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When the FDA places a peptide in a restricted or high-risk category [known as Category 2], it is explicitly signaling that it has identified safety concerns and that enforcement discretion does not apply. But, as Hajduczok notes, just because something is not FDA-approved doesnt mean its illegal to compound, but the restricted peptides should not be compounded

Because all 12 patients scored a 5 on the Global Response Assessment, this therapy was considered successful

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