FDA Commissioner Marty Makary stated: "When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need." What this means for 503B facilities: If finalized, this proposal would permanently close the large-scale outsourcing facility compounding pathway for these three medications - regardless of future shortage conditions
This makes topical serums well-suited for cosmetic use and a potentially valuable part of many professional skincare and hair growth products
Issa GC, Mohanty V, Ayoub E, Wang F, Leighton J, Wu X, Bidikian A, Patsilevas T, Alaniz Z, Zarka J, Kanagal-Shamanna R, Futreal A, Daver N, Konopleva M, Navin N, Zhang J, Chen K, Andreeff M
(PubMed) Mazidi M, Kengne AP, Banach M
Dutta S, Sengupta P, Slama P, Roychoudhury S
This occurs as the platelets activate and trigger a temporary surge of inflammation, which is necessary for healing