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18 CeroveckiT.BojanicI.BrcicL.RadicB.VukojaI.SeiwerthS.et al (2010)
The Upcoming PCAC Meeting The FDA notice confirms that the PCAC will convene this summer to evaluate whether to recommend the following seven bulk drug substances for inclusion on the 503A bulks list: July 23, 2026: BPC-157 (free base / acetate) KPV (free base / acetate) Thymosin Beta-4, Fragment (LKKTETQ) (TB-500) (free base / acetate) MOTs-C (free base / acetate) July 24, 2026: Emideltide (DSIP) (free base / acetate) Semax (free base / acetate) Epitalon (free base / acetate) All seven substances are of considerable interest to compounding pharmacies, prescribers, and patients
Category 2 is used for substances the agency believes may present safety risks, which means compounding pharmacies could not legally prepare those compounds for patient use
Cong, H
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