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

An individual patient requests that the agency continue to allow compounded Tirzepatide through 503b pharmacies. They argue that they require access to specific off-label dosages that are not available through the manufacturer and are not covered by insurance.

A member of the Arizona House of Representatives supports the proposed action to exclude GLP-1 active pharmaceutical ingredients from the 503B bulk list. The commenter argues that this exclusion is necessary to protect patients from the risks of unregulated compounded medications and to ensure the continued use of FDA-approved treatments.

An individual patient who uses compounded semaglutide for weight loss and mental health benefits expresses strong support for keeping these medications on the 503B list. They argue that removing them would result in a loss of access to life-changing treatment and a regression in their health.

The commenter opposes the proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulk Drug Substances List. They argue that restricting 503B outsourcing facilities from compounding these drugs will limit patient access to life-saving treatments for diabetes and heart disease.

An individual who struggles with weight and limited insurance coverage argues that compounded GLP-1 medications are a necessary and affordable alternative to expensive brand-name drugs. They urge the agency to continue allowing the purchase of these compounded medications to improve public health and accessibility.

Nancy Towler, a private individual, 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 versions of these medications are essential for providing affordable access to life-changing obesity treatments for patients who cannot afford brand-name options.

Anna Pawelczyk, a pharmacist and small business owner, supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk drug list. She argues that the mass compounding of these GLP-1 medications lacks the safety regulations and quality standards of FDA-approved manufacturers, posing significant risks to consumers.

Rachel Nickell, a registered nurse, opposes the proposed rule to exclude certain GLP-1 medications from the 503B bulks list. She argues that removing these compounded options will harm patients who lack insurance coverage for branded drugs, have specific clinical needs not met by commercial formulations, and may drive patients toward unregulated and unsafe online sources.

Alla Yusim opposes the proposed rule to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, arguing that it would eliminate a critical treatment pathway for patients who lack insurance coverage or need specific dosages not available in branded versions. The commenter also warns that removing the regulated compounding pathway could drive patients toward unregulated and unsafe online pharmacies.

A healthcare provider expresses concern that removing specific medications from the 503B bulks list will reduce patient access to affordable, medically supervised treatments. They argue that this action could drive patients toward unregulated online sources and jeopardize patient safety and continuity of care.