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
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Stance breakdown
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Comments over time
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Support × commenter type
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Issues raised
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Position map
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Every non-silent position is backed by an excerpt from the comment.
Issues shown
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| 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.
- Nov 7, 2023Anonymous AnonymousOtherIndividualRead comment →
- Oct 21, 2023Anonymous AnonymousOpposeIndividualRead comment →
- Oct 21, 2023Anonymous AnonymousOpposeIndividual
The commenter opposes the FDA's decision to block specific bulk drug substances, arguing that it unfairly penalizes reputable companies while failing to address unregulated entities. They express concern over pharmaceutical industry influence on regulations and suggest the FDA should focus on enforcement against unsafe actors rather than restricting regulated suppliers.
Read comment → - Oct 17, 2023phaedra fegleyOpposeIndividual
The commenter opposes the proposed restrictions on bulk drug substances, arguing that the decision is based on "paid influence" from pharmaceutical companies rather than scientific evidence. They claim that the peptides in question have very few side effects and request that the agency consult with experts in the field before reversing the decision.
Read comment → - Oct 17, 2023Comment from Healthcare family practiceOpposeIndividualRead comment →
- Oct 10, 2023B.J. HoOpposeIndividual
The commenter opposes the proposed action, arguing that it unfairly targets peptides which they claim are safe, natural, and affordable medical treatments. They contend that the FDA lacks clinical evidence of harm for these substances and suggest the move is an attempt to remove products from the market for financial reasons rather than public safety.
Read comment → - Oct 10, 2023Kyle CothernOpposeIndividual
The commenter opposes the potential ban or reclassification of peptides, arguing that they are affordable and improve the quality of life for many patients. They claim the action is driven by "big pharma" lobbying and greed rather than public health concerns.
Read comment → - Oct 9, 2023Anonymous AnonymousOtherIndividualRead comment →
- Feb 23, 2019Comment from AnonymousOpposeIndividualRead comment →
- Feb 23, 2019Comment from Terri WardOpposeIndividual
The commenter opposes the proposed action, arguing that it is a "witch hunt" designed to favor pharmaceutical companies and eliminate competition from compounded medicines. They state that they have personally benefited from compounded drugs and believe removing these substances would be harmful to patients.
Read comment →
