Comment from Dentons Bingham Greenebaum LLP, submitting on behalf of a client, who is a state-licensed 503A compounding pharmacy
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Summary: A state-licensed 503A compounding pharmacy is submitting a formal nomination for the inclusion of KPV Acetate and KPV Free Base on the Section 503A Bulk Drug Substances List. The commenter provides extensive preclinical evidence and pharmacological rationale to support the substance's safety, efficacy, and suitability for compounding in treating various inflammatory conditions.
The attached materials are being submitted on behalf of a state-licensed 503A compounding pharmacy. The materials were prepared by a licensed pharmacist in consultation with other licensed medical professionals and are being submitted as a public comment in support of the proposed nomination. The materials are not intended to constitute legal advice and were neither prepared by nor express the opinions of Dentons Bingham Greenebaum LLP.