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 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.

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.

The commenter, who appears to be a healthcare professional or student based on mentions of clinical rotations, supports the inclusion of various bulk drug substances for compounding. They specifically advocate for low-dose naltrexone and other substances like L-theanine and NAD to provide patients with alternative treatment options for autoimmune and inflammatory conditions.

XeCare LLC is submitting formal nominations for several bulk drug substances, including Ashwagandha root extract, Eurycoma Longifolia root extract, Fenugreek seed, Saffron, Berberine Hydrochloride, and Menaquinone-4, to be included on the FDA's 503A Bulks List. The company provides specific extraction methods, constituent concentrations, and clinical evidence to support the inclusion of these substances for treating various conditions.

The Alliance for Pharmacy Compounding is requesting that the FDA provide more transparency regarding the process and specific safety risks used to determine which substances were added to Category 2. They argue that this information is necessary to help educate stakeholders and to prevent patients from seeking riskier, non-pharmacy versions of these substances.