Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List

An individual patient who uses compounded peptides for chronic pain and fatigue is requesting that specific peptides (BPC-157, TB500, Semax, KPV, and MOTS-C) be added to the 503A Bulk Drug Substances List. They argue that these substances are safe and effective when prescribed by doctors and should be accessible to patients with various health issues.

The commenter, a patient who has benefited from physician-supervised peptide therapy, opposes the potential restriction of access to compounded peptide therapies. They argue that such restrictions could limit individualized treatment options and potentially drive patients toward unregulated sources.

A patient advocates for the inclusion of BPC-157 and MOTS-c on the 503A Bulk Drug Substances List. They argue that these compounds provide significant clinical benefits and that restricting access through licensed compounding pharmacies could drive patients toward unregulated markets.

An individual patient provides personal testimony regarding the therapeutic benefits of various peptide compounds, including BPC-157 and Semax. They urge the FDA to maintain patient access to these substances through compounding pharmacies while establishing a regulatory pathway for safety and purity.

Mandy DeTienne, a Certified Pharmacy Technician and patient, supports the inclusion of the seven nominated peptides on the Section 503A Bulks List. She argues that compounded medications are essential for providing individualized treatment options that meet specific patient needs when commercial products are unavailable or unsuitable.

A patient who experienced a collapsed lung and subsequent inflammation argues in favor of including BPC-157 and TB-500 on the Section 503A Bulk Drug Substances List. They state that these substances significantly improved their quality of life and recovery during a time-limited protocol and advocate for responsible access through regulated compounding pharmacies.

The commenter, a holistic health coach and consumer of peptides, supports the inclusion of more peptides on the bulk drug substances list for legal use under regulated compounding facilities. They advocate for the expansion of approved substances to ensure safety and purity for consumers.

An individual supporter argues in favor of including peptides on the bulk drug substances list. They contend that allowing physician-guided compounding from accredited pharmacies promotes medical freedom and prevents the continued sale of unsafe gray market products.

An individual patient expresses support for the inclusion of specific peptides (such as tirzepatide, semax, and BPC-157) on the bulk drug substances list to ensure continued accessibility. They argue that these treatments have significantly improved their quality of life and health, and warn that restricted access could drive patients toward unsafe black markets.

The commenter, a patient who has personally benefited from peptide therapy, supports including seven peptides on the 503A Bulk Drug Substances List. They argue that these therapies provide essential, individualized treatment options for patients who lack commercially available alternatives.