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And the metabolic endpoint being measured

Per established liability guidance, the worst outcome in a board investigation is a patient who says the physician never even told me this wasnt approved. For long-term prescribing, re-obtain and re-document consent as the evidence base and regulatory status evolve, particularly if FDA acts on the PCAC recommendation and the compounds legal status changes

[NCBI Bookshelf] ncbi.nlm.nih.gov OKane M, Parretti HM, Pinkney J, et al

USP General Chapter 797: Pharmaceutical Compounding Sterile Preparations
