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Several Substances Get Placed on the Category 2 Bulks List The following substances were added to Category 2 because FDA claimed to identify significant safety risks: AOD 9604 BPC-157 Cathelicidin LL-37 CJC-1295 Dihexa Acetate Emideltide (DSIP) Epitalon GHK-Cu (for injectable routes of administration) Ibutamoren Mesylate Ipamorelin Acetate Kisspeptin-10 KPV Melanotan II Mechano Growth Factor, Pegylated (PEG-MGF) MOTs-C Selank Acetate (TP-7) Semax (heptapeptide) Thymosin Alpha-1 (Ta1) Thymosin Beta-4, Fragment (LKKTETQ) Compounding Industry Group Initial Response In early October, Scott Brunner from the Alliance for Pharmacy Compounding (APC) commented on the updates, particularly noting the addition of certain peptides to Category 2

Yao Q, Lan QH, Jiang X, Du CC, Zhai YY, Shen X, et al

Direct answer: FDA does not treat convenience alone as a clinical need for 503B bulk compounding

Together, these mechanisms highlight the bidirectional interaction between gut and liver and support therapeutic strategies targeting microbiota composition and intestinal barrier integrity in MASLD

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