List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
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- Title
- List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Posted
- May 1, 2026
- Comment period
- May 1, 2026 – Jul 31, 2026
- FR Doc
- 2026-08552
- Topics
Overview
What the public is saying — stance, who's commenting, and the issues they raise.
Stance breakdown
Who commented
Breakdown by commenter type.
Comments over time
Weekly arrivals, stacked by stance.
Support × commenter type
How each type splits across stance.
Issues raised
The docket's canonical issues. Select one to browse its comments.
Position map
Who stands where on each issue?
Every non-silent position is backed by an excerpt from the comment.
Issues shown
Uncheck an issue to choose another.
| Organization | Safety of compounded glp-1s | Clinical need for glp-1s | Opposition to 503b inclusion | Opposition to glp-1 exclusion | Affordability of weight loss medication |
|---|---|---|---|---|---|
American Association of Clinical Endocrinology (AACE) Trade associationSupport The American Association of Clinical Endocrinology (AACE) supports the FDA's proposal to remove semaglutide, tirzepatide | · | · | |||
Amneal Pharmaceuticals LLC BusinessSupport Amneal Pharmaceuticals LLC supports the FDA's decision not to include GLP-1 receptor agonists on the 503B Bulks List. | · | · | |||
Arizona Public Health Association AdvocacySupport The Executive Director of the Arizona Public Health Association supports the proposed decision to exclude semaglutide, t | · | · | · | ||
Arizonans for Health Living AdvocacySupport Arizonans for Health Living, a group of medical professionals, supports the proposed decision to exclude semaglutide, ti | · | · | · | ||
Eating Disorders Education Institute (EDEI) AdvocacyOppose Chevese Turner, representing the Eating Disorders Education Institute, argues that three specific GLP-1 drugs (semagluti | · | · | · | · | · |
H.E.A.L.S. of the South AdvocacySupport Pam Lanford of H.E.A.L.S. | · | · | · | · | |
Health Equity Coalition for Chronic Disease AdvocacySupport The Health Equity Coalition for Chronic Disease (HECCD) supports the FDA's decision to remove semaglutide, tirzepatide, | · | · | |||
National Association of Manufacturers (NAM) Trade associationSupport The National Association of Manufacturers (NAM) supports the FDA's proposal to exclude semaglutide, tirzepatide, and lir | · | · | |||
National Consumers League AdvocacySupport The National Consumers League supports the FDA's proposed rule to exclude semaglutide, tirzepatide, and liraglutide from | · | · | · | · | |
Organization for Latino Health Advocacy AdvocacySupport The Organization for Latino Health Advocacy supports the FDA's proposal to exclude Semaglutide, Tirzepatide, and Liraglu | · | · | · | · | |
Pacific Research Institute AdvocacySupport The Pacific Research Institute supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the | · | · | |||
The Texas Conservative Coalition Research Institute AdvocacySupport The Texas Conservative Coalition Research Institute supports the FDA's proposal to exclude semaglutide, tirzepatide, and | · | · | · | ||
We Work For Health AdvocacySupport Dan Leonard, Executive Director of We Work For Health, expresses strong support for the FDA's proposal to exclude semagl | · | · | · |
3 organization-typed comments could not be identified.
Explorer
Every mirrored comment — filter by stance, campaign, or issue.
- Jun 29, 2026Comment from sims jamesSupportIndividual
The commenter supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. They argue that these GLP-1 medications require rigorous regulatory oversight to ensure patient safety, quality, and consistency, particularly for communities facing healthcare inequities.
Read comment → - Jun 29, 2026Comment from Alexis-Castaneda-Noyola AlexisSupportIndividual
The commenter supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. They argue that these GLP-1 medications require rigorous regulatory oversight to ensure patient safety, quality, and consistency, particularly for communities facing healthcare inequities.
Read comment → - Jun 29, 2026Comment from graham mableSupportIndividual
The commenter supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. They argue that these GLP-1 medications require rigorous regulatory oversight to ensure patient safety, quality, and consistency, particularly for communities facing healthcare inequities.
Read comment → - Jun 29, 2026Comment from simpson williamSupportIndividual
The commenter supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. They argue that these GLP-1 medications require rigorous regulatory oversight to ensure patient safety, quality, and consistency, particularly for communities facing healthcare inequities.
Read comment → - Jun 29, 2026Comment from Martinez DianaSupportIndividual
The commenter supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. They argue that these GLP-1 medications require rigorous regulatory oversight to ensure patient safety, quality, and consistency, particularly for communities facing healthcare inequities.
Read comment → - Jun 29, 2026Comment from Cadow NancySupportIndividual
The commenter supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. They argue that these GLP-1 medications require rigorous regulatory oversight to ensure patient safety, quality, and consistency, particularly for communities facing healthcare inequities.
Read comment → - Jun 29, 2026Comment from Fulsom SabraSupportIndividual
The commenter supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. They argue that these GLP-1 medications require rigorous regulatory oversight to ensure patient safety, quality, and consistency, particularly for communities facing healthcare inequities.
Read comment → - Jun 29, 2026Comment from LLanes ChristinaSupportIndividual
The commenter supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. They argue that these GLP-1 medications require rigorous regulatory oversight to ensure patient safety, quality, and consistency, particularly for communities facing healthcare inequities.
Read comment → - Jun 29, 2026Comment from escobedo marieSupportIndividual
The commenter supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. They argue that these GLP-1 medications require rigorous regulatory oversight to ensure patient safety, quality, and consistency, particularly for communities facing healthcare inequities.
Read comment → - Jun 29, 2026Comment from Bailey ElizabethSupportIndividual
The commenter supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. They argue that these GLP-1 medications require rigorous regulatory oversight to ensure patient safety, quality, and consistency, particularly for communities facing healthcare inequities.
Read comment →
