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 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.

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 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.

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.

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.

The National Consumers League supports the FDA's proposed rule to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. They argue that mass compounding of these GLP-1 drugs poses significant safety risks, lacks clinical need, and is being exploited by deceptive marketing practices.

The American Association of Clinical Endocrinology (AACE) supports the FDA's proposal to remove semaglutide, tirzepatide, and liraglutide from the section 503B bulk drug substance list. They argue that the initial shortages have ended and that compounded versions of these medications pose significant safety, quality, and efficacy risks to patients.

The commenter, representing the Washington Obesity Society, supports the FDA's decision to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk list. They argue that compounded versions lack the safety inspections of FDA-approved medications and pose significant health risks to patients.

The commenter, who identifies as a family medicine doctor and a former candidate for township supervisor, supports the FDA's proposal to exclude certain ingredients from the 503B bulk list. They argue that mass compounding of GLP-1s is no longer clinically justified and poses safety risks and opportunities for exploitation of vulnerable patients.