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.

A registered nurse supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503 bulks list. The commenter argues that mass compounding of these GLP-1 medications bypasses safety standards and poses significant risks to patients, especially when sold by online retailers without proper medical oversight.

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.

Amneal Pharmaceuticals LLC supports the FDA's decision not to include GLP-1 receptor agonists on the 503B Bulks List. The company argues that these drugs are widely available, and adding them to the list would pose patient safety risks, undermine the statutory framework for compounding, and discourage investment in domestic manufacturing.

The commenter, a private individual who has successfully used peptides for weight loss, supports the inclusion of these substances on the list. They argue that peptides are a necessary solution to the obesity crisis and advocate for a system that allows for easier access and lower costs for both individuals and doctors.

The National Association of Manufacturers (NAM) supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. They argue that mass-compounding these drugs poses significant patient safety risks, lacks clinical necessity, and undermines the substantial investments made by manufacturers in developing FDA-approved therapies.

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 Health Equity Coalition for Chronic Disease (HECCD) supports the FDA's decision to remove semaglutide, tirzepatide, and liraglutide from the bulk substances list. They argue that removing these substances from the list helps protect vulnerable and marginalized communities from misleading advertisements and safety risks associated with unapproved compounded GLP-1 drugs.