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doi: 10.1016/j.lfs.2019.04.057

Although data has shown that there are fewer CD56dim NK cells in low-risk breast cancer compared to high-risk breast cancer, both CD8 T cells and CD56 bright NK cells were significantly elevated in low-risk samples

Chattopadhyay S, Shubayev VI

Bottom line: even if the FDA eventually recommends that certain peptides can be compounded under Section 503A, many stakeholders could still be blocked by the requirement to source pharmaceutical-grade API from an FDA-registered establishment with a Certificate of Analysis and by FDAs demonstrated willingness to police marketing claims around compounded drugs