Section 503A describes conditions under which a qualifying compounded drug can be exempt from three provisions of the Federal Food, Drug, and Cosmetic Act: premarket drug approval, labeling with adequate directions for use, and current good manufacturing practice requirements
GHK-Cu addresses the collagen rebuilding pathway directly, works without the irritation risk of retinol (which many midlife women can no longer tolerate), and has anti-inflammatory properties that benefit reactive, sensitised skin during hormonal transition
X.McqueenT.HsuT.et al (2005)
And yet there are still no clinical trials that point directly to taking X amount of epitalin several times per week as a way to extend life
By Jaimy Lee The committee recommended the FDA reclassify four peptides, meaning compounding pharmacies can legally produce them