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 FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. They argue that removing these medications from the compounding list will create an access crisis for patients who cannot afford brand-name GLP-1 therapies.

The commenter opposes the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. They argue that removing these medications from the compounding list will create an access crisis for patients who cannot afford brand-name drugs, leading to worse health outcomes and higher long-term costs.

Neley Morales, a healthcare provider, opposes the proposed rule to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. The commenter argues that removing these drugs from the compounding pathway will hurt patients who lack insurance coverage for branded drugs, have specific clinical needs not met by commercial formulations, and may drive them toward unregulated online sources.

The commenter opposes the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulk Drug Substances List, arguing that this will create significant barriers to access and affordability for patients with obesity and diabetes. They contend that the FDA's definition of "clinical need" is too narrow and suggest that the agency should instead implement stricter safety standards for compounding rather than prohibiting the production pathway entirely.

An individual commenter argues that compounded GLP drugs are necessary because brand-name versions are often inaccessible due to high costs and lack of customizable dosing. They urge the agency not to remove these compounded drugs from the list, noting their role in helping patients manage chronic conditions.

An individual patient supports the inclusion of tirzepatide on the list of bulk drug substances for which there is a clinical need. They argue that compounded versions allow for specific dosing increments and schedules that are not available with FDA-approved products, while also being more affordable and better tolerated.

A patient who relies on compounded tirzepatide argues that the medication provides necessary dosing flexibility and affordability that commercial products lack. They urge the FDA to keep tirzepatide on the 503B bulk list to ensure continuity of care and patient access.

The commenter opposes the exclusion of tirzepatide, semaglutide, and liraglutide from the list of bulk substances with a clinical need under section 503B. They argue that 503B pharmacies provide essential, customized medications and flexible dosing that are necessary for patients who lack access to brand-name drugs or insurance coverage.