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

A state-licensed 503A compounding pharmacy is submitting a comment in support of the proposed nomination of MOTS-c (free base and acetate) as a bulk drug substance. The commenter provides extensive scientific literature and physicochemical data to argue that MOTS-c is a synthetic peptide with potential therapeutic applications in metabolic and age-related diseases that can be safely and reproducibly compounded.

A state-licensed 503A compounding pharmacy is submitting a public comment in support of nominating KPV Acetate and KPV Free Base as bulk drug substances for compounding. The submission provides extensive preclinical evidence regarding the anti-inflammatory, antimicrobial, and wound-healing properties of KPV to support its inclusion on the list.

A state-licensed 503A compounding pharmacy is submitting a comment in support of nominating Emideltide (delta sleep-inducing peptide) for inclusion on the list of bulk drug substances for compounding. The pharmacy provides extensive preclinical and clinical evidence regarding the substance's safety, physicochemical properties, and potential therapeutic uses for sleep disorders and withdrawal syndromes.

The commenter supports the FDA's efforts to standardize the data required for substances on the 503A bulks list but argues for stricter evidentiary requirements, such as requiring at least one peer-reviewed source. They also recommend clarifying definitions for "historical use" versus "evidence of effectiveness," establishing minimum completeness thresholds for submissions, and issuing standardized public summaries of the decision rationales.

A patient who recovered from a severe leg injury using peptides argues that the proposed action will prevent other patients from accessing this treatment. The commenter claims the decision is being made without sufficient information and unfairly favors "big pharma" over viable medical options.

Dr. Raymond D. Adamcik, a practicing physician at the Florida Anti-Aging Centre, opposes the reclassification of peptides. He argues that peptides are safe and effective for medical and therapeutic uses and expresses concern that reclassification without considering existing clinical evidence could limit patient access to these treatments.

An individual patient shares their personal experience of how CJC injections helped manage symptoms of early menopause and restored their ability to perform daily tasks. They are requesting that the agency consider the needs of women who rely on this compounded drug for their quality of life.

An independent wellness provider opposes the proposed action, arguing that it will create a barrier to patient care. They state that peptide therapies have been safe and effective in their practice and that restricting them would be detrimental to patient health.