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McHugh K, et al

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

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32 , S93S97 (2008)

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But only 13 million of the previous number were insured by Medicare and 4.7 million were insured by Medicaid, leaving a significant number of people not covered by either form of insurance