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

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 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.

Ms. Annette Baynes supports the FDA's proposed finding that there is no clinical need to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list. She argues that compounding these GLP-1 drugs from bulk substances poses significant patient safety risks and lacks the safety requirements of FDA-approved medicines.

Ms. Susan Prather supports the FDA's proposed finding that there is no clinical need to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list. She argues that compounded GLP-1 drugs lack the necessary safety safeguards and clinical trial scrutiny required by the standard FDA approval process.

Mr. Michael Sparks supports the FDA's proposed finding that semaglutide, tirzepatide, and liraglutide should not be included on the 503B bulk drug substances list. He argues that compounding these GLP-1 drugs poses significant patient safety risks, including higher rates of adverse events and a lack of clinical trial requirements.

Mr. Curtis Wright supports the FDA's proposed finding that there is no clinical need to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list. He argues that compounded GLP-1 drugs bypass essential safety safeguards and can lead to patient harm and recalls.

Jacqueline King supports the FDA's proposed finding that there is no clinical need to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list. She argues that compounded GLP-1 drugs lack the necessary safety safeguards and clinical trials required by the standard FDA approval process.

Mr. Crystal Sampson supports the FDA's proposed finding that there is no clinical need to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list. He argues that compounding these GLP-1 drugs from bulk substances poses significant patient safety risks and lacks the safety requirements of FDA-approved medicines.

Ms. Belinda craft supports the FDA's proposed finding that there is no clinical need to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list. She argues that compounding these GLP-1 drugs from bulk substances poses significant patient safety risks and lacks the necessary clinical trial requirements of FDA-approved medicines.

Mr. Herbert Poole supports the FDA's proposed finding that there is no clinical need to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list. He argues that compounded GLP-1 drugs bypass essential safety safeguards and can lead to patient harm.