Food and Drug Administration has classified BPC-157, GHK-Cu (for injectable routes of administration), and TB-500 (Thymosin 4 fragment) as Category 2 Bulk Drug Substancessubstances with safety concerns that are prohibited from being compounded by licensed pharmacies for human use
Sealed lyophilized vials are stable at room temperature for transit and short-term storage
Mice tolerated doses several times higher than the effective dose with no observable adverse effects
Instead, they are very large and oval-shaped
Relatively little of this impact is scientifically proven, but the potential downsides are minimal and the upsides are significant, so many people find it worth trying
A later congressional investigation described an unusually close collaboration between FDA staff and Biogen during the review.In 2022, an FDA panel rejected the ALS drug Relyvrio for weak data, then reversed course after ALS patients lobbied hard at a second meeting