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

Audrey Wise, a patient who uses compounded peptides for migraines, supports the action to ensure these substances remain available through legitimate 503A pharmacies. She expresses concern that removing them from the list would force patients toward unregulated markets and requests a focus on domestic manufacturing.

A registered nurse with emergency department experience supports the proposed action, emphasizing the need for strong quality standards and domestic manufacturing. The commenter argues that prioritizing U.S.-sourced APIs and rigorous oversight will improve patient safety and supply chain security.

The commenter is advocating for federal legislation to create a regulated pathway for peptide therapies, emphasizing patient safety, U.S.-based manufacturing, and medical oversight. The comment does not directly address the specific action of nominating bulk drug substances for the Section 503A list.

An individual commenter supports the creation of a safe, regulated pathway for compounded peptides, specifically mentioning BPC-157 and TB-500. They argue that these substances should be available to Americans to preserve the patient-provider relationship and support the domestic economy.

The commenter, a patient who uses peptides, supports the creation of a regulated pathway for compounded peptides. They argue that providing a safe, regulated option will improve patient safety, lower costs, and keep patients out of unregulated markets.