List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act

The commenter opposes the proposed action, arguing that GLP-1 compounds are necessary for treating chronic illnesses like Lipedema and obesity, especially for those without insurance coverage. They suggest that if compounding pharmacies are restricted, insurance companies must instead provide coverage for these conditions.

The commenter urges the FDA to include semaglutide, tirzepatide, and liraglutide on the 503B approved compounding list. They argue that these medications are necessary for customized dosing, addressing a public health crisis regarding obesity, and ensuring patient access despite pharmaceutical pricing and supply issues.

Kanesha Jones, an MPH candidate at Yale School of Public Health, submits a comment regarding the FDA's proposal to exclude certain drugs from the 503B Bulks List. While she does not dispute the agency's clinical-need findings, she urges the FDA to acknowledge the potential for "access harm" among vulnerable populations and recommends a commitment to monitor these population-level consequences.

A perimenopausal patient living in a rural area supports the inclusion of compounded tirzepatide and GLP-1 receptor agonists on the list of bulk drug substances with clinical need. The commenter argues that these compounded medications are the only viable treatment option for her due to brand-name shortages and a lack of local specialists.

Katherine Williams, a PhD, supports the inclusion of GLP-1 medications on the list of bulk drug substances for which there is a clinical need. She argues that compounded GLP-1 medications are essential for patients facing barriers to FDA-approved products and that the FDA should focus on enforcing safety standards rather than eliminating access to these medications.

The commenter opposes the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. They argue that these medications are essential for treating obesity and type 2 diabetes and that removing compounded alternatives will create a public health crisis for patients who cannot afford brand-name versions.

A cardiovascular clinical nurse specialist supports the action of ensuring patient access to safe medications while distinguishing between legitimate patient-specific compounding and risky mass compounding. The commenter emphasizes that while compounded medications are important for affordability and specific needs, they should not replace FDA-approved products and must be subject to rigorous quality standards.

The commenter supports the inclusion of GLP-1s on the list of bulk drug substances for 503B pharmacies. They argue that 503B pharmacies provide essential access to custom dosing for patients and that removing this option would harm patients and pharmacies.

The commenter, a Director of Clinical Operations at a primary care clinic, opposes the removal of GLP-1 bulk drug substances from the 503B Bulks List. They argue that these medications are essential for treating obesity and related chronic conditions, and that removing them from the list would restrict patient access to affordable compounded alternatives.

Zoey T, a private individual, supports including tirzepatide on the bulk drug substances list for compounding. The commenter argues that compounded formulations allow for personalized dosages and ingredients that meet specific medical needs, especially for patients in rural areas.