American Association of Clinical Endocrinology (AACE)
Trade associationSupport
Safety of compounded glp-1s
Clinical need for glp-1s
Affordability of weight loss medication
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
FDA-2018-N-3240-0377Notice
Comments
3,901
Last activity Jun 29, 2026
Deadline
1 day
Closes Jul 31, 2026
Net supportiSupport minus oppose · campaigns included
+86%
+86% excluding campaigns
Document
Details
The document's own metadata, straight from the source system.
- 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
Analysis
Overview
What the public is saying — stance, who's commenting, and the issues they raise.
Include campaigns
Analyzed 3,579 of 3,901 comments
92%· analysis in progress
Stance breakdown
+86%
Net support
Support3,315Oppose247Other17Not yet analyzed322
Aggregates include form-letter campaigns. Excluding them, net support is +86% across organic comments.
Who commented
Breakdown by commenter type.
Individual
3,531
Government
8
Trade association
5
Advocacy
22
Academic
4
Business
5
Other
4
Not yet analyzed
322
Comments over time
Weekly arrivals, stacked by stance.
Posted May 1, 2026Deadline Jul 31, 2026
Apr 27May 11May 25Jun 8Jun 22Jun 29
Support3,315Oppose247Other17
Support × commenter type
How each type splits across stance.
Support
Oppose
Other
Individual
93%
7%
0%
Advocacy
77%
18%
5%
Government
100%
0%
0%
Trade association
100%
0%
0%
Business
60%
40%
0%
Academic
100%
0%
0%
Other
25%
50%
25%
Issues raised
The docket's canonical issues. Select one to browse its comments.
Safety of compounded glp-1s3,014
Opposition to glp-1 exclusion2,664
Patient access and affordability329
Clinical need for glp-1s191
Affordability of weight loss medication178
Opposition to 503b inclusion103
Telehealth safety and monitoring85
503b pharmacy access for glp-1s77
Availability of 503b pharmacies56
Individualized dosing and titration50
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 | · | · | · |
Amneal Pharmaceuticals LLC
BusinessSupport
Safety of compounded glp-1s
Clinical need for glp-1s
Opposition to 503b inclusion
Arizona Public Health Association
AdvocacySupport
Safety of compounded glp-1s
Opposition to glp-1 exclusion
Arizonans for Health Living
AdvocacySupport
Safety of compounded glp-1s
Opposition to glp-1 exclusion
Eating Disorders Education Institute (EDEI)
AdvocacyOppose
H.E.A.L.S. of the South
AdvocacySupport
Safety of compounded glp-1s
Health Equity Coalition for Chronic Disease
AdvocacySupport
Safety of compounded glp-1s
Clinical need for glp-1s
Affordability of weight loss medication
National Association of Manufacturers (NAM)
Trade associationSupport
Safety of compounded glp-1s
Clinical need for glp-1s
Opposition to 503b inclusion
National Consumers League
AdvocacySupport
Clinical need for glp-1s
Organization for Latino Health Advocacy
AdvocacySupport
Safety of compounded glp-1s
Pacific Research Institute
AdvocacySupport
Safety of compounded glp-1s
Clinical need for glp-1s
Opposition to 503b inclusion
The Texas Conservative Coalition Research Institute
AdvocacySupport
Safety of compounded glp-1s
Opposition to glp-1 exclusion
We Work For Health
AdvocacySupport
Opposition to 503b inclusion
Opposition to glp-1 exclusion
3 organization-typed comments could not be identified.
Comments
Explorer
Every mirrored comment — filter by stance, campaign, or issue.
Filter:
- Jun 27, 2026Comment from AnonymousOpposeIndividual
A pharmacy student expresses concern over the safety of compounded medications and advocates for stricter regulations, protocols, and oversight of compounding companies. The commenter specifically warns against the risks of telehealth prescribing, the addition of untested supplements, and the off-label marketing of GLP-1 medications.
Read comment → - Jun 25, 2026Comment from Simons RalphSupportIndividual
Mr. Ralph Simons supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk drug substances list. He argues that the current compounded GLP-1 market poses significant patient safety risks due to inadequate medical evaluations and lack of FDA oversight.
Read comment → - Jun 25, 2026Comment from Proctor JudithSupportIndividual
Judith Proctor supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk drug substances list. She argues that the current compounded GLP-1 market poses significant patient safety risks due to inadequate medical evaluations and lack of FDA oversight.
Read comment → - Jun 25, 2026Comment from McGough ChristopherSupportIndividual
Christopher McGough supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk drug substances list. He argues that the current model for compounded GLP-1 medications poses significant patient safety risks due to inadequate medical evaluations and lack of FDA oversight.
Read comment → - Jun 25, 2026Comment from McCracken AnitaSupportIndividual
Ms. Anita McCracken supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk drug substances list. She argues that the current compounded GLP-1 market poses significant patient safety risks due to inadequate medical evaluations and lack of FDA oversight.
Read comment → - Jun 25, 2026Comment from Roop LoriSupportIndividual
Lori roop supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk drug substances list. The commenter argues that the current compounded GLP-1 market poses significant patient safety risks due to inadequate medical evaluations and lack of FDA oversight.
Read comment → - Jun 25, 2026Comment from Towe HaroldSupportIndividual
Mr. Harold Towe supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk drug substances list. He argues that the current compounded GLP-1 market poses significant patient safety risks due to inadequate medical evaluations and lack of FDA oversight.
Read comment → - Jun 25, 2026Comment from Yrigollen IsabellSupportIndividual
Ms. Isabell Yrigollen supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk drug substances list. She argues that the current compounded GLP-1 market poses significant patient safety risks due to inadequate medical evaluations and lack of FDA oversight.
Read comment → - Jun 25, 2026Comment from Gibson NatalieSupportIndividual
Natalie Gibson supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk drug substances list. She argues that the current compounded GLP-1 market poses significant patient safety risks due to inadequate medical evaluations and lack of FDA oversight.
Read comment → - Jun 25, 2026Comment from Mitchell JulietteSupportIndividual
Juliette Mitchell supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk drug substances list. She argues that the current compounded GLP-1 market poses significant patient safety risks due to inadequate medical evaluations and lack of FDA oversight.
Read comment →