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For peptides like BPC-157 and Semax, none of the first two conditions apply

Specifically, we proposed to modify 425.312(a)(2)(iii) to state in the case of an ACO that has selected preliminary prospective assignment with retrospective reconciliation, the beneficiary notice must be provided by the ACO or ACO participant to each beneficiary who received at least one primary care service during the assignment window or applicable expanded window for assignment (as defined at 425.20) from a physician who is an ACO professional in the ACO and who is a primary care physician as defined at 425.20 or who has one of the primary specialty designations included at 425.402(c), a FQHC or RHC that is part of the ACO, or an ACO professional in the ACO whom the beneficiary designated as responsible for coordinating their overall care at 425.402(e)

If the committee recommends and FDA approves its inclusion on the Category 1 list, licensed compounding pharmacies would finally be able to make it legally for patients under a physician's prescription

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