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

An individual is requesting the removal of the ban on BPC 157 Beta 4 from the list of bulk drug substances allowed for compounding. They argue that the substance significantly improved their quality of life and mobility by treating chronic knee pain that other treatments failed to resolve.

The commenter expresses deep distrust in the FDA's regulatory decisions and criticizes the agency's handling of COVID-19 vaccines and medications. They argue that the FDA should leave peptides alone and instead focus on fixing other approved medications they believe are harmful.

The commenter, identifying as someone in the industry who uses and prescribes peptides, opposes the proposed action to restrict these substances. They argue that peptides provide life-changing health benefits and symptom relief, and they urge the agency to conduct more research before implementing the ban.

Dr. Darryl Camp, a physician, opposes the FDA's decision to reclassify many peptides as Schedule II substances. He argues that the move lacks evidence of harm and will instead drive patients toward unregulated black markets where they face greater risks.

Haley Smalley, an employee at a doctor's office, opposes the proposal to ban certain peptides. She argues that these peptides have been effective and safe in her clinical experience, providing significant health benefits to patients.