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 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 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.