | Alivia Health, Nicole Quiles Alves,PharmD, RPh, MPH | Axium Healthcare de Puerto Rico, Specialty Pharmacy
The panel discussed 505(b)(2) products—new formulations of existing drugs—highlighting challenges in benefit coordination, J code management, and authorization due to evolving reimbursement pathways. They emphasized the role of specialty pharmacies, copay assistance, and accurate benefit investigations in improving patient access andmanaging drug shortages.