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They are compounded using US-based 503a compounding pharmacies or cGMP certified labs emphasizing purity and compliance with USP standards

We reiterate our discussion summarizing the responses to previous years' RFIs in each of the CY 2023 and CY 2024 final rules (refer to 87 FR 69429 through 69432 and 88 FR 78841 to 78843)