Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket
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- Title
- Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket
- Posted
- Oct 27, 2015
- Comment period
- Oct 27, 2015 – Feb 22, 2050
- FR Doc
- 2015-27271
- 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 | Bulk compounding substances | Individualized patient care | Compounded medication benefits | Patient access to compounded medications | Patient choice and access |
|---|---|---|---|---|---|
state-licensed 503A compounding pharmacy BusinessSupport A state-licensed 503A compounding pharmacy is submitting a nomination for the bulk drug substance TB-500. | · | · | · |
5 organization-typed comments could not be identified.
Explorer
Every mirrored comment — filter by stance, campaign, or issue.
- Jan 20, 2026Kendall McDanielOpposeIndividual
The commenter, likely a veterinary professional or clinic owner, argues that the proposed regulation imposes significant financial and operational burdens on veterinary practices and compounding pharmacies. They contend that the requirements lack a clear congressional mandate and will restrict clinical judgment and access to essential medications for patients.
Read comment → - Oct 29, 2023Anonymous AnonymousOpposeIndividual
A patient is expressing extreme frustration and requesting that the FDA rescind the decision to place certain peptides on the "category 2 list." The commenter argues that this action prevents compounding pharmacies from providing life-changing therapies to patients.
Read comment → - Oct 29, 2023Antoinette MacAulayOpposeIndividual
Antoinette MacAulay and Jamey Sawallisch are private individuals expressing frustration over the FDA's decision to include certain peptides on the Category 2 list. They argue that this action restricts access to life-changing therapies and request that the FDA rescind the list.
Read comment → - Oct 25, 2023Mark BrooksOpposeIndividual
A patient is expressing extreme frustration and requesting that the FDA rescind the decision to place certain peptides on the "category 2 list." The commenter argues that this action prohibits compounding pharmacies from providing life-changing therapies to patients.
Read comment → - Oct 23, 2023Jeremy HagewoodOpposeIndividual
A private patient is expressing extreme frustration and opposition to the FDA's decision to include certain peptides on the "category 2 list." They argue that these peptides are life-changing therapies and request that the FDA rescind the list to allow compounding pharmacies to continue making them available.
Read comment → - Oct 20, 2023adam williamsOpposeIndividual
A patient is expressing extreme frustration and requesting that the FDA rescind the decision to place certain peptides on the "category 2 list." The commenter argues that this action prevents compounding pharmacies from providing life-changing therapies to patients.
Read comment → - Oct 20, 2023Eddie BryantOpposeIndividual
An individual patient is expressing extreme frustration and requesting that the FDA rescind its decision to place certain peptides on the "category 2 list." The commenter argues that this action prevents compounding pharmacies from providing life-changing therapies for conditions like herniated discs.
Read comment → - Oct 19, 2023Marie HixonOpposeIndividual
A patient is expressing extreme frustration and requesting that the FDA rescind the "category 2 list" for certain peptides. They argue that the decision prevents compounding pharmacies from providing life-changing therapies to patients.
Read comment → - Oct 19, 2023Tana MacalusoOpposeIndividualRead comment →
- Oct 19, 2023Comment from Magnolia Health & WellnessOpposeIndividual
A clinic representative (commenting as an individual) opposes the FDA's decision to move specific peptides to Category 2 of the Bulk Drug Evaluation list. They argue that this move restricts access to beneficial medications for their patients and request that the FDA reconsider the decision based on the compounds' safety and health benefits.
Read comment →
