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 nomination for the bulk drug substance TB-500. They argue that TB-500 is a promising therapeutic peptide for regenerative medicine and tissue repair, citing various preclinical and clinical studies that demonstrate its safety and efficacy in wound healing, cardiovascular, and neurological contexts.

A state-licensed 503A compounding pharmacy is submitting a comment in support of nominating Semax (free base and acetate) as a bulk drug substance for compounding. The submission provides extensive preclinical and clinical literature to support Semax's neuroprotective, neurotrophic, and analgesic properties, while also detailing its chemical identity and compounding suitability.

A state-licensed 503A compounding pharmacy is submitting a nomination to include BPC-157 as a bulk drug substance for compounding. They argue that BPC-157 is a chemically defined, water-soluble peptide with a favorable safety profile and significant preclinical evidence for various tissue repair and regenerative applications.

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.

A state-licensed 503A compounding pharmacy is submitting a comment in support of the proposed nomination of Epitalon (free base and acetate) as a bulk drug substance. The submission provides extensive scientific literature and physicochemical data to support its safety, efficacy, and suitability for compounding.

Wells Pharmacy Network is clarifying a previous submission regarding its nomination of GHK-Cu as a bulk drug substance. They state that while they withdrew the injectable route of administration, they continue to support and pursue the nomination for non-injectable routes.

A private individual opposes the proposed rule, arguing that it will limit the availability of beneficial compounded medications for patients with limited options. They express concern that the rule adds a bureaucratic barrier to healthcare and is medically irresponsible.

A veterinary student argues that the proposed restrictions on compounding drug combinations would negatively impact high-volume spay and neuter programs and limit access to veterinary care. They specifically request that the anesthetic combination of ketamine, tiletamine-zolazepam, and xylazine be exempt from the proposed framework due to its proven safety, homogeneity, and clinical necessity.