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Users must be trained in and consistently apply: Proper vial septum disinfection procedures Sterile needle and syringe use Aseptic vial access and withdrawal techniques Appropriate storage and handling Mountainside Medical is not responsible for improper use, storage, handling, or violations of aseptic technique by end users
The FDA's PCAC meeting on July 23, 2026 will evaluate BPC-157 (free base and acetate) for inclusion on the 503A Bulks List
The 28-day window assumes: Refrigerated storage between 2 C and 8 C (36 F 46 F) Aseptic technique when withdrawing from the vial No visible particulate matter, cloudiness, or color change An intact rubber septum that re-seals after each puncture If any of these conditions are not met, discard the vial earlier
Maintenance and discontinuation SURMOUNT-4, continue vs placebo switch after lead-in to about 20.9% loss: stopping regained about +14% over 52 weeks while continuing lost a further -5.5%
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