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Prescribing an unapproved new drug outside a trial is technically illegal under the FDCA (aside from narrow compassionate-use exceptions)

Not for human or veterinary administration

The prescriber will evaluate the mothers deficiency status, the necessity of injectable therapy, and any potential impact on the breastfed infant

A nearly 25% average weight reduction in less than a year is unprecedented in the published literature

Lyophilised peptide materials are generally protected from unnecessary heat, moisture, and repeated freeze-thaw exposure

That is not a technicality it determines how you may market them, what you must disclose, and what your consent process needs to cover