Comment from Sherri Norton
Sherri NortonOpposeGovernment
Summary: A Director of Case Management at an acute care hospital argues that excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list could disrupt continuity of care for hospitalized patients facing commercial access barriers. They request that the FDA consider a limited, well-regulated allowance for compounded GLP-1 medications in specific clinical scenarios to prevent prolonged hospital stays and readmissions.
I am submitting this comment as a Director of Case Management in an acute care hospital regarding the FDA’s proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. While I support the FDA’s commitment to safety and quality, I urge consideration of the operational and clinical impact on hospitalized patients, particularly those with obesity-related comorbidities requiring timely initiation or continuation of GLP-1 therapy. In practice, access to FDA-approved products remains inconsistent due to prior authorization delays, cost barriers, and coverage limitations, which directly affect discharge planning, prolong length of stay, and increase risk for avoidable readmissions. Compounded GLP-1 medications have, in limited but meaningful cases, supported continuity of care when commercial options were not immediately accessible. Eliminating this pathway without a narrowly defined exception for patient-specific clinical need may unintentionally disrupt care transitions and negatively impact outcomes. I respectfully request the FDA consider a limited, well-regulated allowance for 503B compounding in clearly defined clinical scenarios to balance patient safety with real-world care delivery challenges.